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UNITED NATIONS PUBLICATION

Copyright @ United Nations, 2005

All rights reserved
 TABLE OF CONTENTS

Introduction …………………………………………………………..……..……..….. 4
Alphabetical Listing of products ……..………………………………..….….…..….... 8
Classified Listing of products ………………………………………………………… 20
List of codes for countries, territories and areas ………………………...…….……… 30

PART I. REGULATORY INFORMATION

Pharmaceuticals (monocomponent products) ………………………..………… 31

Pharmaceuticals (combination and group products) ………………….……......... 284

PART II. COMMERCIAL INFORMATION

Pharmaceuticals (trade names) …………………………………...……………… 319

INDEXES

A. Index by Chemical Abstract Service (CAS) Registry numbers ……….……. 415

B. Index to Pharmaceuticals by scientific and common names, and synonyms…. 432
C. Index to Pharmaceuticals by available trade names ….………………..…....…465

ANNEXES

I. Relevant resolutions of the General Assembly and Economic and

Social Council ……………………………………………………......…… 559
II. Criteria for the inclusion of pharmaceutical and chemical products in
the Consolidated List ……………………………………... ……..…...… 573
III. List of references cited in the regulatory text………..…. ……………….… 574
IV. Questionnaire ……………………………………………………...…….…… 595
 ALPHABETICAL LISTING OF PRODUCTS

Product name Page

Acarbose............................................................................................................................................................ 31
ACE-Inhibitors.................................................................................................................................................... 284
Acetanilide.......................................................................................................................................................... 31, 319
Acetarsol............................................................................................................................................................ 31, 319
Acetylfuratrizine.................................................................................................................................................. 32, 319
Acetylleucine...................................................................................................................................................... 32
Acetylsalicylic acid (paediatric).......................................................................................................................... 32, 319
Acetylsalicylic acid/antacid................................................................................................................................. 285
Acetylsalicylic acid/codeine................................................................................................................................ 285
Acetylsalicylic acid/phenacetin/caffeine (APC).................................................................................................. 285
Acitretin.............................................................................................................................................................. 35, 319
Acridine derivatives............................................................................................................................................ 36, 320
Alatrofloxacin mesilate....................................................................................................................................... 37
Albumin.............................................................................................................................................................. 37
Alclofenac........................................................................................................................................................... 38, 320
Aldesleukin......................................................................................................................................................... 39
Allergen extracts................................................................................................................................................. 39, 320
Allopurinol and benzbromarone......................................................................................................................... 286
Almitrine............................................................................................................................................................. 39
Aloxiprin.............................................................................................................................................................. 40, 320
Alpidem.............................................................................................................................................................. 40
Alprostadil........................................................................................................................................................... 40, 320, 321
Amaranth............................................................................................................................................................ 41
Amfepramone hydrochloride.............................................................................................................................. 42
Amfepramone..................................................................................................................................................... 42, 321
Amfetamine........................................................................................................................................................ 42, 321
Amineptine......................................................................................................................................................... 43
Aminoglutethimide.............................................................................................................................................. 44, 322
Aminophenazone............................................................................................................................................... 44, 322, 323
Aminophylline..................................................................................................................................................... 47, 323
Aminorex............................................................................................................................................................ 47, 323
Amiprilose........................................................................................................................................................... 48
Amitriptyline........................................................................................................................................................ 48, 324
Amobarbital........................................................................................................................................................ 49, 324, 325
Amodiaquine...................................................................................................................................................... 49, 325
Amoxicillin/clavulanic acid.................................................................................................................................. 286
Ampicillin/cloxacillin............................................................................................................................................ 286, 325
Amyl nitrite.......................................................................................................................................................... 50
Anabolic steroids................................................................................................................................................ 50
Anagestone acetate........................................................................................................................................... 50
Analgesics in combination................................................................................................................................. 286
Androgens.......................................................................................................................................................... 51
Anorectic drugs.................................................................................................................................................. 287
Anorectic dugs in combinations......................................................................................................................... 288
Antidiarrhoeal combinations............................................................................................................................... 289
Antihistamine (topical)........................................................................................................................................ 51
Antirheumatic combinations with glucocorticosteroids...................................................................................... 289
Aphrodisiac drugs.............................................................................................................................................. 52

8
 ALPHABETICAL LISTING OF PRODUCTS

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Aprobarbital........................................................................................................................................................ 52, 325
Aristolochia......................................................................................................................................................... 52
Aristolochic acid................................................................................................................................................. 52, 325
Arsenic-based compounds................................................................................................................................ 53
Astemizole.......................................................................................................................................................... 54, 325
Atropine in combination...................................................................................................................................... 290
Azapropazone.................................................................................................................................................... 56, 326
Azaribine............................................................................................................................................................. 56, 326
Azatadine maleate/pseudoephedrine sulfate..................................................................................................... 290, 326
Barbital............................................................................................................................................................... 57, 326
Barbiturates in asthma preparations.................................................................................................................. 290
Barbiturates in combination............................................................................................................................... 291
Beclobrate.......................................................................................................................................................... 57
Bencyclane......................................................................................................................................................... 58, 326
Benorilate........................................................................................................................................................... 58, 327
Benoxaprofen..................................................................................................................................................... 58, 327
Benzarone.......................................................................................................................................................... 59, 327
Benzbromarone and Benziodarone................................................................................................................... 292
Benzbromarone.................................................................................................................................................. 59, 327
Benzoylperoxide................................................................................................................................................. 59, 327
Benzyl alcohol.................................................................................................................................................... 60, 327, 328
Benzylpenicillin sodium (topical preparations)................................................................................................... 61, 328
Berberine............................................................................................................................................................ 62, 328
Beta ethoxylacetanilide...................................................................................................................................... 62
Bicalutamide....................................................................................................................................................... 63
Bismuth salts...................................................................................................................................................... 63
Bismuth subsalicylate......................................................................................................................................... 64
Bithionol.............................................................................................................................................................. 65, 328
Boric acid and borates....................................................................................................................................... 65, 292, 329
Bovine tissue derived medicines....................................................................................................................... 66
Bromfenac.......................................................................................................................................................... 67
Bromisoval.......................................................................................................................................................... 67
Bromocriptine..................................................................................................................................................... 68, 329, 330
Broxyquinoline (see also halogenated hydroxyquinoline derivatives)............................................................... 68, 330
Bucetin............................................................................................................................................................... 69, 330
Bufexamac......................................................................................................................................................... 69, 330
Buformin............................................................................................................................................................. 69, 330, 331
Bumadizone....................................................................................................................................................... 70, 331
Bunamiodyl......................................................................................................................................................... 71, 331
Buprenorphine.................................................................................................................................................... 71, 331
Buspirone hydrochloride.................................................................................................................................... 72
Cadralazine........................................................................................................................................................ 72, 331
Calamus............................................................................................................................................................. 73, 331
Calcium bromidum and chloral hydrate............................................................................................................. 292
Calcium channel blockers.................................................................................................................................. 293
Camelia sinensis................................................................................................................................................ 73, 331
Camphor............................................................................................................................................................. 73, 332
Canrenone.......................................................................................................................................................... 74, 332

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Canthaxanthin.................................................................................................................................................... 74, 332
Cartilage extract................................................................................................................................................. 75
Cathine............................................................................................................................................................... 76, 332
Cefaloridine........................................................................................................................................................ 76
Cefalosporins (topical preparations).................................................................................................................. 76, 332
Cell preparations................................................................................................................................................ 77
Cerivastatin........................................................................................................................................................ 77, 332
Chenodeoxycholic acid...................................................................................................................................... 78, 332, 333
Chloramphenicol in combination........................................................................................................................ 293
Chloramphenicol................................................................................................................................................ 78, 333, 334, 335
Chlormadinone acetate...................................................................................................................................... 79, 335
Chlormadinone acetate/mestranol (in oral contraceptives)............................................................................... 294
Chlormezanone.................................................................................................................................................. 80
Chlornaphazine.................................................................................................................................................. 81, 336
Chloroform.......................................................................................................................................................... 81, 336
Chloroquine........................................................................................................................................................ 83, 336
Chlorphentermine............................................................................................................................................... 84, 336, 337
Cianidanol.......................................................................................................................................................... 84, 337
Cinchophen........................................................................................................................................................ 85, 337
Cinepazide......................................................................................................................................................... 85
Cinnarizine......................................................................................................................................................... 86, 337
Ciprofibrate......................................................................................................................................................... 86
Cisapride............................................................................................................................................................ 86, 337
Clemastine......................................................................................................................................................... 89, 337, 338
Clioquinol (see also halogenated hydroxyquinoline derivatives)....................................................................... 89, 338, 339
Clobenzorex....................................................................................................................................................... 91, 339
Clofenotane........................................................................................................................................................ 91
Clofibrate............................................................................................................................................................ 92, 339, 340
Cloforex.............................................................................................................................................................. 94, 340
Clometacin......................................................................................................................................................... 94
Clomethiazole..................................................................................................................................................... 95, 340
Clopamide, reserpine and dihydroergocristine mesilate.................................................................................... 294
Clozapine............................................................................................................................................................ 95, 341
Cobalt (non-radioactive forms)........................................................................................................................... 96, 341
Codeine.............................................................................................................................................................. 97, 341
Contrast media (ionic and non-ionic)................................................................................................................. 294
Coumarin (synthetic).......................................................................................................................................... 97
Cyclamates in drugs........................................................................................................................................... 98, 341
Cyclandelate....................................................................................................................................................... 98
Cyclopenthiazide................................................................................................................................................ 99
Cycloserine/isoniazid.......................................................................................................................................... 295
Cyproheptadine.................................................................................................................................................. 99, 341, 342
Cyproterone acetate........................................................................................................................................... 100
Dalkon shield...................................................................................................................................................... 100
Danazol.............................................................................................................................................................. 101, 342
Dantron............................................................................................................................................................... 101, 342
Depot medroxyprogesterone acetate (DMPA)................................................................................................... 102, 342
Dequalinium chloride.......................................................................................................................................... 103, 342, 343

10
 ALPHABETICAL LISTING OF PRODUCTS

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Dequalinium....................................................................................................................................................... 103
Desensitizing vaccines....................................................................................................................................... 295
Dexamfetamine.................................................................................................................................................. 104, 343
Dexfenfluramine hydrochloride.......................................................................................................................... 104
Dexfenfluramine................................................................................................................................................. 104, 343
Dextromethorphan.............................................................................................................................................. 105, 343
Dibenzepin hydrochloride................................................................................................................................... 105, 343
Diclofenac sodium.............................................................................................................................................. 105, 343, 344
Dicycloverine(dicyclomine)/doxylamine/pyridoxine)........................................................................................... 296
Dicycloverine...................................................................................................................................................... 106, 344
Dienestrol........................................................................................................................................................... 107, 344, 345
Diethylaminoethoxyhexestrol............................................................................................................................. 107, 345
Diethylstilbestrol................................................................................................................................................. 107, 345
Difemerine.......................................................................................................................................................... 108
Difenoxin............................................................................................................................................................. 109, 345
Difurazone.......................................................................................................................................................... 109, 345
Dihydroergotamine/heparin................................................................................................................................ 296
Dihydrostreptomycin sulfate/streptomycin sulfate............................................................................................. 296
Dihydrostreptomycin........................................................................................................................................... 109, 345, 346
Dihydroxymethylfuratrizine................................................................................................................................. 110, 346
Dilevalol.............................................................................................................................................................. 110
Dimazole............................................................................................................................................................ 111, 346
Dinoprostone...................................................................................................................................................... 111, 346
Dionaea muscipula (extract).............................................................................................................................. 112
Diphenazine....................................................................................................................................................... 112
Diphenoxylate..................................................................................................................................................... 112, 346
Dipotassium clorazepate/acepromazine/aceprometazine................................................................................. 297
Dithiazanine iodide............................................................................................................................................. 113, 346, 347
Domperidone(injectable).................................................................................................................................... 114, 347
Doxepin.............................................................................................................................................................. 114, 347
Doxycycline hyclate(injectable).......................................................................................................................... 115, 347, 348
Dronabinol.......................................................................................................................................................... 116
Droperidol........................................................................................................................................................... 116, 348
Droxicam............................................................................................................................................................ 116
Ebrotidine........................................................................................................................................................... 117
Emetine.............................................................................................................................................................. 117, 348
Encainide............................................................................................................................................................ 117
Ephedra.............................................................................................................................................................. 118, 348
Epinephrine........................................................................................................................................................ 118, 348, 349
Epoetin alfa........................................................................................................................................................ 119
Epoetin beta....................................................................................................................................................... 119
Erythrityl tetranitrate........................................................................................................................................... 119
Erythromycin estolate......................................................................................................................................... 120, 349, 350
Estrogen-progestogen preparations for secondary amenorrhea....................................................................... 297
Estrogens (in oral contraceptives)..................................................................................................................... 298
Estrogens........................................................................................................................................................... 297
Estrogens/testosterone...................................................................................................................................... 298
Etamivan in combination.................................................................................................................................... 298

11
 ALPHABETICAL LISTING OF PRODUCTS

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Etanercept.......................................................................................................................................................... 121, 350
Ethambutol......................................................................................................................................................... 121, 350
Ethanol............................................................................................................................................................... 121, 350, 351
Ethinylestradiol/methyltestosterone................................................................................................................... 299
Ethyl nitrite (spirit)............................................................................................................................................... 122
Ethylene dichloride............................................................................................................................................. 123
Ethylestrenol....................................................................................................................................................... 123, 351
Etidocaine hydrocloride/epinephrine tartrate..................................................................................................... 299
Etomidate........................................................................................................................................................... 124, 351
Etretinate............................................................................................................................................................ 124, 351
Factor IX............................................................................................................................................................. 125, 351
Factor VIII........................................................................................................................................................... 126, 351
Famotidine.......................................................................................................................................................... 126, 351, 352
Fenclofenac........................................................................................................................................................ 126, 352
Fenetylline.......................................................................................................................................................... 127, 352
Fenfluramine...................................................................................................................................................... 127
Fenoterol............................................................................................................................................................ 128, 352
Feprazone.......................................................................................................................................................... 128, 352
Fipexide.............................................................................................................................................................. 129, 352
Flecainide........................................................................................................................................................... 129, 352, 353
Floctafenine........................................................................................................................................................ 131, 353
Flosequinan........................................................................................................................................................ 131
Flunarizine.......................................................................................................................................................... 131
Flunitrazepam..................................................................................................................................................... 132, 353
Fluoxetine........................................................................................................................................................... 133
Fluphenazine and nortriptyline........................................................................................................................... 299
Fluvoxamine....................................................................................................................................................... 133, 353
Furazolidone....................................................................................................................................................... 133, 353, 354
Gallopamil.......................................................................................................................................................... 134, 354
Gamelonic acid.................................................................................................................................................. 135, 354
Gangliosides....................................................................................................................................................... 135, 299
Gemfibrozil......................................................................................................................................................... 135, 354
Gentamicin (topical preparations)...................................................................................................................... 136
Germander......................................................................................................................................................... 136
Ginkgo biloba..................................................................................................................................................... 137, 354
Glafenine............................................................................................................................................................ 137, 354, 355
Glucosamine sulfate........................................................................................................................................... 138, 355
Glutethimide....................................................................................................................................................... 139, 355
Glutoxim............................................................................................................................................................. 139
Grepafloxacin hydrochloride.............................................................................................................................. 139
Griseofulvin........................................................................................................................................................ 140, 355
Guaifenesin/camphor/ether................................................................................................................................ 300
Guanofuracin...................................................................................................................................................... 141
H1-Antihistamines.............................................................................................................................................. 141
Halofantrine........................................................................................................................................................ 142
Halogenated hydroxyquinoline derivatives........................................................................................................ 142, 356
Halogenated salicylanilides................................................................................................................................ 143, 356
Heptabarb........................................................................................................................................................... 144, 356

12
 ALPHABETICAL LISTING OF PRODUCTS

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Herbal dietary supplements............................................................................................................................... 300
Herpes simplex vaccines................................................................................................................................... 144, 356
Hexachlorophene............................................................................................................................................... 145, 356, 357
Hexestrol............................................................................................................................................................ 145, 357
Hexobarbital....................................................................................................................................................... 146, 357, 358
Hormonal pregnancy tests................................................................................................................................. 300
Human dura mater............................................................................................................................................. 146
Hyaluronidase.................................................................................................................................................... 147, 358
Hydrochlorothiazide/potassium.......................................................................................................................... 301
Hydroquinidine................................................................................................................................................... 147
Hydroquinone..................................................................................................................................................... 147, 358
Hydroxyquinolines in combination...................................................................................................................... 301
Hyoscine methonitrate....................................................................................................................................... 148, 358
Ibopamine........................................................................................................................................................... 148
Ibuprofen............................................................................................................................................................ 148, 358, 359, 360
Indalpine............................................................................................................................................................. 149, 360
Indometacin and indometacin farnesil............................................................................................................... 149, 360
Indoprofen.......................................................................................................................................................... 150, 360
Iodinated casein strophanthin (neo-barine)....................................................................................................... 150, 361
Iproniazid............................................................................................................................................................ 151, 361
Iron preparations................................................................................................................................................ 302
Isaxonine phosphate.......................................................................................................................................... 151, 361
Isocarboxazid..................................................................................................................................................... 151, 361
Isoprenaline........................................................................................................................................................ 152, 361, 362
Isotretinoin.......................................................................................................................................................... 152, 362
Isoxicam............................................................................................................................................................. 154, 362
Kaolin and pectin................................................................................................................................................ 302
Kaolin.................................................................................................................................................................. 154, 362
Kava products.................................................................................................................................................... 302
Kebuzone........................................................................................................................................................... 155, 362, 363
Ketamine hydrochloride..................................................................................................................................... 155
Ketoconazole...................................................................................................................................................... 156, 363
Ketorolac............................................................................................................................................................ 156
Laetrile................................................................................................................................................................ 157
Lamivudine......................................................................................................................................................... 157
Lamotrigine......................................................................................................................................................... 158
Latamoxef........................................................................................................................................................... 158, 363
Lead oxide and lead salts.................................................................................................................................. 159, 363
Levacetylmethadol............................................................................................................................................. 159, 363
Levamfetamine................................................................................................................................................... 159, 363
Levamisole hydrochloride.................................................................................................................................. 160, 364
Levarterenol....................................................................................................................................................... 160, 364
Lexipafant........................................................................................................................................................... 161
Lidocaine, salicylic acid and chloral hydrate...................................................................................................... 303
Lindane............................................................................................................................................................... 161, 364
Lipoic acid.......................................................................................................................................................... 162, 364
Lobelia................................................................................................................................................................ 162
Loperamide........................................................................................................................................................ 162, 364

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 ALPHABETICAL LISTING OF PRODUCTS

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Loratadine and pseudoephedrine...................................................................................................................... 303
Loxoprofen sodium............................................................................................................................................. 164
L-Tryptophan...................................................................................................................................................... 164, 364
Lynestrenol......................................................................................................................................................... 166, 365
Mazindol............................................................................................................................................................. 166, 365
Meclozine........................................................................................................................................................... 167, 365, 366
Medifoxamine..................................................................................................................................................... 167
Medroxyprogesterone acetate/ethinylestradiol.................................................................................................. 303
Mefloquine.......................................................................................................................................................... 167
Megestrol acetate............................................................................................................................................... 168, 366
Melatonin............................................................................................................................................................ 169
Mepacrine........................................................................................................................................................... 169
Mephenesin........................................................................................................................................................ 170, 366
Meprobamate..................................................................................................................................................... 170, 367, 368
Meprobamate/diazepines................................................................................................................................... 304
Mepyramine maleate/pamabrom....................................................................................................................... 304
Mercuric derivatives (topical)............................................................................................................................. 304, 368
Mesna................................................................................................................................................................. 170, 368
Metamfetamine................................................................................................................................................... 171, 368, 369
Metamizole sodium, fenpiverinium bromide and pitofenone hcl........................................................................ 305
Metamizole sodium............................................................................................................................................ 171, 369, 370, 371
Metformin............................................................................................................................................................ 175
Methanol............................................................................................................................................................. 175
Methapyrilene..................................................................................................................................................... 175, 371
Methaqualone..................................................................................................................................................... 176, 372
Methiodal sodium............................................................................................................................................... 177, 372, 373
Methylphenidate................................................................................................................................................. 177, 373
Methylrosanilinium chloride................................................................................................................................ 178
Methyprylon........................................................................................................................................................ 178, 373
Metoclopramide (paediatric)............................................................................................................................... 179
Metoclopramide/polidocanol.............................................................................................................................. 305
Metofoline........................................................................................................................................................... 179, 373
Metrodin HP....................................................................................................................................................... 179
Mianserin............................................................................................................................................................ 180, 373
Mibefradil............................................................................................................................................................ 180
Mifepristone........................................................................................................................................................ 181, 373
Miglustat............................................................................................................................................................. 181, 373
Minocycline......................................................................................................................................................... 182, 374
Misoprostol......................................................................................................................................................... 182, 374
Mofebutazone..................................................................................................................................................... 182, 374
Moxisylyte........................................................................................................................................................... 183
Mucopolysaccharide polysulfuric acid ester....................................................................................................... 183
Muzolimine......................................................................................................................................................... 184
Nabilone............................................................................................................................................................. 185, 374
Naftidrofuryl (parenteral formulations)............................................................................................................... 185
Nandrolone decanoate (injectable).................................................................................................................... 186, 374
Nandrolone phenylpropionate (injectable)......................................................................................................... 186, 375
Nebacumab........................................................................................................................................................ 187

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Nefazodone........................................................................................................................................................ 187, 375
Neomycin sulfate................................................................................................................................................ 187, 375, 376, 377
Neomycin sulfate/polymyxin bisulfate/nystatin/acetarsol................................................................................... 305
Nevirapine.......................................................................................................................................................... 188, 377
Nialamide........................................................................................................................................................... 188, 377
Nifedipine........................................................................................................................................................... 189
Nimesulide.......................................................................................................................................................... 189, 377
Nitrates............................................................................................................................................................... 306
Nitrefazole.......................................................................................................................................................... 190, 377, 378
Nitrendipine........................................................................................................................................................ 190
Nitrofural............................................................................................................................................................. 190, 378
Nitrofurantoin...................................................................................................................................................... 191, 378
Nitroxoline........................................................................................................................................................... 191, 379
Nomifensine....................................................................................................................................................... 192, 379
Nonsteroidal anti-inflammatory agents.............................................................................................................. 306
Norethisterone enantate (injectable).................................................................................................................. 192, 379
Noscapine.......................................................................................................................................................... 193, 379, 380
Novobiocin.......................................................................................................................................................... 194, 380
Omeprazole........................................................................................................................................................ 194
Opium in antitussive preparations...................................................................................................................... 195, 380
Oral contraceptives (third generation)................................................................................................................ 306
Oral rehydration salts......................................................................................................................................... 195
Oral sodium phosphate bowel preparations...................................................................................................... 307
Orgotein.............................................................................................................................................................. 195
Oxeladin citrate.................................................................................................................................................. 196
Oxeladin............................................................................................................................................................. 196
Oxyphenbutazone.............................................................................................................................................. 197, 380
Oxyphenisatine acetate...................................................................................................................................... 199, 381
Oxytocin.............................................................................................................................................................. 201, 381, 382
Pancreatic enzymes........................................................................................................................................... 308
Pangamic acid.................................................................................................................................................... 201
Paracetamol....................................................................................................................................................... 201, 382
Paracetamol/methionine.................................................................................................................................... 308
Paromomycin..................................................................................................................................................... 202, 382
Paroxetine.......................................................................................................................................................... 202
Pectin.................................................................................................................................................................. 203, 382
Pemoline............................................................................................................................................................ 203
Penicillin/streptomycin........................................................................................................................................ 308
Penicillin/tetracycline.......................................................................................................................................... 309
Pentazocine........................................................................................................................................................ 204, 382, 383
Pentobarbital...................................................................................................................................................... 204, 383
Pentosan polysulfate sodium............................................................................................................................. 204
Pexiganan.......................................................................................................................................................... 205
Phenacetin......................................................................................................................................................... 205, 383, 384, 385
Phenazone......................................................................................................................................................... 207, 385
Phenazopyridine................................................................................................................................................. 208, 385, 386
Phendimetrazine................................................................................................................................................ 208, 386
Phenformin......................................................................................................................................................... 209, 386, 387

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Phenformin/chlorpropamide............................................................................................................................... 309
Phenicarbazide................................................................................................................................................... 211, 387
Phenmetrazine................................................................................................................................................... 211, 387
Phenobarbital, difebarbamate and febarbamate (Tetrabamate)....................................................................... 309
Phenobarbital..................................................................................................................................................... 211, 387, 388, 389
Phenol................................................................................................................................................................ 212, 389
Phenolphthalein.................................................................................................................................................. 213, 389, 390
Phenoxybenzamine............................................................................................................................................ 214, 390
Phentermine....................................................................................................................................................... 214, 390
Phentolamine mesilate....................................................................................................................................... 215
Phenylbutazone.................................................................................................................................................. 215, 390, 391, 392
Phenylephrine.................................................................................................................................................... 218, 392
Phenylpropanolamine........................................................................................................................................ 218, 392, 393
Phlebotonics....................................................................................................................................................... 310
Phthalylsulfathiazole........................................................................................................................................... 220, 393
Pipamazine......................................................................................................................................................... 221, 394
Pipenzolate......................................................................................................................................................... 221, 394
Piperazine.......................................................................................................................................................... 221, 394, 395
Pipradol/hesperidin............................................................................................................................................ 310
Pipradrol............................................................................................................................................................. 222, 395, 396
Pirprofen............................................................................................................................................................. 223
Pituitary-chorionic gonadotropin (injectable)...................................................................................................... 223, 396
Placental tissue derived medicine..................................................................................................................... 223
Podophyllum resin.............................................................................................................................................. 224, 396
Polidexide sulfate............................................................................................................................................... 224
Polyoxyethylated castor oil................................................................................................................................. 225, 396
Polyvidone.......................................................................................................................................................... 225, 396, 397
Potassium canrenoate....................................................................................................................................... 226, 397
Potassium chloride............................................................................................................................................. 226, 397, 398
Potassium nitrate............................................................................................................................................... 227, 398
Practolol............................................................................................................................................................. 227, 398
Prasterone.......................................................................................................................................................... 228, 398
Prednisolone/phenobarbital............................................................................................................................... 310
Prenylamine....................................................................................................................................................... 229
Progabide........................................................................................................................................................... 229, 398
Promethazine in combination............................................................................................................................. 310
Promethazine..................................................................................................................................................... 229
Propafenone....................................................................................................................................................... 230, 399
Propionic acid..................................................................................................................................................... 230
Propofol.............................................................................................................................................................. 231, 399
Propylhexedrine................................................................................................................................................. 231, 399
Propyphenazone................................................................................................................................................ 232, 399
Proxibarbal......................................................................................................................................................... 232
Pseudoephedrine and phenylpropanolamine.................................................................................................... 311
Pumactant.......................................................................................................................................................... 233
Pyrazolones in combination (see also aminophenazone, metamizole sodium)................................................ 311
Pyrethroids......................................................................................................................................................... 312
Pyridoxine (Vitamin B6)...................................................................................................................................... 233

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Pyrithione zinc.................................................................................................................................................... 233
Pyritinol............................................................................................................................................................... 234, 400
Pyrrolizidine........................................................................................................................................................ 234
Quinidine/verapamil........................................................................................................................................... 313
Quinine sulfate................................................................................................................................................... 235
Quinolone antimicrobial agents.......................................................................................................................... 313
Remifentanil....................................................................................................................................................... 235
Remoxipride....................................................................................................................................................... 236
Repaglinide and gemfibrozil............................................................................................................................... 314
Retinol................................................................................................................................................................ 236, 400
Rituximab........................................................................................................................................................... 237
Rubiae tinctorum radix....................................................................................................................................... 237
Santonin............................................................................................................................................................. 237, 400
Scopolamine...................................................................................................................................................... 238, 400
Secobabital......................................................................................................................................................... 238, 400
Selegiline............................................................................................................................................................ 239
Sertindole........................................................................................................................................................... 239
Sibutramine........................................................................................................................................................ 240
Sildenafil............................................................................................................................................................. 240, 400, 401
Silver acetate...................................................................................................................................................... 240, 401
Sodium dibunate................................................................................................................................................ 241, 401
Sodium hydrogen bicarbonate (paediatric)........................................................................................................ 241
Somatropin (pituitary-derived)............................................................................................................................ 241, 401
Sotalol................................................................................................................................................................. 242
Sparfloxacin........................................................................................................................................................ 243
Spironolactone................................................................................................................................................... 243, 401, 402
Streptomycin...................................................................................................................................................... 244, 402
Strychnine and salts........................................................................................................................................... 244
Sulfacarbamide.................................................................................................................................................. 245
Sulfadicramide................................................................................................................................................... 245, 402, 403
Sulfadimidine...................................................................................................................................................... 246, 403
Sulfaguanidine.................................................................................................................................................... 246, 403
Sulfamerazine sodium........................................................................................................................................ 248, 403
Sulfamethizole.................................................................................................................................................... 248, 403, 404
Sulfamethoxypyridazine..................................................................................................................................... 248, 404, 405
Sulfanilamide...................................................................................................................................................... 249, 405
Sulfathiazole sodium with sodium lactate or sodium bicarbonate..................................................................... 314
Sulfathiazole....................................................................................................................................................... 250, 405, 406
Sulfisomidine...................................................................................................................................................... 250, 406
Sulfonamides (topical preparations).................................................................................................................. 251
Suloctidil............................................................................................................................................................. 251, 406
Sulprostone........................................................................................................................................................ 252, 406
Sultopride........................................................................................................................................................... 252, 406
Sumatriptan........................................................................................................................................................ 252
Superheporin...................................................................................................................................................... 314
Suprofen............................................................................................................................................................. 254, 406
Suxamethonium chloride................................................................................................................................... 254
Suxibuzone......................................................................................................................................................... 255, 407

17
 ALPHABETICAL LISTING OF PRODUCTS

Product name Page

Tamoxifen........................................................................................................................................................... 255
Tartrazine........................................................................................................................................................... 256, 407
Temafloxacin...................................................................................................................................................... 257, 407, 408
Temazepam....................................................................................................................................................... 257
Terbinafine......................................................................................................................................................... 257
Terconazole........................................................................................................................................................ 258, 408
Terfenadine........................................................................................................................................................ 258, 408
Terodiline............................................................................................................................................................ 260, 408
Testosterone propionate (injectable)................................................................................................................. 260, 408, 409
Tetracycline (paediatric)..................................................................................................................................... 261, 409
Tetracycline in combination................................................................................................................................ 314
Thalidomide........................................................................................................................................................ 262, 409
Thenalidine......................................................................................................................................................... 263, 410
Theophylline/meprobamate/barbiturates........................................................................................................... 315
Thiazides/potassium chloride............................................................................................................................. 315
Thiomersal.......................................................................................................................................................... 264, 410
Tianeptine sodium.............................................................................................................................................. 264, 410
Tiaprofenic acid.................................................................................................................................................. 265
Ticlopidine.......................................................................................................................................................... 265, 410
Tienilic acid......................................................................................................................................................... 266, 410
Tilbroquinol......................................................................................................................................................... 267
Tilbroquinol/tiliquinol........................................................................................................................................... 315
Tiratricol/cyclovalone/retinol............................................................................................................................... 316
Tocainide............................................................................................................................................................ 267, 410
Tolcapone........................................................................................................................................................... 268
Tolrestat............................................................................................................................................................. 269
Tramadol............................................................................................................................................................ 269, 410, 411
Trancylopramine and trifluoperazine.................................................................................................................. 316
Tranylcypromine................................................................................................................................................. 269, 411
Trazodone.......................................................................................................................................................... 270, 411
Tretinoin............................................................................................................................................................. 270, 411
Triacetyldiphenolisatin........................................................................................................................................ 271, 411, 412
Triazolam............................................................................................................................................................ 271, 412
Trimethoprim/sulfamethoxazole......................................................................................................................... 316
Trimipramine...................................................................................................................................................... 274, 412
Troglitazone........................................................................................................................................................ 274, 412
Trolamine........................................................................................................................................................... 275, 412
Trovafloxacin mesilate....................................................................................................................................... 276
Trypsin................................................................................................................................................................ 276, 412
Tyrothricin/fomocaine/diphenhydramine............................................................................................................ 317
Urethane............................................................................................................................................................. 277
Vaccines for mumps, measles, and rubella....................................................................................................... 277
Valproic acid....................................................................................................................................................... 278, 412
Vigabatrin........................................................................................................................................................... 278, 413
Vinarol and viga (dietary supplements).............................................................................................................. 279
Vinbarbital.......................................................................................................................................................... 279, 413
Vincamine........................................................................................................................................................... 279, 413
Voglibose............................................................................................................................................................ 280

18
 ALPHABETICAL LISTING OF PRODUCTS

Product name Page

Warfarin.............................................................................................................................................................. 280, 413
Xenazoic acid..................................................................................................................................................... 281, 413
Xibornol and lidocaine........................................................................................................................................ 317
Zimeldine............................................................................................................................................................ 281, 413
Zipeprol............................................................................................................................................................... 281, 413, 414
Ziperol................................................................................................................................................................. 282
Zomepirac.......................................................................................................................................................... 282, 414
Zopiclone............................................................................................................................................................ 282, 414

19
 CLASSIFIED LISTING OF PRODUCTS
PHARMACEUTICALS (MONOCOMPONENT PRODUCTS)
ANALGESICS, ANTIPYRETICS, AND NONSTEROIDAL ANTIINFLAMMATORY DRUGS
Acetanilide.....................................................................................................................................................................................
31, 319
Acetylsalicylic acid (paediatric).....................................................................................................................................................32, 319
Alclofenac......................................................................................................................................................................................
38, 320
Aloxiprin.........................................................................................................................................................................................
40, 320
Aminophenazone..........................................................................................................................................................................
44, 322, 323
Azapropazone...............................................................................................................................................................................
56, 326
Benorilate......................................................................................................................................................................................
58, 327
Benoxaprofen................................................................................................................................................................................
58, 327
Beta ethoxylacetanilide................................................................................................................................................................. 62
Bucetin..........................................................................................................................................................................................
69, 330
Bumadizone..................................................................................................................................................................................
70, 331
Cinchophen...................................................................................................................................................................................
85, 337
Clometacin.................................................................................................................................................................................... 94
Dequalinium chloride....................................................................................................................................................................
103, 342, 343
Diclofenac sodium.........................................................................................................................................................................
105, 343, 344
Fenclofenac...................................................................................................................................................................................
126, 352
Feprazone.....................................................................................................................................................................................
128, 352
Floctafenine...................................................................................................................................................................................
131, 353
Germander.................................................................................................................................................................................... 136
Glafenine.......................................................................................................................................................................................
137, 354, 355
Ibuprofen.......................................................................................................................................................................................
148, 358, 359, 360
Indometacin and indometacin farnesil..........................................................................................................................................149, 360
Indoprofen.....................................................................................................................................................................................
150, 360
Isoxicam........................................................................................................................................................................................
154, 362
Kebuzone......................................................................................................................................................................................
155, 362, 363
Ketorolac.......................................................................................................................................................................................156
Metamizole sodium.......................................................................................................................................................................
171, 369, 370, 371
Metofoline......................................................................................................................................................................................
179, 373
Mofebutazone................................................................................................................................................................................
182, 374
Orgotein.........................................................................................................................................................................................195
Oxyphenbutazone.........................................................................................................................................................................
197, 380
Paracetamol..................................................................................................................................................................................
201, 382
Phenacetin....................................................................................................................................................................................
205, 383, 384, 385
Phenazone....................................................................................................................................................................................
207, 385
Phenazopyridine............................................................................................................................................................................
208, 385, 386
Phenicarbazide.............................................................................................................................................................................
211, 387
Phenylbutazone.............................................................................................................................................................................
215, 390, 391, 392
Pirprofen........................................................................................................................................................................................223
Propyphenazone...........................................................................................................................................................................
232, 399
Suprofen........................................................................................................................................................................................
254, 406
Suxibuzone....................................................................................................................................................................................
255, 407
Tiaprofenic acid............................................................................................................................................................................. 265
Tramadol.......................................................................................................................................................................................
269, 410, 411
Zomepirac.....................................................................................................................................................................................
282, 414

ANESTHETICS
Ketamine hydrochloride................................................................................................................................................................ 155
Promethazine................................................................................................................................................................................ 229
Propofol.........................................................................................................................................................................................
231, 399

ANTIALLERGICS
Allergen extracts...........................................................................................................................................................................
39, 320
Antihistamine (topical)................................................................................................................................................................... 51
Astemizole.....................................................................................................................................................................................
54, 325
Cinnarizine....................................................................................................................................................................................
86, 337
Clemastine....................................................................................................................................................................................
89, 337, 338

20
 CLASSIFIED LISTING OF PRODUCTS
ANTIALLERGICS
H1-Antihistamines......................................................................................................................................................................... 141
Methapyrilene................................................................................................................................................................................
175, 371
Nitrendipine................................................................................................................................................................................... 190
Terfenadine...................................................................................................................................................................................
258, 408
Thenalidine....................................................................................................................................................................................
263, 410

ANTICOAGULANTS
Ticlopidine.....................................................................................................................................................................................
265, 410
Warfarin.........................................................................................................................................................................................
280, 413

ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS

Mesna............................................................................................................................................................................................
170, 368

ANTIINFECTIVE DRUGS
Acetarsol.......................................................................................................................................................................................
31, 319
Acetylfuratrizine.............................................................................................................................................................................
32, 319
Acridine derivatives.......................................................................................................................................................................
36, 320
Amodiaquine.................................................................................................................................................................................
49, 325
Amyl nitrite..................................................................................................................................................................................... 50
Benzylpenicillin sodium (topical preparations).............................................................................................................................. 61, 328
Bithionol.........................................................................................................................................................................................
65, 328
Boric acid and borates..................................................................................................................................................................
65, 329
Cefaloridine................................................................................................................................................................................... 76
Cefalosporins (topical preparations)............................................................................................................................................. 76, 332
Chloramphenicol...........................................................................................................................................................................
78, 333, 334, 335
Chloroquine...................................................................................................................................................................................
83, 336
Dequalinium chloride....................................................................................................................................................................
103, 342, 343
Difenoxin.......................................................................................................................................................................................
109, 345
Difurazone.....................................................................................................................................................................................
109, 345
Dihydrostreptomycin.....................................................................................................................................................................
109, 345, 346
Dihydroxymethylfuratrizine............................................................................................................................................................
110, 346
Dimazole.......................................................................................................................................................................................
111, 346
Diphenoxylate................................................................................................................................................................................
112, 346
Dithiazanine iodide........................................................................................................................................................................
113, 346, 347
Doxycycline hyclate(injectable).....................................................................................................................................................
115, 347, 348
Emetine.........................................................................................................................................................................................
117, 348
Erythromycin estolate....................................................................................................................................................................
120, 349, 350
Furazolidone..................................................................................................................................................................................
133, 353, 354
Gentamicin (topical preparations)................................................................................................................................................. 136
Griseofulvin...................................................................................................................................................................................
140, 355
Guanofuracin................................................................................................................................................................................. 141
Halogenated hydroxyquinoline derivatives...................................................................................................................................142, 356
Halogenated salicylanilides...........................................................................................................................................................
143, 356
Hexachlorophene..........................................................................................................................................................................
145, 356, 357
Ketoconazole................................................................................................................................................................................
156, 363
Latamoxef......................................................................................................................................................................................
158, 363
Levamisole hydrochloride.............................................................................................................................................................
160, 364
Mefloquine.....................................................................................................................................................................................167
Minocycline....................................................................................................................................................................................
182, 374
Neomycin sulfate...........................................................................................................................................................................
187, 375, 376, 377
Nitrofural........................................................................................................................................................................................
190, 378
Nitrofurantoin.................................................................................................................................................................................
191, 378
Nitroxoline.....................................................................................................................................................................................
191, 379
Novobiocin....................................................................................................................................................................................
194, 380
Paromomycin................................................................................................................................................................................
202, 382
Pexiganan..................................................................................................................................................................................... 205
Phenol...........................................................................................................................................................................................
212, 389
Phthalylsulfathiazole.....................................................................................................................................................................
220, 393

21
 CLASSIFIED LISTING OF PRODUCTS
ANTIINFECTIVE DRUGS
Piperazine.....................................................................................................................................................................................
221, 394, 395
Propionic acid................................................................................................................................................................................ 230
Quinine sulfate.............................................................................................................................................................................. 235
Santonin........................................................................................................................................................................................
237, 400
Silver acetate................................................................................................................................................................................
240, 401
Sparfloxacin.................................................................................................................................................................................. 243
Streptomycin.................................................................................................................................................................................
244, 402
Sulfacarbamide............................................................................................................................................................................. 245
Sulfadicramide..............................................................................................................................................................................
245, 402, 403
Sulfadimidine.................................................................................................................................................................................
246, 403
Sulfaguanidine..............................................................................................................................................................................
246, 403
Sulfamerazine sodium..................................................................................................................................................................
248, 403
Sulfamethizole...............................................................................................................................................................................
248, 403, 404
Sulfamethoxypyridazine................................................................................................................................................................
248, 404, 405
Sulfanilamide.................................................................................................................................................................................
249, 405
Sulfathiazole..................................................................................................................................................................................
250, 405, 406
Sulfisomidine.................................................................................................................................................................................
250, 406
Sulfonamides (topical preparations)............................................................................................................................................. 251
Temafloxacin.................................................................................................................................................................................
257, 407, 408
Terconazole..................................................................................................................................................................................
258, 408
Tetracycline (paediatric)................................................................................................................................................................
261, 409
Tilbroquinol.................................................................................................................................................................................... 267
Trovafloxacin mesilate.................................................................................................................................................................. 276
Xenazoic acid................................................................................................................................................................................
281, 413

ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGS

Aminoglutethimide........................................................................................................................................................................
44, 322
Chlornaphazine.............................................................................................................................................................................
81, 336
Progabide......................................................................................................................................................................................
229, 398
Tamoxifen..................................................................................................................................................................................... 255
Urethane........................................................................................................................................................................................277

CARDIOVASCULAR DRUGS
Alprostadil.....................................................................................................................................................................................
40, 320, 321
Beclobrate..................................................................................................................................................................................... 57
Bencyclane....................................................................................................................................................................................
58, 326
Benzarone.....................................................................................................................................................................................
59, 327
Cadralazine...................................................................................................................................................................................
72, 331
Cinepazide.................................................................................................................................................................................... 85
Clofibrate.......................................................................................................................................................................................
92, 339, 340
Diethylaminoethoxyhexestrol........................................................................................................................................................
107, 345
Encainide...................................................................................................................................................................................... 117
Epinephrine...................................................................................................................................................................................
118, 348, 349
Flecainide......................................................................................................................................................................................
129, 352, 353
Flunarizine..................................................................................................................................................................................... 131
Levarterenol..................................................................................................................................................................................
160, 364
Moxisylyte......................................................................................................................................................................................183
Naftidrofuryl (parenteral formulations).......................................................................................................................................... 185
Nifedipine......................................................................................................................................................................................189
Phenoxybenzamine.......................................................................................................................................................................
214, 390
Polidexide sulfate.......................................................................................................................................................................... 224
Practolol........................................................................................................................................................................................
227, 398
Prenylamine.................................................................................................................................................................................. 229
Propafenone..................................................................................................................................................................................
230, 399
Sotalol...........................................................................................................................................................................................242
Suloctidil........................................................................................................................................................................................
251, 406
Terodiline......................................................................................................................................................................................
260, 408
Tocainide.......................................................................................................................................................................................
267, 410

22
 CLASSIFIED LISTING OF PRODUCTS
CARDIOVASCULAR DRUGS
Vincamine.....................................................................................................................................................................................
279, 413

DERMATOLOGICAL DRUGS
Acitretin.........................................................................................................................................................................................
35, 319
Azaribine.......................................................................................................................................................................................
56, 326
Benzoylperoxide............................................................................................................................................................................
59, 327
Bufexamac....................................................................................................................................................................................
69, 330
Clofenotane................................................................................................................................................................................... 91
Etretinate.......................................................................................................................................................................................
124, 351
Hydroquinone................................................................................................................................................................................
147, 358
Isotretinoin.....................................................................................................................................................................................
152, 362
Lead oxide and lead salts.............................................................................................................................................................
159, 363
Lindane..........................................................................................................................................................................................
161, 364
Methylrosanilinium chloride........................................................................................................................................................... 178
Podophyllum resin.........................................................................................................................................................................
224, 396
Pyrithione zinc............................................................................................................................................................................... 233
Thalidomide...................................................................................................................................................................................
262, 409
Tretinoin........................................................................................................................................................................................
270, 411

DIURETICS
Benzbromarone.............................................................................................................................................................................
59, 327
Canrenone....................................................................................................................................................................................
74, 332
Ethyl nitrite (spirit)......................................................................................................................................................................... 122
Muzolimine.................................................................................................................................................................................... 184
Potassium canrenoate..................................................................................................................................................................
226, 397
Potassium nitrate..........................................................................................................................................................................
227, 398
Spironolactone..............................................................................................................................................................................
243, 401, 402
Tienilic acid...................................................................................................................................................................................
266, 410

DRUGS NOT SCHEDULED INTERNATIONALLY

Aminorex.......................................................................................................................................................................................
47, 323
Amitriptyline...................................................................................................................................................................................
48, 324
Cathine..........................................................................................................................................................................................
76, 332
Chlorphentermine.........................................................................................................................................................................
84, 336, 337
Cloforex.........................................................................................................................................................................................
94, 340
Clozapine......................................................................................................................................................................................
95, 341
Cyproheptadine.............................................................................................................................................................................
99, 341, 342
Dibenzepin hydrochloride..............................................................................................................................................................
105, 343
Dilevalol.........................................................................................................................................................................................110
Doxepin.........................................................................................................................................................................................
114, 347
Fipexide.........................................................................................................................................................................................
129, 352
Fluvoxamine..................................................................................................................................................................................
133, 353
Indalpine........................................................................................................................................................................................
149, 360
Iodinated casein strophanthin (neo-barine).................................................................................................................................. 150, 361
Iproniazid.......................................................................................................................................................................................
151, 361
Isaxonine phosphate.....................................................................................................................................................................
151, 361
Isocarboxazid................................................................................................................................................................................
151, 361
Lamotrigine................................................................................................................................................................................... 158
Levamfetamine.............................................................................................................................................................................
159, 363
L-Tryptophan.................................................................................................................................................................................
164, 364
Medifoxamine................................................................................................................................................................................ 167
Mephenesin...................................................................................................................................................................................
170, 366
Mianserin.......................................................................................................................................................................................
180, 373
Nialamide......................................................................................................................................................................................
188, 377
Nomifensine..................................................................................................................................................................................
192, 379
Pemoline....................................................................................................................................................................................... 203
Propylhexedrine............................................................................................................................................................................
231, 399
Pyritinol..........................................................................................................................................................................................
234, 400

23
 CLASSIFIED LISTING OF PRODUCTS
DRUGS NOT SCHEDULED INTERNATIONALLY
Remifentanil.................................................................................................................................................................................. 235
Sertindole...................................................................................................................................................................................... 239
Sodium dibunate...........................................................................................................................................................................
241, 401
Sultopride......................................................................................................................................................................................
252, 406
Suxamethonium chloride.............................................................................................................................................................. 254
Temazepam.................................................................................................................................................................................. 257
Tianeptine sodium.........................................................................................................................................................................
264, 410
Tranylcypromine............................................................................................................................................................................
269, 411
Trazodone.....................................................................................................................................................................................
270, 411
Trimipramine.................................................................................................................................................................................
274, 412
Vigabatrin......................................................................................................................................................................................
278, 413
Zimeldine.......................................................................................................................................................................................
281, 413
Zopiclone.......................................................................................................................................................................................
282, 414

ENDOCRINE SYSTEM, DRUGS ACTING ON THE

Anabolic steroids........................................................................................................................................................................... 50
Anagestone acetate...................................................................................................................................................................... 50
Androgens..................................................................................................................................................................................... 51
Aphrodisiac drugs......................................................................................................................................................................... 52
Bromocriptine................................................................................................................................................................................
68, 329, 330
Buformin........................................................................................................................................................................................
69, 330, 331
Chlormadinone acetate.................................................................................................................................................................
79, 335
Depot medroxyprogesterone acetate (DMPA).............................................................................................................................. 102, 342
Dienestrol......................................................................................................................................................................................
107, 344, 345
Diethylstilbestrol............................................................................................................................................................................
107, 345
Dinoprostone.................................................................................................................................................................................
111, 346
Ethylestrenol..................................................................................................................................................................................
123, 351
Gemfibrozil....................................................................................................................................................................................
135, 354
Hexestrol.......................................................................................................................................................................................
145, 357
Lynestrenol....................................................................................................................................................................................
166, 365
Megestrol acetate..........................................................................................................................................................................
168, 366
Mepacrine......................................................................................................................................................................................169
Metformin......................................................................................................................................................................................175
Mifepristone...................................................................................................................................................................................
181, 373
Nandrolone decanoate (injectable)...............................................................................................................................................186, 374
Nandrolone phenylpropionate (injectable).................................................................................................................................... 186, 375
Norethisterone enantate (injectable).............................................................................................................................................192, 379
Phenformin....................................................................................................................................................................................
209, 386, 387
Pituitary-chorionic gonadotropin (injectable)................................................................................................................................. 223, 396
Prasterone.....................................................................................................................................................................................
228, 398
Somatropin (pituitary-derived).......................................................................................................................................................
241, 401
Testosterone propionate (injectable)............................................................................................................................................
260, 408, 409

GASTROINTESTINAL DRUGS
Berberine.......................................................................................................................................................................................
62, 328
Bismuth salts................................................................................................................................................................................. 63
Broxyquinoline (see also halogenated hydroxyquinoline derivatives).......................................................................................... 68, 330
Chenodeoxycholic acid.................................................................................................................................................................
78, 332, 333
Clioquinol (see also halogenated hydroxyquinoline derivatives)..................................................................................................89, 338, 339
Dantron..........................................................................................................................................................................................
101, 342
Dicycloverine.................................................................................................................................................................................
106, 344
Difemerine.....................................................................................................................................................................................108
Domperidone(injectable)...............................................................................................................................................................
114, 347
Hyoscine methonitrate..................................................................................................................................................................148, 358
Loperamide...................................................................................................................................................................................
162, 364
Meclozine......................................................................................................................................................................................
167, 365, 366
Metoclopramide (paediatric)......................................................................................................................................................... 179
Omeprazole................................................................................................................................................................................... 194

24
 CLASSIFIED LISTING OF PRODUCTS
GASTROINTESTINAL DRUGS
Oral rehydration salts.................................................................................................................................................................... 195
Oxyphenisatine acetate.................................................................................................................................................................
199, 381
Phenolphthalein............................................................................................................................................................................
213, 389, 390
Pipamazine...................................................................................................................................................................................
221, 394
Pipenzolate....................................................................................................................................................................................
221, 394
Scopolamine.................................................................................................................................................................................
238, 400
Strychnine and salts...................................................................................................................................................................... 244
Triacetyldiphenolisatin...................................................................................................................................................................
271, 411, 412

IMMUNOLOGICALS
Herpes simplex vaccines..............................................................................................................................................................
144, 356
Vaccines for mumps, measles, and rubella.................................................................................................................................. 277

LIVER, DRUGS ACTING ON THE

Cianidanol.....................................................................................................................................................................................
84, 337
Nitrefazole.....................................................................................................................................................................................
190, 377, 378

MEDICAL DEVICES
Dalkon shield................................................................................................................................................................................. 100

MUSCULOSKELETAL DRUGS
Cartilage extract............................................................................................................................................................................ 75
Mucopolysaccharide polysulfuric acid ester................................................................................................................................. 183

NARCOTICS SCHEDULED UNDER SINGLE CONVENTION ON NARCOTIC DRUGS

Buprenorphine...............................................................................................................................................................................
71, 331
Codeine.........................................................................................................................................................................................
97, 341
Noscapine.....................................................................................................................................................................................
193, 379, 380
Opium in antitussive preparations................................................................................................................................................195, 380
Pentazocine..................................................................................................................................................................................
204, 382, 383
Zipeprol.........................................................................................................................................................................................
281, 413, 414

NERVOUS SYSTEM, DRUGS ACTING ON THE

Zopiclone.......................................................................................................................................................................................
282, 414

NOT CLASSIFIED
Acarbose....................................................................................................................................................................................... 31
Acetylleucine................................................................................................................................................................................. 32
Alatrofloxacin mesilate.................................................................................................................................................................. 37
Albumin......................................................................................................................................................................................... 37
Aldesleukin.................................................................................................................................................................................... 39
Alpidem......................................................................................................................................................................................... 40
Amfepramone hydrochloride......................................................................................................................................................... 42
Amineptine.................................................................................................................................................................................... 43
Amiprilose..................................................................................................................................................................................... 48
Aristolochia.................................................................................................................................................................................... 52
Bismuth subsalicylate................................................................................................................................................................... 64
Bromfenac..................................................................................................................................................................................... 67
Buspirone hydrochloride............................................................................................................................................................... 72
Chlormezanone............................................................................................................................................................................. 80
Ciprofibrate.................................................................................................................................................................................... 86
Cisapride.......................................................................................................................................................................................
86, 337
Coumarin (synthetic)..................................................................................................................................................................... 97
Cyclandelate.................................................................................................................................................................................. 98
Cyclopenthiazide........................................................................................................................................................................... 99
Cyproterone acetate...................................................................................................................................................................... 100
Dequalinium.................................................................................................................................................................................. 103
Dexfenfluramine hydrochloride..................................................................................................................................................... 104
Dexfenfluramine............................................................................................................................................................................
104, 343
Dronabinol..................................................................................................................................................................................... 116
Droperidol......................................................................................................................................................................................
116, 348

25
 CLASSIFIED LISTING OF PRODUCTS
NOT CLASSIFIED
Droxicam.......................................................................................................................................................................................116
Ebrotidine...................................................................................................................................................................................... 117
Epoetin alfa................................................................................................................................................................................... 119
Epoetin beta.................................................................................................................................................................................. 119
Erythrityl tetranitrate...................................................................................................................................................................... 119
Fenfluramine................................................................................................................................................................................. 127
Flosequinan................................................................................................................................................................................... 131
Fluoxetine......................................................................................................................................................................................133
Ginkgo biloba................................................................................................................................................................................
137, 354
Grepafloxacin hydrochloride......................................................................................................................................................... 139
Halofantrine...................................................................................................................................................................................142
Human dura mater........................................................................................................................................................................ 146
Hydroquinidine.............................................................................................................................................................................. 147
Ibopamine......................................................................................................................................................................................148
Lamivudine....................................................................................................................................................................................157
Levacetylmethadol........................................................................................................................................................................
159, 363
Lexipafant......................................................................................................................................................................................161
Loxoprofen sodium........................................................................................................................................................................ 164
Melatonin.......................................................................................................................................................................................169
Mibefradil.......................................................................................................................................................................................180
Misoprostol....................................................................................................................................................................................
182, 374
Nimesulide....................................................................................................................................................................................
189, 377
Oxeladin citrate............................................................................................................................................................................. 196
Oxeladin........................................................................................................................................................................................196
Oxytocin.........................................................................................................................................................................................
201, 381, 382
Pentosan polysulfate sodium........................................................................................................................................................ 204
Phentolamine mesilate................................................................................................................................................................. 215
Proxibarbal.................................................................................................................................................................................... 232
Pumactant.....................................................................................................................................................................................233
Rituximab......................................................................................................................................................................................237
Selegiline.......................................................................................................................................................................................239
Sibutramine................................................................................................................................................................................... 240
Sodium hydrogen bicarbonate (paediatric)................................................................................................................................... 241
Sumatriptan................................................................................................................................................................................... 252
Terbinafine.................................................................................................................................................................................... 257
Tolcapone..................................................................................................................................................................................... 268
Tolrestat........................................................................................................................................................................................269
Troglitazone...................................................................................................................................................................................
274, 412
Voglibose...................................................................................................................................................................................... 280

OPTHALMOLOGICAL PREPARATIONS
Phenylephrine...............................................................................................................................................................................
218, 392
Thiomersal....................................................................................................................................................................................
264, 410

OTHER PHARMACEUTICAL PRODUCTS

Aristolochic acid............................................................................................................................................................................
52, 325
Arsenic-based compounds........................................................................................................................................................... 53
Berberine.......................................................................................................................................................................................
62, 328
Bovine tissue derived medicines.................................................................................................................................................. 66
Calamus........................................................................................................................................................................................
73, 331
Canthaxanthin...............................................................................................................................................................................
74, 332
Cell preparations........................................................................................................................................................................... 77
Dionaea muscipula (extract)......................................................................................................................................................... 112
Diphenazine.................................................................................................................................................................................. 112
Factor IX........................................................................................................................................................................................
125, 351
Factor VIII......................................................................................................................................................................................
126, 351
Gangliosides................................................................................................................................................................................. 135
Iodinated casein strophanthin (neo-barine).................................................................................................................................. 150, 361

26
 CLASSIFIED LISTING OF PRODUCTS
OTHER PHARMACEUTICAL PRODUCTS
Laetrile...........................................................................................................................................................................................157
Nebacumab................................................................................................................................................................................... 187
Placental tissue derived medicine................................................................................................................................................ 223
Pyrrolizidine................................................................................................................................................................................... 234
Rubiae tinctorum radix.................................................................................................................................................................. 237

PHARMACEUTIC AIDS (SOLVENTS, etc)

Amaranth....................................................................................................................................................................................... 41
Benzyl alcohol...............................................................................................................................................................................
60, 327, 328
Canthaxanthin...............................................................................................................................................................................
74, 332
Chloroform....................................................................................................................................................................................
81, 336
Cyclamates in drugs......................................................................................................................................................................
98, 341
Ethanol..........................................................................................................................................................................................
121, 350, 351
Ethylene dichloride........................................................................................................................................................................ 123
Glucosamine sulfate.....................................................................................................................................................................
138, 355
Kaolin............................................................................................................................................................................................
154, 362
Methanol........................................................................................................................................................................................175
Pectin............................................................................................................................................................................................
203, 382
Polyoxyethylated castor oil............................................................................................................................................................
225, 396
Polyvidone.....................................................................................................................................................................................
225, 396, 397
Tartrazine......................................................................................................................................................................................
256, 407
Trolamine......................................................................................................................................................................................
275, 412

PLASMA FRACTIONS
Factor IX........................................................................................................................................................................................
125, 351
Factor VIII......................................................................................................................................................................................
126, 351

PSYCHOTROPICS SCHEDULED UNDER CONVENTION ON PSYCHOTROPIC SUBSTANCES

Amfepramone...............................................................................................................................................................................
42, 321
Amfetamine...................................................................................................................................................................................
42, 321
Amobarbital...................................................................................................................................................................................
49, 324, 325
Aprobarbital...................................................................................................................................................................................
52, 325
Barbital..........................................................................................................................................................................................
57, 326
Bromisoval.................................................................................................................................................................................... 67
Clomethiazole...............................................................................................................................................................................
95, 340
Dexamfetamine.............................................................................................................................................................................
104, 343
Etomidate......................................................................................................................................................................................
124, 351
Fenetylline.....................................................................................................................................................................................
127, 352
Flunitrazepam...............................................................................................................................................................................
132, 353
Glutethimide..................................................................................................................................................................................
139, 355
Heptabarb......................................................................................................................................................................................
144, 356
Hexobarbital..................................................................................................................................................................................
146, 357, 358
Levamfetamine.............................................................................................................................................................................
159, 363
Mazindol........................................................................................................................................................................................
166, 365
Meprobamate................................................................................................................................................................................
170, 367, 368
Metamfetamine.............................................................................................................................................................................
171, 368, 369
Methaqualone................................................................................................................................................................................
176, 372
Methylphenidate............................................................................................................................................................................
177, 373
Methyprylon...................................................................................................................................................................................
178, 373
Nabilone........................................................................................................................................................................................
185, 374
Pentobarbital.................................................................................................................................................................................
204, 383
Phendimetrazine...........................................................................................................................................................................
208, 386
Phenmetrazine..............................................................................................................................................................................
211, 387
Phenobarbital................................................................................................................................................................................
211, 387, 388, 389
Phentermine..................................................................................................................................................................................
214, 390
Pipradrol........................................................................................................................................................................................
222, 395, 396
Propylhexedrine............................................................................................................................................................................
231, 399
Remoxipride.................................................................................................................................................................................. 236

27
 CLASSIFIED LISTING OF PRODUCTS
PSYCHOTROPICS SCHEDULED UNDER CONVENTION ON PSYCHOTROPIC SUBSTANCES
Secobabital...................................................................................................................................................................................
238, 400
Triazolam......................................................................................................................................................................................
271, 412
Vinbarbital.....................................................................................................................................................................................
279, 413

RADIOCONTRAST MEDIA
Bunamiodyl...................................................................................................................................................................................
71, 331
Methiodal sodium..........................................................................................................................................................................
177, 372, 373

RESPIRATORY TRACT, DRUGS ACTING ON THE

Almitrine........................................................................................................................................................................................ 39
Aminophylline................................................................................................................................................................................
47, 323
Camphor.......................................................................................................................................................................................
73, 332
Fenoterol.......................................................................................................................................................................................
128, 352
Isoprenaline...................................................................................................................................................................................
152, 361, 362
Lobelia...........................................................................................................................................................................................162
Phenylpropanolamine...................................................................................................................................................................
218, 392, 393
Ziperol...........................................................................................................................................................................................282

VITAMINS, MINERALS, ENZYMES

Cobalt (non-radioactive forms).....................................................................................................................................................96, 341
Pangamic acid.............................................................................................................................................................................. 201
Potassium chloride........................................................................................................................................................................
226, 397, 398
Pyridoxine (Vitamin B6)................................................................................................................................................................ 233
Retinol...........................................................................................................................................................................................
236, 400

PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS)

`
ACE-Inhibitors............................................................................................................................................................................... 284
Acetylsalicylic acid/antacid............................................................................................................................................................ 285
Acetylsalicylic acid/codeine........................................................................................................................................................... 285
Acetylsalicylic acid/phenacetin/caffeine (APC)............................................................................................................................. 285
Amoxicillin/clavulanic acid............................................................................................................................................................ 286
Ampicillin/cloxacillin......................................................................................................................................................................
286, 325
Analgesics in combination............................................................................................................................................................ 286
Anorectic drugs............................................................................................................................................................................. 287
Anorectic dugs in combinations.................................................................................................................................................... 288
Antidiarrhoeal combinations......................................................................................................................................................... 289
Antirheumatic combinations with glucocorticosteroids................................................................................................................. 289
Atropine in combination................................................................................................................................................................ 290
Azatadine maleate/pseudoephedrine sulfate............................................................................................................................... 290, 326
Barbiturates in asthma preparations............................................................................................................................................. 290
Barbiturates in combination.......................................................................................................................................................... 291
Calcium channel blockers............................................................................................................................................................. 293
Chloramphenicol in combination.................................................................................................................................................. 293
Chlormadinone acetate/mestranol (in oral contraceptives).......................................................................................................... 294
Clopamide, reserpine and dihydroergocristine mesilate.............................................................................................................. 294
Contrast media (ionic and non-ionic)............................................................................................................................................ 294
Cycloserine/isoniazid.................................................................................................................................................................... 295
Desensitizing vaccines.................................................................................................................................................................. 295
Dicycloverine(dicyclomine)/doxylamine/pyridoxine)..................................................................................................................... 296
Dihydroergotamine/heparin........................................................................................................................................................... 296
Dihydrostreptomycin sulfate/streptomycin sulfate........................................................................................................................ 296
Dipotassium clorazepate/acepromazine/aceprometazine............................................................................................................ 297
Estrogen-progestogen preparations for secondary amenorrhea................................................................................................. 297
Estrogens (in oral contraceptives)................................................................................................................................................ 298
Estrogens......................................................................................................................................................................................297
Estrogens/testosterone................................................................................................................................................................. 298
Etamivan in combination............................................................................................................................................................... 298

28
 CLASSIFIED LISTING OF PRODUCTS
`
Ethinylestradiol/methyltestosterone.............................................................................................................................................. 299
Etidocaine hydrocloride/epinephrine tartrate................................................................................................................................ 299
Guaifenesin/camphor/ether........................................................................................................................................................... 300
Hormonal pregnancy tests............................................................................................................................................................ 300
Hydrochlorothiazide/potassium..................................................................................................................................................... 301
Hydroxyquinolines in combination................................................................................................................................................ 301
Iron preparations........................................................................................................................................................................... 302
Kaolin and pectin........................................................................................................................................................................... 302
Loratadine and pseudoephedrine................................................................................................................................................. 303
Medroxyprogesterone acetate/ethinylestradiol............................................................................................................................. 303
Meprobamate/diazepines.............................................................................................................................................................. 304
Mepyramine maleate/pamabrom.................................................................................................................................................. 304
Mercuric derivatives (topical)........................................................................................................................................................ 304
Metamizole sodium, fenpiverinium bromide and pitofenone hcl.................................................................................................. 305
Metoclopramide/polidocanol......................................................................................................................................................... 305
Neomycin sulfate/polymyxin bisulfate/nystatin/acetarsol.............................................................................................................. 305
Nitrates..........................................................................................................................................................................................306
Nonsteroidal anti-inflammatory agents......................................................................................................................................... 306
Oral contraceptives (third generation).......................................................................................................................................... 306
Oral sodium phosphate bowel preparations................................................................................................................................. 307
Pancreatic enzymes...................................................................................................................................................................... 308
Paracetamol/methionine............................................................................................................................................................... 308
Penicillin/streptomycin.................................................................................................................................................................. 308
Penicillin/tetracycline..................................................................................................................................................................... 309
Phenformin/chlorpropamide.......................................................................................................................................................... 309
Pipradol/hesperidin....................................................................................................................................................................... 310
Prednisolone/phenobarbital.......................................................................................................................................................... 310
Promethazine in combination....................................................................................................................................................... 310
Pseudoephedrine and phenylpropanolamine............................................................................................................................... 311
Pyrazolones in combination (see also aminophenazone, metamizole sodium).......................................................................... 311
Pyrethroids....................................................................................................................................................................................312
Quinidine/verapamil...................................................................................................................................................................... 313
Quinolone antimicrobial agents.................................................................................................................................................... 313
Sulfathiazole sodium with sodium lactate or sodium bicarbonate................................................................................................ 314
Superheporin................................................................................................................................................................................. 314
Tetracycline in combination.......................................................................................................................................................... 314
Theophylline/meprobamate/barbiturates...................................................................................................................................... 315
Thiazides/potassium chloride....................................................................................................................................................... 315
Tilbroquinol/tiliquinol..................................................................................................................................................................... 315
Tiratricol/cyclovalone/retinol.......................................................................................................................................................... 316
Trancylopramine and trifluoperazine............................................................................................................................................ 316
Trimethoprim/sulfamethoxazole.................................................................................................................................................... 316
Tyrothricin/fomocaine/diphenhydramine....................................................................................................................................... 317

29
 LIST OF CODES USED FOR COUNTRIES, TERRITORIES AND AREAS

@EC European Union ITA Italy

@WD World JAM Jamaica
ARE United Arab Emirates JOR Jordan
ARG Argentina JPN Japan
ARM Armenia KOR Republic of Korea
AUS Australia KWT Kuwait
AUT Austria LBN Lebanon
BDS Brunei Darussalam LIY Libyan Arab Jamahiriya
BEL Belgium LKA Sri Lanka
BGD Bangladesh LTH Lithuania
BGR Bulgaria MAR Morocco
BHR Bahrain MEX Mexico
BLZ Belize MUS Mauritius
BRA Brazil MYS Malaysia
BRB Barbados NGA Nigeria
CAN Canada NLD Netherlands
CHE Switzerland NOR Norway
CHL Chile NPL Nepal
COE Council of Europe NZL New Zealand
COG Congo OMN Oman
COL Colombia PAK Pakistan
CRI Costa Rica PAN Panama
CUB Cuba PER Peru
CYP Cyprus PHL Philippines
DEU Germany PRT Portugal
DNK Denmark ROM Romania
DOM Dominican Republic RWA Rwanda
EGY Egypt SAU Saudi Arabia
EME European Agency SDN Sudan
ESP Spain SGP Singapore
ETH Ethiopia SLV Slovak Republic
FIN Finland SUN Union of Soviet Socialist Republics
FRA France SUR Suriname
GBR United Kingdom SWE Sweden
GHA Ghana SYR Syria
GRC Greece TCD Chad
HKG Hong Kong THA Thailand
HND Honduras TUN Tunisia
HUN Hungary TUR Turkey
IDN Indonesia URT United Republic of Tanzania
IND India USA United States
IRL Ireland VEN Venezuela
IRN Iran VTN Viet Nam
IRQ Iraq YEM Yemen
ISL Iceland ZAF South Africa
ISR Israel ZMB Zambia
ZWE Zimbabwe

The designations employed and the presentations of the material in this publication do
not imply the expression of any opinion whatsoever on the part of the Secretariat of the United
Nations concerning the legal status of any country, territory, city or area or its authorities, or
concerning the delimitation of its frontiers or boundaries.

30
 Pharmaceuticals(Monocomponent Products)
Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 31

Product Name Acarbose

C.A.S. number 56180-94-0
Scientific and common names, and synonyms
D-GLUCOSE, O-4,6-DIDEOXY-4-[[[1S-(1?,4?, 5?, 6?)]-4,5,6-TRIHYDROXY-3-(HYDROXYMETHYL)-2-CYCLOHEXEN-1-
YL]-AMINO]-?-D-GLUCOPYRANOSYL-(1?4)-O-?-D-GLUCOPYRANOSYL-(1?4)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Dec 1994 The product information has been rvised to state that acarbose drug may cause ileus-like
symptoms and that the drug should be discontinued should such symptoms appear.
Concomitant use of acarbose and oral hypo- glycaemics or insulin is contraindicated as
this may lead to hypoglycaemia.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.129, , Dec 1994)
JPN Dec 1996 The product information has been revised to state that hypoglycaemia and
hypoglycaemic symptoms developed in elderly debilitated patients when no other
antidiabetics were administered. [See also voglibose.].
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.140, , Dec 1996)
WHO Comment : Acarbose, ana-glucosidase inhibitor, is used as an adjunctive
therapy in the control of postprandial hyperglycaemia in non-insulin-dependent
diabetes mellitus. Use of two or more hypoglycaemic drugs is not recommended.

Product Name Acetanilide

C.A.S. number 103-84-4
Scientific and common names, and synonyms
ANTIFEBRIN
N-PHENYLACETAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1971 This analgesic and antipyretic has been banned for use in over-the-counter preparations
due to the risk of aplastic anaemia. It was subsequently voluntarily withdrawn from
prescription products.
WHO Comment : Acetanilide, a para-aminophenol derivative with analgesic,
antipyretic and weak antiinflammatory activity, was introduced into medicine in
1886. It subsequently proved to be excessively myelosuppressive and has been
superseded by safer alternatives.

Product Name Acetarsol

C.A.S. number 97-44-9
Scientific and common names, and synonyms
ACETARSONE
N-ACETYL-4-HYDROXY-M-ARSANILIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 32

Product Name Acetarsol

C.A.S. number 97-44-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
WHO Comment : Acetarsol, which has antiprotozoal and antitrichomonal activity,
has largely been discarded for systemic use because of its potential to cause
systemic poisoning. However, topical preparations for vaginal trichomoniasis are
still available and it is included in low concentrations (equal to or less than 0.45%)
in some medicated toothpastes.

Product Name Acetylfuratrizine

C.A.S. number 1789-26-0
Scientific and common names, and synonyms
N-(6-(2-(5-NITRO-2-FURYL)VINYL)-1,2,4-TRIAZIN-3-YL) ACETAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Withdrawn from all marketed preparations on the grounds that it has been superseded by
safer and more effective preparations.
SAU The withdrawal of nitrofuran compounds is under consideration since they have been
superseded by safer and more effective preparations.
VEN Not approved for use and/or sale.
WHO Comment : Acetylfuratrizine, a nitrofuran derivative, was formerly used as an
antiinfective agent. It has, however, been superseded by safer compounds and
WHO has no information to suggest that it remains commercially available.

Product Name Acetylleucine

C.A.S. number 149-80-6
Scientific and common names, and synonyms
N-ACETYL-DL-LEUCINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD 1995 The Committee for the Evaluation of Medicines has decided that products containing
acetylleucine may no longer be dispensed because the manufacturer has not provided
any evidence of efficacy.
(Reference: (NPHWB) Pharmaceutisch Weekblad, 28(5):128, , 1994)
WHO Comment : The products were indicated for the treatment of vertigo and had
been authorized for marketing under the "grandfather" clause, which waives full
registration requirements for products marketed before 1963.

Product Name Acetylsalicylic acid (paediatric)

C.A.S. number 50-78-2
Scientific and common names, and synonyms
ASPIRIN

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 33

Product Name Acetylsalicylic acid (paediatric)

C.A.S. number 50-78-2
Scientific and common names, and synonyms
BENZOIC ACID, 2-(ACETYLOXY)-
SALICYLIC ACID ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHE 1986 The Intercantonal Office for Drug Control has decided that products containing salicylates
should bear on the package a warning against use by children under twelve years of age,
except on medical advice. The package leaflets directed to both physicians and patients
should additionally include warnings concerning Reye's syndrome in both the sections
"Limitations of use" and "Undesirable effects".
(Reference: (CHBCM) Bulletin Mensuel, 8, , 1986)
IRQ 1986 The National Board for the Selection of Drugs has decided to prohibit the sale of products
containing acetylsalicylic acid without a medical prescription. The product information
should contain a warning that acetylsalicylic acid should be avoided in children suffering
from influenza or chickenpox and that children under 12 years of age should receive
acetylsalicylic acid only on medical advice.
ISR Feb 1986 The Ministry of Health has ordered that preparations of acetylsalicylic acid intended
specifically for children be subjected to prescription control and that all preparations
should contain a warning referring to the reported risk of Reye's syndrome in children and
young adults with fever due to viral infections.
ITA Jun 1986 The Italian Health Council has decided that all products containing acetylsalicylic acid
should bear the following warning: "Consult your physician before administering this
product to children and teenagers with viral diseases such as influenza or chicken pox.
Discontinue use immediately if persistent vomiting or undue sleepiness occurs.".
IRL 9 Jun 1986 The National Drugs Advisory Board, in agreement with manufacturers, requires that all
paediatric dosage forms be available on prescription only. All preparations should carry
the warning "This product should not be given to children, particularly those under 12
years of age, without medical advice.".
GBR 10 Jun 1986 The Committee on Safety of Medicines has advised that acetylsalicylic acid should not be
administered to children under 12 years of age except on medical advice. Leading
manufacturers have declared their intention to stop supplying paediatric preparations.
AUS 11 Jun 1986 The Adverse Drug Reactions Advisory Committee has warned that acetylsalicylic acid
should not be given to children and teenagers with fever. The warning does not relate to
use for disorders in children and teenagers who do not have fever.
ESP 7 Aug 1986 The Director General for Pharmacy and Health Products of the Ministry of Health has
issued guidelines for package inserts for preparations containing acetylsalicylic acid. A
warning should be included stating that the preparation should be administered to
children and adolescents with febrile conditions such as influenza or varicella only on
medical advice.
HKG 1 Sep 1986 The Medical and Health Department requires that the product information for all
preparations containing acetylsalicylic acid must warn against its use in children under 12
years of age, except on medical advice. Manufacturers are urged to withdraw all
paediatric preparations.
DEU Oct 1986 The Federal Health Office requires pharmaceutical preparations containing acetylsalicylic
acid to bear a warning against use for feverish conditions in children and young people
unless on medical advice and only if other measures have failed.
OMN Dec 1986 The Central Drug Committee has informed doctors and pharmacists that no products
containing acetylsalicylic acid (aspirin) should be given to children under 12 years of age
who have chicken pox, influenza or any other febrile illness. Paediatric aspirin
preparations will be available only from pharmacies. Products for export containing
acetylsalicylic acid should bear the following statutory warning on new packs:"This
product should not be given to children, particularly those under 12 years of age, without

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 34

Product Name Acetylsalicylic acid (paediatric)

C.A.S. number 50-78-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
medical advice."
EGY 1987 The Technical Committee for Drug Control has decided that the product information of all
paediatric pharmaceutical products containing acetylsalicylic acid should bear the
following warning: "Consult a physician before giving aspirin to children aged less than 12
years, especially in cases of influenza and chickenpox, to avoid risk of Reye's Syndrome."
(Reference: (EGYDC) Decision of the Egyptian Technical Committee for Drug control,
Vol.5(2), 1, 1987)
NGA Jan 1987 Because of the suspected link between the use of acetylsalicylic acid in children below
the age of 12 years and Reye's syndrome, importation, manufacture, sale and distribution
of paediatric products containing acetylsalicylic acid or other salicylates have been
prohibited. The labels of non-paediatric products must bear the warning: "Not for use in
children below 12 years of age".
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
CHL 2 Feb 1987 The Institute of Public Health of Chile has decided that all pharmaceutical products
containing acetylsalicylic acid should carry a warning on the label that the drug should not
be given to children under 12 years of age with febrile viral diseases without consulting a
doctor.
(Reference: (CHLRS) Resolution of the Minister of Health, No.01042, , Feb 1987)
DNK 1 Jul 1987 The National Board of Health has decided that pharmaceutical preparations containing
acetylsalicylic acid in paediatric dosages (less than 200mg/tablet) should bear the
following warning: "Not to be given to feverish children without consulting a doctor.".
SGP 1 Dec 1987 The Ministry of Health has made it mandatory for all aspirin products to bear the
cautionary label: "Caution: not to be given to persons below the age of 16 years except
under the direction of a doctor" before the products can be sold in the market. The public
is advised not to give their children any medicine containing aspirin unless otherwise
advised by the doctor.
(Reference: (SGPMA) Medicines Act (Chapter 176), No.S 230/87, 1078, Aug 1987)
SWE 1988 The National Board of Health and Welfare has revised the product information for
preparations containing acetylsalicylic acid to recommend that they should not be taken
by febrile children under 18 years of age and to indicate that paracetamol is the drug of
choice in these circumstances.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning,
Vol.12(6), 145, 1987)
BEL 1 Jan 1988 The Ministry of Public Health and the Environment requires pharmaceutical products
containing acetylsalicylic acid to bear the following warning: "This medicine contains
acetylsalicylic acid. Do not use in feverish children without medical advice.".
(Reference: (BELMD) Ministerial Decree, , , June 1987)
USA Jun 1988 The United States Food and Drug Administration has revised the labelling of products
containing acetylsalicylic acid to read: "Children and teenagers should not use this
medicine for chickenpox or flu symptoms before a doctor is consulted about Reye's
syndrome, a rare but serious illness, reported to be associated with aspirin."
(Reference: (FEREAC) Federal Register, 53(111), 21633, 1988)
USA Apr 1994 The FDA proposed to revise the labelling of products containing acetylsalicylic acid
(including buffered acetylsalicylic) alone or in combination with an antacid to include the
following statement: ?IMPORTANT: See your doctor before taking this product for your
heart or for other new uses of aspirin [acetylsalicylic acid], because serious side effects
could occur with self- treatment?. [See also Combinations]
(Reference: (FEREAC) Federal Register, 58(201) , p. 54224, 1993)
USA Apr 1994 The Food and Drug Administration proposed to extend to products containing bismuth
subsalicylate and all oral and rectal over-the- counter products that contain acetylsalicylic

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 35

Product Name Acetylsalicylic acid (paediatric)

C.A.S. number 50-78-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
acid (aspirin) or other salicylates the following warning: "Children and teenagers who
have or are recovering from chicken pox, flu symptoms or flu should not use this
product. If nausea or fever occur, consult a doctor because these symptoms could be an
early sign of Reye syndrome, a rare but serious illness." [See also Bismuth subsalicylate]
(Reference: (FEREAC) Federal Register, 58(201) , p. 54228, 1993)
LKA 9 Jul 1996 Registration of a particular product was rejected because the picture of children on the
label was considered inappropriate.
(Reference: (LKADES) Drug Evaluation Sub-Committee, , , )
FRA May 1997 A special form of 100 mg tablets to chew or suck was withdrawn because of risk of
aspiration in small children. The manufacturer stopped marketing of this medicinal
product.
(Reference: (FRAAMP) Press Release, , , 14 May 1997)
BRA Jun 2001 The National Health Surveillance Agency requires all pharmaceutical products containing
acetylsalicylic acid to bear a warning against using such products in children with chicken
pox or flu symptoms without consulting a physician about Reye's syndrome.
(Reference: (BRARES) Resolucao n., 529/ANVISA, , 06 Aug 2001)
GBR Oct 2002 The Medicines Control Agency (MCA) has restricted the use of acetylsalicylic acid
products in 16 year old and younger children since the risk of aspirin associated Reye's
syndrome exists in all children up to this age group. All acetylsalicylic acid containing
products are required to include this restriction in the product monograph.
(Reference: (GBRSTE) Statement, 2002/0436, , 22 Oct 2002)
ESP 20 Jun 2003 All paediatric OTC medicinal preparations containing salicylates/acetylsalicylic acid
(Aspirin) are being withdrawn from the market. This measure has been undertaken to
prevent the use of these products in children with viral fever and thereby reduce the risk
of Reye's syndrome in these children. For non-paediatric OTC products containing
salicylates/acetylsalicylic acid the Summary of Product Characteristics (SPC) will have to
be modified to include that OTC products for adult use are contraindicated in children
below the age of 16 years and prescription products are contraindicated for the treatment
of fever, chickenpox and viral fevers in patients below 16 years of age.
(Reference: (ESPSPS) Communication to WHO, , , 08 July 2003)
NLD The Board for the Evaluation of Medicines requires information for patients on products
containing acetylsalicylic acid to contain the statement: "To be used in children with
chickenpox or influenza only on the advice of a doctor.".
WHO Comment : Acetylsalicylic acid, a nonsteroidal anti-inflammatory, analgesic
and antipyretic agent, was introduced into medicine in 1899 and has since been
widely available in over-the-counter preparations. Recent studies carried out in the
USA have shown an association between acetylsalicylic acid consumption in
children and the development of Reye's syndrome (a rare condition characterized
by a combination of encephalopathy and liver disorder and usually preceded by an
acute viral illness, such as influenza, diarrhoea, or chickenpox). Many drug
regulatory authorities have acted to caution against the use of the drug in children
and young adults with febrile conditions. Even within this group the risk of
exposure is remote and has been estimated to be of the order of 1.5 per million.
This warning also concerns products containing other salicylates. The new
indication of acetylsalicylic acid - prophylaxis of myocardial infarction due to its
antithrombotic effect - requires long-term use and may lead to serious adverse
reactions, including cerebral haemorrhage. Acetylsalicylic acid retains a valuable
place in medicine and remains in the WHO Model List of Essential Drugs.
(Reference: (WHODI) WHO Drug Information, 1:5, , 1985)

Product Name Acitretin

Legislative or regulation action
Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 36

C.A.S. number 55079-83-9

Scientific and common names, and synonyms
2,4,6,8-NONATRAENOIC ACID, 9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-3,7-DIMETHYL-2,4,6,8-NONATETRAENOIC
ACID, (ALL-E)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@EC 14 Dec 1990 The Committee for Proprietary Medicinal Products recommended that the product
information for preparations containing acitretin should state that contraception should be
maintained for 2 years after cessation of treatment and that patients should not donate
blood for 1 year after the end of therapy.
(Reference: (CPMPPO) Pharmacovigilance Opinion, 9, , 14 Dec 1990)
FRA Jun 1991 The marketing authorization for products containing acitretin was suspended, on the
grounds that the analysis of blood samples from patients receiving the drug had indicated
etretinate to be a possible metabolite. Acitretin was reintroduced in April 1991 with an
amended product information stating that contraceptive measures must be taken for a
minimum of one year after discontinuation of treatment and preferably for two years and
that patients should not donate blood either during treatment or for one year thereafter.
(Reference: (FRAMS) Ministry of Social Affairs and Integration, , , June 1991)
(Reference: (FRAMHS) Ministry of Health and Social Affairs, , , 27 Oct 1990)
WHO Comment : Acitretin, a retinol derivative, was introduced in 1989 for the
treatment of severe psoriasis. By the end of 1990, acitretin was confirmed to be
metabolized in part to etretinate. Marketing authorization was suspended
temporarily in France while the product information was modified to conform to the
recommendations issued by the Committee for Proprietary Medicinal Products of
the European Communities. Acitretin remains registered in several countries. See
also WHO comment for etretinate.

Product Name Acridine derivatives

C.A.S. number 260-94-6
Scientific and common names, and synonyms
AMINACRINE
ACRIFLAVINE
EUFLAVINE
ETHACRIDINE
PROFLAVINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 1973 These products are only available as topical disinfectants in concentrations not higher
than 1%.
DNK Sep 1979 Proflavine was withdrawn from all dental-care products in May 1978, following
demonstration of mutagenic activity in vitro. Euflavine was similarly withdrawn as of
September 1979. No direct evidence exists of any risk to man and the extent to which
these substances penetrate mammalian cells is uncertain. Nevertheless, the Registration
Board has recommended that the restriction should apply to all acridine disinfectants
"that many regard as obsolete and whose safety is questionable".
VEN Not approved for use and/or sale.
WHO Comment : Acridine derivatives with antiseptic and disinfectant activity,
including acriflavine, proflavine and euflavine, were formerly used in the treatment
of infected wounds and burns. Such use has largely been discontinued on the
grounds that safer and more effective alternatives are now available. Following
demonstration of the mutagenic activity of proflavine in 1978 it was withdrawn from

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 37

Product Name Acridine derivatives

C.A.S. number 260-94-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
dental products in Denmark. Subsequently, euflavine was similarly withdrawn.

Product Name Alatrofloxacin mesilate

C.A.S. number 157605-25-9
Scientific and common names, and synonyms
7-{(1R,5S,6S)-6-[(S)-2-AMINOPROPIONAMIDO)PROPIONAMIDO]-3-AZABICYCLO[3.1.0]HEX-3-YL}-1-(2,4-
DIFLUOROPHENYL)-6-FLUORO-1,4-DIHYDRO-4-OXO-1,8-NAPHTHYRIDINE-3-CARBOXYLIC ACID
MONOMETHANESULPHONATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARM Jul 2000 The Drug and Medical Technology Agency have rejected registration of alatrofloxacin
because recent studies have shown serious and unpredictable liver injuries after
administration of the drug.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
SGP The National Pharmaceutical Administration in the Ministry of Health has not approved
alatrofloxacin since it is associated with hepatic adverse reactions.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Albumin

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 5 Dec 1993 The Ministry of Health decided that all blood and every placenta used for the manufacture
of albumin must be shown to be derived from a donor who has never received an extract
of human growth hormone and has no family history of neurodegenerative disease.
(Reference: (FRAAMC) Communiqué de Presse, , , 01 Dec 1993)
DEU Nov 1994 Following plans of the Federal Health Office to suspend marketing authorization of a
product containing albumin manufactured from human placenta, the manufacturer has
voluntarily withdrawn the licence.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 134(2), , 1994)
GBR Nov 1997 Acting on advice from the Medicines Control Agency, the UK supplier has recalled 3
batches of human serum albumin (Amerscan Pulmonate II Technetium Lung Agent®:
Nycomed Amersham), as a precautionary measure after post-donation information
revealed that a blood donor was subsequently diagnosed with New Variant Creutzfeldt-
Jakob disease.
(Reference: (GBRNBA) Communication, , , 20 Nov 1997)
(Reference: (GBRDPR) EU/EEA Rapid Alert - Defective Product Recall, , , 17 Nov 1997)
WHO Comment : Although there is no proven or even probable instance of
transmission of Creutzfeldt-Jakob Disease (CJD), also known as Trans- missible
Spongiform Encephalopathy, by blood, blood components or plasma derivatives,
increased awareness has raised concern about such a possibility. While published
epidemiological studies give some reassurances that transmission of CJD has not
occurred through blood, they are limited in scope, and improved surveillance for
CJD is essential. In addition to routine internationally recognized donor selection

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 38

Product Name Albumin

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
criteria the following donors should be excluded: donors who have been treated
with extracts from human pituitary glands, donors who have familial history of
CJD, Gerstmann- Sträussler-Scheinker syndrome (GSS) or Fatal Familial Insomnia
(FFI), and donors who have received a human dura mater graft. (Report of a WHO
Consultation on Medicinal and other Products in Relation to Human and Animal
Transmissible Spongiform Encephalopathies. (WHO/EMC/ZOO/97.3;
WHO/BLG/97.2, WHO, Geneva, 24-26 March 1997.))
(Reference: (WHOCON) See also Placental tissue derived medication in full edition,
,, )

Product Name Alclofenac

C.A.S. number 22131-79-9
Scientific and common names, and synonyms
BENZENEACETIC ACID, 3-CHLRO-4-(2-PROPENYLOXY)-
(4-ALLYLOXY-3-CHLOROPHENYL) ACETIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1977 Products containing alclofenac were rejected following evidence of metabolite
mutagenicity.
CYP 1979 Withdrawn following reports that an epoxide urinary metabolite has mutagenic activity.
DEU 1979 Registration has been suspended following the voluntary withdrawal of alclofenac in the
United Kingdom.
GBR 1979 Alclofenac was voluntarily withdrawn by the manufacturer following reports of skin rashes
associated with its use.
ITA 1979 Withdrawn following reports that an epoxide urinary metabolite has mutagenic activity.
NZL 1979 Voluntarily withdrawn from the market.
EGY Mar 1984 Pharmaceutical preparations containing this antiinflammatory agent no longer qualify for
registration to avoid the potential risk associated with a urinary metabolite having
mutagenic activity.
GRC 1985 Withdrawn from the market.
DNK Voluntarily withdrawn by the manufacturer.
IDN Registration has been refused following reports that an epoxide urinary metabolite has
mutagenic activity.
IND Not approved for marketing following reports that an epoxide urinary metabolite has
mutagenic activity.
JOR Registration has been refused following reports that an epoxide urinary metabolite has
mutagenic activity.
MAR Registration has been refused following reports that an epoxide urinary metabolite has
mutagenic activity.
WHO Comment : Alclofenac, a phenylacetic acid derivative with analgesic,
antipyretic and antiinflammatory activity, was introduced in 1972 for the treatment
of rheumatic disorders. In the late 1970s its use was associated with a high
incidence of adverse effects, mainly skin rashes, and a urinary metabolite was

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 39

Product Name Alclofenac

C.A.S. number 22131-79-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
reported to have mutagenic activity (positive Ames test). This resulted in the
withdrawal of the drug, in some cases voluntarily, from several countries. In others
registration has been refused. The reported mutagenic potential has been
questioned by some investigators and the drug remains on the market in at least
three countries with highly evolved regulatory authorities.

Product Name Aldesleukin

Scientific and common names, and synonyms

EPIDERMAL THYMOCYTE ACTIVATING FACTOR
INTERLEUKIN-2
T-CELL GROWTH FACTOR

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP The National Pharmaceutical Administration in the Ministry of Health has restricted the
use of aldesleukin to medical oncologists in view of life-threatening toxicities, which have
been reported with the drug.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Allergen extracts

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1 Apr 1986 The National Board of Health and Welfare required producers of all marketed allergen
extracts to file registration applications before 1 April 1986. Extracts currently available
were allowed to remain on the market pending a final decision. However, having regard
to recently reported adverse reactions, existing preparations derived from mites, moulds
and certain domestic animals were withdrawn with immediate effect. Provision was,
however, made for further clinical trial of such formulations.

Product Name Almitrine

C.A.S. number 27469-53-0
Scientific and common names, and synonyms
2,4-BIS(ALLYLAMINO)-6-(4-(BIS-(P-FLUOROPHENYL)METHYL)-1-PIPERAZINYL)-S- TRIAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU The indications for use of almitrine have been restricted to chronic obstructive pulmonary
disease with respiratory insufficiency.
WHO Comment : Peripheral neuropathy has been reported in a few patients
receiving almitrine for long periods. The indications for treatment have

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 40

Product Name Almitrine

C.A.S. number 27469-53-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
consequently been restricted in the Federal Republic of Germany. Some other
countries have advised doctors to maintain patients under close supervision
throughout treatment and to restrict dosage to two out of every three months.

Product Name Aloxiprin

C.A.S. number 9014-67-9
Scientific and common names, and synonyms
POLYMERIC CONDENSATION PRODUCT OF ALUMINIUM OXIDE AND 0- ACETYLSALICYLIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Dec 1986 The Committee on Safety of Medicines has advised that preparations containing the
acetylsalicylic acid pro-drug aloxiprin should not be administered to children under 12
years of age except on medical advice.
(Reference: (GBMIL) Medicines Act Information Letter, No.48, , Oct 1986)
WHO Comment : Aloxiprin is a pro-drug of acetylsalicylic acid. See WHO comment
for acetylsalicylic acid.

Product Name Alpidem

C.A.S. number 82626-01-5
Scientific and common names, and synonyms
IMIDAZOL[1,2-?]PYRIDINE-3-ACETAMIDE, 6-CHLORO-2-(4-CHLOROPHENYL)-N,N-DIPROPYL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jan 1994 The marketing authorization of the anxiolytic agent alpidem has been withdrawn because
of several reports of hepatotoxicity, some of them fatal.
(Reference: (FRAAMC) Communiqué de Presse, , , 06 Jan 1994)

Product Name Alprostadil

C.A.S. number 745-65-3
Scientific and common names, and synonyms
PROST-13-EN-1-OIC ACID, 11,15,-DIGYDROXY-9-OXO, (11ALPHA, 13E, 15S)-
PGE1, PROSTAGLANDIN E1
(1R,2R,3R)-3-HYDROXY-2-[(E)-(3S)-HYDROXY-1-OCTENYL]-5-OXOCYCLOPENTANEHEPTANOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1991 Products for intravenous administration containing alprostadil were contraindicated in
patients with cardiac disease, including inadequately treated coronary atherosclerosis,
cardiac insufficiency and arrhythmia, cardiac infarction within the last six months, clinical
or radiological suspicion of pulmonary oedema or infiltration, severe chronic airway
obstruction, acute liver damage with elevation of transaminases or gamma-GT and an

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 41

Product Name Alprostadil

C.A.S. number 745-65-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
increased bleeding tendency.
(Reference: (BGHBL) Bundesgesundheitsblatt, 3/91, 139, 1991)
WHO Comment : Alprostadil, a prostaglandin with vasodilating and platelet anti-
aggregatory activity, was introduced in 1984 for the treatment of chronic arterial
obstruction. Intravenous administration of the drug has been associated with
adverse effects that have sometimes been severe. These include allergic reactions,
pulmonary oedema and cardiac insufficiency. Interactions with antihypertensive
agents, vasodilators, anticoagulants and inhibitors of platelet aggregation have
also occurred. This has led the German agency to modify the approved product
information of alprostadil preparations to warn against these adverse effects.

Product Name Amaranth

C.A.S. number 915-67-3
Scientific and common names, and synonyms
BORDEAUX-S
COLOUR INDEX NO.16185
CI FOOD RED 9
CI ACID RED 27
E123
FD&C RED NO.2

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1976 The provisional approval for use of amaranth as a colour additive has been withdrawn
since no study is available to resolve the uncertainty over its safety.
EGY 1981 Having regard to the potential carcinogenicity of amaranth, no new preparations
containing this substance will henceforth be considered for registration and
manufacturers are to replace amaranth with alternative substances within a period of
three years.
(Reference: (EGYDC) Decision of the Egyptian Technical Committee for Drug control, ,
, 1981)
KWT Apr 1984 Amaranth is no longer approved for use in pharmaceutical preparations and food
products.
(Reference: (KTMD) Ministerial Decree, 156/84, , 1984)
OMN 1 Apr 1986 Import of pharmaceutical products containing the colouring agent amaranth is prohibited.
LKA The Drug Evaluation Sub-Committee (Ministry of Health and Highways and Social Affairs)
decided not to accept new applications for registration of pharmaceutical products
containing the colouring agent, amaranth, because of its potential carcinogenicity.
(Reference: (LKADES) Drug Evaluation Sub-Committee, , , )
WHO Comment : Approval of amaranth as a permitted colouring agent in foods and
pharmaceutical products was withdrawn by the United States FDA in 1976, on the
basis of positive findings in carcinogenicity tests which were later disputed on
technical grounds and which have not been confirmed in subsequent tests. It has
since been withdrawn by some other national regulatory authorities because of
uncertainty regarding its safety, but elsewhere it remains widely used.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 42

Product Name Amfepramone

C.A.S. number 90-84-6
Scientific and common names, and synonyms
DIETHYLPROPION
1-PROPANONE, 2-(DIETHYLAMINO)-1-PHENYL-,
2-(DIETHYLAMINO)PROPIOPHENONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 1975 Amfepramone is prohibited for import, export, production, sale and distribution for
reasons of harmful health effects; the lack of evidence of value in the long-term
management of obesity; and the risk of dependency.
SWE Jan 1981 Amfepramone containing appetite suppressants have been withdrawn from the market.
There is a lack of evidence of their value in long-term management of obesity, they have
the potential for abuse and despite warnings they are frequently used over unacceptably
prolonged periods.
OMN 11 Jan 1987 Import and marketing of products containing amfepramone were prohibited.
(Reference: (OMNCR) Circular, 2/87, , Jan 1987)
ARE Pharmaceutical preparations containing amfepramone are banned.
NOR As a centrally acting appetite-reducing preparation, amfepramone is considered harmful
and is not approved in Norway.
VEN Amfepramone is not approved for use and/or sale.
WHO Comment : Amfepramone, a phenethylamine derivative introduced in 1957, is
controlled under Schedule IV of the 1971 Convention on Psychotropic Substances.
It remains available in many other countries with highly evolved drug regulatory
authorities as an aid to weight reduction.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Amfepramone hydrochloride

C.A.S. number 134-80-5
Scientific and common names, and synonyms
DETHYLPROPION HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Apr 2000 The Medicines Control Agency has banned the anorectic agent, amfepramone
hydrochloride on the basis of a European Commission decision stating that risks
outweigh the benefits.
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)

Product Name Amfetamine

C.A.S. number 300-62-9
Scientific and common names, and synonyms
AMPHETAMINE
BENZENEETHANAMINE, ALPHA-METHYL-, (+/-)
(+/-)-ALPHA-METHYLPHENETHYLAMINE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 43

Product Name Amfetamine

C.A.S. number 300-62-9
Country Effective Description of action taken
Date Grounds for decision
USA 1973 Anorectic drugs containing amfetamine were withdrawn from the market by the Food and
Drug Administration due to evidence of abuse and a high risk of dependence.
ARE 9 Jun 1981 Pharmaceutical preparations containing amfetamine are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
OMN 10 May 1982 Import and marketing of products containing amfetamine were prohibited.
(Reference: (OMNCR) Circular, 11/82, , May 1982)
MYS Jul 1987 All products containing amfetamine or derivatives indicated as appetite suppressants
have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.10, , Apr 1987)
NGA 1988 All products containing amfetamine have been banned.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
SAU Centrally-acting appetite suppressants are severely restricted since they have been found
to be ineffective in the management of obesity and they are subject to misuse.
WHO Comment : Amfetamine and its derivatives are potent central stimulants. Use
of amfetamines has widely been discouraged due to abuse of their euphoric effect
and their limited field of usefulness. Amfetamines have a place in the treatment of
narcolepsy and in hyperkinetic syndrome in children. However, they are no longer
recommended for use in obesity or depressive illness. Amfetamine is controlled
under Schedule II of the 1971 Convention on Psychotropic Substances.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Amineptine

C.A.S. number 57574-09-1
Scientific and common names, and synonyms
7-[(10,11-DIHYDRO-5H-DIBENZO{A,D}CYCLOHEPTEN-5-YL)AMINO]HEPATANOIC ACID HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jan 1999 The Medicines Agency has announced that the marketing authorization for the
antidepressant, amineptine (SurvectorR: Servier) has been suspended and withdrawn in
France. These actions have been taken after an evaluation of amineptine revealed a
potential for abuse and risk of dependence.
(Reference: (FRAAMI) Infofax - Pharmacovigilance, , , 22 Jan 1999)
THA Jan 1999 The Ministry of Health has withdrawn preparations of amineptine following action taken in
France.
(Reference: (THAFDA) Communication to WHO, , , 28 Jan 1999)
ARE 12 Jan 1999 The Ministry of Health has banned the sale of amineptine on account of a potential for
abuse and risk of dependence.
(Reference: (UAECW) Communication to WHO, , , 10 July 2000)
BDS Jun 1999 The Medical Health Services Headquarters in the Ministry of Health has withdrawn all
tablets of amineptine (Survector) from the market with effect from 30 June 1999.
(Reference: (BDSOL) Official letter to Regulatory Agencies, , , Feb 1999)
MAR Jun 1999 The National Advisory Commission for Pharmacovigilance has decided to suspend the
marketing authorization for amineptine. This action is based on international data

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 44

Product Name Amineptine

C.A.S. number 57574-09-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
concerning the potential abuse and risk of dependence associated with the intake of this
product.
(Reference: (MARDMP) Letter to WHO, , , 24 Aug 1999)
VTN Aug 1999 The Drug Administration of Viet Nam in the Ministry of Health has withdrawn approval for
the antidepressant, amineptine (Survector). This follows the decision taken by France to
suspend amineptine on the basis of abuse and dependency potential.
(Reference: (VTNMHD) Directive, 41(1999), QD-QLD, 05 Aug 1999)
OMN Apr 2000 The Directorate General of Pharmaceutical Affairs & Drug Control has rescheduled
amineptine as a non-psychotropic restricted controlled item because of international data
concerning its potential abuse and risk of dependence.
(Reference: (OMNCR) Circular, No. 25/2000, , 25 Apr 2000)

Product Name Aminoglutethimide

C.A.S. number 125-84-8
Scientific and common names, and synonyms
2,6-PIPERIDINEDIONE, 3-(4-AMINOPHENYL)-3-ETHYL-
2-(4-AMINOPHENYL)-2-ETHYLGLUTARIMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1966 Withdrawn from the market following demonstration of serious toxic effects to thyroids,
ovaries, adrenals and uteri of female rats, as well as atrophy and mottling of the adrenals
of some male rats. Clinical experience showed that in some children it caused sexual
precocity, masculinization of young females and other untoward effects including goitre
with thyroid hypofunction.
SAU Withdrawn from the market due to reported serious side effects.
WHO Comment : Aminoglutethimide, a weak anticonvulsant, was introduced in
1960 for use in the treatment of epilepsy. However, its adrenocortical suppressant
activity gave rise to serious adverse effects. The FDA decision in 1966 was taken in
respect of a preparation indicated in epilepsy. In 1980 preparations containing
aminoglutethimide were reintroduced in the USA exclusively for the treatment of
Cushing's disease. In 1986 they were also registered in Saudi Arabia for use in
Cushing's syndrome and for the treatment of breast cancer. In some other
countries these preparations are additionally approved for carcinoma of the
prostate.

Product Name Aminophenazone

C.A.S. number 58-15-1
Scientific and common names, and synonyms
ANTIPYRINE
AMINOPYRINE
AMIDOPYRINE-PYRAMIDON
AMIDOPYRINE
AMIDAZOFEN
DIMETHYLAMINOPHENAZONE
DIMETHYLAMINOANTIPYRINE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 45

Product Name Aminophenazone

C.A.S. number 58-15-1
Scientific and common names, and synonyms
4-DIMETHYLAMINO-2,3-DIMETHYL-1-PHENYL-3-PYRAZOLIN-5-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 1965 Importation has been prohibited because of the potential hazard of bone marrow
depression and fatal agranulocytosis.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, No. 90, , )
FIN 1976 This ingredient was removed from non-prescription drugs owing to the potential hazard of
bone marrow depression and agranulocytosis.
CHE 1977 Because of the potential to produce carcinogenic nitrosamines, this substance has been
withdrawn from all analgesic/antipyretic preparations. Two major international
manufacturers of such preparations voluntarily decided to remove this substance from
their products.
DEU 1977 Because of the potential to produce carcinogenic nitrosamines, this substance has been
withdrawn from all analgesic/antipyretic preparations. Two major international
manufacturers of such preparations voluntarily decided to remove this substance from
their products.
USA Nov 1977 The regulation providing for marketing of aminophenazone was revoked. However this
drug is not known to have been marketed in the United States.
(Reference: (FEREAC) Federal Register, 42, 53954, Oct 1977)
JPN Dec 1977 Because of the potential to produce carcinogenic nitrosamines, this substance has been
withdrawn from all oral preparations and subsequently from all other preparations.
ITA 1978 Products for oral use were withdrawn from the market due to the risk of formation of
carcinogenic nitrosocompounds. Injectable products require warnings about the risk of
hypersensitivity reactions.
KOR 1978 In view of its propensity to form a potentially carcinogenic n-nitroso compound, this
product has been withdrawn from use.
AUT Mar 1978 In view of its propensity to form a potentially carcinogenic n-nitroso compound,
pharmaceutical products containing aminophenazone and intended for oral use have
been withdrawn.
THA Nov 1978 Registration permit has been revoked for pharmaceutical preparations containing this
ingredient.
IRL 1979 Products containing aminophenazone have been withdrawn.
DNK Apr 1979 At the recommendation of the Registration Board in Denmark, preparations containing
aminophenazone and noramidopyrine for systemic use were withdrawn. This decision
was based on the potential danger of bone-marrow depression and fatal agranulocytosis,
suspected carcinogenic hazards and the availability of alternative products.
(Reference: (UGLAAD) Ugeskrift for Laeger, 141, 873, Mar 1979)
KWT Dec 1979 Banned for use and/or sale because of its dangerous side effects, mainly agranulocytosis.
(Reference: (KTMD) Ministerial Decree, 556, , 1978)
YEM Jan 1980 The Supreme Board of Drugs has called for the withdrawal of all preparations containing
aminophenazone.
GRC Oct 1980 The Ministry of Health and Welfare has withdrawn this product from domestic use.
(Reference: (GRAGA) Ministry of Health Decision, 12946, , Dec 1980)
ARE 9 Jun 1981 Pharmaceutical preparations containing aminophenazone are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
ROM 1982 The Minister of Health has recommended the gradual reduction in the use of this product
until it has been phased out of use completely.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 46

Product Name Aminophenazone

C.A.S. number 58-15-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SDN 1982 The Ministry of Health no longer allows registration of preparations containing
aminophenazone.
FRA 25 Jan 1982 The Committee for Registration of Medicines has recommended that all preparations
containing aminophenazone be withdrawn from the market by 1 January 1982.
TUR Feb 1982 After review of published information about this product, the Ministry of Health has
decided on its withdrawal and recommends changing the composition of all products
containing aminophenazone for systemic use, due to the potential danger of bone
marrow depression and fatal agranulocytosis and the availability of alternative products.
Export of this product is prohibited.
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
IND 1983 Prohibited for manufacture, sale and import due to questionable therapeutic value;
evidence of adverse effects on bone marrow as well as suspected carcinogenic hazards;
and the availability of safer analgesic drugs.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
NPL 1983 All preparations containing aminophenazone have been banned from use.
PHL Oct 1983 Preparations containing aminophenazone are no longer allowed for use/sale due to
serious side effects such as bone marrow depression and agranulocytosis.
RWA 1 Oct 1983 Preparations containing aminophenazone have been banned following established
evidence of the adverse effects of these preparations.
CHL 1984 Products containing aminophenazone have been withdrawn from the market in view of its
carcinogenic potential.
ETH 1984 Withdrawn due to the potential to produce carcinogenic nitrosamines.
HKG 1 Jan 1984 The Pharmacy and Poisons Committee no longer allows the registration, sale or
distribution of products containing aminophenazone.
BRA 23 May 1986 Registration of pharmaceutical products containing aminophenazone has been withdrawn
and further production prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, 9, , May 1986)
MYS Nov 1986 All products containing aminophenazone have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.4, , Nov 1986)
OMN Mar 1987 Import and marketing of products containing aminophenasone were prohibited.
(Reference: (OMNCR) Circular, 11/87, , Mar 1987)
BEL 1 Jan 1988 Preparations containing aminophenazone have been placed in List IV of the Arr^t, du
R,gent of 2 June 1946 and as such can be administered only on prescription. They must
be kept in a poisons cabinet and carry the skull and cross-bones label.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
GHA 01 Sep 1989 Products containing aminophenazone or its derivatives have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
BHR Preparations containing aminophenazone have been withdrawn.
GBR Products containing aminophenazone have been withdrawn from the market due to the
risk of agranulocytosis.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 47

Product Name Aminophenazone

C.A.S. number 58-15-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP Aminophenazone and related salts have been banned for importation.
SWE Products containing aminophenazone have been withdrawn from the market due to the
risk of agranulocytosis.
VEN Withdrawn from the market due to its carcinogenic potential.
WHO Comment : Aminophenazone, a pyrazolone derivative, has been used as an
antiinflammatory and analgesic agent for over a century. Its use has been
associated with cases of bone marrow depression and agranulocytosis and more
recently it has been claimed to have a carcinogenic potential. Products containing
aminophenazone have been formally withdrawn in many countries and marketing
has been voluntarily suspended in others. Elsewhere, however, proprietary
preparations containing this ingredient may remain available.
(Reference: (WHODI) WHO Drug Information, 3, 9, 1977)

Product Name Aminophylline

C.A.S. number 317-34-0
Scientific and common names, and synonyms
AMINOPHYLLINUM

EUPHYLLINUM
ETHYLENEDIAMINE
METAPHYLLIN
THEOPHYLLINE
THEOPHYLLAMINUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD May 1992 The Medicines Evaluation Board in The Netherlands has decided that tablet and
suppository formulations ofpharmaceutical products containing aminophylline should no
longer be marketed. Absorption rate from these formulations is slow and unpredictable,
bioavailability of the suppository varies widely and the therapeutic range is narrow.
(Reference: (GENMB) Geneesmiddelenbulletin, 25(5), 27, May 1992)
WHO Comment : Aminophylline, the ethylenediamine salt of theophylline, was
introduced many years ago as a treatment for asthma and is listed in the 8th WHO
Model List of Essential Drugs. It has been recognized for some 10 years that
aminophylline preparations are not interchangeable because bioavailability can
vary considerably. The resulting variability in drug absorption can lead to adverse
effects including irritation of the mucosa. Allergic reation can also be an adverse
effect of aminophylline. Theophylline functions similarly but is considered less of
an irritant.

Product Name Aminorex

C.A.S. number 2207-50-3
Scientific and common names, and synonyms
AMINOXAPHEN
2-OXAZOLAMINE, 4,5-DIHYDRO-5-PHENYL-
2-AMINO-5-PHENYL-2-OXAZOLINE

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 48

Product Name Aminorex

C.A.S. number 2207-50-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1967 The Ministry of Health withdrew preparations containing aminorex, cloforex and
chlorphentermine as a precautionary measure pending scientific evidence of a
relationship between their use and the development of pulmonary hypertension.
VEN Banned for use and/or sale.
WHO Comment : Aminorex, an anorexic agent, was introduced over twenty years
ago for the treatment of obesity. Between 1967 and 1971 its use was associated
with cases of pulmonary hypertension which led to its withdrawal in the Federal
Republic of Germany. WHO has no information to suggest that this drug remains
commercially available.

Product Name Amiprilose

C.A.S. number 56824-20-5
Scientific and common names, and synonyms
?-D-GLUCOFURANOSE, 3-0-[3-(DIMETHYLAMINO)PROPYL]-1,2-0-(1-METHYLETHYLIDENE)-, HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 27 Jan 1994 The Arthritis Advisory Committee of the FDA has recommended against approval of the
anti-inflammatory agent, amiprilose, for the treatment of rheumatoid arthritis because
adequate evidence of effectiveness and safety had not been provided.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T94-7, , 27 Jan 1994)

Product Name Amitriptyline

C.A.S. number 50-48-6
Scientific and common names, and synonyms
3-(10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTEN-5-YLIDENE)PROPYLDIMETHYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1992 The Medicines Control Authority has decided that the 50 mg tablet formulation of
amitriptyline may be prescribed only in hospitals and specialized clinics because of the
toxic potential of these products and the risk of overdosage and suicide with the high
dose formula.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, 9, 1992)
WHO Comment : Amitriptyline, a tricyclic antidepressant was introduced in 1961
for the management of endogenous depression and is listed in the 8th WHO Model
List of Essential Drugs. Much of the adverse effects are caused by its
antimuscarinic actions. These include dry mouth, cardiac arrhythmias, central
nervous system disturbances, blood disorders and risk of suicide. The risk of
suicide and dangers related to overdosage led the Norwegian Medicines Control
Authority to put the higher strength formulation under prescribing restriction in
1992. The risk of death following overdosage is apparently higher for products
containing tricyclic compounds as compared with nontricyclic products.

Product Name Amobarbital

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 49

C.A.S. number 57-43-2

Scientific and common names, and synonyms
5-ETHYL-5-ISOPENTYLBARBITURIC ACID
AMYLBARBITONE
2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-ETHYL-5-(3-METHYL-BUTYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jul 1985 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing amobarbital.
NZL 1990 In agreement with the Department of Health, products containing amobarbital and
amobarbital sodium have been withdrawn by the manufacturer.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 258, , 16 July 1990)
WHO Comment : Amobarbital is an intermediate-acting barbiturate which is
controlled under Schedule III of the 1971 Convention on Psychotropic Substances.
See WHO comment for barbiturates.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Amodiaquine

C.A.S. number 86-42-0
Scientific and common names, and synonyms
PHENOL, 4-((7-CHLORO-4-QUINOLINYL)AMINO)-2-((DIETHYLAMINO)METHYL)-
4-((7-CHLORO-4-QUINOLYL)AMINO)-ALPHA-(DIETHYLAMINO)-O-CRESOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Jul 1986 Having regard to cases of agranulocytosis associated with prophylactic use of
amodiaquine, the major manufacturer has removed malaria prophylaxis from the data
sheet worldwide.
WHO Comment : Amodiaquine, an antimalarial agent related to chloroquine, was
introduced over 40 years ago for the treatment and prophylaxis of malaria. The
drug was voluntarily withdrawn in the United Kingdom in 1975 for commercial
reasons but was subsequently reintroduced in 1985 to meet the medical demand
for an antimalarial drug to deal with the rapid spread of chloroquine-resistant
falciparum malaria in Asia and Africa. By 1986 a significant number of cases of
agranulocytosis associated with prophylactic use, some of which were fatal, had
been reported there and it has been estimated that the frequency of this risk is of
the order of 1:2,000. Although most cases occurred when amodiaquine had been
used in combination with other antimalarials, the major manufacturer decided to
withdraw the prophylactic indication worldwide following discussions with experts.
Preparations remain available for the treatment of acute attacks of malaria which
involves only a short period of exposure to the drug.
(Reference: (WHODI) WHO Drug Information, 1, 5, 1987)

Product Name Amyl nitrite

Scientific and common names, and synonyms

MIXTURE OF NITROUS ACID, 2-METHYLBUTYL ESTER AND NITROUS ACID, 3-METHYLBUTYL ESTER

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 50

Product Name Amyl nitrite

Country Effective Description of action taken

Date Grounds for decision
GBR Aug 1996 The Medicines Control Agency has proposed that amyl nitrite should become a
prescription-only medicine in view of its misuse as a stimulant.
(Reference: (GBRPHJ) The Pharmaceutical Journal, Vol.257, p.785, 10 Aug 1996)

Product Name Anabolic steroids

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Oct 1989 Products containing anabolic steroids indicated for increasing appetite in children have
been withdrawn, due to the risks of undesirable androgenic effects. All products
containing anabolic steroids have been subjected to prescription control.
(Reference: (THAMH) Ministry of Public Health, , , 15 Apr 1991)
CAN 26 Jun 1992 Products containing androgenic-anabolic steroids are claffified in Schedule G of the Food
and Drugs Act and the Schedule to the Food and Drugs Regulations with regard to the
high prevalence of their abuse by athletes and high school children. They are now subject
to import/export permits, licensing and prescription control.
(Reference: (CANHW) Canada Health and Welfare, , , 13 Oct 1992)
WHO Comment : Anabolic steroids were formerly used to increase weight in
patients suffering from emaciation or debilitating diseases but have not proved
totally successful. They are also used in the treatment of certain aplastic anaemias,
breast cancer and in the prevention of osteoporosis. They have been subject to
much abuse in athletes and malnourished children to increase body weight.
Misuse in prepubertal children has been associated with undesirable effects,
including precocious sexual development in males and virilization in females,
which have led the Thai agency to withdraw products containing anabolic steroids
indicated for increasing appetite in children.

Product Name Anagestone acetate

C.A.S. number 3137-73-3
Scientific and common names, and synonyms
PREGN-4-EN-20-ONE, 17-(ACETYLOXY)-6-METHYL-, (6ALPHA)
17-HYDROXY-6ALPHA-METHYL-PREGN-4EN-20-ONE-ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1969 Following reports of breast tumours in dogs receiving anagestone acetate in combination
with mestranol, the manufacturer withdrew preparations containing these drugs.
AUT 23 May 1969 Following reports of breast tumours in dogs receiving anagestone acetate in combination
with mestranol, the manufacturer withdrew preparations containing these drugs.
KWT 1 Apr 1970 Importation and marketing of preparations containing anagestone acetate is prohibited.
WHO Comment : Anagestone acetate, a synthetic progestogen, was introduced in
1968 as a component in oral contraceptive preparations. In 1969, it was shown to
be associated with an increased risk of mammary tumours in dogs which led the
United States Food and Drug Administration to order the termination of its use in
all clinical trials. Subsequently the manufacturer withdrew preparations containing
anagestone acetate, ultimately on a worldwide basis.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 51

Product Name Anagestone acetate

C.A.S. number 3137-73-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Androgens

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Sep 1989 Products containing androgens may no longer be indicated for suppression of lactation
and prevention of breast engorgement in mothers who elect not to breastfeed.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T89-56, , 27 Sep 1989)
WHO Comment : Androgens have been used for the prevention of postpartum
breast pain and engorgement. However, because of the risk of rebound effect and
since only 10% of women benefit therapeutically from such intervention, the United
States Food and Drug Administration has requested manufacturers to stop labeling
preparations containing androgens for this indication. The World Health
Organization is not aware of similar action having been taken elsewhere.

Product Name Antihistamine (topical)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS Nov 1986 Antihistamines intended for local use were not approved.
(Reference: (MYSDC) Malaysian Drug Control Authority, 1985-1987, , )
LKA 1 Jan 1992 The Ministry of Health withdrew from sale cream formulations of antihistamines. It
considers that antihistamine cream is of no value in hypersensitive skin rashes and that
the preparations can themselves induce such rashes.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
WHO Comment : Antihistamines have been used for many years as a treatment for
hypersensitive reactions. The topical application of antihistamines is, however,
associated with an unacceptable incidence of skin irritation and hypersensitivity
reactions.

Product Name Aphrodisiac drugs

Scientific and common names, and synonyms

CANTHARIDES
ESTROGENS
METHYLTESTOSTERONE
NUX VOMICA
STRYCHNINE
TESTOSTERONE
YOHIMBINE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 52

Product Name Aphrodisiac drugs

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 8 Jan 1990 All nonprescription products claiming to have aphrodisiac effects have been banned, on
the grounds that they are unsafe and of doubtful effectiveness. Among the ingredients
contained in these products are: cantharides, estrogens, methyltestosterone, nux vomica,
strychnine, testosterone and yohimbine.
(Reference: (FEREAC) Federal Register, 54(129), 28780, 1989)
(Reference: (FDATP) Food and Drug Administration Talk Paper, T89-42, , 07 July 1989)

Product Name Aprobarbital

C.A.S. number 77-02-1
Scientific and common names, and synonyms
5-ALLYL-5-ISOPROPYLBARBITURIC ACID
APROBARBITONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jul 1985 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing aprobarbital.
WHO Comment : Aprobarbital is an intermediate-acting barbiturate. See WHO
comment for barbiturates.

Product Name Aristolochia

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Jul 1999 The Medicines Control Agency has banned the import, sale and supply of medicinal
products containing the Chinese herbal medicine Aristolochia. This was on account of
end-stage renal failure associated with the use of this product.
(Reference: (GBRSIN) Statutory Instrument, The Medicines (Aristolochia) (Temporary
Prohibition) Order 1999, , , 28 Oct 1999)

Product Name Aristolochic acid

C.A.S. number 313-67-7
Scientific and common names, and synonyms
8-METHOXY-6-NITROPHENANTHRO(3,4-D)-1,3-DIOXOLE-5-CARBOXYLIC ACID
ARISTOLOCHINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1981 The Federal Health Office withdrew all preparations containing aristolochic acid from the
national market following demonstration of a carcinogenic potential in a three-month
toxicity study in rats. The Federal Health Office considers that aristolochic acid is a

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 53

Product Name Aristolochic acid

C.A.S. number 313-67-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
particularly potent carcinogen having regard to the unusually short period of exposure
required for induction; the variety of tissues involved; the marked dose-effect relationship
and the rapid progression of malignant changes after suspension of dosage. The
regulatory decision relates not only to branded drugs containing aristolochic acid but to
the sale of herbal preparations or extracts prepared from plants of the aristolochiaceae
family. Only homeopathic preparations prepared to a dilution of at least
1:100,000,000,000 were exempted.
AUT Aug 1981 The Federal Ministry of Health and Environmental Protection has instructed pharmacists
that, having regard to their apparent risks, preparations containing aristolochic acid have
no justifiable use.
EGY 1982 Products containing aristolochic acid were withdrawn following demonstration of
carcinogenicity in rats.
USA Apr 2001 The FDA has cautioned consumers against consuming any dietary supplement or
traditional medicine containing aristolochic acid.
(Reference: (USAMDR) Media Release, , , 11 Apr 2001)
FRA Jul 2001 All homeopathic preparations containing Aristolochia brasiliensis and homeopathic
preparations containing products belonging to Aristolochiaceae or related plant families
have been withdrawn due to risks of nephrotoxicity and carcinogenicity associated with
aristolochic acid.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)
OMN Jul 2001 Prohibition of import and marketing in view of kidney toxicity and urinary tract cancer
associated with aristolochic acid.
(Reference: (OMNCR) Circular, 25/2001, , 02 Oct 2001)
CAN Oct 2001 Health Canada has issued a Customs Alert to prevent the sale and import of products
containing aristolochic acid. Manufacturers, retailers and importers have been requested
to withdraw from the market all existing products containing aristolochia and aristolochic
acid.
(Reference: (CANWHC) Warnings/Advisories, 20011005, 20020516, 24 Aug 2001)
AUS Dec 2001 A traditional product named Longdan Qiegan Wan (Wetness Heat Pill) has been
removed from the Australian Register of Therapeutic Goods since it contains aristolochic
known to cause kidney damage and urinary tract cancer.
(Reference: (AUSMDR) Media Release, , , 07 Dec 2001)
VEN Not approved for use and/or sale.
WHO Comment : Extracts of aristolochiaceae have traditionally been used as a
bitter for which a broad range of therapeutic effects has been claimed. Aristolochic
acid is claimed to promote phagocytosis and to have immunostimulant activity.
However, in 1981, a three-month toxicity study in rats revealed the carcinogenic
potential of aristolochic acid and preparations containing this substance have
since been withdrawn in several countries.

Product Name Arsenic-based compounds

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT Oct 1969 All tonics, parenteral preparations, oral asthma remedies and vaginal tablets containing
arsenic have been withdrawn in the light of the carcinogenic potential of arsenic-

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 54

Product Name Arsenic-based compounds

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
containing compounds.
PHL Mar 1976 Banned in any form for use in pharmaceuticals.
ESP 1 Oct 1983 Preparations containing inorganic arsenicals have been withdrawn.
(Reference: (ESPMC) Programa Selectivo de Revisión de Medicamentos, (1), , Sep
1983)
ITA These substances in tonics and reconstituents have been removed from the market
owing to an unfavourable risk/benefit ratio.
WHO Comment : Arsenic-based compounds, which were used over 2000 years ago
as both therapeutic agents and poisons, became the mainstay of chemotherapy
earlier this century. Although such compounds have been largely superseded by
safer and more effective alternatives, they remain important in the treatment of
certain tropical diseases.

Product Name Astemizole

C.A.S. number 68844-77-9
Scientific and common names, and synonyms
1H-BENZIMIDAZOL-2-AMINE, 1[(4-FLUOROPHENYL)METHYL]-N-[1-[2-(4-METHOXYPHENYL)ETHYL]-4-PIPERIDINYL]-
1[(4-FLUOROPHENYL)METHYL]-N-[1-[2-(4-METHOXYPHENYL)ETHYL]- 4-PIPERIDINYL]-1H-BENZIMIDAZOL-2-AMINE
1-(P-FLUOROBENZYL)-2-[[1-(P-METHOXYPHENETHYL)-4-PIPERIDYL]AMINO]BENZIMIDAZOLE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1987 The medicines control authority has refused registration of astemizole because its
prolonged half-life renders appropriate dosage difficult and the possibility of hepatic
toxicity and adverse immunologically-mediated effects have not been adequately
excluded.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 4, 4, 1987)
NZL Oct 1996 Astemizole has been reclassified to Restricted Medicine (an OTC classification, but may
only be sold personally by a pharmacist).
(Reference: (NZLPU) Prescriber Update, No.13, , Oct 1996)
ARG 1997 Product information and labelling of pharmaceutical products containing the histamine H-
antagonists astemizole and terfenadine have to include a warning1 concerning
prolongation of the QT interval and ventricular arrhythmias.
(Reference: (ARGBO) Boletín oficial, No.28.616, 1535/97, )
GBR 1998 Astemizole has been reclassified to Prescription only Medicine as a result of new data on
interactions from postmarketing surveillance studies. These data highlight an increased
risk of QT prolongation with concomitant administration of oral or parenteral formulations
of azole antifungals, macrolide antibiotics except azithromycin, selective serotonin
reuptake inhibitors, HIV protease inhibitors and mibefradil (now withdrawn worldwide). In
addition, astemizole is contraindicated for use in patients with hepatic dysfunction.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 261, p.9, 04 July 1998)
PHL 1998 The Department of Health Bureau of Food and Drugs have noted the voluntary
withdrawal by the sponsoring company of the antihistamine, astemizole due to its
association with severe cardiac adverse events when used inappropriately with
contraindicated drugs.
(Reference: (PHLCTW) Communication to WHO, , , 15 Aug 2000)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 55

Product Name Astemizole

C.A.S. number 68844-77-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1999 Janssen, the manufacturer of the histamine H1-receptor antagonist, astemizole,
(HismanalR) has announced that it is voluntarily withdrawing the 10-mg formulation from
the market. Since the drug's approval in 1988, new adverse reaction data has
necessitated a series of labelling changes and warnings. In the light of the choices of
other prescription antihistamines now available and the overall risk benefit profile of this
drug, the Food and Drug Administration supports the decision of the company to
withdraw the product.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T99-29, , 21 June 1999)
ZAF 1999 The South African Medicines Control Council has withdrawn products containing
astemizole because of the potential for serious drug interactions.
(Reference: (ZAFPS) Information from the Pharmaceutical Services, , , )
ARE Jun 1999 The Ministry of Health has banned the sale of astemizole with effect from 23 June 1999
on account of increased risk of QT prolongation with concomitant administration of oral or
parenteral formulations of azole antifungals, macrolide antibiotics except azithromycin,
selective serotonin reuptake inhibitors and HIV protease inhibitors.
(Reference: (UAECW) Communication to WHO, , , 10 July 2000)
MUS Jun 1999 Astemizole was withdrawn from the market following reports of adverse drug reactions
published by the FDA and the decision of Janssen Pharmaceutica to remove the drug in
the USA.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)
BDS Jul 1999 The manufacturer withdrew astemizole worldwide because of serious adverse
cardiovascular reactions.
(Reference: (BDSOL) Official letter to Regulatory Agencies, , , 01 July 1999)
URT 2 Jul 1999 The Pharmacy Board of the Ministry of Health, in the United Republic of Tanzania has
withdrawn astemizole from the market.
(Reference: (URTMH) Communication to WHO, , , 20 Nov 2000)
ARM Jul 2000 Astemizole has been voluntarily withdrawn on the basis of prolongation of the QT-interval
and ventricular arrhythmias.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
BRA Jun 2001 Registration cancelled due to several adverse reactions.
(Reference: (BRARES) Resolucao n., 526/ANVISA, , 06 Aug 2001)
ESP 08 Apr 2003 The Spanish Medicines Agency has withdrawn the marketing authorization for 10
medicinal products containing astemizole due to the potential of these products to
produce life-threatening ventricular ar-rhythmias.
(Reference: (ESPSMA) Communication to WHO, , , 08 Apr 2003)
ARG 19 Aug 2003 The Food, Drug and Medical Devices agency in Argentina, ANMAT, has withdrawn all
medicinal products containing astemizole since these products have the potential to
cause life-threatening ventricular arrhythmias.
(Reference: (ARGFDM) Communication from ANMAT, , , 19 Aug 2003)
SGP The National Pharmaceutical Administration in the Ministry of Health has banned
astemizole since it has been associated with adverse drug reactions including irregular
heart rhythms and severe allergic reactions if taken at higher than recommended doses
or in conjunction with some other drugs including antihypertensives and anti-asthmatics.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)
WHO Comment : The first clinically interesting histamine H-antagonists were1
introduced in the late forties and early fifties. Several histamine H-antagonists1
have a similar cardiac effect to that seen with astemizole and terfenadine. Serious
cardiovascular adverse reactions have been reported when used concomitantly
with imidazole antifungals and macrolide antibiotics. See also under terfenadine.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 56

Product Name Astemizole

C.A.S. number 68844-77-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Azapropazone

C.A.S. number 13539-59-8
Scientific and common names, and synonyms
5-DIMETHYLAMINO-9-METHYL-2-PROPYL-1H-PYRAZOLO(1,2-A)(1,2,4)BENZOTRIAZINE-1, 3(2H)-DIONE
APAZONE

1H-PYRAZOLO(1,2-A)(1,2,4)BENZOTRIAZINE-1,3(2H)-DIONE, 5-(DIMETHYLAMINO) -9-METHYL-2-PROPYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1985 Indications are restricted to exacerbations of inflammatory degenerative rheumatism, soft
tissue rheumatism and pain, post-traumatic swelling or inflammation. Preparations are
contraindicated in children under six years of age.
OMN Sep 1986 The Ministry of Health has prohibited the import of preparations containing azapropazone
except those intended for topical use.
BEL 1 Jan 1988 Preparations containing azapropazone have been placed in List IV of the 'Arr^t, du
R,gent' of 2 June 1946 and as such can be administered only on prescription. They must
be kept in a poisons cabinet and carry the skull and cross-bones label.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
AUT Indications restricted to exacerbations of gout and other arthritic conditions. Treatment
should not exceed seven days and doctors are advised not to prescribe this drug to
children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
WHO Comment : Azapropazone, which has anti-inflammatory, analgesic and
antipyretic activity, was introduced in 1970 for the treatment of rheumatic
disorders. Although sometimes classified as a pyrazolone derivative, the
relationship with this group of compounds has been disputed and classification as
a benzotriazine derivative might be preferable. Although, to date, it has not been
associated with blood dyscrasias, some regulatory authorities have applied the
same rigorous restrictions to its indications as they have applied to pyrazolone
derivatives. The World Health Organization was informed that as of December 1987
azapropazone was available in some 27 countries.

Product Name Azaribine

C.A.S. number 2169-64-6
Scientific and common names, and synonyms
AS-TRIAZINE-3,5-(2H,4H)-DIONE, 2-(2',3',5'-TRIACETYL-BETA-D- RIBOFURANOSYL)-
TRIACETYL AZAURIDINE
1,2,4-TRIAZINE-3,5(2H,4H)-DIONE, 2-(2,3,5-TRI-O-ACETYL-BETA- RIBOFURANOSYL)-
2-BETA-D-RIBOFURANOSYL-AS-TRIAZINE-3, -5(2H,4H)-DIONE 2',3',5',- TRIACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Aug 1976 This antineoplastic agent, which was indicated only for severe, recalcitrant, disabling
arthritis, was withdrawn from the market following reports of several serious

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 57

Product Name Azaribine

C.A.S. number 2169-64-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
thromboembolic and thrombotic reactions. Several of these lesions occurred in relatively
unusual arterial sites (including the radial, ulnar, femoral and popliteal arteries) and one
death resulted from pulmonary embolism.
THA Feb 1977 Products containing this ingredient have been banned.
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
SAU Withdrawn from the market following reports of adverse effects.
VEN Not approved for use and/or sale.
WHO Comment : Azaribine, an antineoplastic agent, was introduced in 1975 for the
treatment of severe, recalcitrant, disabling arthritis. Following reports of
thromboembolic and thrombotic reactions, the drug was withdrawn in the USA in
1976. The causal relationship between azaribine and these events has been
questioned and the drug remains available in the USA for investigational purposes.

Product Name Barbital

C.A.S. number 57-44-3
Scientific and common names, and synonyms
5,5-DIETHYLBARBITURIC ACID
BARBITONE
DIETHYLMALONYLUREA
DIEMALUM
MALONAL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA This substance for use as a sedative has been removed from the market owing to an
unfavourable risk-benefit ratio and the lack of substantial evidence of efficacy.
WHO Comment : Barbital is a long-acting barbiturate which is controlled under
Schedule IV of the 1971 Convention on Psychotropic Substances. See WHO
comment for barbiturates.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Beclobrate

C.A.S. number 55937-99-0
Scientific and common names, and synonyms
ETHYL(+)-2-[[ALPHA-(P-CHLOROPHENYL)-P-TOLYL]OXY]-2-METHYLBUTYRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 58

Product Name Beclobrate

C.A.S. number 55937-99-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHE 1990 Having regard to two reports of fatal hepatitis, the marketing authorization of products
containing beclobrate has been withdrawn.
(Reference: (CHBCM) Bulletin Mensuel, 8, , 24 Sep 1990)
WHO Comment : Beclobrate, an antihyperlipidaemic agent, was introduced into
medicine in 1985. Although a causal relationship between the use of the drug and
hepatic toxicity has not been established, the Intercantonal Office for the Control of
Medicines has withdrawn marketing authorization since safer therapeutic
alternatives are available. Beclobrate is not registered elsewhere.

Product Name Bencyclane

C.A.S. number 2179-37-5
Scientific and common names, and synonyms
3-[(1/BENZYLCYCLOHEPTYL)OXY]-N,N-DIMETHYLPROPYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Feb 1991 In collaboration with the Federal Health Office, the manufacturer amended the approved
product information of preparations containing bencyclane to contraindicate their use in
epileptic patients; in patients who had sustained head injury within the previous 12
months; and in patients receiving treatment with pentoxifylline, naftidrofuryl, flunarizine or
buflomedil.
(Reference: (DEUFHO) Communication from Federal Health Office, , , 29 June 1992)
WHO Comment : Bencyclane, a vasodilator, was introduced in 1970 for the
treatment of peripheral and cerebral vascular disorders. In 1991, its use was
contraindicated by the German authorities in patients at risk of epilepsy following
reports of convulsions in patients under treatment. Bencyclane is widely registered
and the World Health Organization is not aware of restrictive action having been
taken elsewhere.

Product Name Benorilate

C.A.S. number 5003-48-5
Scientific and common names, and synonyms
BENORYLATE
4-ACETAMIDOPHENYL SALICYLATE ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Dec 1986 The Committee on Safety of Medicines has advised that preparations containing
benorilate should not be administered to children under 12 years of age except on
medical advice.
(Reference: (GBMIL) Medicines Act Information Letter, No.48, , Oct 1986)
WHO Comment : Benorilate is the acetylsalicylic ester of paracetamol. See WHO
comment for acetylsalicylic acid.

Product Name Benoxaprofen

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 59

C.A.S. number 51234-28-7

Scientific and common names, and synonyms
5-BENZOXAZOLEACETIC ACID, 2-(4-CHLOROPHENYL)-ALPHA-METHYL, (+/-)
(+/-)-2-(P-CHLOROPHENYL)-ALPHA-METHYL-5-BENZOXAZOLEACETIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Aug 1982 Following action in Denmark and reports from other countries, in particular of hepatic
reactions in elderly patients from the United Kingdom, the drug was withdrawn worldwide
by the manufacturer. Benoxaprofen had previously been withdrawn in several countries
because of serious toxic effects on various organ systems, particularly the gastro-
intestinal tract, the liver and bone marrow, in addition to previously known effects on the
skin, eyes and nails. Subsequent to this decision, limited clinical trials were abandoned
following demonstration of positive findings in carcinogenicity studies in mice.
WHO Comment : Benoxaprofen, a nonsteroidal antiinflammatory agent, was
introduced in 1980 for the treatment of rheumatic disorders. Following reports of
serious adverse effects, some of which were fatal, it was withdrawn in several
countries prior to worldwide withdrawal by the manufacturer in 1982.

Product Name Benzarone

C.A.S. number 1477-19-6
Scientific and common names, and synonyms
2-ETHYLBENZOFURAN-3-YL 4-HYDROXYPHENYL KETONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 19 Oct 1992 The Federal Health Office suspended the marketing authorization for pharmaceutical
products containing benzarone.
(Reference: (DEUPD) BGA Pressedienst, , , 20 Oct 1992)
(Reference: (DEUFHO) Communication from Federal Health Office, , , 19 Oct 1992)
WHO Comment : Benzarone is given by mouth and applied topically for treatment
of various vascular peripheral disorders.The decision to suspend the marketing
authorization results from several reports of toxic hepatitis, including one fatal
case from within Germany. The product remains registered in Italy and France.

Product Name Benzbromarone

C.A.S. number 2004-0-0001

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PRT Apr 2003 Suspended due to unfavourable benefit-risk evaluation.
(Reference: (PRTRAC) Communication to WHO, , , Apr 2003)
FRA 22 Apr 2003 The hyperuricaemic product benzbromarone (Desuric) has been withdrawn following
reports of serious liver damage associated with the product's use.
(Reference: (FRAAMP) Press Release, , , 22 Apr 2003)

Product Name Benzoylperoxide

C.A.S. number 94-36-0
Scientific and common names, and synonyms
BENZOYL PEROXIDE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 60

Product Name Benzoylperoxide

C.A.S. number 94-36-0
Scientific and common names, and synonyms
BENZOIC ACID, PEROXIDE
DIBENZOYL PEROXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Aug 1995 The FDA has proposed additional labelling (warning and directions) for topically applied
acne treatment drug products containing benzoyl peroxide. It advises consumers to
avoid unnecessary exposure to the sun and to apply a sunscreen when using benzoyl
peroxide to treat acne.
(Reference: (FEREAC) Federal Register, 60(33) , p. 9545, 1995)
WHO Comment : Benzoyl peroxide slowly releases oxygen and hence is
bactericidal. It is also keratolytic, antiseborrheic and irritant. It is used in the
treatment of acne. Benzoyl peroxide is listed in the WHO Model List of Essential
Drugs.

Bibliographical references
IARC MONOGRAPH, 36, 267, 1985

Product Name Benzyl alcohol

C.A.S. number 100-51-6
Scientific and common names, and synonyms
ALPHA-TOLUENOL
ALPHA-HYDROXYTOLUENE
BENZENEMETHANOL
BENZENECARBINOL
PHENYLMETHYL ALCOHOL
PHENYLMETHANOL
PHENYLCARBINOL
(HYDROXYMETHYL)BENZENE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISR 1982 The Ministry of Health has ordered that this preservative be excluded from solutions
intended for parenteral infusions (in large volumes). In other parenteral preparations
containing this preservative, the following warning should be added to the label:
"Caution - not to be used in newly-born or premature infants".
OMN 1982 Prohibited for import or sale as a preservative in water and normal saline intended for
injection.
USA 1982 The Food and Drug Administration has advised that benzyl alcohol should not be used as
a preservative in drugs or fluids intended for parenteral administration in neonates,
following reports of 16 deaths in neonates attributed to the use of 0.9% benzyl alcohol in
water and saline used to clear intravascular catheters and to reconstitute drugs. Death
followed signs of metabolic acidosis and convulsions. Both blood and urine contained
high concentrations of benzoic and hippuric acid.
ITA 1983 The label for products containing this compound advises "Owing to benzyl alcohol
presence, do not administer to children less than two years old".
GRC 1984 All preparations containing benzyl alcohol must carry the warning "Its use should be
avoided in children under two years of age. Not to be used at all in neonates.".

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 61

Product Name Benzyl alcohol

C.A.S. number 100-51-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU The contraindications have been extended to include "Not to be used in neonates,
particularly in the premature".
(Reference: (AFS) Arbetarskyddsstyrelsens Foerfattningssamling, 32, 3, 4332)
THA The use of pharmaceutical preparations containing benzyl alcohol is severely restricted.
VEN Subject to restricted use and/or sale.
WHO Comment : Benzyl alcohol has been used as an antimicrobial agent in
pharmaceutical preparations for many years. Parenteral administration of
preparations containing 0.9% benzyl alcohol resulted in the death of 16 neonates in
the USA in the early 1980s. Many countries subsequently warned against using
such preparations in neonates. This decision is not applicable to the use of benzyl
alcohol as a preservative in other circumstances or to its use in topical
preparations and no country has placed a total ban on the compound.

Product Name Benzylpenicillin sodium (topical preparations)

C.A.S. number 69-57-8
Scientific and common names, and synonyms
BENZYLPENICILLIN
CRYSTALLINE PENICILLIN G SODIUM
MONOSODIUM (2S,5R,6R)-3,3-DIMETHYL-7-OXO-6-(2-PHENYLACETAMIDO)-4-THIA- 1-AZABICYCLO(3.2.0)HEPTANE-2-
CARBOXYLATE
PENICILLIN G
PENICILLIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Feb 1972 Topical preparations have been withdrawn from the market and are prohibited for export
by the Food and Drug Administration due to the lack of effectiveness of these products
and an unfavourable benefit-to-risk ratio.
(Reference: (FEREAC) Federal Register, 37, 438, Feb 1972)
ITA 1976 Preparations for rectal and topical use, including those intended for use in the mouth,
have been withdrawn from the market owing to the risk of sensitization.
PHL 1976 Penicillin ointment and other penicillin-containing products for topical application have
been banned for use/sale due to the risk of sensitization.
(Reference: (PHADO) Administrative Order, 238, , 1976)
ETH 1978 Preparations for topical use have been withdrawn following reports of hypersensitivity.
BGD Jun 1982 Use of all topical preparations was discontinued due to lack of effectiveness and risk of
hypersensitivity reactions.
IND 1983 Skin and eye ointments have been prohibited for manufacture and sale for reasons of
health risks associated with use and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
CHL Pharmaceutical preparations intended for topical use containing penicillin and its
derivatives were prohibited.
(Reference: (CHLRS) Resolution of the Minister of Health, No. 10154, , Oct 1986)
CYP All products containing penicillin intended for topical use were withdrawn following a
review of published information on hypersensitivity in treated patients.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 62

Product Name Benzylpenicillin sodium (topical preparations)

C.A.S. number 69-57-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP Combination products containing penicillin for topical or rectal use will no longer be
considered for registration since topically applied penicillin may evoke serious dermatitis
and rectal absorption is insecure, irregular and inadequate.
THA Ointment containing benzylpenicillin is not approved for use.
VEN Not approved for use and/or sale.
WHO Comment : Benzylpenicillin sodium, one of the first penicillin derivatives to
be used in medicine, was introduced in the early 1940s. Topical preparations
intended for use on the skin have been associated with allergic rashes and are in
general no longer acceptable. However, topical preparations for specialized use, in
particular in the eye and on open wounds, are available in many countries.
Injectable preparations of benzylpenicillin are included in the WHO Model List of
Essential Drugs.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Bibliographical references
WHO FOOD ADD., 27, 105, 1991

Product Name Berberine

C.A.S. number 2086-83-1
Scientific and common names, and synonyms
5,6-DIHYDRO-9,10-DIMETHOXY-BENZO(G)-1,3-BENZODIOXOLO(5,6-A) QUINOLIZINIUM
7,8,13,13A-TETRAHYDRO-9,10-DIMETHOXY-2,3-METHYLENEDIOXY-BERBINIUM
BERBERIN
BERBERICINE
UMBELLATIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP Oct 1978 The Ministry of Health announced a prohibition on the importation and sale of
preparations containing berberine following reports of jaundice, haemolytic anemia and
kernicterus with brain damage in infants with glucose 6-phosphate dehydrogenase
deficiency who were exposed either in utero or post-natally.
VEN Not approved for use and/or sale.
WHO Comment : Berberine, an alkaloid contained in many plants including
Berberis species, remains available in many tropical countries. Both traditional
herbal remedies and tablet formulations containing this substance have been used
in the treatment of gastrointestinal disease, and injectable preparations have been
claimed to be of value in the treatment of cutaneous leishmaniasis. The action
taken in Singapore relates to reports of jaundice, haemolytic anaemia and
kernicterus with brain damage in infants with G6PD deficiency who were exposed
either in utero or post-natally. Preparations for topical application are also
available in some countries. These have not been associated with reports of
systemic toxicity.

Product Name Beta ethoxylacetanilide

C.A.S. number 539-08-2

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 63

Product Name Beta ethoxylacetanilide

C.A.S. number 539-08-2
Scientific and common names, and synonyms
LACTYLPHENETIDINE
LACTIC ACID-P-PHENETIDINE
N-(PARA-ETHOXYPHENYL) LACTAMIDE
N-(4-ETHOXYPHENYL)-2-HYDROXYPROPANAMIDE

P-LACTOPHENETIDINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Mar 1986 Preparations containing beta-ethoxylacetanilide have been withdrawn and will no longer
be considered for registration.
WHO Comment : Beta-ethoxylacetanilide is an analogue of phenacetin. See WHO
comment for phenacetin.

Product Name Bicalutamide

C.A.S. number 2004-0-0002

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CAN 18 Aug 2003 Withdrawn due to reports of accelerated deaths of patients with localized prostate cancer.
(Reference: (CANWHC) Warnings/Advisories, , , 18 Aug 2003)
GBR 28 Oct 2003 Withdrawn due to reports of accelerated deaths of patients with localized prostate cancer.
(Reference: (GBRCW) Communication, , , 28 Oct 2003)

Product Name Bismuth salts

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
EGY 1975 Products containing bismuth subgallate were withdrawn due to a possible association
with encephalopathy.
JPN Jun 1975 Bismuth was banned in over-the-counter drugs due to psychoneurotic disorders found
with use. In 1981 the indication for bismuth in preparations available only on prescription
was restricted to diarrhoea.
GRC 1976 Bismuth subgallate was withdrawn in 1976 and bismuth subnitrate was withdrawn in 1980.
FRA Sep 1978 All oral proprietary medicinal products containing insoluble bismuth salts were removed
provisionally from the market for a period of one year and have subsequently remained
suspended on grounds of apparent neuropsychiatric toxicity. Relevant entries have not,
however, been deleted from the French Pharmacopoeia and pharmacists remain entitled
to compound prescriptions on the order of a doctor.
AUT 31 Dec 1980 Pharmaceutical preparations containing salts or esters of bismuth were withdrawn
following reports of encephalopathy associated with their use. Some eye ointments were
exempted from this decision.
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, products with bismuth have been
banned. This substance is cited as a cause of encephalopathy.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 64

Product Name Bismuth salts

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 1982 After review of published information about this product, the Ministry of Health required
manufacturers to remove insoluble bismuth salts from pharmaceutical products intended
for oral use, with the exception of colloidal bismuth potassium citrate complex. Export of
these products is prohibited.
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
SWE Sep 1983 Preparations containing bismuth salts are now available on prescription only.
OMN Apr 1989 Import and marketing of antidiarrhoeal preparations intended for paediatric use
containing bismuth salts were prohibited.
(Reference: (OMNCR) Circular, 9/89, , Apr 1989)
CUB The use of bismuth subnitrate in paediatric preparations is prohibited on the
recommendation of the National Paediatricians Group.
IND Prohibited for manufacture and sale for reasons of health risks associated with use
and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
ITA Insoluble bismuth salts for oral administration carry a label with a warning concerning the
advisability of avoiding prolonged use and high dosages. Products with other
chemotherapeutic activity (other than anti-luetics) have been withdrawn from the market.
SAU Bismuth subgallate remains available only for use in suppositories.
WHO Comment : Bismuth salts were first introduced into medicine over two
centuries ago and have since been used in over-the-counter preparations for the
treatment of dyspepsia. In 1972 prolonged intake of high doses of bismuth
subgallate was associated with cases of encephalopathy in Australia.
Subsequently a similar association involving the subnitrate salt became evident in
France. Preparations containing bismuth salts have since either been withdrawn or
subjected to restrictive regulatory action in many countries. However, in some
countries preparations containing bismuth subsalicylate, which retains a place in
the management of dyspepsia, have been exempted from this restriction.
Additionally, colloidal bismuth subcitrate is widely used in the treatment of
gastritis and peptic ulcer disease.
(Reference: (WHODI) WHO Drug Information, 2, 8, 1977)

Product Name Bismuth subsalicylate

C.A.S. number 14882-27-4
Scientific and common names, and synonyms
(2-HYDROXY-BENZOATO-O)-OXOBISMUTH
2-HYDROXYBENZOIC ACID BISMUTH (3+) SALT1

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Apr 1994 The Food and Drug Administration proposed to extend to products containing bismuth
subsalicylate and all oral and rectal over-the-counter products that contain acetylsalicylic
acid (aspirin) or other salicylates the following warning: "Children and teenagers who
have or are recovering from chicken pox, flu symptoms or flu should not use this

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 65

Product Name Bismuth subsalicylate

C.A.S. number 14882-27-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
product. If nausea or fever occur, consult a doctor because these symptoms could be an
early sign of Reye's syndrome, a rare but serious illness."
(Reference: (FEREAC) Federal Register, 58(201) , p. 54228, 1993)
WHO Comment : See under Acetylsalicylic acid.

Product Name Bithionol

C.A.S. number 97-18-7
Scientific and common names, and synonyms
BIS(2-HYDROXY-3,5-DICHLOROPHENYL)SULFIDE
2,2'-THIOBIS(4,6-DICHLOROPHENOL)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Oct 1967 Withdrawn from the market and prohibited for export by the Food and Drug
Administration due to photosensitivity and cross-photosensitivity with other chemicals.
JPN Jul 1971 Banned as an ingredient in cosmetics due to photosensitivity reactions.
WHO Comment : Bithionol, which has bactericidal and anthelminthic activity, was
formerly available in soaps. By the late 1960s use of such preparations had been
associated with a risk of photosensitivity reactions and cross-sensitivity with other
halogenated disinfectants. This resulted in their withdrawal in the USA. Oral
preparations of bithionol remain available for the treatment of paragonimiasis and
fascioliasis.

Product Name Boric acid and borates

C.A.S. number 10043-35-3
Scientific and common names, and synonyms
BORIC ACID (H3BO3)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
KWT 30 Mar 1970 Any drug preparation intended for external use and containing boric acid should be
labelled with the following warnings: "Only for external use." and "Do not apply to
extensive areas of abraded or damaged skin.".
ISR 1973 Use of boric acid is prohibited except as a preservative in eyedrops and in dermal
preparations in concentrations not higher than 1%.
KOR 1973 The Ministry of Health and Social Affairs has prohibited the manufacture of any baby
powder which contains boric acid and sodium borate.
PHL 1973 By Administrative Order No. 195, all products for oral use and products for use in infants
and children under three years of age have been prohibited. Products for external use
must carry a special warning. These products have been reported to cause certain toxic
reactions (disturbances in circulation, profound shock, convulsion) and fatalities with
systemic absorption.
(Reference: (PHADO) Administrative Order, 195, , 1973)
THA Oct 1973 Boric acid and borax are prohibited for use in baby powders.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 66

Product Name Boric acid and borates

C.A.S. number 10043-35-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1981 The Drugs Advisory Board has withdrawn all oral preparations. Some preparations for
topical administration remain available but must bear a warning that they should not be
administered to infants.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, 12, , 1981)
DNK 1983 Subject to maximum concentration limits of 0.5% for peroral use, 1% for vaginal use and
3% for use in ear, eye or nose.
DEU Jul 1983 The Federal Health Office has withdrawn the registration of the last remaining
preparations containing either boric acid or its salts and esters. Exceptions to this order
are made for ophthalmic preparations, mineral waters in which the boron content does
not surpass that of ordinary drinking water, and some previously registered products
containing phenylmercury dihydrogen borate.
JPN Jul 1985 The Ministry of Health and Welfare banned boric acid and its salts except for eye
application because of the toxicity of boric acid.
MYS 31 Dec 1990 Products containing boric acid or borax for use in the oral cavity, rectum, vagina or on the
skin and wounds have been withdrawn, having regard to reports of fatalities among
infants and young children following accidental ingestion of these products or as a result
of absorption from abraided skin.
(Reference: (MYSPR) Ministry of Health Press Release, 15, , 28 Feb 1990)
CRI The Ministry of Public Health has prohibited the production, importation and sale of all
products containing sodium borate (borax, sodium tetraborate) and boric acid in their
composition, as well as their use as separate ingredients.
GBR Following evidence that boric acid absorbed from topical preparations was responsible for
the death of many healthy infants, the use of boric acid in topical preparations intended
for use in infants has been prohibited.
(Reference: (CFRUS) Code of Federal Regulations, 21-369.20, 204, 1985)
IND Preparations for children under three years of age prohibited for manufacture and sale for
reasons of health risks associated with use and/or questionable therapeutic value.
ITA Products for topical use are marketed with the following concentration limitations: not
higher than 0.5% for stomatological use and not higher than 3% for any other use.
PER Prohibited from use in cosmetic powders, due to their serious effects on the liver and
kidney; and on the cardiovascular, digestive and nervous systems. Some fatalities have
been connected to the use of these substances.
SAU Use is restricted to ophthalmic preparations only.
USA Following evidence that boric acid absorbed from topical preparations was responsible for
the death of many healthy infants, the use of boric acid in topical preparations intended
for use in infants has been prohibited.
(Reference: (CFRUS) Code of Federal Regulations, 21-369.20, 204, 1985)
VEN Subject to restricted use and/or sale.
WHO Comment : Boric acid and some borates were formerly extensively used as
disinfectants and antiinflammatory agents. By the late 1960s an association
between the death of many infants and application of high concentrations of boric
acid contained in topical preparations used in the treatment of napkin rash had
been established. This led to the restriction of the use of boric acid in
pharmaceutical preparations by many regulatory authorities. In some countries it is
now permitted only as an ingredient in ophthalmological preparations.

Product Name Bovine tissue derived medicines

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 67

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1989 The National Drugs Advisory Board has decided that products containing bovine-derived
components will notbe approved for marketing unless adequate evidence is provided that
there is no potential for infectivity.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, 1989, 28, Dec 1990)
CHE 26 Mar 1991 The Intercantonal Office for the Control of Medicines has prohibited as a part of the
precautionary measures, the use of tissue from the high risk organs from cattle for the
manufacture of medicines unless the tissues are derived from animals that are younger
that six months, come from a country were no cases of bovine spongiform
encephalopathy (BSE) have been reported and have not been fed animal material such
meat, bone flour or fat. In addition, the manufacturing process should be capable of
removing or reducing any potential for infection with BSE. Products containing only
lactose of those that have the bovine material largely removed during manufacture
procedure and those that cannot be withdrawn at short notice due to therapeutic
importance are excluded from these measures, the latter only for a limited time.
(Reference: (CHBCM) Bulletin Mensuel, , , 26 Mar 1991)
FRA 23 Jul 1992 The Directorate of Pharmacy and Medicines of the Ministry of Health and Humanitarian
Action has suspendedthe marketing authorization for medicinal products derived from
bovine tissues.
(Reference: (FRAMHH) Ministry of Health and Humanitarian Action, , , 23 July 1992)
WHO Comment : Bovine tissues are used to make important medicinal products
such as heparin, glucagon, insulin and bloodfactors. In, 1986, bovine spongiform
encephalopathy (transmitted from scrapie) was diagnosed in the United Kingdom.
Restrictions on use of bovine material took into consideration the fact that the
prion (sub-viral agent) causing the spongiform encephalopathy appears to be
transmissible orally between species. As yet, there is no evidence of any direct
causal relationship between scrapie and creutzfeld-jacob disease or any other
spongiform encephalopathy of man. Nonetheless, a substantial array of research
projects have been funded and in the interim precautionary measures were taken
by the regulatory agencies.

Product Name Bromfenac

C.A.S. number 91714-94-2
Scientific and common names, and synonyms
AHR-10282
SODIUM[2-AMINO-3-(P-BROMOBENZOYL)PHELYL]ACETATE SESQUIHYDRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Jun 1998 Wyeth Ayerst Laboratories have voluntarily withdrawn from the market capsules of
bromfenac sodium, a nonsteroidal anti- inflammatory analgesic indicated for the short-
term management of acute pain. This action was taken on the basis of reports of severe
hepatic failure resulting in four deaths and 8 liver transplants.
(Reference: (FEREAC) Federal Register, 64 (44) , p. 10944, 1999)
SAU Jun 1999 The Ministry of Health has withdrawn from the market products containing bromfenac
because of reports of liver failure, sometimes fatal.
(Reference: (SAUCW) Notification, , , 20 June 1999)

Product Name Bromisoval

C.A.S. number 496-67-3

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 68

Product Name Bromisoval

C.A.S. number 496-67-3
Scientific and common names, and synonyms
BROMYLUM
BROMVALETONE
BROMVALERYLUREA
BROMISOVALERYLUREA

2-BROMO-3-METHYLBUTYRYLUREA

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD Jan 1987 On request of the Board for the Evaluation of Medicines the manufacturers have
withdrawn all products containing bromisoval having regard to their dependence potential
and the risk of subsequent chronic intoxication.
WHO Comment : Bromisoval is a monureide sedative of long standing. It remains
available in several countries. However, it releases the bromide ion and prolonged
usage can result in chronic bromide accumulation and intoxication.

Product Name Bromocriptine

C.A.S. number 25614-03-3
Scientific and common names, and synonyms
ERGOTAMAN-3',6',18-TRIONE,2-BROMO-12'-HYDROXY-2'-(1-METHYLETHYL)-5-(2-METHYLPROPYL)-,(5'ALPHA)-
2-BROMO-ALPHA-ERGOCRYPTINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Sep 1989 Products containing bromocriptine may no longer be indicated for suppression of breast
engorgement in mothers who elect not to breastfeed.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T89-56, , 27 Sep 1989)
WHO Comment : Bromocriptine, a semisynthetic ergot alkaloid derivative and
prolactin inhibitor was introduced into medicine in 1976. It is used in the
prevention of lactation, but because of the risk of rebound effect and since only
10% of women benefit therapeutically from such intervention, the United States
Food and Drug Administration has requested manufacturers to no longer indicate
preparations containing bromocriptine for this purpose. The World Health
Organization is not aware of similar action having been taken elsewhere.

Product Name Broxyquinoline (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 521-74-4
Scientific and common names, and synonyms
5,7-DIBROMO-8-QUINOLINOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Sep 1970 The Ministry of Health and Welfare has prohibited the sale of clioquinol and
broxyquinoline, and preparations containing them. These decisions were taken following
reports that clioquinol might be one of the causes of subacute myelo-optic neuropathy
(SMON).

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 69

Product Name Broxyquinoline (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 521-74-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARE 9 Jun 1981 Pharmaceutical preparations containing broxyquinoline are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
SAU Import of this product is prohibited.
VEN Subject to restricted use and/or sale.
WHO Comment : Broxyquinoline is a halogenated hydroxyquinoline. See entry for
halogenated hydroxyquinoline derivatives and WHO comment for clioquinol.

Product Name Bucetin

C.A.S. number 1083-57-4
Scientific and common names, and synonyms
3-HYDROXY-P-BUTYROPHENETIDIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1986 Preparations containing bucetin have been withdrawn from the market and will no longer
be considered for registration.
WHO Comment : Bucetin is an analogue of phenacetin. See WHO comment for
phenacetin.

Product Name Bufexamac

C.A.S. number 2438-72-4
Scientific and common names, and synonyms
2-(P-BUTOXYPHEYL)ACETOHYDROXAMIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Dec 1990 Because of reports of eczematous reactions, the indications for preparations containing
bufexamac intended for topical application were restricted to the relief of pruritus in
inflammatory dermatological conditions. These preparations could no longer be used for
the treatment of eczema.
(Reference: (FRARP) La Revue Prescrire, 11(106), 182, 1991)
DEU Aug 1991 The approved product information for preparations containing bufexamac was amended
to warn against hypersensitivity reactions, including allergic contact dermatitis,
generalized skin sensitization, urticaria, and contact eczema.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 131(31), VI, 1991)
WHO Comment : Bufexamac, an analgesic and anti-inflammatory agent, was
introduced in 1974 for the topical treatment of a wide range of dermatoses. The
drug is widely marketed and the World Health Organization is not aware of
restrictive action having been taken elsewhere.

Product Name Buformin

C.A.S. number 692-13-7

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 70

Product Name Buformin

C.A.S. number 692-13-7
Scientific and common names, and synonyms
BUTYLFORMIN
BUTYLDIGUANIDE
BUTYLBIGUANIDE
BUTFORMIN

BUFORMINE
GLYBIGIDUM
N-BUTYL-IMIDODICARBONIMIDIC DIAMIDE
N-BUTYLDIGUANIDE
1-BUTYLBIGUANIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 1978 Warnings and contraindications have been added to currently marketed products with
this ingredient. It has been recommended that dosages lower than 100 mg/day be
followed due to the risk of lactic acidosis.
DEU Mar 1978 Withdrawn from the market because of occurrence of lactic acidosis.
AUT Sep 1978 In conformity with decisions taken in several other countries, and following reports of
occasional fatal cases of lactic acidosis, all products containing phenformin and buformin
will be withdrawn. Metformin will remain available for use for limited indications.
BEL 1979 Voluntarily withdrawn from the market by the manufacturer.
IRL 1979 The biguanide hypoglycaemics, phenformin and buformin, were withdrawn from the
market in Ireland in 1979 as a result of concern regarding lactic acidosis. Metformin will
remain available but doctors are urged to ensure that patients receiving it are kept under
regular surveillance.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, 14, , 1979)
VEN Subject to restricted use and/or sale.
WHO Comment : Buformin is an analogue of phenformin. See WHO comment for
phenformin.
(Reference: (WHODI) WHO Drug Information, 2, 4, 1977)

Product Name Bumadizone

C.A.S. number 3583-64-0
Scientific and common names, and synonyms
BUTYLMALONIC ACID MONO(1,2-DIPHENYLHYDRAZIDE)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1985 Indications restricted to severe exacerbations of rheumatism and acute gout. Duration of
oral treatment should not exceed one week. Parenteral preparations are indicated
exclusively for initiating therapy. A single injection only is recommended because local
tissue damage may occur. Preparations are contraindicated in children under 14 years of
age.
OMN Sep 1986 The Ministry of Health has prohibited the import of preparations containing bumadizone
except those intended for topical use.
AUT Indications restricted to exacerbations of gout and other arthritic conditions. Treatment
should not exceed seven days and doctors are advised not to prescribe this drug to

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 71

Product Name Bumadizone

C.A.S. number 3583-64-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
WHO Comment : Bumadizone, a pyrazolone derivative with antiinflammatory,
analgesic and antipyretic activity, was introduced in 1972 for the treatment of
rheumatic disorders. As it is structurally related to phenylbutazone it is subjected
to rigorously restricted indications by some national regulatory authorities. See
WHO comment for phenylbutazone.

Product Name Bunamiodyl

C.A.S. number 1233-53-0
Scientific and common names, and synonyms
CINNAMIC ACID, 3-BUTYRAMIDO-ALPHA-ETHYL-2,4,6-TRIIODO-,

2-(3-BUTYRAMIDO-3,4,6-TRIIODOPHENYL-METHYLENE)-BUTYRIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1964 The National Board of Health refused the approval of bunamiodyl on the grounds that its
use is associated with adverse reactions.
USA 1964 The Food and Drug Administration withdrew bunamiodyl for oral cholecystography since
repeat doses may be associated with oliguria, renal tubular necrosis, and death; the use
of other cholecystographic agents within one week after bunamiodyl ingestion may be
dangerous. It is contraindicated in patients with a history of renal disease. Evaluation of
renal function should be performed before use of the drug.
(Reference: (FEREAC) Federal Register, 36, 14493, Aug 1971)
VEN Not approved for use and/or sale.
WHO Comment : Bunamiodyl, an orally administered radio-opaque medium, was
introduced in 1958 for use in the examination of the biliary tract. By 1964 its use
had been associated with cases of renal failure, in some cases fatal, which resulted
in its withdrawal by the United States Food and Drug Administration. Buniamiodyl
was withdrawn worldwide by the manufacturer in 1984.

Product Name Buprenorphine

C.A.S. number 52485-79-7
Scientific and common names, and synonyms
6,14-ETHENOMORPHINAN-7-METHANOL, 17-(CYCLOPROPYLMETHYL)-ALPHA-(1,1- DIMETHYLETHYL)-4,5-EPOXY-
18,19-DIHYDRO-3-HYDROXY-6-METHOXY-ALPHA-METHYL-,[5ALPHA, 7ALPHA, (S)]-
21-CYCLOPROPYL-7ALPHA-((S)-1-HYDROXY-1,2,2-TRIMETHYLPROPYL))-6,14-ENDO-ETHANO-6,7,8,14-TETRAHYDRO-
ORIPAVINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL 22 Sep 1983 Buprenorphine was included in Part IV of the Third Schedule of the Misuse of Drugs Act
1975. This implies that this substance is now subjected to the same controls as
amobarbital, butobarbital and cyclobarbital. These include a requirement that
prescriptions be written in triplicate on forms provided by the Department of Health.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 72

Product Name Buprenorphine

C.A.S. number 52485-79-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT 1 Jun 1984 Subjected to control at national level analogous to that provided by Schedule I of the
1961 Single Convention on Narcotic Drugs.
DEU 1 Sep 1984 Subjected to control at national level analogous to that applied to substances included in
the 1961 Single Convention on Narcotic Drugs.
EGY 26 Nov 1986 Withdrawn from the market.
MUS 2000 The Ministry of Health and Quality of Life has listed buprenorphine as a Schedule II
medicine under the new Dangerous Drugs Act 2000. This is because abuse of the drug
by intravenous as opposed to oral use has been reported to cause a number of deaths.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)
WHO Comment : Buprenorphine, an opioid analgesic with both morphine agonist
and antagonist activity, was introduced in 1978. It was originally considered to
possess low dependence potential. However, it has latterly been identified as
causing a socially significant abuse problem in several countries which have
consequently subjected it to control in 1989 under Schedule III of the 1971
Convention of Psychotropic Substances.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Buspirone hydrochloride

C.A.S. number 33386-08-2
Scientific and common names, and synonyms
8-[4-(4-PYRIMIDIN-2-YLPIPERAZIN-L-YL)BUTYL]-8-AZASPIRO[4,5]DECANE-7,9-DIONE HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS May 2000 The Ministry of Health and Quality of Life has rescheduled the antipsychotic agent
buspirone into Schedule III of the consolidated Dangerous Drugs Act 2000 following
observations of irrational use and emerging abuse.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)

Product Name Cadralazine

C.A.S. number 64241-34-5
Scientific and common names, and synonyms
ETHYL 6-[(2-HYDROXYPROPYL)AMINO]-3-PYRIDAZINYL]HYDRAZINECARBOXYLIC ACID ETHYL ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1992 The Medicines Control Authority refused an application for registration of the peripheral
vasodilator, cadralazine on the grounds that the pharmacological and clinical
documentation was inadequate.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, 25, 1992)
WHO Comment : Cadralazine, a peripheral vasodilator, was introduced in 1989 for
the treatment of arterial hypertension.In 1992, its association with serious side
effects led to the refusal of registration in Norway. Animal experiments have
demonstrated drug-related impairment of thyroid function as well as potential

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 73

Product Name Cadralazine

C.A.S. number 64241-34-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
carcinogenicity and genotoxicity. It remains available for treatment of hypertension
in Italy.

Product Name Calamus

C.A.S. number 8015-79-0
Scientific and common names, and synonyms
OIL OF CALAMUS

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Nov 1968 Withdrawn from the market and prohibited for export by the Food and Drug
Administration on the basis of findings of animal carcinogenicity.
(Reference: (FEREAC) Federal Register, 33, 17204, Nov 1968)
WHO Comment : Calamus, the dried rhizome of acorus calamus, has been used as
a bitter and carminative. The World Health Organization has no information further
to the above regarding preparations containing calamus or to indicate that they are
still commercially manufactured.

Product Name Camelia sinensis

C.A.S. number 2004-0-0003

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA The French and Spanish Advisory Board have suspended the marketing authorization of
a green tea (camelia sinensis) product (exolise), prepared from the ethanolic extract of
green tea, due to several reports of hepatic disorders.
ESP 11 Apr 2003 The French and Spanish Advisory Board have suspended the marketing authorization of
a green tea (camelia sinensis) product (exolise), prepared for the ethanolic extract of
green tea, due to several reports of hepatic disorders.
(Reference: (ESPSPS) Communication to WHO, , , 11 Apr 2003)

Product Name Camphor

C.A.S. number 76-22-2
Scientific and common names, and synonyms
ALCANFOR
CAMPHORA
ROOT BARK OIL

1,7,7-TRIMETHYLBICYCLO(2,2,1)HEPTANE-2-ONE
2-CAMPHANONE
2-BORNANONE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 74

Product Name Camphor

C.A.S. number 76-22-2
Country Effective Description of action taken
Date Grounds for decision
FRA 17 Nov 1983 The National Commission of Pharmacovigilance has recommended that preparations
containing camphor be contraindicated in infants under 30 months and that they be used
with caution in older children. This action results from reports of convulsions associated
with topical application or inhalation.
ZAF 1999 The South African Medicines Control Council has removed camphor from all medicines
unless efficacy data is submitted.
(Reference: (ZAFPS) Information from the Pharmaceutical Services, , , )
EGY The Technical Committee for Drug Control has published a warning that products
containing camphor be contraindicated in infants under 30 months and that they be used
with caution in older children. This action results from reports of convulsions associated
with topical application or inhalation.
ITA All pharmaceutical products containing camphor must bear the following warning: "This
product is contraindicated in children under two years of age with a history of
laryngospasm or convulsions. Caution must be exercised when older children are
treated.".
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, (12), , 1984)
WHO Comment : Camphor, an aromatic crystalline substance with mild local
anaesthetic activity, is available in preparations for both external application and
inhalation. The use of such preparations has precipitated convulsions in
susceptible infants. This has led several regulatory authorities to require the
inclusion of appropriate warnings on labelling.

Product Name Canrenone

C.A.S. number 976-71-6
Scientific and common names, and synonyms
ALDADIENE
PREGNA-4,6-DIENE-21-CARBOXYLIC ACID, 17-HYDROXY-3-OXO-, GAMMA-LACTONE ( 17ALPHA)-
17-HYDROXY-3-OXO-17ALPHA-PREGNA-4,6-DIENE-21-CARBOXYLIC ACID GAMMA- LACTONE
17ALPHA-(2-CARBOXYETHYL)-17BETA-HYDROXYANDROSTA-4,6-DIEN-3-ONE LACTONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1986 Preparations containing canrenone have been withdrawn having regard to the possible
carcinogenic risk associated with long-term use.
WHO Comment : Canrenone, which has aldosterone antagonist activity, is a major
metabolite of spironolactone and the major metabolite of potassium canrenoate.
See WHO comments for potassium canrenoate and spironolactone.

Product Name Canthaxanthin

C.A.S. number 514-78-3
Scientific and common names, and synonyms
BETA,BETA-CAROTENE-4,4'-DIONE
COLOUR INDEX NO.40850
CI FOOD ORANGE 8
E.161.G

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 75

Product Name Canthaxanthin

C.A.S. number 514-78-3
Country Effective Description of action taken
Date Grounds for decision
DEU May 1985 The Federal Health Office has prohibited the use of canthaxanthin which is used in the
treatment of certain photodermatoses and is contained in orally administered bronzing
agents following reports of crystalline deposits in the retina.
AUT 31 Dec 1985 The Federal Ministry of Health and Environmental Protection has agreed with the
manufacturer to withdraw pharmaceutical preparations containing canthaxanthin following
reports of crystalline deposits in the retina.
IRL 1986 Having regard to reported ocular toxicity associated with long-term use of the tanning
agent canthaxanthin, the National Drugs Advisory Board has informed manufacturers that
it will no longer be permitted as a constituent of medicinal products. In 1989 the Board
was additionally advised that the compound be excluded from tanning preparations.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , , 1986)
EGY 1987 The Technical Committee for Drug Control has decided that canthaxanthin will no longer
be accepted as a bronzing agent to avoid ophthalmic problems.
(Reference: (EGYDI) Drug Information, 5(2), 1, 1987)
OMN Sep 1987 Import and marketing of products containing canthaxanthin were prohibited.
(Reference: (OMNDI) Drug Information, 5(2):1, , 1987)
WHO Comment : Canthaxanthin, a naturally-occurring carotenoid with a deep red-
orange colour, is widely used as a food colouring agent. Since the mid-1970s it has
been included in oral 'artificial suntan' preparations. It is also available in
preparations used in the treatment of certain photodermatoses. By the mid-1980s
its use in such preparations had been associated with the accumulation of
crystalline deposits in the retina. Reported functional changes relating to dark
adaptation have been of marginal clinical significance and largely reversible.
Nevertheless, this has led to the withdrawal of artificial suntan preparations
containing canthaxanthin by several regulatory authorities. Preparations for
treatment of photodermatoses remain available in some but not all of these
countries.

Product Name Cartilage extract

Scientific and common names, and synonyms

AQUEOUS CALF CARTILAGE & BONE MARROW EXTRACT

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Jun 1992 The marketing authorization of injectable preparations containing calf cartilage and bone
marrow extract was suspended, in the first instance, until 31 December 1992. The
decision resulted from an apparent association with serious adverse effects including
local intolerance and anaphylactoid reactions, renal insufficiency, pulmonary fibrosis and
autoimmune diseases of the skin and muscles.
(Reference: (DEUPD) BGA Pressedienst, 24, , 1992)
WHO Comment : A preparation containing calf cartilage and bone marrow extract
was introduced in 1960 for the treatment of degenerative joint disease, and it is
currently registered in several countries. In 1987, a risk-benefit assessment of the
product was commissioned in Germany. This resulted initially in its use being
contraindicated in patients with altered immune responses. Subsequently, the
marketing authorization was suspended in Germany in 1992 when the product was
associated with serious adverse effects.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 76

Product Name Cathine

C.A.S. number 492-39-7
Scientific and common names, and synonyms
(+)-THREO-2-AMINO-1-HYDROXY-1-PHENYLPROPYLPROPANE
(+)-NORPSEUDOEPHEDRINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Jul 1981 Administration of centrally active appetite inhibiting preparations containing cathine has
been restricted to four weeks. A warning concerning the risk of dependence has been
included in the package leaflet.
PHL Oct 1983 Disapproved for use in appetite control due to the risk of drug dependency and other
adverse effects such as apathy, depression, chronic gastroduodenitis, dyspeptic
disorders and dreamy euphoria with loquacity.
GRC 1985 Not accepted as an appetite suppressant having regard to its low benefit-to-risk ratio
(systemic side-effects).
WHO Comment : Cathine, a sympathomimetic amine, was formerly widely available
in proprietary anorexic preparations. As dependence can occur and abuse has
been reported, cathine has recently (1986) been subjected to control under
Schedule III of the 1971 Convention on Psychotropic Substances.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Cefaloridine

C.A.S. number 50-59-9
Scientific and common names, and synonyms
CEPHALORIDINE
PYRIDIUM,1-[[2-CARBOXY-8-OXO-7-[(2-THIENYLACETYL)AMINO]-5-THIA-1-AZABICYCLO[4.2.0]-OCT-2-EN-3-
YL]METHYL]-,HYDROXIDE, INNER SALT, (6R-TRANS)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP 1989 The marketing authorization of products containing cefaloridine has been withdrawn,
having regard to their nephrotoxicity.
(Reference: (ESPINS) Información Terapéutica de la Seguridad Social, 13(1), 7, 1989)
WHO Comment : Cefaloridine, a semi-synthetic cephalosporin antibiotic, was
introduced into medicine in 1964 for the treatment of bacterial infections. It is
considered to be the most toxic of the cephalosporins, and for this reason is now
seldom used. Nevertheless, it still remains available in certain countries and the
World Health Organization is not aware of restrictive actions taken elsewhere.

Product Name Cefalosporins (topical preparations)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHL Pharmaceutical preparations for topical use containing cefalosporin and its derivatives
are prohibited.
(Reference: (CHLRS) Resolution of the Minister of Health, No.10154, , Oct 1986)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 77

Product Name Cell preparations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT Aug 1987 Deep-frozen cell preparations used in the practice of cell therapy have been banned, on
the grounds that fatalities associated with these products have been reported in the
Federal Republic of Germany and that marketing authorization has been suspended in
this country.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 127(34), 1720, 1987)
DEU 30 Jun 1988 The marketing authorization for injectable preparations used in the practice of cell
therapy has been withdrawn, having regard to the serious and sometimes fatal reactions
associated with these products, which have not been demonstrated to possess any
therapeutic effect.
(Reference: (DEUPD) BGA Pressedienst, 22, , 1988)
CHE Jul 1988 All products prepared from fresh animal cells have been banned, on the grounds that
fatalities associated with their use had been reported in the Federal Republic of Germany
and that efficacy had not been demonstrated.
(Reference: (CHBCM) Bulletin Mensuel, , , 31 Aug 1988)
WHO Comment : Injectable preparations used in the practice of cell therapy were
introduced into medicine many years ago.They contain cells from organs or tissues
of fetal or juvenile animals of species such as sheep, cattle, swine and rabbits. A
variety of indications were claimed by the manufacturers of these products,
including adjuvant tumour therapy, Down's syndrome, ageing, immune defects,
endocrine disturbances, diseases of the motor system, the central nervous system,
the heart and vascular system and chronic liver disease. Whilst proof of efficacy in
these indications has never been established, the use of cell preparations has been
associated with severe, sometimes fatal adverse immunological reactions,
particularly with anaphylactic shock and serum sickness. This has led to their
withdrawal by regulatory authorities in the countries listed above.

Product Name Cerivastatin

C.A.S. number 145599-86-6
Scientific and common names, and synonyms
(3R,5S,6E)-7-[4-(4-FLUOROPHENYL)-2,6-DIISOPROPYL-5-(METHOXYMETHYL)-3-PYRIDYL]-3,5-DIHYDROXY-6-
HEPTENOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Nov 1999 Prescribing information was changed to include a contraindication for the combined use
of cerivastatin and gemfibrozil.
AUS Feb 2001 Prescribing information was changed to include a contraindication for the combined use
of cerivastatin and gemfibrozil and warning issued to alert prescribers to the possibility of
rhabdomyolysis with all statins.
(Reference: (AUSADR) Australian Adverse Drug Reactions Bulletin, Vol. 20(1), , Feb
2001)
CAN Mar 2001 Prescribing information was changed to include a contraindication for the combined use
of cerivastatin and gemfibrozil.
USA May 2001 The Dosage and Administration section was revised to highlight that 0.4 mg is the
starting dose for cerivastatin.
(Reference: (USADHP) "Dear Healthcare Professional " letter, , , )
@EC Jun 2001 Europe-wide regulatory action was taken to reduce the risk of rhabdomyolysis, when the
concomitant use of cerivastatin and gemfibrozil was contraindicated and the maximum

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 78

Product Name Cerivastatin

C.A.S. number 145599-86-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
daily dose of cerivastatin was reduced to 0.4 mg.
(Reference: (GBRDSI) Drug Safety Information, , , 08 Aug 2001)
CAN Jul 2001 The prescribing information was revised to recommend a starting dose of 0.2 mg.
(Reference: (CANDHP) "Dear Healthcare Professional" letter, , , )
@WD Aug 2001 Cerivastatin was voluntarily withdrawn from the world market by the parent company
(Bayer) on account of the increased risk of rhabdomyolysis associated with its use,
particularly when used in combination with gemfibrozil.
(Reference: (FDATP) Food and Drug Administration Talk Paper, TOI-34, , 08 Aug 2001)

Product Name Chenodeoxycholic acid

C.A.S. number 474-25-9
Scientific and common names, and synonyms
CHOLAN-24-OIC ACID, 3,7-DIHYDROXY-, (3ALPHA,5BETA,7ALPHA)-
CHENODIOL
3ALPHA,7ALPHA-DIHYDROXY-5BETA-CHOLAN-24-OIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1987 Chenodeoxycholic acid is not approved for registration on grounds of animal studies
indicating a carcinogenic effect and because the risk of a cancer-promoting effect in man
is considered significant.
WHO Comment : Chenodeoxycholic acid was introduced in 1975 for the treatment
of cholelithiasis. It is available in several countries and the World Health
Organization is not aware that registration has been refused in any other country.

Product Name Chloramphenicol

C.A.S. number 56-75-7
Scientific and common names, and synonyms
ACETAMIDE, 2,2-DICHLORO-N-(2-HYDROXY-1-(HYDROXYMETHYL)-2-(4- NITROPHENYL)ETHYL)-, (R-(R*,R*))
D-THREO-(-)-2,2-DICHLORO-N-(BETA-HYDROXY-ALPHA-(HYDROXYMETHYL)-P-NITROPHENETHYL)ACETAMIDE
LAEVOMYCETINUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1975 Use should be limited to treatment of acute attacks of typhoid and paratyphoid fever,
purulent meningitis and life-threatening infections caused by sensitive organisms in which
less dangerous antibiotics are ineffective or contraindicated.
JPN Oct 1975 Indications have been restricted.
DNK 1978 Doctors have been advised that systemic chloramphenicol should be used only in
patients requiring admission to hospital. It is contraindicated in uncomplicated urinary
tract infections.
(Reference: (UGLAAD) Ugeskrift for Laeger, 140, 1165, 1978)
FRA 22 Sep 1978 Products for topical application containing chloramphenicol have been withdrawn from

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 79

Product Name Chloramphenicol

C.A.S. number 56-75-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
the market, with the exception of eyedrops and ophthalmic ointments. Indications for
products intended for internal use are restricted to serious infections caused by
organisms sensitive to chloramphenicol when other potentially less dangerous products
are ineffective.
PHL Jul 1982 Severely restricted in use due to the risk of developing agranulocytosis. Limited to
indications of typhoid fever, meningitis and brain abcess.
EGY Jul 1983 All pharmaceutical preparations containing chloramphenicol should bear the following
warning: "Not to be used for long periods or repeatedly, even in small doses, to avoid the
risk of toxic effects such as bone marrow aplasia and acute leukaemia. Use should be
restricted to cases not responding to other antibiotics".
NLD 1984 Doctors have been reminded that, even when applied topically in the eye,
chloramphenicol may induce blood dyscrasias. When chloramphenicol appears to be the
drug of choice, the susceptibility of the pathogenic organism should always be confirmed
bacteriologically.
CAN 1985 Prohibited for administration to animals that may be consumed as food due to persistent
residues in food products.
ESP 1 Mar 1985 Registration of combination products containing chloramphenicol will no longer be
considered because of the propensity of this drug to cause aplastic anaemia.
HUN 1987 Chloramphenicol has been banned for therapeutic purposes in milk- and egg-producing
animals, having regard to its potential to induce aplastic anaemia in man, and the
prolonged period during which residues remain demonstrable after withdrawal.
(Reference: (HUNIH) National Institute of Occupational Health Notification, , , 25 May
1988)
IRL Oct 1989 The administration of chloramphenicol to all food-bearing animals (including horses) has
been prohibited, on the grounds that the drug enters the food chain and may therefore
cause adverse effects and transferable drug resistance in man.
(Reference: (IRDAP) Animal Pharm, 187, 4, Sep 1989)
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , 312, 1987)
WHO Comment : Chloramphenicol, an antibiotic isolated from Streptomyces
venezuelae in 1947, first became available for general clinical use in 1948. By 1950
it was evident that its use could cause serious, sometimes fatal, blood dyscrasias.
However, it remains one of the most effective antibiotics for treating invasive
typhoid fever and salmonellosis, some rickettsioses and serious infections caused
by Haemophilus influenzae or anaerobic organisms. This is considered to justify its
retention in the WHO Model List of Essential Drugs.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Chlormadinone acetate

C.A.S. number 302-22-7
Scientific and common names, and synonyms
6-CHLORO-17-HYDROXYPREGNA-4,6-DIENE-3,20-DIONE ACETATE
PREGNA-4,6-DIENE-3,20-DIONE, 17-(ACETYLOXY)-6-CHLORO

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Mar 1972 Application for approval of oral contraceptives containing chlormadinone acetate

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 80

Product Name Chlormadinone acetate

C.A.S. number 302-22-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
withdrawn by the manufacturer on recommendation by the Food and Drug Administration
after findings in beagle bitches showing an increased incidence of mammary tumours
resulting from this component.
(Reference: (FEREAC) Federal Register, 37(52), 5516, 1972)
GBR 1977 The product licence for an oral contraceptive containing this substance has been
cancelled due to the risk of carcinogenicity.
ITA 1979 Withdrawn from the market because of an increased incidence of breast tumours in
beagle dogs during the course of long-term toxicity tests.
EGY 1980 Chlormadinone was not approved having regard to its potential to cause breast tumours
in dogs.
VEN Not approved for use and/or sale.
WHO Comment : Chlormadinone acetate, a synthetic progestogen, was introduced
in 1965 as a component in oral contraceptive preparations. In 1967, as a result of
new regulations required by the United States Food and Drug Administration,
chlormadinone acetate was submitted to long-term toxicity studies and by the early
1970s it was shown to be associated with an increased incidence of mammary
tumours in beagle bitches which led to its withdrawal by several regulatory
authorities. Subsequently the validity of the beagle bitch model as a predictor of
carcinogenicity of steroid contraceptives has been contested by many national
regulatory authorities and chlormadinone remains available in some countries for
contraceptive purposes. In some instances it is indicated for treatment of
progesterone deficiency and endometriosis, and of irregular uterine bleeding due
to fibroids.
(Reference: (WHODI) WHO Drug Information, 84.1, 5, 1984)

Product Name Chlormezanone

C.A.S. number 80-77-3
Scientific and common names, and synonyms
CHLORMETHAZANONE

2-(P-CHLOROPHENYL)-TETRAHYDRO-3-METHYL-4H-1,3-THIAZIN-4-ONE 1,1-DIOXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 15 Nov 1996 Because of severe cutaneous reactions including life-threatening toxic epidermal
necrolysis, Stevens-Johnson syndrome, and fixed drug eruptions, the manufacturer of
chlormezanone withdrew the drug worldwide. This coincided with local action undertaken
in several countries. The withdrawal concerns chlormezanone used alone or in
combination.
(Reference: (SANOFI) Letter to Regulatory Agencies, Sanofi, , , 09 Oct 1996)
ARE 1997 The Ministry of Health has withdrawn marketing approval for pharmaceutical products
containing chlormezanone because it has been associated with an unacceptable
incidence of Stevens-Johnson syndrome.
(Reference: (UAEDIB) Drug Information Bulletin, No. 3, p.2, 1997)
ZAF 1998 The South African Medicines Control Council has withdrawn products containing
chlormezanone because of the unacceptable risk-benefit profile which is not in the
interest of public health.
(Reference: (ZAFPS) Information from the Pharmaceutical Services, , , )

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 81

Product Name Chlormezanone

C.A.S. number 80-77-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ZWE 1998 The Medicines Control Authority has cancelled the registration of all chlormezanone-
containing products in the light of international actions taken on the basis of a safety
evaluation of chlormezanone. This drug has been associated with an unacceptable
incidence of Stevens-Johnson syndrome.
(Reference: (ZWEDIB) Drug Information Bulletin, Vol.2 No.1, , Mar 1998)
SAU Jun 1999 The Ministry of Health has withdrawn from the market products containing
chlormezanone because of an unacceptable incidence of Stevens-Johnson syndrome.
(Reference: (SAUCW) Notification, , , 20 June 1999)
SGP The National Pharmaceutical Administration in the Ministry of Health has banned
chlormezanone since it has been associated with reports of life-threatening toxic
epidermal necrolysis and borderline major bullous forms.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)
WHO Comment : Chlormezanone is a sedative with antianxiety properties and a
central skeletal muscle relaxant effect. It had already been falling into
obsolescence for several years.

Product Name Chlornaphazine

C.A.S. number 494-03-1
Scientific and common names, and synonyms
BETA-NAPHTHYLBIS(BETA-CHLOROETHYL)AMINE
NAPHTHYLAMINE MUSTARD
N,N-BIS(2-CHLOROETHYL)- 2-NAPHTHYLAMINE
2-NAPHTHALENAMINE, N,N-BIS(2-CHLOROETHYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DNK 1964 The National Health Service withdrew chlornaphazine, a drug used against lympho-
granulomatosis, polycythaemia and chronic leukaemia, as it appeared to be carcinogenic
especially in the bladder.
VEN Not approved for use and/or sale.
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing chlornaphazine or to indicate that they
are still commercially manufactured.

Product Name Chloroform

C.A.S. number 67-66-3
Scientific and common names, and synonyms
METHANE, TRICHLORO-
TRICHLOROMETHANE
TRICHLOROFORM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 82

Product Name Chloroform

C.A.S. number 67-66-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1976 Not accepted in pharmaceuticals or cosmetics.
TUR 1976 Removed from all cough syrups after a decision by the Ministry of Health based on a
review of published information regarding carcinogenicity in rats. Export of this product is
prohibited.
JPN May 1976 Banned by the Pharmaceutical Affairs Bureau in Drugs and Cosmetics for reasons of
carcinogenicity.
USA Jul 1976 Withdrawn from the market and prohibited for export in drugs and cosmetics by the Food
and Drug Administration on the basis of findings of liver cancer in experimental mice and
rats by the National Cancer Institute.
(Reference: (FEREAC) Federal Register, 41, 26842, July 1976)
PAN 30 Nov 1976 The Ministry of Health has banned the sale of pharmaceuticals containing chloroform.
(Reference: (PANMR) Ministry of Health Resolution, 1843, , Aug 1976)
SAU 1977 Sale or supply of any medicinal product containing chloroform has been prohibited by the
Drug Committee.
BRA 25 May 1977 Products containing chloroform are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, No.15, , May 1977)
ITA 1978 Withdrawn from the market owing to suspected carcinogenicity.
CAN Jan 1978 National legislation has provided that no manufacturer or importer shall sell a drug for
human use that contains chloroform as an ingredient. The Health Protection Branch has
reviewed evidence from the National Cancer Institute in the US which suggests that
chloroform may be carcinogenic in rats and mice when administered in high doses over
prolonged periods. Export of this product is allowed with no requirement of foreign
notification regarding domestic restrictions on its use.
(Reference: (CANGZ) Canada Gazette, , , Nov 1977)
NOR Apr 1978 Prohibited for use in pure form or as an additive to pharmaceutical preparations.
PHL Apr 1978 Prohibited for use as an ingredient in human drugs and cosmetics on the grounds of
results of a study by the National Cancer Institute in the United States, suggesting that
the substance may be carcinogenic in rats and mice when administered over prolonged
periods.
(Reference: (PHADO) Administrative Order, 341S, , 1978)
GBR 1979 The Chloroform Prohibition Order has prohibited the sale or supply of any medicinal
product containing chloroform. Certain exemptions apply.
(Reference: (GBCHL) Chloroform Prohibition Order, , , 1979)
NZL 1980 Toothpaste formulations containing chloroform have been voluntarily withdrawn from the
market.
DNK 1981 Registered for veterinary use only.
(Reference: (DENBH) Danish National Board of Health, Circular Letter, , , Sep 1981)
ETH 1981 Prohibited because of its carcinogenic effects.
ZWE May 1981 Medicinal products containing more than 0.5% chloroform are prohibited because of the
toxicity of the drug. Certain exemptions apply.
(Reference: (ZWDCC) Drugs Control Council, News Bulletin, 1, , 1983)
DEU 1982 Prohibited for use and/or sale.
BGD Jun 1982 Use of chloroform as an excipient in pharmaceutical preparations has been banned due
to reported adverse effects.
DOM 1983 Domestic manufacturers and importers have been requested to eliminate this ingredient

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 83

Product Name Chloroform

C.A.S. number 67-66-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
from their marketed products since pharmacological studies have shown it to be toxic to
the liver and the heart, and to be carcinogenic.
BEL 12 Feb 1983 Prohibited for sale.
(Reference: (BELAR) Arrêté Royal, , , Feb 1983)
NGA 1 Feb 1985 Chloroform is not allowed in cosmetic and drug products since 1 Feb. 1985. From that
date, import, export and sale of products containing chloroform became illegal. The
decision was based on reports from literature of the carcinogenic effects of chloroform on
animals and possible hepatotoxic and nephrotoxic effects after prolonged use by humans.
(Reference: (AARNO) Administrative Action, MH.1856/S.3T, 112, 15 Sep 1983)
IRL 1989 Having regard to their toxicity, approval for marketing of all preparations containing
chloroform was withdrawn.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , 29, 1989)
OMN 27 Jul 1992 Sale and marketing of products containing chloroform were prohibited, having regard to
reported adverse effects and toxicity.
(Reference: (OMNCR) Circular, 27/92, , July 1992)
CUB Following the action taken by the US Food and Drug Administration, the National
Formulary Commission requested removal of chloroform from pharmaceutical
preparations.
THA The use of pharmaceutical preparations containing chloroform is severely restricted.
VEN Subject to restricted use and/or sale.
WHO Comment : Chloroform was formerly widely used in pharmaceutical
preparations as a solvent and preservative as well as for its anaesthetic and
flavouring properties. By the late 1970s reservations concerning its safety,
including positive results in a carcinogenicity screening programme sponsored by
the National Cancer Institute in the USA, had led to considerable restrictions in its
use in pharmaceutical preparations. While many pharmaceutical products
containing chloroform have been withdrawn or reformulated to exclude this
substance, it may still be incorporated in toothpastes and other specified products
in some countries, subject to statutorily-imposed concentration limits.
(Reference: (IARCCD) Chloroform: IARC Monograph, 20(20), 401-427, 1979)

Product Name Chloroquine

C.A.S. number 54-05-7
Scientific and common names, and synonyms
7-CHLORO-4-((4-(DIETHYLAMINO)-1-METHYLBUTYL)AMINO)-QUINOLINE
1,4-PENTANEDIAMINE, N4-(7-CHLORO-4-QUINOLINYL)-N1,N1-DIETHYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN 1975 Chloroquine was voluntarily withdrawn from production and sale by the manufacturer due
to the risk of retinopathy associated with its use at high doses in the treatment of
rheumatoid arthritis and related diseases.
WHO Comment : Chloroquine, a 4-aminoquinoline derivative, was introduced in the
1940s for the treatment and prophylaxis of malaria. It was subsequently found to be
effective in higher and prolonged dosage in the treatment of lupus erythematosus,
rheumatoid arthritis and nephritis. In the early 1970s its use in these latter

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 84

Product Name Chloroquine

C.A.S. number 54-05-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
conditions was largely discontinued when it was found that prolonged daily
administration at high dosage was associated with cases of retinopathy resulting
from local deposition of the compound. Chloroquine however remains a valuable
drug. It can be used continuously at the dosages required for malaria prophylaxis
for as long as five years without risk of undue accumulation and it is included in
the WHO Model List of Essential Drugs for both its antimalarial and antiamoebic
activity.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Chlorphentermine

C.A.S. number 461-78-9
Scientific and common names, and synonyms
P-CHLORO-ALPHA,ALPHA-DIMETHYLPHENETHYLAMINE
1-(P-CHLOROPHENYL)-2-METHYL-2-AMINOPROPANE
4-CHLORO-ALPHA,ALPHA-DIMETHYL-BENZENEETHANAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1969 The Ministry of Health withdrew preparations containing aminorex, cloforex and
chlorphentermine as a precautionary measure pending scientific evidence of a
relationship between their use and the development of pulmonary hypertension.
BEL 1 Jan 1988 Preparations containing chlorphentermine have been placed in List IV of the 'Arr^t, du
R,gent' of 2 June 1946 and as such can be administered only on prescription. They must
be kept in a poisons cabinet and carry the skull and cross-bones label.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
VEN Banned for use and/or sale.
WHO Comment : Chlorphentermine, a sympathomimetic phenethylamine
derivative, was introduced over twenty years ago for the treatment of obesity.
Concern that its use was associated with cases of pulmonary hypertension led to
its withdrawal in several countries. However, it remains available in some other
countries.

Product Name Cianidanol

C.A.S. number 154-23-4
Scientific and common names, and synonyms
CIANIDOL
(+)-CATECHOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 5 Sep 1985 Provisionally withdrawn by the Pharmaceutical Division of the Ministry of Health.
@WD 6 Sep 1985 Marketing of cianidanol was temporarily suspended worldwide by the manufacturer.
EGY 22 Oct 1985 Cianidanol has been withdrawn from the market and importation temporarily prohibited.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 85

Product Name Cianidanol

C.A.S. number 154-23-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 26 Jun 1987 Subsequent to its decision to suspend the marketing authorization of products containing
cianidanol, the Federal Health Office has definitively withdrawn registration of these
products.
(Reference: (FRGGH) Bundesgesundheitsamt Pressedienst, , , June 1987)
CHE Jun 1988 The Intercantonal Office for Drug Control has withdrawn the marketing license for
cianidanol.
@WD Jun 1988 Cianidanol was definitively withdrawn worldwide by the manufacturer.
AUT Use of preparations containing cianidanol has been prohibited until further notice.
WHO Comment : Cianidanol, which is extracted from the tropical plant Uncaria
gambir, was introduced in 1976 as an adjunct in the treatment of liver disorders.
Following a cluster of cases of haemolytic anaemia reported in 1985 from Naples,
Italy, four of which were fatal, the company suspended sales worldwide. Although
subsequently reintroduced in Switzerland and France for the treatment of acute
and chronic hepatitis-B, it was later definitively withdrawn in Switzerland on
detailed reassessment and the manufacturer has now withdrawn the product
worldwide.

Product Name Cinchophen

C.A.S. number 132-60-5
Scientific and common names, and synonyms
CINCHONINIC ACID, 2-PHENYL-
2-PHENYLQUINOLINE-4-CARBOXYLIC ACID.
2-PHENYLCINCHONINIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Jun 1991 Products containing cinchophen were withdrawn, because of the associated risks of
hepatic toxicity, including jaundice, hepatitis and cirrhosis and a greater incidence of
gastric ulceration than is associated with other nonsteroidal antiinflammatory agents.
(Reference: (FRGGH) Bundesgesundheitsamt Pressedienst, , , June 1991)
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
WHO Comment : Cinchophen, an analgesic and antipyretic, was formerly available
in preparations for the treatment of gout. Its use was associated with adverse
effects including hepatitis, cirrhosis, skin lesions and angioneurotic oedema. WHO
has no information to suggest that preparations containing cinchophen remains
commercially available.

Product Name Cinepazide

C.A.S. number 23887-46-9
Scientific and common names, and synonyms
1-[(1-PYRROLIDINYLCARBONYL)METHYL]-4-(3,4,5-TRIMETHOXYCINNAMOYL) PIPERAZINE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 86

Product Name Cinepazide

C.A.S. number 23887-46-9
Country Effective Description of action taken
Date Grounds for decision
EGY 1988 Registration of products containing cinepazide was refused, having regard to international
reports of blood dyscrasias associated with their use.
(Reference: (EGYDI) Drug Information, 6(4), 1, 1988)
ESP 1988 In agreement with the Ministry of Health, products containing cinepazide have been
withdrawn by the manufacturers.
(Reference: (ESPOR) Ministerio de Sanidad y Consumo, , , 13 Feb 1991)
WHO Comment : Cinepazide, a vasodilating agent, was first introduced into
medicine in 1974. It is used in the treatment of peripheral and cerebral vascular
disorders. Following reports of blood dyscrasias, including agranulocytosis and
thrombocytopenia, associated with the use of the drug, the Spanish Committee on
Drug Surveillance has recommended its withdrawal. In other countries, the
approved product information of preparations containing cinepazide has been
amended to include a relevant warning on these adverse effects.

Product Name Cinnarizine

C.A.S. number 298-57-7
Scientific and common names, and synonyms
PIPERAZINE,1-(DIPHENYLMETHYL)-4-(3-PHENYL-2-PROPENYL)
1-CINNAMYL-4-(DIPHENYLMETHYL) PIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP Aug 1989 Having regard to their potential to induce extrapyramidal symptoms, products containing
cinnarizine may no longer be indicated for cerebral and peripheral arterial insufficiency,
including loss of memory, insomnia, intermittent claudication, rest pain or vasospastic
disturbances. The approved indications are restricted to vestibular disturbances, vertigo,
prophylaxis of vascular headache and prevention of motion sickness.
(Reference: (ESPINS) Información Terapéutica de la Seguridad Social, 13(8), 176,
1989)
WHO Comment : Cinnarizine, an antihistaminic and vasodilator agent, was
introduced into medicine in 1962. It is indicated for the treatment of labyrinthine
disturbances and vascular disorders, although its effectiveness in the latter
indication has not been convincingly demonstrated.

Product Name Ciprofibrate

C.A.S. number 52214-84-3
Scientific and common names, and synonyms
PROPANOIC ACID, 2-[4-(2,2-DICHLOROCYCLOPROPYL)PHENOXYL]-2-METHYL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jun 1995 The use of ciprofibrate has been restricted because of dose-dependent rhabdomyolysis.
The distribution of the 200 mg dose formulation has been stopped.
(Reference: (FRAAMC) Communiqué de Presse, , , 14 June 1995)
WHO Comment : The safety profile of ciprofibrate is similar to that of clofibrate.
See also under clofibrate in full edition.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 87

Product Name Cisapride

C.A.S. number 810968-60-4
Scientific and common names, and synonyms
CISAPRIDUM
CIS-4-AMINO-5-CHLORO-N-[1-[3-(P-FLUOROPHENOXY)PROPYL]-3-METHOXY-4-PIPERIDYL]-O-ANISAMIDE;
R-51619

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL Sep 1999 The Irish Medicines Board has restricted the indications for cisapirde following reports of
cardiac arrhythmia, cardiac arrest and sudden death.
(Reference: (IRDDS) Drug Safety Newsletter, , , Sep 1999)
PHL 2000 The Department of Health Bureau of Food and Drugs has banned the use of cisapride
because of documented reports on adverse events including deaths associated with its
use.
(Reference: (PHADO) Administrative Order, (97) s. 2000, , 09 Aug 2000)
OMN Apr 2000 The Directorate General of Pharmaceutical Affairs & Drug Control has suspended the
marketing of cisapride because of the possibility of rare but serious heart complications
including arrhythmias and sudden death.
(Reference: (OMNCR) Circular, No. 28/2000, , 30 Apr 2000)
USA Apr 2000 Cisapride has been voluntarily withdrawn from the market because of the risk of rare but
serious cardiac events associated with the drug. These include heart rhythm disorders
associated with the drug. These include heart rhythm disorders and deaths associated
mostly with the use of the drug in people who are either taking certain other medications
or who have certain underlying conditions that are known risk factors.
(Reference: (FDAWWW) www.fda.gov/medwatch/safety/2000/propull.htm, , , )
ARE 15 Apr 2000 Indications for use of cisapride have been severely restricted because of the risk of rare
but serious cardiac events associated with the drug.
(Reference: (UAECW) Communication to WHO, , , 10 July 2000)
COL May 2000 The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia,
Colombian Ministry of Health has restricted the use of cisapride. It should be made
available only if other therapeutic management is insufficient.
(Reference: (COLVMA) Letter from INVIMA to WHO, , , 21 Aug 2000)
DEU Jun 2000 The Federal Institute for Drugs and Medical Devices has suspended the marketing
authorization of cisapride because of the association with cardiac arrhythmias and a
number of deaths.
(Reference: (DEUCFI) Communication, , , 03 July 2000)
GBR Jul 2000 The Medicines Control Agency has withdrawn cisapride from the market because of rare
but serious cardiac adverse effects.
(Reference: (GBRMCA) Communication to WHO, , , 21 July 2000)
MUS Jul 2000 Cisapride was withdrawn from the market following reports of adverse cardiac events
published by the FDA.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)
CAN 7 Aug 2000 Health Canada has withdrawn cisapride because of the possibility of rare but serious
heart complications including arrhythmias and sudden death.
(Reference: (CANWHC) Warnings/Advisories, , , 31 May 2000)
BDS Sep 2000 The Drug Advisory Committee of the Ministry of Health has withdrawn cisapride
(Prepulsid) from the market because of reports of serious cardiovascular adverse effects.
(Reference: (BDSMHS) Official letter to WHO, , , 30 Sep 2000)
TUR May 2000 General Directorate of Pharmaceuticals and Pharmacy of the Ministry of Health has
withdrawn cisapride from the market because of serious cardiovascular adverse effects
seen in the world.
(Reference: (TURCW) Communication to WHO, , , 20 Sep 2001)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 88

Product Name Cisapride

C.A.S. number 810968-60-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IDN 30 Jun 2000 The Directorate General of Drug and Food Control has suspended the marketing
authorization for cisapride and has withdrawn it from the market until the risk/benefit ratio
is further reviewed because of the possibility of rare but serious heart complications
including arrhythmias and sudden death.
(Reference: (IDNCW) Communication to WHO, , , 13 Sep 2001)
SGP Sep 2000 The product licences for all cisapride containing preparations were suspended by the
National Pharmaceutical Administration, Ministry of Health, Singapore in September 2000
following reports of increased risk of serious cardiac arrhythmia. Cisapride may still be
made available on an individual basis.
IDN Oct 2000 The Directorate General of Drug and Food Control has allowed the marketing
authorization for 5 mg cisapride with restrictions on indication, dosage, access and
distribution. Availability has been restricted to only a few hospitals, with close monitoring
for adverse reactions.
(Reference: (SGPCW) Communication to WHO, , , 19 Sep 2001)
(Reference: (IDNCW) Communication to WHO, , , 13 Sep 2001)
JPN Oct 2000 The Ministry of Health and Welfare, Tokyo has decided to suspend marketing
authorization of cisapride until its risk/benefit ratio is further reviewed.
(Reference: (JPNMHC) Communication to WHO, , , 18 Oct 2000)
CUB Jan 2001 The Centre for State Control of Drug Quality in Cuba (CECMED) has banned the use of
cisapride until its risk/benefit ratio is further reviewed.
(Reference: (CUBCDQ) CECMED Resolution, No. 1/2001, , 08 Jan 2001)
BRA Apr 2001 The National Health Surveillance Agency severely restricted the use of cisapride through
prescription and suspended the marketing authorization with the exception of
manufacturers with their own Pharmacovigilance System.
(Reference: (BRARES) Resolucao n., 530/ANVISA, , 18 Apr 2001)
BHR May 2001 Cisapride was withdrawn from the local market in May 2001. The action was based on
reports of serious cardiac events.
(Reference: (BHRCW) Communication with WHO, , , 20 Aug 2001)
THA Jun 2001 Severely restricted for prescription use by gastrointestinal physicians and limited use in
gastro-esophageal-reflux-disease patients only.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)
CHL Jul 2001 The Public Health Institute of Chile has restricted the indications for cisapride because of
the risk of serious cardiac adverse effects. The use in children is contraindicated.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)
AUS Dec 2002 Highest strength tablets of cisapride have been withdrawn and product information has
been revised. All patients now require measurements of renal function and ECGs before
and during treatment. Follow up measures should be undertaken every three months.
Concerns about cardiac arrhythmias led to restrictions being placed on the prescription of
cisapride.
(Reference: (AUSPRE) Australian Prescriber, 25, No.6, Dec 2002)
ARM Cisapride has been voluntarily withdrawn because of the increased risk of cardiac
arrhythmias in patients taking other medications or suffering from underlying conditions
known to increase risk of cardiac arrhythmias.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
NZL The Therapeutics section of the Ministry of Health, Wellington has severely restricted the
use of cisapride in view of reports of cardiac arrhythmias associated with its use
particularly in conjunction with erythromycin, clarithromycin, fluconazole, itraconazole or
miconazole.
(Reference: (NZLPU) Prescriber Update, No.14, , Feb 1997)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 89

Product Name Cisapride

C.A.S. number 810968-60-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Clemastine

C.A.S. number 15686-51-8
Scientific and common names, and synonyms
PYRROLIDINE, 2-[[1-(4-CHLOROPHENYL)-1-PHENYLETHOXY]ETHYL]-1-METHYL-,[R-(R*,R*)]-
(+)-(2R)-2-[-[[(R)-P-CHLORO-ALPHA-METHYL-ALPHA-PHENYLBENZYL]OXY]ETHYL]-1-METHYLPYRROL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1991 Products containing clemastine were disallowed in children under one year of age,
because of their possible association with sleep apnoea.
(Reference: (GBRPHJ) The Pharmaceutical Journal, , , 24 Aug 1991)
WHO Comment : See WHO comment for H1-antihistamines.

Product Name Clioquinol (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 130-26-7
Scientific and common names, and synonyms
5-CHLORO-7-IODOQUINOLINOL
5-CHLORO-7-IODO-8-QUINOLINOL
CHLOROIODOQUIN
CHINOFORM
IODOCHLORHYDROXYQUINOLINE
IODOCHLORHYDROXYQUIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Sep 1970 The Ministry of Heath and Welfare prohibited the sale of clioquinol and broxyquinoline,
and preparations containing them, following reports that clioquinol might be one of the
causes of subacute myelo-optic neuropathy (SMON).
NOR Jan 1974 Withdrawn from the market.
SWE Jun 1975 Withdrawn by the manufacturer after mutual discussions due to neurological adverse
reactions. It remains on the market for external use.
BEL 1976 Following cases of subacute myelo-optic neuropathy (SMON) in Japan, manufacturers of
clioquinol in Belgium have limited the indications for use and duration of treatment. Since
1975 clioquinol has been available only on prescription.
DEU 1 Jan 1977 Preparations containing clioquinol intended for internal use have been placed under
prescription control because of a propensity to cause neurological disorders.
DNK 1978 Products have been withdrawn from the market.
(Reference: (UGLAAD) Ugeskrift for Laeger, 140, 1181, 1978)
FRA 3 Nov 1978 Clioquinol has been placed under Schedule A of the Poisonous Substances Regulations.
ARE 9 Jun 1981 Pharmaceutical preparations containing clioquinol are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 90

Product Name Clioquinol (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 130-26-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NGA 1982 Importation, sale and manufacture of clioquinol and clioquinol-containing products for oral
administration have been prohibited, because of evidence of neurological disorders,
including SMON, associated with their use.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
BGD Jun 1982 Banned as a single ingredient or in combination due to its implication in subacute myelo-
optic neuropathy.
PHL Aug 1982 This drug, used to treat infectious diarrhea, has been withdrawn from the domestic
market due to reports of neurological disorders (SMON) associated with its use in Japan.
ITA 1983 Withdrawn from the market.
NPL 1983 All preparations containing this substance have been banned.
DOM Feb 1983 Prohibited for use and/or sale after authorities were informed of the manufacturer's intent
to gradually replace this ingredient in all preparations currently marketed worldwide.
ZWE Feb 1983 Use of clioquinol is prohibited because of its propensity to cause neurological disorders.
(Reference: (ZWDCC) Drugs Control Council, News Bulletin, 1, , 1983)
ESP 29 Jul 1983 The Ministry of Health and Consumer Protection has withdrawn approval for clioquinol.
(Reference: (ESPMC) Programa Selectivo de Revisión de Medicamentos, (I), , Sep
1983)
ZMB 7 Dec 1983 Preparations of clioquinol for internal use may only be imported or exported on a licence
issued by the Director of Medical Services.
(Reference: (ZMBSI) Statutory Instrument, 166-167, , Dec 1983)
HKG 1 Jan 1984 The Pharmacy and Poisons Committee no longer allows the registration, sale or
distribution of products containing clioquinol.
ETH 7 Sep 1984 Prohibited due to its association with sub-acute myelo-optic neuropathy.
HND 24 Oct 1985 The importation, manufacture and sale of products containing clioquinol have been
prohibited having regard to the drug's potential to cause SMON.
(Reference: (HNDSP) Circular, 10-85, , 1985)
OMN Mar 1987 Import and marketing of oral and parenteral preparations containing clioquinol and
related substances intended for the treatment of diarrhoea in children were prohibited.
Topical preparations remain on the market.
(Reference: (OMNCR) Circular, 11/87, , Mar 1987)
PAK 1988 Oral preparations containing clioquinol were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
GHA 1 Sep 1989 Products containing clioquinol have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
LIY 21 May 1990 The General People's Health Committee banned the use of clioquinol in children.
(Reference: (LIYRL) Resolution of the General People's Health Committee, 141, , May
1990)
BHR Preparations containing clioquinol have been withdrawn.
CHE Oral preparations of clioquinol have been subjected to prescription control and the
approved indications restricted to intestinal amoebiasis and diarrhoea caused by
sensitive organisms following cases of subacute myelo-optic neuropathy (SMON) in
Switzerland.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 91

Product Name Clioquinol (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 130-26-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CUB Use restricted to treatment of parasitic infections.
NLD Preparations containing clioquinol have been withdrawn from the market.
SAU Following reports of subacute myelo-optic neuropathy (SMON) in patients treated with
this drug, the Drug Committee has prohibited its import.
THA The use of pharmaceutical preparations containing clioquinol is severely restricted.
VEN Subject to restricted use and/or sale.
WHO Comment : Clioquinol, a halogenated hydroxyquinoline derivative, was
introduced into medicine around 1900 as a topical antiseptic and in 1934 oral
preparations for the treatment of amoebic dysentery and simple diarrhoea became
available. By 1964 its use in Japan had been associated with cases of sub-acute
myelo-optic neuropathy (SMON) which reached epidemic proportions resulting in
its withdrawal there in 1970. Although relatively few cases of SMON were
documented elsewhere, clioquinol was subsequently withdrawn from use in many
countries and placed under prescription control in others. It was phased out
worldwide by the major manufacturer between 1983 and 1985 on grounds of
obsolescence. No adequately controlled evidence was ever generated to
demonstrate that clioquinol is effective in bacterial or viral diarrhoea. However,
products containing clioquinol and related halogenated hydroxyquinolines
continue to be used in some tropical and subtropical countries where amoebiasis
remains endemic. Other amoebocides are preferred in the WHO Model List of
Essential Drugs.
(Reference: (WHODI) WHO Drug Information, 77.1, 9, 1977)

Product Name Clobenzorex

C.A.S. number 13364-32-4
Scientific and common names, and synonyms
(+)-N-(O-CHLOROBENZYL)-ALPHA-METHYLPHENETHYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS Aug 2000 Removed from the market following a similar decision of the Agence Francaise de
Securite Sanitaire des Produits de Sante in respect of appetite suppressants in
September 1999.
(Reference: (MUSCW) Communication to WHO, , , 27 Aug 2001)

Product Name Clofenotane

C.A.S. number 50-29-3A
Scientific and common names, and synonyms
ALPHA,ALPHA-BIS(P-CHLOROPHENYL)-BETA,BETA,BETA-TRICHLORETHANE
CHLOROPHENOTHANE
DICHLORODIPHENYLTRICHLOROETHANE (USA)
DDT
ETHANE, 1,1,1-TRICHLORO-2,2-BIS(P-CHLOROPHENYL)
P,P'-DICHLORODIPHENYLTRICHLOROETHANE
TRICHLOROBIS(4-CHLOROPHENYL)ETHANE

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 92

Product Name Clofenotane

C.A.S. number 50-29-3A
Scientific and common names, and synonyms
1,1,1-TRICLORO-2,2-BIS(4-CLORO-FENIL)-ETANO (ITA)
1,1,1-TRICHLORO-2,2-DI(4-CHLOROPHENYL)-ETHANE
1,1,1-TRICHLORO-2,2-BIS(P-CHLOROPHENYL)ETHANE
1,1,1-TRICHLORO-2,2-BIS(4-CHLOROPHENYL)ETHANE

1,1,1-TRICHLOR-2,2-BIS(4-CHLOR-PHENYL)-AETHAN (DEU)
1,1,1-TRICHLOOR-2,2-BIS(4-CHLOOR FENYL)-ETHAAN (NLD)
2,2-BIS(P-CHLOROPHENYL)-1,1,1-TRICHLOROETHANE
4,4'-DICHLORODIPHENYLTRICHLOROETHANE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Jul 1972 The Environmental Protection Agency has cancelled all DDT products, except the
following list of uses: the U.S. Public Health Service and other health service officials for
control of vector diseases; the USDA or military for health quarantine; in drugs, for
controlling body lice. (To be dispensed only by a physician). These compounds have
been found to pose carcinogenic risk to humans and to be toxic to the ecosystem.
(Reference: (FEREAC) Federal Register, 37, 13369, 1972)
LKA 1 Jan 1976 DDT is banned for use as a pesticide. It was prohibited for crop use prior to 1970. It was
phased out of vector control in 1976. No remaining uses allowed. The substance was
banned on grounds of long persistant residues and bioaccumulation.
(Reference: (LKAPFC) Meeting of the Pesticide Formulary Committee, , , 1988)
BLZ 28 Dec 1985 Severely restricted. Vector control for use only by public health officials. Residue
persistency and bio-accumulation.
(Reference: (EP1) UNEP/FAO - PIC Circular X - 12/1999, , , )

Bibliographical references
IARC MONOGRAPH, 5, 83, 1974
IPCS ENVIRONMENTAL HEALTH CRITERIA, 9, , 1979
IARC MONOGRAPH, SUPPL.4, 105, 1982
WHO GUIDELINES FOR DRINKING WATER QUALITY, 2, , 1984
FAO PLANT PRODUCTION & PROTECTION PAPER, 62, , 1984

Product Name Clofibrate

C.A.S. number 637-07-0
Scientific and common names, and synonyms
ETHYL CLOFIBRATE
ETHYL ALPHA-(4-CHLOROPHENOXY)-ALPHA-METHYLPROPIONATE
ETHYL 2-(P-CHLOROPHENOXY)ISOBUTYRATE
ETHYL 2-(PARA-CHLOROPHENOXY)-2-METHYLPROPIONATE
PROPANOIC ACID, 2-(P-CHLOROPHENOXY)-2-METHYL, ETHYL ESTER
PROPANOIC ACID, 2-(4-CHLOROPHENOXY)-2-METHYL, ETHYL ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1978 Although withdrawn following reports of increased mortality associated with its use,
clofibrate was subsequently reinstated for treatment of high-risk patients in whom diet,
weight reduction, exercise and control of diabetes had failed to elicit adequate control.
DNK 1979 Indications for use have been restricted.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 93

Product Name Clofibrate

C.A.S. number 637-07-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISR 1979 Withdrawn from the market following reports of increased mortality associated with use.
NOR 1979 Withdrawn from the market following reports of increased mortality associated with use.
FRA 2 Feb 1979 The indications have been restricted, as for every hypolipidaemic drug, to the treatment
of endogenous hypercholesterolaemia and hypertriglyceridaemia a) when a suitable and
assiduously followed diet has proved inadequate; and b) when cholesterolaemia is still
raised after dieting and/or there are associated risk factors present.
(Reference: (FRAPC) Press Communiqué, , , Feb 1979)
USA Aug 1979 Indications are restricted to treatment of patients with hyperlipidaemia refractory to
dietary measures.
(Reference: (FDADB) FDA Drug Bulletin, 9(3), 14, 1979)
PHL 1980 Severely restricted in use to certain patients only. This compound has been shown to
cause hepatic tumours in rodents. There is an increased risk of malignancy and
cholelithiasis with use in humans. A warning statement is required to be placed on the
labels of all products.
ITA 1981 Currently marketed in Italy with limited therapeutic indications (certain
hyperproteinaemias with ascertained diagnoses; diabetic exudative retinopathy;
xanthomes).
SWE Jan 1981 Used only in cases of severe hyperlipoproteinaemia due to increased mortality connected
with long-term treatment.
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, this drug has been banned since
it increases the incidence of gallstones and cholecystitis, drug-induced cardiac
arrhythmias, cardiomegaly, angina, claudication and thromboembolic phenomena. It also
enhances the effects and toxicity of other acidic drugs and it is implicated in the
incidence of various tumours.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
CHL 16 Dec 1982 Indications are restricted to treatment of patients with high plasma lipid levels, resistant to
dietary control.
(Reference: (CHLRS) Resolution of the Minister of Health, 3261, , Dec 1982)
CHE Indications are restricted to treatment of patients with hyperlipidaemia refractory to
dietary measures.
(Reference: (FDADB) FDA Drug Bulletin, 9(3), 14, 1979)
CUB Indications are restricted to treatment of patients with hyperlipidaemia.
GBR Indications are restricted to treatment of patients with hyperlipidaemia refractory to
dietary measures.
(Reference: (FDADB) FDA Drug Bulletin, 9(3), 14, 1979)
GRC Indications are restricted to treatment of patients with severe hyperlipidaemia.
IND Currently available on the market. Precautionary information is required to be given with
this drug.
SAU Severely restricted for use and/or sale.
VEN Subject to restricted use and/or sale.
WHO Comment : Clofibrate, an antihyperlipidaemic agent, was introduced in 1967
and was subsequently extensively studied in the primary and secondary prevention
of ischaemic heart disease. Following reports, published in 1978, of increased
mortality among patients receiving clofibrate in a WHO-sponsored cooperative trial
concerned with the primary prevention of ischaemic heart disease, the drug was
withdrawn in some countries and its approved indications were severely restricted

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 94

Product Name Clofibrate

C.A.S. number 637-07-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
in many others. These restrictions have become the norm for more recently
developed analogues of clofibrate.
(Reference: (WHODI) WHO Drug Information, 2, 6, 1979)

Product Name Cloforex

C.A.S. number 14261-75-7
Scientific and common names, and synonyms
CLOPHOREX
ETHYL(P-CHLORO-ALPHA,ALPHA-DIMETHYLPHENETHYL)-CARBAMATE
(P-CHLORO-ALPHA,ALPHA-DIMETHYLPHENETHYL)-CARBAMIC ACID
(2-(4-CHLOROPHENYL)-1,1-DIMETHYLETHYL)-CARBAMIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1969 The Ministry of Health withdrew preparations containing aminorex, cloforex and
chlorphentermine as a precautionary measure pending scientific evidence of a
relationship between their use and the development of pulmonary hypertension.
SWE 14 Feb 1969 All antiobesity preparations containing cloforex were withdrawn from the market following
several reports of pulmonary hypertension in patients treated with the related drug
chlorphentermine in West Germany, and pre-existing knowledge of a relationship
between pulmonary hypertension and the antiobesity drug aminorex.
VEN Not approved for use and/or sale.
WHO Comment : Cloforex, a sympathomimetic phenethylamine derivative, was
introduced over twenty years ago for the treatment of obesity. Concern that its use
was associated with cases of pulmonary hypertension led to its withdrawal in
several countries. WHO has no information to suggest that this drug remains
commercially available.

Product Name Clometacin

C.A.S. number 25803-14-9
Scientific and common names, and synonyms
3-(P-CHLOROBENZOYL)-6-METHOXY-2-METHYLINDOLE-1-ACETIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 1990 All preparations containing clometacin were withdrawn, having regard to severe cases of
hepatitis associated with their use.
(Reference: (FRARP) La Revue Prescrire, 10(95), 148, 1990)
WHO Comment : Clometacin, an analogue of indometacin, was introduced on the
market in 1971. Subsequently several cases of severe - in some cases fatal -
hepatitis were reported, which led in 1987 to the withdrawal of a high-dosage tablet
formulation, while the indications for a lower dosage tablet were restricted and
duration of the treatment was limited. Eventually all tablet formulations were
removed from the market. Clometacin is not widely registered in other countries.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 95

Product Name Clomethiazole

C.A.S. number 533-45-9
Scientific and common names, and synonyms
5-(2-CHLOROETHYL)-4-METHYLTHIAZOLE
CHLORETHIAZOLE
CHLORETHIAZOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : Clomethiazole, which has sedative, anxiolytic and anticonvulsant
activity, was introduced in 1960 for the treatment of acute alcohol withdrawal,
delirium tremens, status epilepticus, eclamptic toxaemia, sleep disturbances in the
elderly and agitation in psychogeriatic patients. It is also used as a sedative in
certain anaesthetic procedures. There is little evidence of primary dependence in
man but secondary dependence can occur in patients with a history of abuse of
other substances, particularly alcohol. Dependence of this type has been reported
as a result of inappropriate, long-term prescribing to outpatient alcoholics.
Clomethiazole should not be prescribed to alcoholics who continue to drink.
Adverse interactions with alcohol have been fatal. Although not controlled under
the 1971 Convention on Psychotropic Substances, clomethiazole is subject to
analogous controls in some countries.

Product Name Clozapine

C.A.S. number 5786-21-0
Scientific and common names, and synonyms
5H-DIBENZO(B,E),(1,4)DIAZEPINE, 8-CHLORO-11-(4-METHYL-1-PIPERAZINYL)-
8-CHLORO-11-(4-METHYL-1-PIPERAZINYL)-5H-DIBENZO(B,E)(1,4)DIAZEPINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FIN 1975 Withdrawn from general use and restricted to named patients subject to permission of
the competent authority.
SGP Aug 1977 Importation prohibited.
DEU 1978 Clozapine, a tricyclic neuroleptic, was introduced in 1972 for the treatment of psychosis.
In 1975 its use was associated with cases of agranulocytosis, particularly in Finland.
These cases, which included several fatalities, resulted in the withdrawal of the drug in
some countries. However, clozapine remains available in at least 30 countries, in some
cases only on special request, for the treatment of severe psychotic disorders
unresponsive to other neuroleptics provided that close monitoring of the blood count is
feasible. In 1989, it was introduced in the United States for the treatment of severe
schizophrenia. Lately, the use of clozapine in the United Kingdom has been associated
with convulsions.
(Reference: (WHODI) WHO Drug Information, 2, 10, 1977)
NOR 1986 Registration refused since the balance of safety and efficacy does not justify registration.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 2, 15, 1986)
ESP Oct 1993 The Directorate General of Pharmacy and Health Products of the Ministry of Health and
Consumer Affairs has restricted the use of the neuroleptic agent, clozapine (Leponex®:
Sandoz) because incorrect use of this product could result in serious adverse reactions.
The package will state that clozapine is subject to medical prescription and supervision
and the outside container will bear the words ?SPECIAL MEDICAL CONTROL". The
product information will also state immediately after the name "SPECIALITY SUBJECT
TO SPECIAL MEDICAL CONTROL". Clozapine should be prescribed only by a
psychiatrist, who must ensure at the onset that the patient's leukocyte count is within

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 96

Product Name Clozapine

C.A.S. number 5786-21-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
normal limits, and arrange for subsequent counts to be performed at weekly intervals for
18 weeks, and at monthly intervals thereafter for as long as treatment is continued.
(Reference: (ESPCR) Circular, No. 10/93, , )
GBR 1 Jan 1994 The manufacturer of the neuroleptic agent, clozapine (Clozaril) has modified® the
instructions regarding dosage and administration. A section on drug interactions has
been added, and the section on adverse effects has been expanded.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 252: 37, , 1994)
NZL May 1994 Because of the risk of agranulocytosis, patients taking clozapine should have weekly
blood count checks during the first 18 weeks of therapy and monthly thereafter. Patients
taking clozapine and presenting with symptoms of infection should be checked
immediately for neutropenia.
(Reference: (NZLPU) Prescriber Update, No.5, , May 1994)
FRA Feb 1995 The French Commission of Pharmacovigilance has agreed with the manufacturer of the
antipsychotic agent, clozapine (Leponex®: Sandoz), to revise the product information to
include detailed instructions on use and to warn against the risk of neutropenia,
agranulocytosis and neurologic disorders.
(Reference: (FRAAMC) Communiqué de Presse, , , 14 June 1995)
WHO Comment : Clozapine, a tricyclic neuroleptic, was introduced in 1972 for the
treatment of psychosis. In 1975 its use was associated with cases of
agranulocytosis, particularly in Finland. These cases, which included several
fatalities, resulted in the withdrawal of the drug in some countries. However,
clozapine remains available in at least 30 countries, in some cases only on special
request, for the treatment of severe psychotic disorders unresponsive to other
neuroleptics provided that close monitoring of the blood count is feasible. In 1989,
it was introduced in the United States for the treatment of severe schizophrenia.
Lately, the use of clozapine in the United Kingdom has been associated with
convulsions.
(Reference: (WHODIB) WHO Drug Information Bulletin, 2: 10, , 1977)

Product Name Cobalt (non-radioactive forms)

C.A.S. number 7440-48-4

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Jul 1967 Withdrawn from the market and prohibited for export (non-radioactive forms only) by the
Food and Drug Administration due to the lack of evidence of effectiveness in treating iron-
deficiency anemia and on the basis of toxic effects in humans including liver damage,
claudication, myocardial damage, thyroid hyperplasia, hypothyroidism, dermatitis, nausea
and anorexia.
(Reference: (FEREAC) Federal Register, 32, 7945, 1967)
KWT 26 Oct 1967 Importation and marketing of preparations containing inorganic cobalt salts are prohibited.
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing cobalt or to indicate that they are still
commercially manufactured.

Product Name Codeine

C.A.S. number 6095-47-8

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 97

Product Name Codeine

C.A.S. number 6095-47-8
Scientific and common names, and synonyms
6-HYDROXY-3-METHOXY-N-METHYL-4,5 EPOXYMORHIN-7-ENE
7,8-DIDEHYDRO-4,5-ALPHA-EPOXY-3-METHOXY-17-METHYLMORPHINAN-6-ALPHA-OL MONOHYDRATE
MORPHINAN-6-OL, 7,8-DIDEHYDRO-4,5-EPOXY-3-METHOXY-17-METHYL-,MONOHYDRATE,(5ALPHA,6ALPHA)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD Sep 1985 Use of codeine in any dosage form has been banned due to liability for addiction and
misuse.
MYS 1 Jan 1996 The Drug Control Authority has banned the import of all cough preparations containing
codeine with effect on 1 January 1996 and all imported products have been recalled.
Local manufacture of all combination products containing codeine with ephedrine or
pseudoephedrine has also been banned and product registrations have been withdrawn.
The products can be reformulated and new applications for registration submitted. The
agency has not registered any new product containing codeine since 1992, when a
decision was made to stop registration of new codeine-containing products.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 9(4): 2, , Dec 1995)
MUS Aug 2001 All codeine based products have been moved to the prescription-only status, import of
these products require authorization from the Ministry of Health, Importers and
distributors are required to submit monthly returns of sales.
(Reference: (MUSCW) Communication to WHO, , , 27 Aug 2001)
MYS 31 Dec 2002 The Drug Control Authority in Malaysia has announced that liquid codeine-containing
preparations will not be available after 31 December 2002. This announcement follows its
decision to cancel the registration of these products due to the growing problem of
codeine misuse and abuse in Malaysia.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 19:5, , Aug 2002)
WHO Comment : Codeine, which has antitussive, opioid analgesic and
antidiarrhoeal activity, was first extracted from opium in 1832 and has since been
widely used in medicine. The development of dependence and its potential for
abuse resulted in the control of the substance under Schedule II of the 1961 Single
Convention on Narcotic Drugs. Preparations containing codeine remain widely
available and are included in the WHO Model List of Essential Drugs.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Coumarin (synthetic)

C.A.S. number 91-64-5
Scientific and common names, and synonyms
2H-1-BENZOPYRAN-2-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 15 Aug 1996 The Department of Health and Family Services cancelled the registration of 200 mg
coumarin tablets (Lodema®) on the grounds that the safety and quality of the product are
unacceptable, after reports of death in women who developed hepatotoxicity associated
with its use.
(Reference: (AUSTGA) Therapeutic Goods Administration, Department of Community
Services and Health, , , 23 Aug 1996)
FRA Dec 1996 The manufacturer, with the agreement of the Agence du Médicament, has decided to
suspend the marketing authorization of coumarin (Lysedem®) because of its

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 98

Product Name Coumarin (synthetic)

C.A.S. number 91-64-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
unfavourable risk/benefit profile, and particularly because of several reports of hepatic
adverse effects.
(Reference: (FRAAMR) Rapid Alert - Pharmacovigilance, , , 23 Dec 1996)

Product Name Cyclamates in drugs

C.A.S. number 139-05-9
Scientific and common names, and synonyms
CYCLOHEXANESULFAMIC ACID
SULFAMIC ACID, CYCLOHEXYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PER Oct 1969 Banned in pharmaceuticals due to its carcinogenic effects in experimental animals.
PHL Jan 1971 Cyclamic acid (or its salts) used as a sweetening agent in drugs has been withdrawn due
to evidence of its carcinogenicity in animals.
PAN 23 Nov 1971 Cyclamates are no longer allowed in pharmaceutical preparations.
(Reference: (PANMR) Ministry of Health Resolution, 534, , Nov 1971)
THA Dec 1974 As pharmaceutical ingredients, cyclamate and its salts are restricted to dosages of 3.5
g/day in adults and 1.2 g/day in children.
BGD Jun 1982 Use of cyclamate as a sweetening agent has been banned due to reported adverse
effects.
GRC 1986 Registration not approved.
NGA 1988 Sodium cyclamate has been banned, because its use has been associated with
carcinogenicity in experimental animals.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
WHO Comment : Cyclamates, non-nutritive sweetening agents, have been used as
additives in food and drugs since 1950. They have been demonstrated to have a
carcinogenic potential at very high and long-sustained dosage in experimental
animals. Some countries have consequently banned their use as food additives,
whereas in others they remain available for this purpose. Most countries, however,
continue to allow their use in small quantities in pharmaceutical preparations.
(Reference: (WHODI) WHO Drug Information, 77.2, 12, 1977)

Product Name Cyclandelate

C.A.S. number 456-59-7
Scientific and common names, and synonyms
3,3,5-TRIMETHYLCYCLOHEXYL MANDELATE
3,3,5-TRIMETHYLCYCLOHEXANOL ?-PHENYL-?-HYDROXYACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Dec 1996 The Food and Drug Administration withdrew the marketing approval for the peripheral
vasodilator cyclandelate on the grounds that this product has not been shown to be

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 99

Product Name Cyclandelate

C.A.S. number 456-59-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
effective for such use.
(Reference: (FEREAC) Federal Register, 61(233) , p. 64099, 1996)
WHO Comment : Cyclandelate is a papaverine type spasmolytic and vasodilating
drug intended for symptomatic treatment of various peripheral vascular disorders,
such as intermittent claudication in arteriosclerosis obliterans as well as a
treatment for cognitive dysfunction in patients suffering from senile dementia of
the multi-infarct or Alzheimer's type. Cyclandelate remains registered in several
countries.

Product Name Cyclopenthiazide

C.A.S. number 742-20-1
Scientific and common names, and synonyms
2H-1,2,4-BENZOTHIADIAZINE-7-SULFONAMIDE, 6-CHLORO-3-(CYCLOPENTYLMETHYL)-3,4-DIHYDRO-,1,1-DIOXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL Feb 1997 The Therapeutics Section has restricted the indications for the thiazide diuretic,
cyclopenthiazide, by deleting the indications for idiopathic hypercalciuria and oedema
due to heart failure.
(Reference: (NZLPU) Prescriber Update, No.14, , Feb 1997)
WHO Comment : Cyclopenthiazide, a thiazide diuretic, was introduced in 1968. It
continues to be used mainly in combination drugs.

Product Name Cyproheptadine

C.A.S. number 129-03-3
Scientific and common names, and synonyms
PIPERIDINE,4-(5H-DIBENZO(A,D)CYCLOHEPTEN-5-YLIDENE)-1-METHYL-
PIPERIDINE, 4-(5H-DIBENZO[A,D]-CYCLOHEPTEN-5-YLIDENE)-1-METHYL-, HYDROCHLORIDE, SESQUIHYDRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GHA 1979 Sale and use of preparations containing cyproheptadine have been severely restricted
due to abuse of its appetite stimulant effect.
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, cyproheptadine was banned
following unacceptable promotion encouraging its use as an appetite stimulant.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
MYS Nov 1986 All products containing cyproheptadine marketed as an appetite stimulant have been
withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.4, , Nov 1986)
GBR Jan 1994 The manufacturer of the antihistamine, cyproheptadine, has announced that it is no
longer indicated as an appetite stimulant. The syrup formulation as the most often used
in children will no longer be available in the United Kingdom. Use of the product as an
antihistamine is not affected.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 252:136, , 1994)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 100

Product Name Cyproheptadine

C.A.S. number 129-03-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : Cyproheptadine, an antihistamine with anticholinergic and
serotonin-antagonist properties, was introduced in 1961 for the symptomatic relief
of allergy and was subsequently used as an appetite stimulant. In 1982 the drug
was prohibited in Bangladesh because of its misuse as an appetite stimulant due
to inappropriate promotion. Cyproheptadine remains widely available and the
current marketing policy of the major manufacturer requires that it should be used
as an appetite stimulant only under the supervision of a physician who should be
assured that adequate food is available.

Product Name Cyproterone acetate

C.A.S. number 2098-66-0
Scientific and common names, and synonyms
3'H-CYCLOPROPA[1,2]PREGNA-1,4,6-TRIENE-3,20-DIONE, 17-(ACETYLOXY)-6-CHLORO-1,2-DIHYDRO-, (1?,2?)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Feb 1995 The Committee on Safety of Medicines decided that in view of the hepatoxicity
associated with long-term daily use of cyproterone in prostatic cancer, it should be
restricted to short courses to cover flare associated with testosterone agonists, to
treatment of hot flushes after orchidectomy or LHRH agonists and to patients who have
not responded to, or are intolerant of other treatments.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, vol.21, , Feb 1995)
WHO Comment : Cyproterone was introduced in the late sixties. It is an orally-
active anti-androgen with competitive inhibitory effects on androgen-sensitive
target organs. It also has anti-gonadotropic and progestative properties. In 1995
the drug was found to have a hepatotoxic effect.

Product Name Dalkon shield

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1974 The Dalkon shield has not been marketed since 1974, when the manufacturer withdrew
the product from distribution following reports of mid-trimester septic abortions. In
September 1980 the manufacturer issued a letter to all doctors recommending removal
of all Dalkon shields due to an increased risk of pelvic inflammatory disease caused by
actinomyces israeli. The Food and Drug Administration has recently stated that due to an
increased risk of pelvic inflammatory disease, the Dalkon shield intrauterine device
should be removed from any woman still using one. Women using the Dalkon shield
were shown to have a fivefold increased risk of pelvic inflammatory disease compared
with women using other types of IUD.
(Reference: (FDADB) FDA Drug Bulletin, 13(2), , 1983)
GBR 1985 The manufacturer of the device has written to all doctors reminding them that women still
wearing the Dalkon shield should have the device removed. Marketing was discontinued
in 1975 and a similar letter was distributed in 1980.
NZL 1985 The New Zealand Health Authorities have instituted a programme to ensure that all
women still wearing a Dalkon shield IUD have their device removed.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 101

Product Name Dalkon shield

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 234, , July 1985)

Product Name Danazol

C.A.S. number 2004-0-0004

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 10 Sep 2003 The use of danazol (Danol) has been restricted to second-line therapy in endometriosis
and benign fibrocystic breast disease, as a result of safety and risk-benefit assessments
suggesting that it may increase the baseline risk of ovarian cancer in patients being
treated for endometriosis.
(Reference: (GBRMI) News and updates, , , 10 Sep 2003)

Product Name Dantron

C.A.S. number 117-10-2
Scientific and common names, and synonyms
9,10-ANTHRACENEDIONE,1,8-DIHYDROXY,1,8-DIHYDROXYANTHRAQUINONE
9,10-ANTHRACENEDIONE,1,8-DIHYDROXY-
ANTRAPUROL
CHRYSAZIN
DIANTHON

DANTHRON
1,8-DIHYDROXYANTHRAQUINONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1987 The major manufacturer has discontinued production of products containing dantron. All
other manufacturers in Norway have subsequently withdrawn such preparations.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 3(6), , 1987)
DEU 31 Jan 1987 The Federal Health Office no longer permits the use of dantron in pharmaceutical
preparations.
JPN Feb 1987 The Ministry of Health and Welfare has requested manufacturers to discontinue
production and marketing of laxatives containing dantron.
USA 30 Mar 1987 The United States Food and Drug Administration advised manufacturers to discontinue
production of laxatives containing dantron and to recall all such products from retail
stores.
GBR Apr 1987 The Committee on Safety of Medicines advised that the licensed indications for those
products containing dantron that remain on the market should be limited to: (1)
constipation in geriatric practice and analgesic-induced constipation in the terminally ill
and (2) constipation in cardiac failure and coronary thrombosis (conditions in which
defaecation must be free of strain). The Committee also advised that these products
should be subjected to prescription control as quickly as possible.
SGP 15 Jan 1988 The Ministry of Health has prohibited the import and sale of dantron on the basis of
potential carcinogenicity.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 102

Product Name Dantron

C.A.S. number 117-10-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (SGPRD) The Sale of Drugs (Prohibited Drugs) Regulations, S9, 7, Jan
1988)
CAN Nov 1997 After reviewing the benefits and risks associated with the use of dantron-containing
stimulant laxatives, Health Canada has concluded that dantron is a genotoxic animal
carcinogen and that the risks of using these products outweigh the therapeutic benefits.
Dantron is a synthetic anthraquinone and, although there is no direct evidence that it has
caused cancer in humans, it may have a carcinogenic potential. Manufacturers have
voluntarily ceased sale of their products.
(Reference: (CANPR) Press Release, 1997-64, , 25 Nov 1997)
CAN 25 Nov 1997 After reviewing the benefits and risks associated with the use of dantron-containing
stimulant laxatives, Health Canada has concluded that dantron is a genotoxic animal
carcinogen and that the risks of using these products outweigh the therapeutic benefits.
Dantron is a sythetic anthraquinone and, although there is no direct evidence that it has
caused cancer in humans, it may have a carcinogenic potential. Manufacturers have
voluntarily ceased sale of their products.
(Reference: (CANPR) Press Release, 1997-64, , 25 Nov 1997)
GBR May 2000 The Medicines Control Agency has severely restricted the use of the laxative, dantron
following studies showing genotoxicity. It is now restricted to use in terminally ill adult
patients only.
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)
WHO Comment : Dantron, an anthroquinone derivative, has been available for over
twenty years and is widely used as a laxative. The results of two chronic toxicity
studies in rodents, published in 1985 and 1986, have shown that administration of
high doses is associated with the development of intestinal and liver tumours.

Bibliographical references
IARC MONOGRAPH, 50, 265, 1990

Product Name Depot medroxyprogesterone acetate (DMPA)

C.A.S. number 71-58-9
Scientific and common names, and synonyms
DMPA
PREGN-4-ENE,3,20-DIONE, 17-(ACETYLOXY)-6-METHYL-,(6ALPHA)
17-HYDROXY-6ALPHA-METHYLPREGN-4-ENE-3,20-DIONE ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1983 The use of injectable steroid preparations for contraceptive purposes has been restricted
to use by women with a normal menstrual cycle who do not tolerate other forms of
contraception. Pregnancy must be excluded before treatment is started and it is
contraindicated during lactation. The label must bear a warning about adverse effects
including menstrual disturbances and headaches.
GBR 1983 Approved for long-term contraception when other methods are unacceptable or
inappropriate.
SWE 1983 Approved for long-term contraception when other methods have given rise to adverse
reactions or otherwise been judged as inappropriate. Patients must accept that after
conclusion of treatment return of fertility may be slow.
ZMB 7 Dec 1983 The use of medroxyprogesterone acetate in injectable form as a contraceptive is

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 103

Product Name Depot medroxyprogesterone acetate (DMPA)

C.A.S. number 71-58-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
prohibited. The drug may only be imported or exported on a licence issued by the
Director of Medical Services.
(Reference: (ZMBSI) Statutory Instrument, No.166-167, , Dec 1983)
EGY 1984 Use of this drug was restricted to contraception in women with a normal menstrual cycle
who do not tolerate other forms of contraception.
USA 1984 Approval for this product was not granted on the grounds that the available evidence did
not provide a sufficient basis for determining that depot medroxyprogesterone acetate is
safe for general marketing in the USA. However, multinational studies subsequently
indicated that the risk of cancer associated with its use was minimal or absent and the
drug was registered in 1992.
(Reference: (HHSNS) HHS News: US Department of Health and Human Services, , , 29
Oct 1992)
(Reference: (FEREAC) Federal Register, 49, 43507, Oct 1984)
WHO Comment : A depot preparation containing 150 mg medroxyprogesterone
acetate was introduced over 20 years ago for use as a long-acting injectable
contraceptive. Subsequently, positive results of carcinogenicity studies carried out
in beagle bitches led to refusal of registration in the United States. These findings
were later considered irrelevant to contraceptive use in women and the drug was
approved by the Food and Drug Administration. Menstrual irregularities are the
most common adverse effect associated with depot medroxyprogesterone acetate.
Risk-benefit judgements differ significantly from country to country, having regard
to differing national circumstances. The preparation is, however, widely available
and is included in the WHO Model List of Essential Drugs.
(Reference: (WHTAC4) The Use of Essential Drugs, 4th Report of the WHO Expert
Committee, 796, , 1990)
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)
(Reference: (WHODI) WHO Drug Information, 2(1), 31, 1988)

Product Name Dequalinium

C.A.S. number 6707-58-0
Scientific and common names, and synonyms
DECAMINIUM
DECALINIUM CHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGR Aug 1998 The Bulgarian Drug Agency in the Ministry of Health withdrew the vaginal tablet of
dequalinium (Efisol) because of serious adverse reactions reported in the country.
(Reference: (BGRBDA) Communication to WHO, , , )

Product Name Dequalinium chloride

C.A.S. number 522-51-0
Scientific and common names, and synonyms
1,1'-DECAMETHYLENEBIS (4-AMINOQUINALDINIUM CHLORIDE)

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 104

Product Name Dequalinium chloride

C.A.S. number 522-51-0
Country Effective Description of action taken
Date Grounds for decision
GRC 1984 Withdrawn from the market due to an unacceptable benefit to risk ratio (low efficacy/skin
reactions).
WHO Comment : Skin reactions to dequalinium chloride, including necrotic
lesions, have been reported. It remains available as a mouth and throat disinfectant
in many countries.

Product Name Dexamfetamine

C.A.S. number 51-64-9
Scientific and common names, and synonyms
BENZENEETHANAMINE, ALPHA-METHYL-,(S)-
DEXTROAMPHETAMINE
DEXAMPHETAMINE
(+)-ALPHA-METHYLPHENETHYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1973 Anorectic drugs containing dexamfetamine were withdrawn from the market by the Food
and Drug Administration due to evidence of abuse and a high risk of dependence.
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
OMN 10 May 1982 Import and marketing of products containing dexamfetamine were prohibited.
(Reference: (OMNCR) Circular, 11/82, , May 1982)
NGA 1988 All products containing dexamfetamine have been banned.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
WHO Comment : Dexamfetamine, an amfetamine derivative, is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances. See WHO
comment for amfetamine.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Dexfenfluramine

C.A.S. number 3239-44-9
Scientific and common names, and synonyms
(S)-N-ETHYL-ALPHA-METHYL-3-(TRIFLUOROMETHYL)BENZENEETHANAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BRA Aug 2001 Registration has been cancelled due to risks of heart valve disorders.
(Reference: (BRARES) Resolucao n., 147/ANVISA, , 14 Aug 2001)

Product Name Dexfenfluramine hydrochloride

C.A.S. number 3239-45-0
Scientific and common names, and synonyms
(S)-N-ETHYL-A-METHYL-3-TRIFLUROROMETHYLPHENETHYLAMINE HYDROCHLORIDE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 105

Product Name Dexfenfluramine hydrochloride

C.A.S. number 3239-45-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MAR Sep 1997 The manufacturer of dexfenfluramine removed the product dexfenfluramine from the
market because of the risk of rare, but potentially fatal pulmonary artery hypertension.
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
PHL Sep 1998 The Department of Health Bureau of Food and Drugs has noted the voluntary withdrawal
by the sponsoring company of the anorectic drugs fenfluramine and dexfenfluramine.
(Reference: (PHLCTW) Communication to WHO, , , 15 Aug 2000)
LTH May 2000 The State medicines Control Agency has withdrawn for the market capsules of
dexfenfluramine for reasons of safety.
(Reference: (LTHMCA) Order of State Medicines Control Agency, No. 8, , 10 Jan 2000)

Product Name Dextromethorphan

C.A.S. number 125-71-3
Scientific and common names, and synonyms
(9ALPHA,13ALPHA,14ALPHA)-3-METHOXY-17-METHYLMORPHINAN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN Jun 2001 All preparations containing dextramethorphan, either alone or in combination, have been
classified as controlled non-psychotropic drugs. This action was taken to ensure that the
drug is not misused, in view of a huge increase in its consumption in the form of cough
preparations etc.
(Reference: (OMNCR) Circular, 22/2001, , 22 July 2002)

Product Name Dibenzepin hydrochloride

C.A.S. number 315-80-0
Scientific and common names, and synonyms
11H-DIBENZO(B,E)(1,4)-DIAZEPIN-11-ONE, 10-(2-DIMETHYLAMINO)-ETHYL)-5, 10-DIHYDRO-5-METHYL-,
MONOHYDROCHLORIDE
10-(2-DIMETHYLAMINO)ETHYL)-5,10-DIHYDRO-5-METHYL-11H-DIBENZO(B,E),(1,4)-DIAZEPIN-11-ONE
MONOHYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1 Jan 1983 Dibenzepin hydrochloride was associated with an unexpectedly high number of fatal
suicidal attempts. The drug was withdrawn following discussions between the company
and the National Board of Health and Welfare.
WHO Comment : Dibenzepin hydrochloride, a tricyclic antidepressant, was
introduced in 1968 for the treatment of depressive illness. By 1973 its use in
Sweden had been associated with an unexpectedly high number of suicide
attempts which led to its withdrawal in that country. Although its use has lapsed in
several countries, it remains available in at least eight European countries.

Product Name Diclofenac sodium

C.A.S. number 15307-79-6

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 106

Product Name Diclofenac sodium

C.A.S. number 15307-79-6
Scientific and common names, and synonyms
ACETIC ACID, O-(2,6-DICHLOROANILINO)PHENYL)-, MONOSODIUM SALT
BENZENEACETIC ACID, 2-((2,6-DICHLOROPHENYL)AMINO)-, MONOSODIUM SALT
SODIUM (O-(2,6-DICHLOROANILINO)PHENYL) ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Sep 1983 Disapproved for use due to fear of exposure of young children to risks of agranulocytosis,
leucopenia and thrombocytopenia.
NOR 1987 Diclofenac acid is not approved for registration because the results of carcinogenicity
testing in rats were not clearly negative and testing in another species is required.
WHO Comment : The World Health Organization currently has no information to
suggest that diclofenac is less safe than other widely available non-steroidal
antiinflammatory substances of this type, or that children are particularly liable to
react adversely. It is registered in many countries in several dosage forms,
including a 12.5 mg suppository indicated for juvenile arthritis.

Product Name Dicycloverine

C.A.S. number 77-19-0
Scientific and common names, and synonyms
DICYCLOMINE
(BICYCLOHEXYL)-1-CARBOXYLIC ACID, 2-(DIETHYLAMINO)ETHYL ESTER
2-(DIETHYLAMINO)ETHYL (BICYCLOHEXYL)-1-CARBOXYLATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1985 The Swedish Board of Drugs has recommended that dicycloverine be used only by
specialists for the treatment of very severe cases of infantile colic.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, No.6, ,
Oct 1985)
AUS 20 Feb 1985 The manufacturer has warned against administration of dicycloverine to infants under six
months of age and deleted colic from the indications.
NZL 18 Mar 1986 The Department of Health has issued a statement that liquid dicycloverine preparations
for the treatment of colic are no longer recommended for infants under six months of age.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 242, , 1986)
BGD Dec 1986 Syrup and drop forms are being withdrawn to avoid possible misuse and adverse
reactions in children.
GBR The manufacturer has warned against administration of dicycloverine to infants under six
months of age and deleted colic from the indications.
NOR In view of its propensity to cause serious adverse reactions in infants under six months of
age, the Drug Control Board has prohibited the import of dicycloverine.
WHO Comment : Dicycloverine, an anticholinergic agent with antispasmodic and
local anaesthetic activity, was introduced in 1952 for treatment of functional
conditions involving smooth muscle of the gastrointestinal tract. Its use in the
treatment of colic in infants under six months of age has been associated with
irritability and restlessness, convulsions and apnoea which has led the major
manufacturer to issue revised global prescribing information in 1985
contraindicating the use of dicycloverine in this age group. Subsequently
restrictive regulatory action directed to other available brands of this drug was

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 107

Product Name Dicycloverine

C.A.S. number 77-19-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
taken in several countries. Preparations containing dicycloverine remain available
in at least ten major markets.

Product Name Dienestrol

C.A.S. number 84-17-3
Scientific and common names, and synonyms
DINOVEX
DIENOL
PHENOL, 4,4'-(DIETHYLIDENEETHYLENE)DI-
4,4'-(1,2-DIETHYLIDENE-1,2-ETHANEDIYL)BIS-PHENOL,(E,E)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT Feb 1977 Pharmaceutical specialities containing dienestrol, diethylstilbestrol, hexestrol and their
derivatives have been withdrawn following reports indicating an association between
prenatal exposure to diethylstilbestrol and the subsequent development of
adenocarcinoma in post pubertal girls and young women. The use of stilbene derivatives
is only authorized for the treatment of cancer of the prostate.
ITA 1979 Withdrawn from the market due to suspected carcinogenicity in newborns following
prenatal exposure.
KWT Apr 1980 Prohibited for import.
SAU Following reports indicating the development of adenocarcinoma in post-pubertal girls
and young women exposed prenatally to preparations containing diethylstilbestrol,
dienestrol and their derivatives, the Drug Committee prohibited the use of these products
during pregnancy.
VEN Subject to restricted use and/or sale.
WHO Comment : Dienestrol is a stilbene derivative. See WHO comment for
diethylstilbestrol. Vaginal forms of dienestrol, which were introduced in 1947, are
currently available in over 35 countries for the management of hypoestrogenic
vaginal atrophy.
(Reference: (WHODI) WHO Drug Information, 77.1, 16, 1977)

Product Name Diethylaminoethoxyhexestrol

C.A.S. number 2691-45-4

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Dec 1970 This product for the treatment of angina pectoris was voluntarily withdrawn from
production by the manufacturer due its effects on the liver.
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing diethylaminoethoxyhexestrol, a coronary
vasodilator, or to indicate that they are still commercially manufactured.

Product Name Diethylstilbestrol

Legislative or regulation action
Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 108

C.A.S. number 56-53-1

Scientific and common names, and synonyms
ALPHA,ALPHA'-DIETHYL-(E)-4,4'-STILBENEDIOL
DIETHYLSTILBOESTROL
PHENOL, 4,4-'(1,2-DIETHYL-1,2-ETHENEDIYL)BIS-,(E)-
STILBOESTROL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PAN 15 Jul 1973 Sale and use of diethylstilbestrol or its derivatives in subcutaneous implants is prohibited.
(Reference: (PANMR) Ministry of Health Resolution, No.1A, , Jan 1973)
USA 4 Aug 1975 Because of a statistically significant association between maternal ingestion during
pregnancy of diethylstilbestrol (and close congeners) and the occurrence of vaginal
carcinoma in the offspring, the labelling of all such products has previously been required
to state that their use in pregnancy is contraindicated. An additional warning is now
required concerning the possible development of vaginal adenosis in postpubertal girls
whose mothers received diethylstilbestrol during pregnancy.
(Reference: (FEREAC) Federal Register, 40, 32773, Aug 1975)
AUT Feb 1977 Pharmaceutical specialities containing diethylstilbestrol, dienestrol, hexestrol and their
derivatives have been withdrawn following reports indicating an association between
prenatal exposure to diethylstilbestrol and the subsequent development of
adenocarcinoma in postpubertal girls and young women. The use of stilbene derivatives
is only authorized for the treatment of cancer of the prostate.
DEU Feb 1977 Indications for use restricted to the treatment of carcinoma of the prostate.
GRC 1980 Diethylstilbestrol is registered solely for the treatment of cancer of the prostate.
KWT Jan 1980 Importation of pharmaceutical preparations containing diethylstilbestrol and
diethylstilbestrol diphosphate is prohibited.
TUN May 1983 Prohibited for pregnancy-related uses in women; restricted to urological use only.
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
SAU Following reports indicating the development of adenocarcinoma in post-pubertal girls
and young women exposed prenatally to preparations containing diethylstilbestrol,
dienestrol and their derivatives, the Drug Committee prohibited the use of these products
during pregnancy.
WHO Comment : Diethylstilbestrol, a synthetic estrogen which is a stilbene
derivative, was introduced into obstetric practice in the late 1940s and
subsequently widely used for the treatment of threatened abortion. This use was
later shown to be associated with an increased risk of vaginal cancer in the
offspring which resulted in restrictive regulatory action in several countries.
Diethylstilbestrol and other stilbenes remain available in many countries, however,
for the treatment of certain hormone-dependent neoplasms including carcinoma of
the prostate and postmenopausal breast cancer.
(Reference: (WHODI) WHO Drug Information, 77.1, 16, 1977)

Bibliographical references
IARC MONOGRAPH, 6, 55, 1974
IARC MONOGRAPH, 21, 173, 1979
IARC MONOGRAPH, SUPPL.4, 184, 1982

Product Name Difemerine

C.A.S. number 80387-96-8
Scientific and common names, and synonyms
2-(DIMETHYLAMINO)-1,1-DIMETHYLETHYL BENZILATE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 109

Product Name Difemerine

C.A.S. number 80387-96-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Mar 1986 Oral preparations of difemerine were withdrawn by the manufacturer on the grounds of
exceptionally frequent adverse effects.

Product Name Difenoxin

C.A.S. number 28782-42-5
Scientific and common names, and synonyms
DIFENOXYLIC ACID
1-(3-CYANO-3,3-DIPHENYLPROPYL)-4-PHENYL-ISONIPECOTIC ACID
4-PIPERIDINECARBOXYLIC ACID, 1-(3-CYANO-3,3-DIPHENYLPROPYL)-4-PHENYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PAK Jun 1990 Drop and syrup formulations of products containing difenoxin intended for the treatment
of diarrhoea in children were banned.
OMN Sep 1990 Import and marketing of oral preparations intended for paediatric use containing difenoxin
were prohibited.
(Reference: (OMNMH) Ministry of Health, , , 29 Sep 1990)
KOR May 1991 Antidiarrhoeal products containing difenoxin were not accepted for registration.
(Reference: (KRMHSA) Ministry of Health and Social Affairs - Communication to WHO, ,
, 13 Dec 1991)
LBN Aug 1991 Use of products containing difenoxin in children under 5 years of age was discontinued
and preparations for paediateic use were withdrawn.
(Reference: (LBNMHD) Ministry of Health and Social Affairs Decree, 150/1, , Aug 1991)
WHO Comment : Difenoxin is the principal metabolite of diphenoxylate. See WHO
comment for diphenoxylate.

Product Name Difurazone

C.A.S. number 804-36-4
Scientific and common names, and synonyms
1,3-BIS(5-NITROFURFURYLIDEN)ACETONEGUANYLHYDRAZONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Withdrawn from all marketed preparations on the grounds that it has been superseded by
safer and more effective preparations.
SAU The withdrawal of nitrofuran compounds is under consideration since they have been
superseded by safer and more effective preparations.
VEN Not approved for use and/or sale.
WHO Comment : Difurazone, a nitrofuran derivative, was formerly used as an
antiinfective agent. It has, however, been superseded by safer compounds and
WHO has no information to suggest that it remains commercially available.

Product Name Dihydrostreptomycin

Legislative or regulation action
Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 110

C.A.S. number 128-46-1

Scientific and common names, and synonyms
DST
DHSM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Sep 1970 Withdrawn from the market (injectable form) and prohibited for export by the Food and
Drug Administration on the grounds of an unfavourable benefit/risk ratio. This antibiotic is
considered unsafe due to its ototoxic hazards.
PHL 1972 Dihydrostreptomycin and its salts, singly or in combination, were withdrawn from sale for
human use. The drug can cause severe vestibular damage.
ESP 1 Oct 1983 The Ministry of Health and Consumer Protection has withdrawn approval for
dihydrostreptomycin except in oral preparations.
(Reference: (ESPMC) Programa Selectivo de Revisión de Medicamentos, , , Sep 1983)
DOM Prohibited for use and/or sale since scientific studies have shown that it can cause
deafness.
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
PER Prohibited for use in its injectable form. It has been found to cause permanent deafness.
WHO Comment : Dihydrostreptomycin, a derivative of the aminoglycoside
antibiotic streptomycin with similar antibacterial activity, was first synthesized in
1947 and subsequently used in the treatment of tuberculosis and gram-negative
infections. Preparations for systemic use have been widely withdrawn as a result
of concern regarding their severe ototoxicity. Dihydrostreptomycin is poorly
absorbed from the gastrointestinal tract. It remains available in oral preparations in
some countries.

Product Name Dihydroxymethylfuratrizine

C.A.S. number 794-93-4
Scientific and common names, and synonyms
BIS(HYDROXYMETHYL)FURATRIZINE
(((6-2(5-NITRO-2-FURYL)VINYL)-AS-TRIAZIN-3-YL)IMIDO)DI-METHANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Withdrawn from all marketed preparations on the grounds that it has been superseded by
safer and more effective preparations.
SAU The withdrawal of nitrofuran compounds is under consideration since they have been
superseded by safer and more effective preparations.
VEN Not approved for use and/or sale.
WHO Comment : Dihydroxymethylfuratrizine, a nitrofuran derivative, was formerly
used as an antiinfective agent. It has, however, been superseded by safer
compounds and WHO has no information to suggest that it remains commercially
available.

Product Name Dilevalol

C.A.S. number 75659-07-3
Scientific and common names, and synonyms
BENZAMIDE,2-HYDROXY-5-[1-HYDROXY-2-[(1-METHYL-3-PHENYLPROPYL)AMINO]ETHYL]-,[R-(R*,R*]-

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 111

Product Name Dilevalol

C.A.S. number 75659-07-3
Scientific and common names, and synonyms
(-)-5-[(1R)-1-HYDROXY-2-[[(1R)-1-METHYL-3-PHENYLPROPYL]AMINO]ETHYL] SALICYLAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 9 Aug 1990 Products containing dilevalol hydrochloride have been voluntarily discontinued by the
manufacturer, haveing regard to evolving evidence of isolated cases of liver toxicity.
(Reference: (SPCNR) Schering-Plough Corporation news release, , , 09 Aug 1990)
WHO Comment : Dilevalol, a beta-adrenoreceptor antagonist, was introduced into
medicine in 1989 for the treatment of hypertension. Shortly afterwards, its use
became associated with isolated cases of hepatic toxicity. Although few cases
were reported, the manufacturer discontinued sales in Japan and Portugal, the
only countries where the drug was marketed, and withdrew applications for
registration elsewhere.

Product Name Dimazole

C.A.S. number 95-27-2
Scientific and common names, and synonyms
AMYCAZOL
BENZOTHIAZOL,6-(2-DIETHYLAMINOETHOXY)-2-DIMETHYLAMINO-
DIAMTHAZOLE DIHYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Jul 1977 Withdrawn from the market and prohibited for export by the Food and Drug
Administration on the grounds that the drug was not shown to be safe for its indicated
uses. Neurotoxic effects had been found in humans. Products containing this ingredient
had been used for the prophylaxis and treatment of athletes' foot.
(Reference: (FEREAC) Federal Register, 42, 37057, July 1977)
WHO Comment : Dimazole, an antifungal agent, was introduced in 1951 for the
treatment of tinea infections. Although the major manufacturer subsequently
discontinued marketing preparations in the United States, the US Food and Drug
Administration formally withdrew marketing approval for such preparations in 1977
on the grounds of their association with severe neurotoxic reactions, their
potential for misuse and the availability of safer alternative products. Topical
preparations of dimazole remain available in some 40 countries.

Product Name Dinoprostone

C.A.S. number 363-24-6
Scientific and common names, and synonyms
PROSTAGLANDIN E2
PROSTA-5,13-DIEN-1-OIC ACID,11,15-DIHYDROXY-9-OXO-,(5Z,11ALPHA,13E,15S)-
(E,Z)-(1R,2R,3R)-7-[3-HYDROXY-2-[(3S)-(3-HYDROXY-1-OCTENYL)]-5-OXOCYCLOPENTYL]-5-HEPTENOIC ACID
(5Z, 11ALPHA, 13E, 15S)-11, 15-DIHYROXY-9-OXOPROSTA-5, 13-DIEN-1-OIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 112

Product Name Dinoprostone

C.A.S. number 363-24-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 19 Jul 1990 In consultation with the Department of Health, a controlled-release pessary containing
dinoprostone has been withdrawn by the manufacturer, having regard to reports of an
unacceptable incidence of uterine hypertonia and foetal distress.
(Reference: (CRDDL) Communication from Roussel enclosing "Dear Doctor" letter, , , 19
July 1990)
THA Apr 2001 Severely restricted for use as a prescription drug in hospitals only.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)
WHO Comment : Dinoprostone, prostaglandin E2, was introduced into medicine in
1971 and is primarily used for cervical ripening during the induction of labour. It is
available in various formulations for oral, parenteral and vaginal administration.
Tablets, ampoules and vaginal dosage forms (tablets, pessaries, gel) remain
registered in many countries.

Product Name Dionaea muscipula (extract)

Scientific and common names, and synonyms

VENUS FLY TRAP

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Jan 1986 The Federal Health Office has suspended the sale of an injectable herbal anticancer drug
prepared from the carnivorous plant Dionaea muscipula following hypersensitivity
reactions in almost two-thirds of patients.
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing Dionaea muscipula or to indicate that
they are still commercially manufactured.

Product Name Diphenazine

C.A.S. number 13838-14-7
Scientific and common names, and synonyms
1,4-BIS(ALPHA-METHYLPHENETHYL)PIPERAZINE
1,4-BIS(1-PHENYLISOPROPYL)PIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
HUN 1967 Withdrawn from the market on account of photosensitivity, and possibly cataract,
associated with its use.
VEN Not approved for use and/or sale.
WHO Comment : The World Health Organization has no further information
regarding preparations containing diphenazine and is not aware that they are still
commercially manufactured.

Product Name Diphenoxylate

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 113

C.A.S. number 915-30-0

Scientific and common names, and synonyms
DIPHENOXYLATI HYDROCHLORIDIUM
ETHYL 1-(3-CYANO-3,3-DIPHENYLPROPY-4-PHENYLISONIPECOTATE
R-1132
4-PIPERIDINECARBOXYLIC ACID, 1-(3-CYANO-3,3-DIPHENYLPROPYL)-4-PHENLY,-ETHYL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
LIY 21 May 1990 Use of products containing diphenoxylate in children was banned.
(Reference: (LIYRL) Resolution of the General People's Health Committee, 141, , May
1990)
PAK Jun 1990 Drop and syrup formulations of products containing diphenoxylate intended for the
treatment of diarrhoea in children were banned.
MEX Dec 1990 Elixir formulations of products containing diphenoxylate intended for the treatment of
diarrhoea in children were withdrawn.
(Reference: (MEXMH) Communication from the Ministry of Health, , , 28 Nov 1990)
NPL 1991 Liquid formulations of products containing diphenoxylate either alone or in combination,
and intended forthe treatment of diarrhoea in children, were banned
(Reference: (NPLDDA) Communication from the Department of Drug Administration, , ,
27 Feb 1992)
PHL 1991 Paediatric formulations of products containing diphenoxylate were withdrawn.
KOR May 1991 Antidiarrhoeal products containing diphenoxylate were not accepted for registration.
(Reference: (KRMHSA) Ministry of Health and Social Affairs - Communication to WHO, ,
, 13 Dec 1991)
LBN 03 Aug 1991 Use of products containing diphenoxylate in children under 5 years of age was
discontinued and preparations for paediatric use were withdrawn.
(Reference: (LBNMHD) Ministry of Health and Social Affairs Decree, 150/1, , Aug 1991)
THA 27 May 1992 The Ministry of Public Health, withdrew the registration of products containing
diphenoxylate formulated as either syrup or drop formulation.
(Reference: (THAMH) Ministry of Public Health, , , 27 May 1992)
BHR 2000 The Ministry of Health has restricted the prescription of medicines containing
diphenoxylate as controlled medicines that should be dispensed only on special
prescriptions issued by the Directorate of Pharmacy and Drug Control at the Ministry of
Health with effect from 2 May 2000.
(Reference: (BHRCW) Communication with WHO, , , 27 June 2000)
WHO Comment : Diphenoxylate, a derivative of pethidine without analgesic
activity, is used in the symptomatic treatment of acute and chronic diarrhoea to
reduce intestinal motility. There is no clear evidence that it has any beneficial effect
in diminishing fluid losses and it has been associated with central nervous system
toxicity, particularly in children, which results in anorexia, nausea and vomiting,
headache, drowsiness, confusion, insomnia, dizziness, restlessness, euphoria and
depression. The World Health Organization recommends that diphenoxylate should
not be used for the management of diarrhoea in children and many countries have
since withdrawn products containing this compound indicated for paediatric use.
(Reference: (WHORUD) The Rational Use of Drugs, , , 1990)

Product Name Dithiazanine iodide

C.A.S. number 514-73-8
Scientific and common names, and synonyms
3-ETHYL-2-(5-(3-ETHYL-2-BENZOTHIAZOLINYLIDENE)-1,3-PENTADIENYL) BENZOTHIAZOLIUM IODIDE
3-ETHYL-2-(5-(3-ETHYL-2(3H)-BENZOTHIAZOLYLIDENE)-1,3-PENTADIENYL)- BENZOTHIAZOLIUM IODIDE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 114

Product Name Dithiazanine iodide

C.A.S. number 514-73-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1964 Reports of death associated with the use of dithiazanine iodide led the Food and Drug
Administration to limit the indications for its use to trichuris trichuria and strongyloides
stercoralis infestations of a clinically severe nature.
FRA Nov 1964 Withdrawn from the market in agreement with the manufacturer following reports of death
associated with its use.
TCD 1965 Following reports of fatal incidents associated with the use of dithiazanine iodide, the
Ministry of Foreign Affairs prohibited importation and marketing of this drug.
ITA 1979 Withdrawn from the market owing to an unfavourable risk/benefit balance.
CUB Withdrawn from use on grounds of adverse effects on the gastrointestinal tract. This drug
has been superseded by more effective and less toxic products.
WHO Comment : Dithiazanine iodide, an anthelminthic, was introduced in 1959 for
the treatment of strongyloid worms and whipworms. Between 1961 and 1964 its
use was associated with eight fatal cases of severe acidosis and shock. Although
the drug is not significantly absorbed from the gut, in normal circumstances it was
assumed that these fatalities were due to atypically high uptake from inflamed
intestinal mucosa. Dithiazanine iodide has been superseded by safer and more
effective drugs; however, it may remain available in some countries.

Product Name Domperidone(injectable)

C.A.S. number 57808-66-9
Scientific and common names, and synonyms
5-CHLORO-1-(1-(3-(2-OXO-1-BENZIMIDAZOLINYL)PROPYL)-4-PIPERIDYL)-2- BENZIMIDAZOLINONE
2H-BENZIMIDAZOL-2-ONE, 5-CHLORO-1-(1-(3-(2,3-DIHYDRO-2-OXO-1H- BENZIMIDAZOL-1-YL)PROPYL)-4-
PIPERIDINYL)1,3-DIHYDRO-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 31 Jan 1985 The manufacturer has informed the World Health Organization that injectable dosage
forms of the antiemetic domperidone have been voluntarily withdrawn from all markets
following reports of cases of cardiotoxicity associated with intravenous administration.
Suppositories remain available and injectable forms will continue to be supplied for a
named patient at the written request of a doctor.
WHO Comment : Domperidone, a peripheral dopaminergic antagonist, was
introduced in 1979 for the symptomatic relief of acute nausea and vomiting. The
major manufacturer became aware that the injectable formulation was being used
in some countries in much higher doses than those recommended to combat
nausea and vomiting in cancer patients treated with cytostatic agents. Such use -
which was not in conformity with the approved indications - was associated with
cardiotoxicity, which in some cases was fatal, and the manufacturer decided to
withdraw the injectable dosage form from the market worldwide in January 1985.
Suppositories, tablets and a suspension remain available and the manufacturer
continues to supply the injection for the treatment of a named patient at the written
request of a doctor on the understanding that the appropriate dosage
recommendations will be followed.

Product Name Doxepin

C.A.S. number 1668-19-5

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 115

Product Name Doxepin

C.A.S. number 1668-19-5
Scientific and common names, and synonyms
3-(DIBENZ[B,E]OXEPIN-11-YLIDENE)PROPYL-DIMETHYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1992 The Medicines Control Authority has decided that the 50 mg tablet formulation of doxepin
may be prescribed only in hospitals and specialized clinics because of the toxic potential
of this product and the risk of overdosage and suicide with the high dose formula.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, 9, 1992)
WHO Comment : Doxepin, a tricyclic antidepressant was introduced in 1964 for the
management of endogenous depression. Much of the adverse effects are caused
by its antimuscarinic actions. These include dry mouth, cardiac arrhythmias,
central nervous system disturbances, blood disorders and risk of suicide. The risk
of suicide and dangers related to overdosage led the Norwegian Medicines Control
Authority to put the higher strength formulation under prescribing restriction in
1992. The risk of death following overdosage is apparently higher for products
containing tricyclic compounds as compared with nontricyclic products.

Product Name Doxycycline hyclate(injectable)

C.A.S. number 24390-14-5
Scientific and common names, and synonyms
6-DEOXY-5BETA-HYDROXYTETRACYCLINE HYDROCHLORIDE
2-NAPHTACENECARBOXAMIDE,4-(DIMETHYLAMINO)-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-3,5,10,12,12A-
PENTAHYDROXY-6-METHYL-1,11-DIOXO-,MONOHYDROCHLORIDE, COMPD. WITH
ETHANOL(2:1),MONOHYDRATE,[4S-(4ALPHA,4AALPHA,5ALPHA,5AALPHA,6ALPHA,12AALPHA)]-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 1989 The use of injectable preparations containing doxycycline hyclate has been restricted
exclusively to hospitals, on the grounds that cases of anaphylactic shock and
bronchospasm, some of which have been fatal, have occurred during intravenous
administration of the product. Furthermore, these preparations should only be prescribed
to patients unable to take medicines orally and should always be administered by slow
intravenous infusion and under close supervision.
(Reference: (FRAMH) Ministry of Solidarity, Health and Social Protection, , , 17 Feb 1989)
MAR May 2000 The National Advisory Commission for Pharmacovigilance has suspended marketing
authorization for all pharmaceutical products containing doxycycline in capsule form.
There is evidence of a high risk of oesophageal damage with the administration of
capsules of doxycycline.
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
FRA Feb 2001 The gel form of doxycycline preparations remain suspended in France due to frequent
associations of adverse effects on the oesophagus.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)
WHO Comment : Doxycycline, a semi-synthetic tetracycline derivative, was first
introduced into medicine in 1960 for the treatment of bacterial, rickettsial and
amoebic infections. Although allergic manifestations are uncommon, injectable
preparations have occasionally resulted in severe anaphylactoid reactions. Clinical
features and the fact that asthmatic patients seemed to be particularly at risk lead
to suspect a sulfite preservative in the formulation more than doxycycline itself.
Rapid administration may also be a factor. Injectable preparations of doxycycline
hyclate are included in the WHO Model List of Essential Drugs.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 116

Product Name Doxycycline hyclate(injectable)

C.A.S. number 24390-14-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (WHTAC4) The Use of Essential Drugs, 4th Report of the WHO Expert
Committee, 796, , 1990)

Product Name Dronabinol

C.A.S. number 1972-08-3
Scientific and common names, and synonyms
NSC-134454

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1998 Dronabinol is reclassified from Schedule II to Schedule III of the US Controlled
Substances Act. Dronabinol is internationally controlled in Schedule II of the 1971
Convention on Pyschotropic Substances.
(Reference: (FEREAC) Federal Register, 63(214) , p. 59751, 1998)

Product Name Droperidol

C.A.S. number 548-73-2
Scientific and common names, and synonyms
1-[1-[4-(FLUOROPHENYL)-4-OXOBUTYL]-1,2,3,6-TETRAHYDRO-4-PYRIDINYL]-1,3-DIHYDRO-2H-BENZIMIDAZOL-2-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Mar 2001 Droperidol has been withdrawn in the UK following concerns about serious cardiac
adverse effects.
(Reference: (GBRISM) Information Safety Message, , , 11 Jan 2001)
IDN Jun 2001 The National Agency for Drug and Food Control (NADFC) has suspended the marketing
authorization of droperidol because of serious cardiac adverse effects.
(Reference: (IDNCW) Communication to WHO, , , 13 Sep 2001)

Product Name Droxicam

C.A.S. number 90101-16-9
Scientific and common names, and synonyms
5-METHYL-3-(2-PYRIDYL)-2H,5H-1,3-OXAZINO[5,6-C]-[1,2]BENZOTHIAZINE-2,4(3H)-DIONE 6,6-DIOXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@EC 14 Dec 1994 The Committee on Proprietary Medicinal Products has advised that the marketing
authorization of droxicam should be suspended pending receipt of further data on
epidemiological and pharmacokinetic studies.
(Reference: (CPMPPO) Pharmacovigilance Opinion, No.18, , 14 Dec 1994)
WHO Comment : Droxicam is authorized to be marketed in many European
countries. Although droxicam is metabolized to piroxicam, it is considered that the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 117

Product Name Droxicam

C.A.S. number 90101-16-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
risk of hepatic damage differs from that shown by other NSAIDs products,
including piroxicam.

Product Name Ebrotidine

C.A.S. number 100981-43-9
Scientific and common names, and synonyms
P-BROMO-N-[(E)-({2-[{(2-[DIAMINOMETHYLENE)AMINO]-4-
THIAZOYL}METHYL)THIO]ETHYL}AMINO)METHYLENE]BENZENESULFONAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PER La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of
Health withdrew marketing authorization for the histamine H2 receptor antagonist
ebrotidine( Ebrocit) because of reports of serious liver dysfunction particularly on long-
term treatment and when the drug was administered with anti-inflammatory agents and
corticosteroids.
(Reference: (PERDGM) Alerta DIGEMID, No. 07-98, , 12 Oct 1998)

Product Name Emetine

C.A.S. number 483-18-1
Scientific and common names, and synonyms
EMETAN, 6',7',10,11-TETRAMETHOXY

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
WHO Comment : Emetine, an alkaloid obtained from ipecacuanha, was first used
rationally as an amoebocide in 1912. It was subsequently widely used and was
included in earlier editions of the WHO Model List of Essential Drugs but has now
been replaced by the less cardiotoxic synthetic derivative dehydroemetine.
Although it is valuable in the treatment of systemic amoebic hepatitis it has now
been largely superseded by considerably less toxic drugs, and in particular by
metronidazole.

Product Name Encainide

C.A.S. number 37612-13-8
Scientific and common names, and synonyms
BENZAMIDE,4-METHOXY-N-[2-[2-(1-METHYL-2-PIPERIDINYL)ETHYL]-PHENY]-,(Ñ)-
(Ñ)-2'-[2-(1-METHYL-2-PIPERIDYL)ETHYL]-P-ANISANILIDE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 118

Product Name Encainide

C.A.S. number 37612-13-8
Country Effective Description of action taken
Date Grounds for decision
MYS Jul 1980 Products containing encainide will only be considered for registration if the indications are
restricted to the treatment of life-threatening arrhythmias only.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 3(3), 3, 1989)
SWE 26 Oct 1990 The indications for products containing encainide are restricted to prophylaxis and
treatment of life-threatening ventricular tachyarrhythmia such as ventricular tachycardia in
patients unresponsive to conventional treatment.
(Reference: (SWEILS) Information från Läkemedelsverket, 1(3), , 1990)
WHO Comment : The membrane-stabilizing antiarrhythmic agent encainide was
introduced into medicine in the mid-1980's. The decision to delete the indications
for patients with asymptomatic and less severe symptomatic ventricular
arrhythmias was taken on the basis of the results of a trial (CAST study) that
showed a two-fold increase in deaths in post-myocardiac patients taking encainide
compared with the placebo group. (See also WHO comment for flecainide).

Product Name Ephedra

C.A.S. number 2004-0-0005

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 02 Jan 2004 The FDA has banned the weight-loss aid ephedra due to safety concerns that the product
can cause heart attacks and stroke.
(Reference: (USADIZ) News and updates, , , 02 Jan 2004)
JOR 19 Jan 2004 The Jordan Food and Drug Administration has withdrawn a herbal product (Magic Herb),
used to promote weight loss, on the grounds that it contain ephedra. This decision was
based on the US FDA's website information about the unreasonable risk in using food
supplements containing ephedra or ephedrine.
(Reference: (JORPCC) Communication to WHO, , , 19 Jan 2004)
NLD 18 Feb 2004 According to the Ministry of Health in the Netherlands, ephedra herbal products may only
be sold as medicinal products in the Netherlands.
(Reference: (NLDMEB) News and Publications, , , 18 Feb 2004)

Product Name Epinephrine

C.A.S. number 51-43-4
Scientific and common names, and synonyms
ADRENALINE
(-)-3,4-DIHYDROXY-ALPHA-((METHYLAMINO)METHYL)BENZYL ALCOHOL
2-BENZENEDIOL, 4-(1-HYDROXY-2-(METHYLAMINO)ETHYL)-,(R)-
3,4-DIHYDROXY-ALPHA-((METHYLAMINO)METHYL)-BENZYL ALCOHOL
4-(1-HYDROXY-2-(METHYLAMINO)-ETHYL)-1,2-BENZENEDIOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1973 The National Drugs Advisory Board has withdrawn from the market all local anesthetic
preparations intended for infiltration anesthesia containing epinephrine 1:50,000 and
norepinephrine 1:50,000 alone or in combination. This decision, reached in agreement
with the Irish Dental Association, followed reports of serious cardiovascular and

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 119

Product Name Epinephrine

C.A.S. number 51-43-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
cerebrovascular reactions.
VEN Epinephrine is not approved for use for infiltration anaesthesia, either alone or in
combination.
WHO Comment : Epinephrine, first isolated in 1899, is the main hormone secreted
by the adrenal medulla. It is widely used as a vasoconstrictor substance and in the
treatment of anaphylactic shock. Its use in combination with local anaesthetics to
prolong infiltration anaesthesia has been associated with systemic reactions
including serious cardiovascular and cerebrovascular incidents. Regulations
restricting the concentrations permitted in such preparations have been introduced
in many countries but combination products containing epinephrine or levarterenol
in concentrations of 1:80,000 or less remain widely available. Representative
preparations are included in the WHO Model List of Essential Drugs.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Epoetin alfa

C.A.S. number 113427-24-0
Scientific and common names, and synonyms
ERYTHROPOEITIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS The Ministry of Health and Quality of Life has restricted the use of injections of epoetin
alfa and beta, recombinant erythropoeitins, used in the management of anaemia
associates with chronic renal failure in patients requiring renal dialysis to use in hospitals
and renal dialysis centres. This is in order to minimize the risk of abuse of the drug by
athletes and for horse racing.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)

Product Name Epoetin beta

C.A.S. number 122312-54-3
Scientific and common names, and synonyms
ERYTHROPOEITIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS The Ministry of Health and Quality of Life has restricted the use of injections of epoetin
alfa and beta, recombinant erythropoeitins, used in the management of anaemia
associates with chronic renal failure in patients requiring renal dialysis to use in hospitals
and renal dialysis centres. This is in order to minimize the risk of abuse of the drug by
athletes and for horse racing.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)

Product Name Erythrityl tetranitrate

C.A.S. number 7297-25-8

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 120

Product Name Erythrityl tetranitrate

C.A.S. number 7297-25-8
Scientific and common names, and synonyms
ERYTHROL NITRATE
NITROERYTHROL
NITROERYTHRITE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1998 The Food and Drug Administration has withdrawn conditional approval of abbreviated
new drug applications for single-entity drug products containing erythrityl tetranitrate
because there is a lack of substantial evidence that these drugs are effective for
indications relating to the management, prophylaxis or treatment of anginal attacks.
(Reference: (FEREAC) Federal Register, 63(200) , p. 55616, 1998)

Product Name Erythromycin estolate

C.A.S. number 3521-62-8
Scientific and common names, and synonyms
ERYTHROMYCIN, 2'PROPIONATE, DODECYL SULPHATE
ERYTHROMYCIN PROPIONATE LAURYL SULPHATE
ERYTHROMYCIN 2'-PROPANOATE DODECYL SULPHATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP Nov 1976 Banned for importation.
GRC 1977 Withdrawn from the market.
SDN 1982 The Ministry of Health no longer allows registration of preparations containing
erythromycin estolate.
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
BGD 1983 Banned due to its reported hepatotoxicity.
BHR Preparations containing erythromycin estolate are not approved for registration.
DNK Registration has been cancelled.
(Reference: (UGLAAD) Ugeskrift for Laeger, 136, 2093, Sep 1974)
PER The package and/or label for this product requires a warning regarding the possibility of
liver damage with this drug; and, in cases of repeated use, possible side effects including
fever, nausea, vomiting, jaundice, and eosinophilia. It also warns pregnant women that
no safe level for administration during pregnancy has yet been determined.
SWE This product has been banned for use and/or sale for domestic purposes due to cases of
severe cholestatic hepatitis and jaundice.
WHO Comment : Erythromycin estolate, a macrolide antibiotic, was introduced in
1958 for the treatment of gram-positive infections. By the early 1970s its use had
been associated with a higher incidence of hepatic toxicity than that seen with
other salts and esters of erythromycin. This led to its withdrawal by some
regulatory authorities whereas others required the addition of a warning in the
product information. Evidence that the estolate ester is more hepatotoxic than
other salts or esters has subsequently been disputed. It has been claimed to be the

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 121

Product Name Erythromycin estolate

C.A.S. number 3521-62-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
most effective ester for treatment of Legionnaire's disease and preparations remain
widely available.
(Reference: (BMJOAE) British Medical Journal, 286, 1954, 1983)

Product Name Etanercept

C.A.S. number 185243-69-0
Scientific and common names, and synonyms
1-235-TUMOR NECROSIS FACTOR RECEPTOR (HUMAN) FUSION PROTEIN WITH 236-467-IMMUNOGLOBULIN G1
(HUMAN GAMMA1-CHAIN FC FRAGMENT) DIMER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHL Oct 2001 The Public Health Institute of Child has modified the labels to include warnings about the
adverse reactions that affect the central nervous system and the haematological system.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)

Product Name Ethambutol

C.A.S. number 74-55-5
Scientific and common names, and synonyms
[S-(R*, R*)]-2,2 1-(1,2-ETHANEDIYLDIIMINO)BIS(1-BUTANOL);

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Oct 2000 Warning about the risk of loss of eyesight.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)

Product Name Ethanol

C.A.S. number 64-17-5
Scientific and common names, and synonyms
ALCOHOL
ETHYL ALCOHOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
KWT 1966 The permissible limit of ethanol in liquid oral dosage forms should not exceed 10%.
(Reference: (KTMD) Ministerial Decree, 71/66, , 1966)
CHL 1 Sep 1985 The Institute of Public Health has prohibited the use of ethanol in oral pharmaceutical
products. Exemptions from this decision will be allowed when use of ethanol is essential
for galenic reasons, provided that it is used for this purpose at the lowest effective
concentration.
(Reference: (CHLRS) Resolution of the Minister of Health, No.3102, , Apr 1985)
IRQ 1989 The Ministry of Health has approved the restriction of the inclusion of ethanol in

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 122

Product Name Ethanol

C.A.S. number 64-17-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
pharmaceutical preparations.
(Reference: (IRQMH) Resolution of the Arab Ministers of Health 13th Meeting, 9-13, ,
1986)
LKA 1 Jan 1992 The Ministry of Health withdrew from sale, all paediatric oral liquid formulations of
pharmaceutical products containing ethanol, and all formulations for adults containing
more than 5% of ethanol.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
USA 1995 The maximum permissible concentration limits for alcohol (ethanol, ethyl alcohol) as an
inactive ingredient in over-the-counter drug products intended for oral ingestion have
been established as 0.5% alcohol for children under six years of age; 5% for children
between six and twelve years of age and 10% for children over twelve years of age and
adults. The alcohol content should be stated prominently in a display panel on the front
page of all product labelling.
(Reference: (FEREAC) Federal Register, 60(48) , p. 13590, 1995)
BRA Apr 2001 The National Health Surveillance Agency has prohibited the inclusion of ethanol in
pharmaceutical preparations.
(Reference: (BRARES) Resolucao n., 543/ANVISA, , 19 Apr 2001)
ARE Pharmaceutical preparations containing high concentrations of ethanol are banned.
WHO Comment : Ethanol has been used throughout recorded history both in a
medicinal and a social context. It is currently included in pharmaceutical
preparations either as an active or inactive ingredient. At pharmacologically active
doses ethanol is both a powerful cerebral depressant and a drug of addiction. Its
use in pharmaceutical preparations has been severely restricted in several
countries and in 1986 the 39th World Health Assembly adopted a resolution to
prohibit such use except when ethanol is an essential ingredient which cannot be
replaced by an appropriate alternative.

Product Name Ethyl nitrite (spirit)

C.A.S. number 109-95-5
Scientific and common names, and synonyms
NITROUS ETHER SPIRIT
SWEET NITRE SPIRIT

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 26 Jun 1980 Withdrawn from the market and prohibited for export by the Food and Drug
Administration (FDA) due to the lack of scientific evidence for its effectiveness for any
use. This drug was used in infants and children as a diuretic, a diaphoretic and an
intestinal antispasmodic. The FDA has found evidence of a risk of fatal
methaemoglobinaemia and poisoning in some infants.
(Reference: (FEREAC) Federal Register, 45(126), 43400, 1980)
WHO Comment : Ethyl nitrite was formerly available in over-the-counter
preparations for use as a diaphoretic, a diuretic and an intestinal antispasmodic. In
the 1970s its use was associated with cases of methaemoglobinaemia, some of
which were fatal. This led to its withdrawal in 1980 by the United States Food and
Drug Administration. WHO has no information regarding its current availability in
pharmaceutical preparations.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 123

Product Name Ethyl nitrite (spirit)

C.A.S. number 109-95-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Ethylene dichloride

C.A.S. number 107-06-2
Scientific and common names, and synonyms
BROCIDE
DUTCH LIQUID

ETHANE, 1,2-DICHLORO-
1,2-DICHLOROETHANE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1978 Two topical prescription preparations for rheumatic complaints containing ethylene
dichloride were withdrawn. These preparations were implicated in a number of cases of
acute poisoning following accidental ingestion and investigations by the National Cancer
Institute in the USA demonstrated a possible carcinogenic effect.
SAU Prohibited due to reports demonstrating carcinogenic effects in experimental animals.
WHO Comment : Ethylene dichloride was formerly used as an excipient in some
pharmaceutical preparations. It has been reported to be carcinogenic in
experimental animals and its accidental ingestion has resulted in liver and kidney
damage. Although ethylene dichloride continues to be used as an industrial
solvent, WHO has no information to suggest that it remains commercially available
in pharmaceutical products or as a food additive.
(Reference: (WHTAC3) 23rd Report of Joint FAO/WHO Expert Committee on Food
Additives, 648, , 1980)

Bibliographical references
IARC MONOGRAPH, 20, 429, 1979
WHO GUIDELINES FOR DRINKING WATER QUALITY, 2, , 1984
FAO PLANT PRODUCTION & PROTECTION PAPER, 72/1, , 1985
IPCS ENVIRONMENTAL HEALTH CRITERIA, 62, , 1986

Product Name Ethylestrenol

C.A.S. number 965-90-2
Scientific and common names, and synonyms
ETHYLOESTRENOL
19-NORPREGN-4-EN-17-OL,(17-ALPHA)
19-NOR-17-ALPHA-PREGN-4-EN-17-BETA-OL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, low-strength preparations were
banned following unacceptable promotion encouraging their use in children suffering from
malnutrition.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
WHO Comment : Ethylestrenol, an anabolic steroid, was introduced in 1964. In

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 124

Product Name Ethylestrenol

C.A.S. number 965-90-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
1982, low dosage preparations were prohibited in Bangladesh due to inadmissible
promotion of products containing anabolic steroids for malnourished children.
Higher dosage preparations of ethylestrenol remain available in many countries,
including Bangladesh, for several highly specific but limited indications that apply
to patients with chronic debilitating and emaciating diseases, particularly
associated with neoplasia and some types of aplastic anaemia. Ethylestrenol is
additionally used for its fibrinolytic activity.

Product Name Etomidate

C.A.S. number 33125-97-2
Scientific and common names, and synonyms
(+)-ETHYL 1-(ALPHA-METHYLBENZYL)IMIDAZOLE-5-CARBOXYLATE
1H-IMIDAZOLE-5-CARBOXYLIC ACID, 1-(1-PHENYLETHYL)-, ETHYL ESTER(+)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1985 Use of etomidate is restricted to induction of anaesthesia having regard to reports of
reduced serum cortisol levels unresponsive to adrenocorticotropic hormone (ACTH)
injections.
WHO Comment : Etomidate, a potent hypnotic agent, was introduced in 1977 for
use as an intravenous anaesthetic. Its prolonged use can inhibit adrenal
steroidogenesis and, following reports of reduced serum cortisol levels
unresponsive to ACTH injection, the manufacturer suspended promotion of
etomidate for sedation in intensive care in 1983. In 1985 regulatory action taken
only in the United Kingdom further restricted use of the drug to induction of
anaesthesia. Etomidate remains widely available and is currently registered for
induction of anaesthesia in 34 countries and for maintenance of anaesthesia in 17
countries. It has never been registered for sedation.

Product Name Etretinate

C.A.S. number 54350-48-0
Scientific and common names, and synonyms
ETHYL (ALL-E)-9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-3,7-DIMETHYL-2,4,6.8- NONATETRAENOATE
2,4,6,8-NONATETRAENOIC ACID, 9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-, ETHYL ESTER, (ALL-E)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 24 Dec 1985 Having regard to its teratogenicity, etretinate may only be used under the supervision and
control of a hospital dermatologist.
(Reference: (OMNMH) Ministry of Health, 5, , 1985)
SWE 1987 The National Board of Health and Welfare has decided that contraception is essential
during treatment of women of child-bearing age and that contraceptive measures must
be continued for at least two years after discontinuation of treatment.
MYS 1988 The Drug Control Authority has decided that the labelling of preparations containing
etretinate should contain a distinct warning regarding teratogenicity, emphasizing that
contraceptive measures must be instituted throughout treatment and for at least twelve

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 125

Product Name Etretinate

C.A.S. number 54350-48-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
months thereafter, and additional reference is also required to the following adverse
effects: symptoms of hypervitaminosis-A; transient and reversible elevation of
transaminases and alkaline phosphatases; bone changes after long-term high dosage;
benign intracranial hypertension.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 2(1), 3, Feb 1988)
BEL 1 Jan 1988 Preparations containing etretinate have been placed in List IV of the 'Arr^t, du R,gent' of
2 June 1946 and as such can be administered only on prescription. They must be kept in
a poisons cabinet and carry the skull and cross-bones label. They must bear a warning
regarding the embryotoxicity and teratogenicity of the drug which contraindicates its use
during pregnancy.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
NOR Dec 1992 The Medicines Control Authority has withdrawn etretinate from the market.
(Reference: (NORMCA) Norwegian Medicines Control Authority, , , 02 May 1995)
BRA Feb 2001 Use and sale banned because of dangerous side effects, mainly myopathy.
(Reference: (BRACW) , , , 13 Sep 2001)
ESP Contraindications to etretinate must include a boxed paragraph stating that the drug may
be used in women of child-bearing age only when an effective method of contraception
assures protection during and for at least one year after discontinuation of treatment.
Pregnancy must be excluded before initiation of treatment.
ITA Having received reports of two deaths among patients taking etretinate, the Ministry of
Health has decided to restrict the product to hospital use only for the treatment of
particularly serious and/or diffuse forms of psoriasis causing evident psychological stress.
WHO Comment : Etretinate, a retinol derivative, was introduced in 1981 for the
treatment of psoriasis. Its use in pregnant women has resulted in major foetal
abnormalities. The manufacturer's information emphasizes that the drug is
teratogenic and must not be given to women who are pregnant, and that
contraceptive measures must be maintained for at least two years after
discontinuation of treatment. In some countries, blood banks are advised not to
accept as donors persons who have taken etretinate within the previous year.

Product Name Factor IX

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE A manufacturer of Factor IX concentrate has withdrawn the product from the market
following reports of infections with HIV (the AIDS virus) in three patients known to have
been treated with the product.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, 3, 8,
1986)
WHO Comment : Factor IX, a naturally occurring plasma protein fraction, is a vital
component of the normal blood clotting mechanism which is deficient in
haemophiliacs who require replacement therapy for both the treatment and
prevention of bleeding. Factor IX is extracted from the pooled plasma of a large
number of donors and is presented as a concentrate. It has been recognized since
1984 that some viruses, and particularly the HIV (AIDS virus) could be transmitted
to haemophiliacs from such preparations. As a result many regulatory authorities
have issued new directives for the manufacture of blood products that avert this

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 126

Product Name Factor IX

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
danger, by requiring the introduction of specific antiviral treatment measures
during the manufacturing process. Manufacturers have withdrawn pre-existing
preparations.

Product Name Factor VIII

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Jun 1984 Having regard to the transfer of AIDS and other viral diseases, changes in the
manufacturing process of Factor VIII preparations are required. These include selection
of donors, monitoring for viral contamination, limiting the donor-pool as well as the
inclusion of warnings in the product information.
GBR Oct 1986 A manufacturer of Factor VIII products has agreed voluntarily to surrender product
licences for these products following concern about the ability of the heat treatment
procedure used to inactivate HIV (the AIDS virus).
WHO Comment : Factor VIII, a naturally occurring plasma protein fraction, is a vital
component of the normal blood clotting mechanism which is deficient in
haemophiliacs who require replacement therapy for both the treatment and
prevention of bleeding. Factor VIII is extracted from the pooled plasma of a large
number of donors and is presented as a concentrate. It has been recognized since
1984 that some viruses, and particularly the HIV (AIDS virus) could be transmitted
to haemophiliacs from such preparations. As a result many regulatory authorities
have issued new directives for the manufacture of blood products that avert this
danger, by requiring the introduction of specific antiviral treatment measures
during the manufacturing process. Manufacturers have withdrawn pre-existing
preparations.

Product Name Famotidine

C.A.S. number 76824-35-6
Scientific and common names, and synonyms
3-[[[2-[(AMINOIMINOMETHYL)AMINO]-4-THIAZOLYL]METHYL]THIO-N-(AMINOSULFONYL)PROPANIMIDAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Apr 2001 To be used with precaution, especially in renal patients.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)

Product Name Fenclofenac

C.A.S. number 34645-84-6
Scientific and common names, and synonyms
BENZENEACETIC ACID, 2-(2,4-DICHLOROPHENOXY)-
(O-(2,4-DICHLOROPHENOXY)PHENYL)ACETIC ACID

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 127

Product Name Fenclofenac

C.A.S. number 34645-84-6
Country Effective Description of action taken
Date Grounds for decision
GBR 1985 Withdrawn from the market.
NOR 1985 Not approved for registration having regard to its propensity to cause skin reactions
which are not considered to be counter-balanced by any apparent advantage over other
nonsteroidal anti-inflammatory drugs.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, , 1985)
WHO Comment : Fenclofenac, a nonsteroidal anti-inflammatory agent, was
introduced in 1978 for the treatment of rheumatic disorders. By 1984 its use in the
United Kingdom was associated with serious adverse effects, predominantly skin
rashes, some of which were fatal. This led to the UK Committee on Safety of
Medicine's refusal to renew the product licence and to the subsequent withdrawal
of the drug by the manufacturer in all countries in which it was marketed.

Product Name Fenetylline

C.A.S. number 3736-08-1
Scientific and common names, and synonyms
7-[2-[ALPHA-METHYLPHENETHYL)AMINO]ETHYL]THEOPHYLLINE
AMFETYLINE
FENETHYLLINE
1H-PURINE-2,6-DIONE,3,7-DIHYDRO-1,3-DIMETHYL-7-[2-[(1-METHYL-2-PHENYLETHYL)AMINO]ETHYL]-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN May 1991 Import and marketing of products containing fenetylline were prohibited.
(Reference: (OMNCR) Circular, 16/91, , May 1991)
BGR 09 Apr 1992 Manufacture, use, storage, trade, import, and export of the central stimulant fenetylline
were no longer permitted.
(Reference: (BGRNDI) Communication from National Drug Institute, , , 09 Apr 1992)
WHO Comment : Fenetylline, a theophylline derivative of amfetamine, was
introduced in 1966 as a central nervous stimulant. It is subject to abuse and is
therefore controlled under Schedule II of the 1971 Convention on Psychotropic
Substances. Fenetylline is not widely marketed.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Fenfluramine

C.A.S. number 458-24-2
Scientific and common names, and synonyms
BENZENEETHANAMINE, N-ETHYL-?-METHYL-3-(TRIFLUOROMETHYL)-, HYDROCHLORIDE
BENZENEETHANAMINE, N-ETHYL- -METHYL-3-(TRIFLUOROMETHYL)-, HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARE 1997 The Ministry of Health has withdrawn the marketing approval for fenfluramine the only
anorectic drug approved in the UAE.
(Reference: (UAEDIB) Drug Information Bulletin, No. 3, p.2, 1997)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 128

Product Name Fenfluramine

C.A.S. number 458-24-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Aug 1997 The Food and Drug Administration alerted physicians to reports of valvular heart disease
in women treated for obesity with a combination of fenfluramine and phentermine which
were approved in the USA for single-drug, short-term obesity therapy but have more
recently been widely used "off-label" in combination for long-term management of
obesity. The FDA agreed labelling changes with the manufacturers, including a boxed
warning describing valvular heart disease and advising patients to consult a physician if
these symptoms develop.
@WD Sep 1997 The anti-obesity agents fenfluramine and its stereoisomer dexfenfluramine were
withdrawn worldwide following the association of valvular heart disease with these drugs.
PHL Sep 1998 The Department of Health Bureau of Food and Drugs has noted the voluntary withdrawal
by the sponsoring company of the anorectic drugs fenfluramine and dexfenfluramine.
(Reference: (PHLCTW) Communication to WHO, , , 15 Aug 2000)
WHO Comment : Fenfluramine, dexfenfluramine and phentermine were approved
individually more than 20 years ago in the USA for single-drug, short-term
treatment of obesity. The manufacturers of fenfluramine and dexfenfluramine have
since voluntarily withdrawn both products from the market worldwide.
Phentermine remains available.

Product Name Fenoterol

C.A.S. number 13392-18-2
Scientific and common names, and synonyms
1,3-BENZENEDIOL,5-[1-HYDROXY-2-[[2-(4-HYDROXYPHENYL-1-METHYLETHYL]AMINO]ETHYL]-
3,5-DIHYDROXY-ALPHA-[[P-HYDROXY-ALPHA-METHYLPHENYLETHYL)AMINO]METHYL]BENZYL ALCOHOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 27 Mar 1990 The indications of products containing fenoterol have been restricted to the treatment of
mild to moderate asthma, having regard to reports from New Zeland of an increased risk
of death when fenoterol is used in patients with severe asthma.
(Reference: (AUSTGA) Therapeutic Goods Administration, Department of Community
Services and Health, , , 27 Mar 1990)
WHO Comment : Fenoterol, a beta 2-adrenoreceptor agonist with bronchodilator
activity, was introduced in 1971 for the management of asthma. In the 1960's, the
use of other sympathomimetics in pressurised aerosols had already been
associated with an increase in mortality due to asthma. However, it was not clear
whether patients died from the severity of the asthma attack or from its treatment.

Product Name Feprazone

C.A.S. number 30748-29-9
Scientific and common names, and synonyms
PRENAZONE
PHENYLPRENAZONE

4-(3-METHYLBUT-2-ENYL)-1,2-DIPHENYLPYRAZOLIDONE-3,5-DIONE
4-(3-METHYL-2-BUTENYL)-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 129

Product Name Feprazone

C.A.S. number 30748-29-9
Country Effective Description of action taken
Date Grounds for decision
GBR 30 Mar 1984 Voluntarily withdrawn from the market after concern was expressed over its risk-benefit
ratio by the Committee on Safety of Medicines.
DEU Nov 1984 Marketing authorization for the sale of feprazone was withdrawn at the request of the
manufacturer having regard to the frequency of reported adverse reactions, particularly
involving the skin, and demonstration of a carcinogenic potential in rats. The
manufacturer had never exercised its option to market feprazone in the Federal Republic
of Germany.
GRC 1985 Withdrawn from the market.
EGY 26 Feb 1985 Preparations containing feprazone are not approved for registration.
OMN May 1987 Products intended for internal use containing feprazone were subjected to prescription
control and a certificate from the Ministry of Health was required for their importation.
(Reference: (OMNCR) Circular, 26/87, , May 1987)
AUT Indications restricted to exacerbations of gout and other arthritic conditions. Treatment
should not exceed seven days and doctors are advised not to prescribe this drug to
children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
WHO Comment : Feprazone, a pyrazolone derivative with antiinflammatory,
analgesic and antipyretic activity, was introduced in 1978 for the treatment of
rheumatic disorders. As it is structurally related to phenylbutazone it is subjected
to rigorously restricted indications by some national regulatory authorities. See
WHO comment for phenylbutazone. WHO has been informed that to date feprazone
is only available in some 7 countries.

Product Name Fipexide

C.A.S. number 34161-24-5
Scientific and common names, and synonyms
1-[(P-CHLOROPHENOXY)ACETYL]-4-PIPERONYLPIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 1990 Products containing fipexide were contraindicated in children, because their use had
been associated withpneumopathy, neuropsychological disorders and rare cases of
agranulocytosis. In 1991, the manufacturer decided to withdraw all preparations from the
market.
(Reference: (FRAMHH) Ministry of Health and Humanitarian Action, , , 11 Dec 1992)
WHO Comment : Fipexide, a stimulant of the central nervous system, was
introduced in 1973 for the treatment of depression and memory defects. Following
its association with hepatic and hemopoietic disorders, particularly in children, the
drug was withdrawn in France. Although not widely marketed, it may still remain
registered elsewhere.

Product Name Flecainide

C.A.S. number 54143-55-4
Scientific and common names, and synonyms
BENZAMIDE, N-(2-PIPERIDINYLMETHYL)-2,5-BIS(2,2,2-TRIFLUOROETHOXY)-
N-(2-PIPERIDYLMETHYL)-2,5-BIS(2,2,2-TRIFLUOROETHOXY)BENZAMIDE

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 130

Product Name Flecainide

C.A.S. number 54143-55-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 31 May 1989 The indications for products containing flecainide are restricted to prophylaxis and
treatment of life-threatening tachyarrhythmia, supraventricular tachyarrhythmia
unresponsive to conventional treatment and Wolf-Parkinson-White syndrome.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, 14(3),
60, 1989)
FRA Jul 1989 The indications for flecainide have been restricted to the treatment of potentially life-
threatening ventricular arrhythmias, particularly ventricular tachycardia, and symptomatic
arrhythmias (except those resulting from myocardial infarction) with unchanged left
ventricular function. Flecainide is now contraindicated in non-persistent ventricular
arrhythmia after myocardial infarction.
(Reference: (FRARP) La Revue Prescrire, 9(87), 292, 1989)
MYS Jul 1989 The indications of products containing flecainide have been restricted to the treatment of
life-threatening arrhythmias only.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 3(3), 3, 1989)
@EC Nov 1989 Having regard to the CAST (Cardiac Arrhythmia Suppression Trial) study carried out in
the USA, the Committee for Proprietary Medicinal Products has issued the following
statement on products containing flecainide: 1) myocardial infarction as a precondition
must be a contraindication for use except for life-threatening ventricular arrhythmias 2)
asymptomatic and non severe symptomatic ventricular arrhythmias are contraindications
3) life-threatening ventricular arrhythmias may be treated provided that treatment is
started in hospital under specific monitoring; 4) supraventricular arrhythmias may be
treated provided that there is a definite need for treatment and in the absence of left
ventricular function impairment. Patients on safe and effective long-term treatment with
flecainide already before publication of the results of the CAST study may continue to
take the drug.
(Reference: (CECC) Communication from CEC, , , 21 June 1990)
ITA 1990 The indications for products containing flecainide are restricted to some forms of
supraventricular tachycardias and to persistent life-threatening hyperkinetic ventricular
arrhythmia. In the latter indication, patients should be hospitalized when treatment is
commenced and remain under specialized medical supervision throughout therapy. Use
is contraindicated in cases of cardiac block, cardiogenic shock, cardiac insufficiency,
known hypersensitivity and in patients with a history of myocardial infarction, except for
the treatment of life-threatening ventricular arrhythmias.
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, 14(1), 2, 1990)
NOR 1990 The indications for products containing flecainide were restricted to life-threatening
ventricular tachycardia and to treatment and prophylaxis of severe incapacitating
supraventricular arrhythmia. Treatment was required to be instituted in a hospital after full
cardiological assessment of the patient.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 4, 7, 1990)
DEU Jan 1990 The approved indications of flecainide are restricted to supraventricular and severe
ventricular arrhythmias. It is contraindicated in recent myocardial infarction and impaired
ventricular function, except in patients with life-threatening arrhythmias.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 130(5), 10, 1990)
WHO Comment : The membrane-stabilizing antiarrhythmic agent flecainide was
introduced into medicine in 1982. The decision to delete the indications for
patients with asymptomatic and less severe symptomatic ventricular arrhythmias
was taken on the basis of the results of a trial (CAST study) that showed a two-fold
increase in deaths in post-myocardiac patients taking flecainide compared with the
placebo group.

Product Name Floctafenine

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 131

C.A.S. number 23779-99-9

Scientific and common names, and synonyms
BENZOIC ACID, 2-[[8-(TRIFLUOROMETHYL)-4-QUINOLINYL]AMINO]-,2,3-DIHYDROXYPROPYL ESTER
2,3-DIHYDROXYPROPYL-N-(8-TRIFLUOROMETHYL-4-)QUINOLYL)ANTHRANILATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BEL 26 Jun 1987 Having regard to the potential of floctafenine to cause severe anaphylactic shock,
products containing floctafenine may now only be obtained on medical prescription.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
WHO Comment : See WHO comment for glafenine.

Product Name Flosequinan

C.A.S. number 76568-02-0
Scientific and common names, and synonyms
4(1H)-QUINOLINONE, 7-FLUORO-1-METHYL-3-(METHYLSULFINYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Jul 1993 Subsequent to its withdrawal of the 100 mg tablet formulation of the vasodilator,
flosequinan (Manoplax: Boots), the manufacturer has now also withdrawn the remaining
50 mg tablet. The company took this decision after further analysis of interim results of a
trial (100 mg and 75 mg) showed an increase in hospital admissions among patients
taking doses of 75 mg daily (the only available dosage formulation the trial conducted in
the United States). The initial analysis had shown increased risk of death in patients
taking the 100 mg dosage. In view of these data the company considered the continued
use of flosequinan could not be recommended.
(Reference: (GBRPHJ) The Pharmaceutical Journal, p.114, , 24 July 1993)

Product Name Flunarizine

C.A.S. number 52468-60-7
Scientific and common names, and synonyms
PIPERAZINE,1-[BIS(4-FLUOROPHENYL)METHYL]-4-(3-PHENYL-2-PROPENYL)-,(E)-
(E)-1-[BIS-(P-FLUOROPHENYL)METHYL]-4-CINNAMYLPIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP Aug 1989 Having regard to their potential to induce extrapyramidal symptoms, products containing
flunarizine may no longer be indicated for cerebral and peripheral arterial insufficiency,
including loss of memory, insomnia, intermittent claudication, rest pain or vasospastic
disturbances. The approved indications are restricted to vestibular disturbances, vertigo,
prophylaxis of vascular headache and prevention of motion sickness.
(Reference: (ESPINS) Información Terapéutica de la Seguridad Social, 13(8), 176,
1989)
DEU Jan 1991 The indications for products containing flunarizine were restricted to the treatment of
vestibular dysfunction, having regard to association of the compound with Parkinsonism,
extrapyramidal symptoms and depression and to insufficient proof of efficacy in other
indications. Doctors were advised not to continue treatment for longer than is necessary
to obtain an effective response, and in no circumstances for longer than 3 months.
(Reference: (BGHBL) Bundesgesundheitsblatt, 2/91, 81, Feb 1991)
@EC 12 Mar 1991 The Committee for Proprietary Medicinal Products advised that the indications for

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 132

Product Name Flunarizine

C.A.S. number 52468-60-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
products containing flunarizine should be restricted to the prophylaxis of severe refractory
migraine and to the treatment of functional vestibular vertigo, having regard to the risks
associated with their use. In 1989 the Committee had recommended that the approved
product information should: 1) state that the product is contraindicated in patients with a
history of extrapyramidal symptoms, Parkinsonism, Alzheimer's disease and depression;
2) warn that it may induce extrapyramidal signs and depression and unmask
Parkinsonism, particularly in the elderly; 3) provide a description of the signs of
extrapyramidal and depressive reactions.
(Reference: (CPMPPO) Pharmacovigilance Opinion, 6, , 13 Sep 1989)
JPN Jul 1991 The approved labelling of products containing flunarizine was amended to indicate that
reversible extrapyramidal disturbances and, less frequently, depression have been
associated with their use, particularly in the elderly.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, 109, , July 1991)
WHO Comment : Flunarizine, an antihistaminic and vasodilator agent, was
introduced into medicine in 1970. It is indicated for the treatment of central and
peripheral vascular disorders. However, its effectiveness in these conditions has
not been convincingly demonstrated, and its use has been associated with adverse
reactions involving the central nervous system, including extrapyramidal
disturbances and depression. This has led several regulatory authorities to restrict
the approved indications for products containing flunarizine.

Product Name Flunitrazepam

C.A.S. number 1622-62-4
Scientific and common names, and synonyms
5-(O-FLUOROPHENYL)-1,3-DIHYDRO-1-METHYL-7-NITRO-2H-1,4-BENZODIAZEPIN-2- ONE
2H-1,4-BENZODIAZEPIN-2-ONE, 5-(2-FLUOROPHENYL)-1,3-DIHYDRO-1-METHYL-7- NITRO-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 1986 The Ministry of Health and Social Assistance has subjected flunitrazepam to controls
equivalent to those applied to drugs in Schedule II of the 1971 Convention on
Psychotropic Drugs in view of its frequent abuse by drug addicts.
DEU 1 Apr 1994 As from 1 April 1994, pharmaceutical products containing more than 1-mg flunitrazepam
per delivery unit will be scheduled under Narcotic Drugs Regulations. Pharmacists are
now required to maintain records indicating the quantity of stock held and their
destination. The major manufacturers have been requested to comply with relevant
provisions.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 134(13):1130, , 31 Mar 1994)
ZAF The South African Medicines Control Council has withdrawn registration of all 2 mg
formulations of flunitrazepam and has scheduled 1 mg tablets in Schedule 6 of the
Narcotic Drugs Regulations. It has also decreed that all flunitrazepam- containing
products be reformulated to include a bitter taste and colorant in order to minimize risk of
illegal use in facilitating crimes.
(Reference: (ZAFPS) Information from the Pharmaceutical Services, , , )
WHO Comment : Flunitrazepam, a benzodiazepine derivative with sedative and
hypnotic activity, was introduced in 1974 for the management of anxiety. Although
it is subject to international control under Schedule IV of the 1971 Convention on
Psychotropic Substances, its potential for abuse by drug addicts has led at least
two countries (Germany and Turkey) to apply controls equivalent to those of

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 133

Product Name Flunitrazepam

C.A.S. number 1622-62-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
Schedule II.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Fluoxetine

C.A.S. number 54910-89-3
Scientific and common names, and synonyms
BENZENEPROPANAMINE, N-METHYL-G-[4-(TRIFLUOROMETHYL)- PHENOXYL]-, (±)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL Dec 1994 Hyponatraemia which may be life-threatening may occur with fluoxetine and other
selective serotonin reuptake inhibitors particularly in elderly women. Patients in the ?at
risk? category should have electrolyte monitoring during the first month of therapy.
(Reference: (NZLPU) Prescriber Update, No.7, , Dec 1994)

Product Name Fluvoxamine

C.A.S. number 54739-18-3
Scientific and common names, and synonyms
5-METHOXY-4'-(TRIFLUOROMETHYL)VALEROPHENONE (E)-0-(2-AMINOETHYL)OXIME

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISL The Committee on Pharmaceuticals has refused to approve fluvoxamine for registration
because animal experiments have shown teratogenicity and a potential to cause renal
damage.
(Reference: (ISLCP) Notification, , , Feb 1987)

Product Name Furazolidone

C.A.S. number 67-45-8
Scientific and common names, and synonyms
NITROFURAZOLIDONUM
NIFURAZOLIDONUM
2-OXAZOLIDINONE, 3-(((5-NITRO-2-FURANYL)METHYLENE)AMINO)-
3-((5-NITROFURFURYLIDENE)AMINO)-2-OXAZOLIDONE
3-((5-NITROFURFURYLIDENE)AMINO)-2-OXAZOLIDINONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Withdrawn from all marketed preparations on the grounds that it has been superseded by
safer and more effective preparations.
PHL 1980 Approved for restricted use only. Animal tests have shown that this drug has

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 134

Product Name Furazolidone

C.A.S. number 67-45-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
carcinogenic potential. A warning statement is required to be placed on the labels of all
products.
ITA 1982 The following warning has been inserted on the label taking into account experimental
data on animals: "To be used systemically only for short periods and under the
physician's guidance".
IRQ 1986 The National Board for the Selection of Drugs has withdrawn furazolidone form the
market.
MYS Mar 1987 All products containing furazolidone have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.8, , Dec 1986)
KOR Dec 1988 All products containing furazolidone were banned, because there are many preparations
which are safer and more effective.
(Reference: (KRMHSA) Ministry of Health and Social Affairs - Communication to WHO, ,
, 13 Dec 1991)
LBN Aug 1991 Products containing furazolidone intended for the treatment of diarrhoea in children were
withdrawn.
(Reference: (LBNMHD) Ministry of Health and Social Affairs Decree, 150/1, , Aug 1991)
YEM 1998 The Supreme Board of Drugs and Medical Devices has withdrawn all formulations of the
nitrofuran derivative, furazolidone, because many other safer and more effective
alternatives are available.
(Reference: (YEMCW) Communications to WHO, , , 10 Oct 1998)
WHO Comment : Furazolidone, a nitrofuran derivative with antibacterial and
antiprotozoal activity, was introduced in 1954. In the 1970s it was shown to have a
carcinogenic potential following long-term administration to experimental animals.
However, the relevance of this to short-term therapy in man has not been
established. The risk-benefit assessment varies and furazolidone remains widely
available in many countries for the treatment of diarrhoea and enteritis.

Bibliographical references
WHO FOOD ADD., 31, 85, 1993

Product Name Gallopamil

C.A.S. number 1662-47-8
Scientific and common names, and synonyms
ALPHA[3-[[2-(3,4-DIMETHOXYPHENYL)ETHYL]METHYLAMINO]PROPYL]-3,4,5-TRIMETHOXY-ALPHA-(1-METHYL-
ETHYL) BENZENEACETONITRILE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR May 2001 The General Directorate of Pharmaceuticals and Pharmacy of the Ministry of Health
suspended the marketing authorization of gallopamil because of the decision of the
Registration Committee.
(Reference: (TURCW) Communication to WHO, , , 20 Sep 2001)

Product Name Gamelonic acid

C.A.S. number 2003-0-1001
Scientific and common names, and synonyms
PRIMROSE OIL DERIVATIVE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 135

Product Name Gamelonic acid

C.A.S. number 2003-0-1001
Scientific and common names, and synonyms
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Oct 2002 The Medicines Control Agency has withdrawn the marketing authorizations for two
gamelonic acid containing derivatives (Epogam, Efamast) of primrose oil, originally
licensed for the symptomatic relief of eczema in children, due to inadequate standards of
efficacy with these products. However, since no safety issues are involved, these
products will continue to be available in health food shops as dietary supplements.
(Reference: (GBRNUP) News Update, , , )

Product Name Gangliosides

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 31 Aug 1992 The Federal Health Office extended the suspension period for the injectable preparation
of mixed bovine brain gangliosides at least until 30 September 1994. The product was
first suspended in 1989 because of a possible association with Guillian-Barr, syndrome.
(Reference: (DEUFHO) Communication from Federal Health Office, , , 31 Aug 1992)
WHO Comment : Gangliosides are a glycolipid extract of bovine cerebral cortex
claimed to ameliorate peripheral neuropathies of various types, including post-
herpetic neuropathy, tobacco-alcohol amblyopia, toxic acoustic injuries, and
traumatic facial paralysis. Its use has been associated with cases of Guillain-Barr,
syndrome characterized by mixed polyneuropathy and in some instances, flaccid
paralysis.

Product Name Gemfibrozil

C.A.S. number 25812-30-0
Scientific and common names, and synonyms
PENTANOIC ACID, 5-(2,5-DIMETHYLPHENOXY)-2,2-DIMETHYL
2,2-DIMETHY-5-(2,5-XYLYLOXY)VALERIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1987 The Medicines Control Authority has refused registration of gemfibrozil on the grounds
that the risk of adverse effects is not balanced by therapeutic benefit.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 4, 10, 1987)
WHO Comment : Gemfibrozil, an antihyperlipidaemic derivative of clofibrate, was
introduced in the early 1980's. It is registered in several countries for the treatment
of hyperlipidaemia unresponsive to dietary measures. (See also the WHO comment
for clofibrate).

Product Name Gentamicin (topical preparations)

C.A.S. number 1403-66-3
Scientific and common names, and synonyms
O-3-DEOXY-4-C-METHYL-3-(METHYLAMINO-?-L-ARABINO-PYRANOSYL-(1?6)-O-[2,6,DIAMINO-2,3,4,6-TETRADEOXY-
?-D-ERYTHRO-HEXOPYRANOSYL-(1?4)]-2-DEOXY-D-STREPTAMINE (GENTAMICIN C)1A

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 136

Product Name Gentamicin (topical preparations)

C.A.S. number 1403-66-3
Scientific and common names, and synonyms
O-3-DEOXY-4-C-METHYL-3-(METHYLAMINO- -L-ARABINO-PYRANOSYL-(1 6)-O-[2,6,DIAMINO-2,3,4,6-TETRADEOXY- -D-
ERYTHRO-HEXOPYRANOSYL-(1 4)]-2-DEOXY-D-STREPTAMINE (GENTAMICIN C1A)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD 1994 The Committee for the Evaluation of Medicines has withdrawn the marketing
authorization for dermal products containing gentamicin. The Committee considers that
the local use of antibiotics that are also available for systemic administration is no longer
acceptable because of the risk of development of resistance (including cross-resistance
with other aminoglycoside antibiotics).
(Reference: (NPHWB) Pharmaceutisch Weekblad, 28(5):126, , 1994)
MYS May 1997 The Drug Control Agency has decided to lift the ban on topical preparations containing
gentamicin. However, the indications will be restricted to community-based skin
infections only, i.e. treatment of impetigo, erythema and other localized primary bacterial
skin infections with a Gram-negative component and also for secondary bacterial
infections complicating other pre-existing dermatoses. In addition, a boxed warning will
be included in the product information and package insert stating : "Use of topical
gentamicin preparations in closed hospital settings is actively discouraged".
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 11(2): 8, , May 1997)
ARM The Drug and Medical Technology Agency withdrew registration of gentamicin ointment
for ?in situ? treatment of minor infections because antibiotics that are also available for
systemic use are not considered acceptable for topical use because of resistance
development.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
WHO Comment : Gentamicin has been used inin situ preparations for the treatment
of minor infections. Antibiotics that are also available for systemic use are not
considered acceptable for topical use because of the risk of development of
resistance. Neomycin is the topical aminoglycoside listed in the WHO Model List
of Essential Drugs.

Product Name Germander

Scientific and common names, and synonyms

TEUCRIUM CHAMAEDRYS

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office withdrew the marketing authorization for herbal medicines
containing germander based on reports of hepatotoxicity generated within France by the
drug regulatory agency.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(12):20, , 1992)
FRA 1992 The Ministry of Health and Humanitarian Action suspended the marketing authorization
for medicinal products containing the plant germander having regard to 26 cases of liver
necrosis associated with the use of these products.
(Reference: (FRARP) La Revue Prescrire, 12(114):17, , 1992)
BEL 04 Aug 1992 The Minister of Social Integration, Public Health and the Environment decided to suspend
for a period of one year all medicines containing germander having regard to concerns
relating to hepatotoxicity generated within France. This suspension has been prolonged
for another year from 20 July 1993 by order of the Ministry.
(Reference: (BELMD) Ministerial Decree, , , 04 Aug 1992)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 137

Product Name Germander

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (BELMB) Moniteur Belge, , 20542, 25 Sep 1992)
WHO Comment : Germander has been tradionally used as a diet aid, a treatment for
light diarrhoea, or locally as an analgesic for oral pain. In 1991, the first cases of
hepatitis associated with the use of these products were reported to the National
System of Pharmacovigilance in France. It is yet uncertain whether contamination
possible by pesticides or fungi, may be implicated or whether these cases result
from toxic or immuno-allergic reactions to constituents of Germander.

Product Name Ginkgo biloba

Scientific and common names, and synonyms

FOSSIL TREE
GBE-761
KEW TREE
MAIDENHAIR TREE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1998 The Federal Institute for Drugs and Medical Devices has extended the suspension of
parenteral infusion formulations after having received several reports of adverse
reactions associated with its use, most of which described anaphylactic symptoms
(shock, fever, leukocytosis, and cardiac arrhythmia), in some cases life-threatening.
(Reference: (DEUCFI) Communication, , , 19 June 1998)

Product Name Glafenine

C.A.S. number 3820-67-5
Scientific and common names, and synonyms
GLAPHENINE
2,3-DIHYDROXYPROPYL-N-(7-CHLORO-4-QUINOLYL) ANTHRANILATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1984 Following reports of frequent severe allergic reactions, this analgesic was withdrawn from
the market by the manufacturer.
ITA Oct 1987 Having regard to adverse reactions reported in Italy and other countries, the General
Directorate of the Pharmaceutical Service of the Ministry of Health has revoked the
marketing authorization for suppositories containing 1 mg of glafenine. This preparation
contained a higher dosage of the active principle than others available on the market.
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, 10(10), 2, 1987)
BEL 1 Jan 1991 In agreement with the manufacturers, the Ministry of Health suspended the marketing
authorization for all products containing glafenine, including extemporaneous
preparations, following reports of anaphylactic shock, acute tubulo-interstitial renal
insufficiency and immuno-allergic hepatitis. In 1992, glafenine was withdrawn by the
major manufacturer.
(Reference: (BELGPI) General Pharmaceutical Inspectorate, , , 12 Dec 1991)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 138

Product Name Glafenine

C.A.S. number 3820-67-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@EC 14 Jan 1992 The Committee for Proprietary Medicinal Products of the European Communities
recommended the withdrawal of products containing glafenine, because the risk of
serious anaphylactic reactions associated with their use is greater than with other
analgesics.
(Reference: (CPMPPO) Pharmacovigilance Opinion, 8/2, , 14 Jan 1992)
CHE Mar 1992 The marketing authorization for products containing glafenine was suspended and later
withdrawn by the company.
(Reference: (CHBCM) Bulletin Mensuel, , , Mar 1992)
FRA Mar 1992 In agreement with the manufacturer, the Ministry of Health withdrew the marketing
authorization for products containing glafenine, having regard to the risk of anaphylactic
reactions.
(Reference: (FRAMS) Ministry of Social Affairs and Integration, , , Apr 1992)
PRT Mar 1992 The marketing authorization for monocomponent and combination products containing
glafenine was suspended.
(Reference: (PRTMH) Ministry of Health, , , Mar 1992)
OMN Mar 1992 Import and marketing of products containing glafenine were prohibited, and they will not
be considered for registration.
(Reference: (OMNCR) Circular, 5/92, , Mar 1992)
@WD May 1992 Upon agreement of regulatory authorities, products containing glafenine were withdrawn
worldwide by the major manufacturer.
(Reference: (CRU) Communication to WHO from Roussel Uclaf, , , 21 May 1992)
WHO Comment : Glafenine, a quinolylanthranilate derivative, was introduced in
1965 for use as an analgesic. By the late 1970s its use had been associated with
severe allergic responses, including anaphylactoid reactions, which led to its
withdrawal in one country whereas in others a warning to this effect is required in
the product information. In 1992, on the advice of the Committee for Proprietary
Medicinal Products of the European Communities, glafenine was eventually
withdrawn worldwide by the major manufacturer.

Product Name Glucosamine sulfate

C.A.S. number 3416-24-8
Scientific and common names, and synonyms
CHITOSAMINE SULFATE
D-GLUCOSE, 2-AMINO-2-DEOXY-, SULFATE
2-AMINO-2-DEOXY-BETA-D-GLUCOPYRANOSE SULFATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1986 Following reports of local hypersensitivity reactions, preparations containing glucosamine
sulfate are no longer approved for intra-articular administration.
EGY 1987 Preparations of glucosamine sulfate for intra-articular injection will not be considered for
registration because of an unacceptable potential to cause allergic reactions.
(Reference: (EGYDI) Drug Information, 5(3), 1, 1987)
WHO Comment : Glucosamine is found in chitin, mucoproteins and
mucopolysaccharides. It is used as a pharmaceutical aid. Glucosamine sulfate has
been used in the treatment of rheumatic disorders though it is not widely marketed

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 139

Product Name Glucosamine sulfate

C.A.S. number 3416-24-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
for this purpose.

Product Name Glutethimide

C.A.S. number 77-21-4
Scientific and common names, and synonyms
GLUTEMIDE
2-ETHYL-2-PHENYLGLUTARIMIDE
2,6-PIPERIDINEDIONE, 3-ETHYL-3-PHENYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1980 Withdrawn from the market.
ZWE Nov 1984 Prohibited for use.
(Reference: (ZWESI) Statutory Instrument, 366, , Nov 1984)
PAK 1988 Products containing glutethimide were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
WHO Comment : Glutethimide, a piperidine derivative, was introduced in 1955 for
use as a sedative-hypnotic drug. Its addiction liability and severity of withdrawal
symptoms are equal to those of the barbiturates and it is controlled under
Schedule III of the 1971 Convention on Psychotropic Substances.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Glutoxim

C.A.S. number 2003-0-1002

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARM Sep 2000 The Armenian Drug and Medical Technology Agency did not approve the marketing of
the new immunomodulating agency on grounds of doubtful safety and incomplete clinical
trial.
(Reference: (ARMCW) Communication to WHO, , , 31 Aug 2001)

Product Name Grepafloxacin hydrochloride

C.A.S. number 161967-81-3
Scientific and common names, and synonyms
OPC-17116

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 140

Product Name Grepafloxacin hydrochloride

C.A.S. number 161967-81-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Oct 1999 Grepafloxacin (Raxar) was voluntarily withdrawn from the market by the licence holder
from the market because of a small number of severe cardiac arrhythmias among
patients in post-marketing surveillance.
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)
LTH Nov 1999 Marketing authorization for grepafloxacin was suspended by the State Medicines Control
Agency.
(Reference: (LTHMCA) Order of State Medicines Control Agency, No. 96, , 15 Nov 1999)
PER Dec 1999 La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of
Health has communicated to health professionals that Glaxo Wellcome has voluntarily
withdrawn the fluoroquinolone grepafloxacin from the market because of prolongation of
the QT interval giving rise to ventricular arrhythmias known as torsades de pointes.
(Reference: (PERDGM) Alerta DIGEMID, No. 12-99, , 15 Dec 1999)
ARM Jul 2000 Grepafloxacin has been voluntarily withdrawn after the observation of severe
cardiovascular events among patients.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
SGP Grepafloxacin has been voluntarily withdrawn due to an effect of the drug on cardiac
repolarization, manifested as QT interval prolongation. Some patients may be at risk of
the very rare but serious ventricular arrhythmia known as torsades de pointes.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Griseofulvin

C.A.S. number 126-07-8
Scientific and common names, and synonyms
7-CHLORO-2',4,6-TRIMETHOXY-6'BETA-METHYLSPIRO(BENZOFURAN-2(3H),1'-(2) CYCLOHEXENE)-3,4'-DIONE
SPIRO(BENZOFURAN-2(3H), 1'-(2)CYCLOHEXENE)-3,4'-DIONE, 7-CHLORO-2',4,6- TRIMETHOXY-6'-METHYL-,(1'S-
TRANS)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1986 Having regard to recently evaluated reports of carcinogenicity, fetotoxity and
teratogenicity in rodents administered very high doses of griseofulvin, the Committee on
the Review of Medicines has recommended that all products containing griseofulvin
should be restricted in their use to the treatment of dermatophyte infections of the skin,
scalp, hair and nails when topical therapy has failed or is considered inappropriate. It also
recommends that such products should not be used during pregnancy or for prophylactic
treatment.
DEU 1992 Following reports of teratogenicity in experimental animals, the approved product
information for products containing griseofulvin was amended to contraindicate their use
during pregnancy, except in life-threatening conditions, and lactation. The need for
contraceptive measures to be maintained throughout treatment and, for men, for 6
months thereafter was emphasized.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 32(12):XII, , 1992)
WHO Comment : Griseofulvin, isolated from a penicillin producing mould, has
been widely used as a systemically administered antifungal agent in man for over
20 years. It is effective in dermatophyte infections (including tinea barbae and tinea
capitis) but it is inactive against yeasts and bacteria. Evidence that very high doses
of griseofulvin are carcinogenic, teratogenic and fetotoxic in laboratory animals
has led to an acceptance that it should not be used to treat trivial infections that

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 141

Product Name Griseofulvin

C.A.S. number 126-07-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
respond to topical therapy. Oral formulations of griseofulvin are included in the
WHO Model List of Essential Drugs.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Guanofuracin

C.A.S. number 300-25-4
Scientific and common names, and synonyms
5-NITROFURFURYLIDENAMINOGUANIDINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Withdrawn from all marketed preparations on the grounds that it has been superseded by
safer and more effective preparations.
VEN Not approved for use and/or sale.
WHO Comment : Guanofuracin, a nitrofuran derivative, was formerly used as an
antiinfective agent. It has, however, been superseded by safer compounds and
WHO has no information that it remains commercially available.

Product Name H1-Antihistamines

Scientific and common names, and synonyms

HISTAMINE H1 RECEPTOR ANTAGONISTS

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1987 Products containing histamine H1 receptor antagonists indicated for vomiting during
pregnancy may only be dispensed on medical prescription, because they have been
associated with an increased risk of neonatal pyloric stenosis. H1-antihistamines labelled
for other indications should mention pregnancy as a contraindication.
(Reference: (BGHBL) Bundesgesundheitsblatt, 30, 186, 1987)
CHE 28 Mar 1990 Over-the-counter preparations containing phenothiazine antihistamines indicated for
children under one year of age may only be dispensed on medical prescription. The
product information directed to physicians must carry a warning stating that caution is
recommended in treating children of less than one year of age and that the use of the
preparation is clearly contra-indicated under the following circumstances: neonates
(particularly premature births), history of apnoeic crises (near-miss-SIDS), SIDS in
brothers and sisters and cardiorespiratory problems. The information intended for
patients must carry a warning that a doctor is to be consulted before children of less than
one year of age are treated.
(Reference: (CHEAZ) Schweizer Apotheker Zeitung, 128(11), 311, 1990)
@EC 13 May 1991 The Committee for Proprietary Medicinal Products advised that products containing
phenothiazines, including alimemazine, mequitazine, oxomemazine and promethazine
indicated for the treatment of cough, allergic reactions, motion sickness and for sedation,
should not be used in children below the age of one year, having regard to their possible

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 142

Product Name H1-Antihistamines

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
association with sudden infant death syndrome.
(Reference: (CPMPDP) Draft Position Statement on Phenothiazines and sudden infant
death syndrome, , , 13 May 1991)
BEL The approved information of products containing histamine H1 receptor antagonists must
warn in the section"Precautions" against their administration to children aged less than
one year without medical advice, because their sedative effect may be associated with
episodes of sleep apnoea. The package leaflets of preparations containing of
phenothiazine antihistamine must bear an idential warning in the section "Contra-
indications".
(Reference: (BELGPI) General Pharmaceutical Inspectorate, , , 18 June 1987)
WHO Comment : Histamine H1 receptor antagonists were introduced in 1937 as
over-the-counter medicines for the treatment of allergies of the upper respiratory
tract and skin. They are also widely used to reduce the symptoms of the common
cold, although there is little evidence of their effectiveness in this condition. The
sedative and antiemetic effects of antihistamines are of value in the treatment of
sleep disorders, motion sickness and vomiting. In 1979, the possibility was raised
that the use of phenothiazine antihistamines, particularly promethazine, could be
associated with sleep aapnoea in young children and with sudden infant death
syndrome (SIDS). Studies carried out subsequently, although they have not
established a causal relationship, have led some drug regulatory authorities to
subject products containing phenothiazine antihistamines to prescription control
and/or to caution against their use in young children. In some countries, similar
warnings have also been included in the package leaflets of other H1-
antihistamines.

Product Name Halofantrine

C.A.S. number 69756-53-2
Scientific and common names, and synonyms
9-PHENANTHRENEMETHANOL, 1,3-DICHLORO-?-[2-(DIBUTYLAMINO)ETHYL]-6-(TRIFLUOROMETHYL)-
,HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jan 1994 The National Commission for Pharmacovigilance has contraindicated the use of the
antimalarial agent, halofantrine, in patients with congenital or acquired QT prolongation,
in those with a family history of congenital QT prolongation, and in patients taking
antiarrhythmic medicines or hypokalaemic substances.
(Reference: (FRAAMC) Communiqué de Presse, , , 14 Jan 1994)
WHO Comment : Halofantrine is an antimalarial introduced to medicine in 1982. It
should be reserved for use in areas where multiple drug-resistant falciparum
malaria is prevalent. Cases of serious cardiotoxicity have been reported.

Product Name Halogenated hydroxyquinoline derivatives

C.A.S. number 148-24-3
Scientific and common names, and synonyms
8-QUINOLINOL
OXYQUINOLINE
OXYQUINOL

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 143

Product Name Halogenated hydroxyquinoline derivatives

C.A.S. number 148-24-3
Scientific and common names, and synonyms
OXINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DNK 1978 All halogenated hydroxyquinoline derivatives intended for oral administration have been
withdrawn from use.
(Reference: (UGLAAD) Ugeskrift for Laeger, 140, 1181, 1978)
CYP 1980 The Drug Council withdrew all products containing halogenated hydroxyquinoline
derivatives intended for internal use due to the possible risk of occurrence of sub-acute
myelo-optic neuropathy (SMON) in treated patients.
PHL Aug 1980 Withdrawn from the domestic market due to reports of neurological disorders (SMON)
with their use in Japan.
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, these preparations have been
banned. Clioquinol is implicated in sub-acute myelo-optic neuropathy (SMON),
manifested by pain and persistent diarrhoea and proceeding to bilateral sensory
disturbances, paraesthesias and dysaesthesias. Similar toxic effects have been observed
with other halogenated hydroxyquinolines.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
GHA 1982 All preparations containing halogenated hydroxyquinoline derivatives for oral
administration have been withdrawn from use.
TUR 20 Dec 1982 Banned for production and sale having regard to severe adverse reactions.
ITA 1983 Withdrawn from the market.
GRC Mar 1984 Pharmaceutical products containing halogenated hydroxyquinolines have been withdrawn
having regard to experimental and clinical evidence of toxicity.
OMN Mar 1987 Import and marketing of oral and parenteral preparations containing oxyquinoline and its
halogenated derivatives intended for the treatment of diarrhoea in children were
prohibited. Topical preparations remained on the market.
(Reference: (OMNCR) Circular, 11/87, , Mar 1987)
ARE The following halogenated hydroxyquinoline derivatives used for intestinal amoebiasis are
banned: broxyquinoline, clioquinol and diiodohydroxyquinoline.
IND Currently available on the market. Precautionary information is required to be given with
this drug.
VEN Subject to restricted use and/or sale.
WHO Comment : Halogenated hydroxyquinoline is structurally related to clioquinol.
See WHO comment for clioquinol.
(Reference: (WHODI) WHO Drug Information, 77.1, 9, 1977)

Product Name Halogenated salicylanilides

Scientific and common names, and synonyms

DIBROMSALAN
METABROMSALAN
TRIBROMSALAN
TETRACHLOROSALICYLANILIDE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 144

Product Name Halogenated salicylanilides

Country Effective Description of action taken

Date Grounds for decision
USA 1 Dec 1975 Withdrawn from the market and prohibited for export in drugs and cosmetic products by
the Food and Drug Administration due to the risks of disabling skin disorders and
photosensitivity in humans.
(Reference: (FEREAC) Federal Register, 40(210), 50527, 1975)
JPN Jan 1976 Banned by the Pharmaceutical Affairs Bureau due to potential for photosensitivity
reactions.
WHO Comment : Halogenated salicylanilides, including dibromsalan,
metabromsalan, tribromsalan and tetrachlorosalicylanilide, which have
antibacterial and antifungal activity, have been used both as active ingredients for
antimicrobial purposes and as inactive ingredients (preservatives) in drug and
cosmetic products. Their use has been associated with photosensitive eruptions
and disabling skin disorders which has resulted in their withdrawal by some
national drug regulatory authorities.

Product Name Heptabarb

C.A.S. number 509-86-4
Scientific and common names, and synonyms
5-(CYCLOHEPT-1-ENYL)-5-ETHYLBARBITURIC ACID
HEPTAMALUM
HEPTABARBITONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jul 1984 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing heptabarb.
WHO Comment : Heptabarb is an intermediate-acting barbiturate. See WHO
comment for barbiturates.

Product Name Herpes simplex vaccines

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Aug 1984 Sale of Herpes simplex vaccines has not been approved by the National Control Authority
having regard to their potential hazards.
SAU Preparations containing Herpes simplex vaccines have been withdrawn from the market.
VEN Not approved for use and/or sale.
WHO Comment : Preparations containing Herpes simplex vaccine have been
available for at least 15 years. As a result of a review of unlicensed products
marketed in the Federal Republic of Germany in 1984 the National Control Authority
banned the use of such preparations having regard to their potential harmfulness.
Preparations remain available elsewhere, however.

Product Name Hexachlorophene

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 145

C.A.S. number 70-30-4

Scientific and common names, and synonyms
HEXACHLOROPHANE
PHENOL, 2,2'-METHYLENEBIS[3,4,6-TRICHLORO-
2,2'-METHYLENEBIS(3,4,6-TRICHLOROPHENOL)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL 1972 All talcum powders for infant use containing more than 0.75% hexachlorophene were
withdrawn. All other products with a greater concentration shall be available on
prescription basis only.
JPN Mar 1972 Banned by the Pharmaceutical Affairs Bureau in preparations such as nursing powder,
since edema of the brain is observed with test animals. Export is prohibited.
TUR 1981 Withdrawn from all toothpaste formulations by the Ministry of Health due to published
evidence of its harmful effects. Export of this product is prohibited.
COE 1984 The Committee of Experts on Cosmetics of the Council of Europe has reclassified
hexachlorophene in the list of preservatives published in the second edition 1984 of
"Cosmetic Products and their Ingredients" from class A (recommended) to class D (not
recommended). Hexachlorophene is now considered an ingredient which, on the basis of
information provided, presents a health hazard and which therefore is not recommended
for use in cosmetic products.
(Reference: (COECI) Cosmetic products and their ingredients 2nd edition, , , 1984)
SUN 25 Aug 1988 Pharmaceutical products containing hexachlorophene are prohibited for production and
use on grounds of teratogenicity, embryotoxicity, neurotoxicity, photosensitizing and
allergic potential.
PER Prohibited for use in hygienic preparations with the exception of deodorants, which may
contain as much as 0.1%, and antiseptic soaps, which may contain 0.2% of
hexachlorophene.
THA The use of pharmaceutical preparations containing hexachlorophene is severely
restricted.
WHO Comment : Hexachlorophene, an antimicrobial agent, was introduced in 1948
in proprietary liquid preparations and powders and was subsequently used
extensively as a topical antiseptic. By the early 1970s its use in infants had been
conclusively demonstrated to cause encephalopathy as a result of transdermal
absorption. More recently it has been suggested that the drug has a teratogenic
potential. Many regulatory authorities have placed rigorous restrictions on the
medicinal use of hexachlorophene, particularly in preparations intended for
infants. However, its use still commonly remains permissible at low concentrations
as a preservative in toiletries and cosmetics.
(Reference: (WHODI) WHO Drug Information, 3, 6, 1978)

Bibliographical references
IARC MONOGRAPH, 20, 241, 1979

Product Name Hexestrol

C.A.S. number 5635-50-7
Scientific and common names, and synonyms
DIHYDROSTILBOESTROL
HEXOESTROL
SYNESTROL
4,4'-(1,2-DIETHYLETHYLENE)DIPHENOL
4-4 1-(1,2-DIETHYL-1,2-ETHANEDIYL)BIS[PHENOL]

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 146

Product Name Hexestrol

C.A.S. number 5635-50-7
Country Effective Description of action taken
Date Grounds for decision
AUT Feb 1977 Pharmaceutical specialities containing diethylstilbestrol, dienestrol, hexestrol and their
derivatives have been withdrawn following reports indicating an association between
prenatal exposure to diethylstilbestrol and the subsequent development of
adenocarcinoma in postpubertal girls and young women. The use of stilbene derivatives
is only authorized for the treatment of cancer of the prostate.
ITA 1979 This product has been withdrawn from the market due to suspected carcinogenicity in
newborns following prenatal exposure.
KWT Jan 1980 Prohibited for import.
ARM Sep 2000 The Armenian Drug and Medical Technology Agency did not approve the marketing of
this product on grounds of risk of carcinogenicity and withdrew the product from the
entire market.
(Reference: (ARMCW) Communication to WHO, , , 31 Aug 2001)
SAU Following reports indicating the development of adenocarcinoma in post-pubertal girls
and young women exposed prenatally to preparations containing diethylstilbestrol,
dienestrol and their derivatives, the Drug Committee prohibited the use of these products
during pregnancy.
VEN Not approved for use and/or sale.
WHO Comment : Hexestrol is a stilbene derivative. See WHO comment for
diethylstilbestrol.
(Reference: (WHODI) WHO Drug Information, 77.1, 16, 1977)

Product Name Hexobarbital

C.A.S. number 56-29-1
Scientific and common names, and synonyms
5-(CYCLOHEX-1-ENYL)-1,5-DIMETHYLBARBITURIC ACID
5-(1-CYCLOHEXEN-1-YL)-1,5-DIMETHYLBARBITURIC ACID
HEXOBARBITONE
2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-(1-CYCLOHEXEN-1-YL)-1,5-DIMETHYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Oct 1984 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing hexobarbital.
WHO Comment : Hexobarbital is a short-acting barbiturate. See WHO comment for
barbiturates.

Product Name Human dura mater

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 30 Dec 1997 In order to minimize the risk of transmission of pathogens of spongiform
encephalopathies (e.g. Creutzfeldt-Jakob disease), the Federal Institute for Drugs and
Medical Devices has restricted the indications for medicinal products containing freeze-
dried human dura mater "soft" to : use in neuro- surgery if autologous tissue is not

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 147

Product Name Human dura mater

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
available in sufficient quantities or not sufficiently stable, and when synthetic materials
are not indicated; use in paediatric surgery for omphalocele/gastroschisis or in tracheal
stenosis when autologous tissue is not available in sufficient quantities, and when
synthetic materials are not indicated. At the same time, strict criteria for the selection of
donors have been implemented.
(Reference: (DEUCFI) Communication, , , 30 Dec 1997)

Product Name Hyaluronidase

C.A.S. number 9001-54-1

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SLV Jun 2001 Injections for intramuscular or subcutaneous use were withdrawn from sale nationally
because of incomplete data on BSE risk.
(Reference: (SLVCW) Communication to WHO, , , 24 Aug 2001)

Product Name Hydroquinidine

Scientific and common names, and synonyms

DIHYDROQUINIDINE
(ETHYL-5 QUINUCLIDINYL-2(2)) (METHOXY-6' QUINOLYL-(4))

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 14 Jan 1994 The Ministry of Health has issued a decree reclassifying the antiarrhythmic,
hydroquinidine (Serecor®: Houde), as a prescription medicine available only on non-
renewable prescription unless otherwise indicated by the prescriber. This action brings
hydroquinidine in line with other antiarrhythmics which are all subject to prescription
control, with the exception of the related product, quinidine. The need for reclassifying
the latter drug remains under consideration.
(Reference: (FRARP) La Revue Prescrire, 14(141):338, , 1994)
(Reference: (FRAAM) Arrêté ministériel of 14 January 1994, , , 02 Feb 1994)

Product Name Hydroquinone

C.A.S. number 123-31-9A
Scientific and common names, and synonyms
HYDROCHINONUM, BENZENE-1,4-DIOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NGA 1 Feb 1982 The manufacture, import, export, distribution and sale of any cosmetic products
containing hydroquinone in amounts exceeding 5% (w/w) are prohibited. Reasons for the
decisions: There has been gross misuse for skin bleaching purposes of hydroquinone-
containing cosmetic products, many of which contain over 5% hydroquinone.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 148

Product Name Hydroquinone

C.A.S. number 123-31-9A
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (AARNO) Administrative Action, FDA/RU/242-2, 171, Dec 1982)
DEU 1991 The Federal Health Office has restricted the use of products containing hydroquinone to
pathological hyperpigmentation. Children under 12 years of age should not be treated.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(42), , 1991)
WHO Comment : Hydroquinone was introduced in 1965 as a topical depigmenting
agent for hyperpigmentation. At high concentrations hydroquinone is corrosive
and in most countries has been restricted to the level of approximately 2% and
limited to the period of less than 2 months. Additional consideration for restrictive
action is that animal experiments have also demonstrated carcinogenic and
mutagenic potential of hydroquinone.

Product Name Hyoscine methonitrate

C.A.S. number 6106-46-3
Scientific and common names, and synonyms
HYOSCINE METHYLNITRATE
METHYLSCOPOLAMINE NITRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jun 1981 Hyoscine methonitrate, an antimuscarinic agent, has been withdrawn from appetite
suppressant preparations.
WHO Comment : Hyoscine methonitrate, a quaternary ammonium anticholinergic
agent, was introduced in 1947 for use as a gastrointestinal antispasmodic. The
action taken in Sweden relates to the use of this compound in preparations for
suppressing the appetite. Preparations may remain available elsewhere.

Product Name Ibopamine

C.A.S. number 66195-31-1
Scientific and common names, and synonyms
PROPANOIC ACID, 2-METHYL-, 4-[2-(METHYLAMINO)ETHYL]-1,2-PHENYLENE ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD Sep 1995 The Committee for the Evaluation of Medicines has restricted the indications for
ibopamine to mild cardiac insufficiency in combination with diuretics. Treatment must be
withdrawn gradually if the symptoms worsen.
(Reference: (NPHWB) Pharmaceutisch Weekblad, 130(37/38) , p. 999, 1995)
WHO Comment : Ibopamine belongs to the group of dopaminergic drugs, i.e.,
agents stimulating the dopaminergic system and potentiating the effects of the
neurotransmitter dopamine.

Product Name Ibuprofen

C.A.S. number 15687-27-1

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 149

Product Name Ibuprofen

C.A.S. number 15687-27-1
Scientific and common names, and synonyms
2-(4-ISOBUTYLPHENYL)PROPIONIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Feb 1992 The Federal Health Office has amended the approved product information for a tropical
formation of the non-steroidal anti-inflammatory agent, ibuprofen. The contraindications
were extended to include patients with a history of allergy and children under 6 years of
age.
(Reference: (BGHBL) Bundesgesundheitsblatt, 2/92, 109, Feb 1992)
WHO Comment : Ibuprofen, a non-steroidal anti-inflammatory agent, was
introduced in 1969. It was approved for sale without prescription in packages
containing no more than 400 mg, in the United Kingdom in 1983. This action was
followed by the USA, Canada and several European countries. Since this time
reports of suspected adverse effects have increased. Most of these relate to gastro-
intestinal disturbances, hypersensitivity reactions but aseptic meningitis, skin
rashes and renal damage have been recorded.

Product Name Indalpine

C.A.S. number 63758-79-2
Scientific and common names, and synonyms
2-(3-(4-PIPERIDYL)ETHYL)INDOLE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 13 Jul 1985 Following reports of agranulocytosis and severe neutropenia associated with the use of
indalpine, the major manufacturer in consultation with the French health authorities
decided to suspend the marketing of this drug.
(Reference: (FMOPL) Le Moniteur des Pharmacies et des Laboratoires, 1666, , June
1985)
WHO Comment : Indalpine, an antidepressant with serotoninergic action, was
introduced in 1983 and marketed exclusively in France. In 1984 its use was
associated with cases of leucopenia and agranulocytosis which led to the
voluntary suspension of clinical trials in the USA. In 1985 the major manufacturer
voluntarily withdrew the drug from the market.

Product Name Indometacin and indometacin farnesil

C.A.S. number 53-86-1
Scientific and common names, and synonyms
1H-INDOLE-3-ACETIC ACID, 1-(4-CHLOROBENZOYL)-5-METHOXY-2-METHYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN May 1994 The Pharmaceutical Affairs Bureau has amended the approved product information for
indometacin to include convulsions in the list of adverse reactions.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.126, , May 1994)
JPN Oct 1996 The data sheet for indometacin farnesil has been revised to include in the section on
serious adverse effects haemorrhagic colitis as well as perforation of pre-existing sigmoid

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 150

Product Name Indometacin and indometacin farnesil

C.A.S. number 53-86-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
lesions.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.139, , Oct 1996)
WHO Comment : Indometacin was introduced in 1963 and it is one of the first
NSAIDs. Convulsions are rarely reported in relation with the use of this group of
agents. Indometacin farnesil is a pro-drug of indometacin, and the occurrence of
gastro-intestinal adverse effects could be expected. See also under nonsteroidal
antiinflammatory agents.

Product Name Indoprofen

C.A.S. number 31842-01-0
Scientific and common names, and synonyms
BENZENEACETIC ACID, 4-(1,3-DIHYDRO-1-OXO-2H-ISOINDOL-2-YL)-ALPHA-METHYL

P-(1-OXO-2-ISOINDOLINYL)HYDRATROPIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CYP Dec 1983 Withdrawn from the market following reports of serious adverse gastrointestinal reactions.
GBR Dec 1983 Withdrawn from the market following reports of serious adverse gastrointestinal reactions.
@WD 1984 The nonsteroidal anti-inflammatory drug, indoprofen, was voluntarily withdrawn worldwide
by the manufacturer following the demonstration of tumours in a carcinogenicity study
undertaken in rats.
CHL Jul 1984 Voluntarily withdrawn by the manufacturer.
DEU Jul 1984 The Federal Health Office, in agreement with the manufacturer, withdrew products
containing indoprofen on an interim basis pending an evaluation of the results of a
recently undertaken carcinogenicity study.
ITA Jul 1984 The manufacturer withdrew all formulations of indoprofen following decisions by the
Ministry of Health to suspend promotion and disallow repeat prescriptions pending further
evaluation of the safety of the drug.
WHO Comment : Indoprofen, a nonsteroidal anti-inflammatory agent, was
introduced in 1976 for the treatment of rheumatic disorders. By 1983 its use had
been associated with serious adverse effects, some of which were fatal. This led to
its withdrawal in the United Kingdom and Cyprus. In 1984 reports of intestinal
tumours in rats led to the drug's temporary withdrawal in Germany and Italy. This
was followed immediately by the suspension of marketing worldwide by the major
manufacturer.

Product Name Iodinated casein strophanthin (neo-barine)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Oct 1964 Withdrawn from the market and prohibited for export by the Food and Drug
Administration due to the risk of thyrotoxic side effects. This drug was marketed as an
appetite suppressant.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 151

Product Name Iodinated casein strophanthin (neo-barine)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing iodinated casein strophanthin or to
indicate that they are still commercially manufactured.

Product Name Iproniazid

C.A.S. number 54-92-2
Scientific and common names, and synonyms
ISONICOTINIC ACID 2-ISOPROPYLHYDRAZIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
WHO Comment : Iproniazid, a monoamine oxidase inhibitor (MAOI), was
introduced in 1952 for the treatment of depressive illness. Subsequently concern
regarding potentially serious interactions between MAOIs and foods containing
tyramine inspired much restrictive regulatory action. However, MAOIs still retain a
place in the treatment of serious depressive illness although there is no
international consensus on which compounds should be preferred. Thus iproniazid
remains available in several countries.

Product Name Isaxonine phosphate

C.A.S. number 4214-72-6
Scientific and common names, and synonyms
2-(ISOPROPYLAMINO)PYRIMIDINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 25 Jun 1983 Isaxonine phosphate has been withdrawn following the occurrence of toxic hepatitis
associated with its use.
TUN Not approved for registration on grounds of safety.
WHO Comment : Isaxonine phosphate was introduced in 1981 and marketed
exclusively in France for the treatment of peripheral neuropathy. In January 1983
indications for use were restricted following its association with cases of toxic
hepatitis. It was subsequently withdrawn in June 1983.

Product Name Isocarboxazid

C.A.S. number 59-63-2
Scientific and common names, and synonyms
5-METHYL-3-ISOXAZOLECARBOXYLIC ACID 2-BENZYLHYDRAZIDE
3-ISOXAZOLECARBOXYLIC ACID, 5-METHYL-, 2-(PHENYLMETHYL)HYDRAZIDE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 152

Product Name Isocarboxazid

C.A.S. number 59-63-2
Country Effective Description of action taken
Date Grounds for decision
JPN Nov 1974 The Ministry of Health and Welfare has withdrawn all products containing isocarboxazid
and nialamide on the grounds that they lack substantial evidence of efficacy and safety.
CUB Prohibited from use by the National Formulary Commission (1982) on grounds of
reported toxicity and in view of the availability of other less toxic drugs.
SAU Products now controlled by the authorities.
VEN Not approved for use and/or sale.
WHO Comment : Isocarboxazid, a monoamine oxidase inhibitor (MAOI), was
introduced in 1959 for the treatment of depressive illness. Subsequently concern
regarding potentially serious interactions between MAOIs and foods containing
tyramine inspired much restrictive regulatory action. However, MAOIs still retain a
place in the treatment of serious depressive illness although there is no
international consensus on which compounds should be preferred. Thus
isocarboxazid remains available in several countries and is cited in the British
National Formulary as a relatively safe example of this class of compound.

Product Name Isoprenaline

C.A.S. number 7683-59-2
Scientific and common names, and synonyms
ISOPROTERENOL
ISOPROPYLNORADRENALINE
ISOPROPYLARTERENOL
1-(3,4-DIHYDROXYPHENYL)-2-ISOPROPYLAMINOETHANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
LKA 1 Jan 1992 The Ministry of Health withdrew from sale inhalers containing the beta-adrenoreceptor
agonist, isoprenaline, because of its potential to induce serious cardiovascular adverse
effects.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
WHO Comment : Isoprenaline, a beta-adrenoreceptor agonist, was introduced in
1949 as treatment for a number of cardiac disorders and as a bronchial dilator for
the symptomatic treatment of asthma. There is evidence that regular inhalation of
bronchodilator drugs is associated, in some cases with exacerbation of the
disease and with increased fatality rates. The underlying causes are disputed, but
an increasing body of opinion now advocates regular maintenance therapy with
inhaled, corticosteroids coupled with supplementary use as required of bronchial
drugs to suppress exacerbations.

Product Name Isotretinoin

C.A.S. number 4759-48-2
Scientific and common names, and synonyms
RETINOIC ACID, 13-CIS
3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)2-CIS-4-TRANS-6- TRANS-8-TRANS-NONATETRAENOIC
ACID

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 153

Product Name Isotretinoin

C.A.S. number 4759-48-2
Country Effective Description of action taken
Date Grounds for decision
AUS 1984 Isotretinoin is approved only for the treatment of severe cystic acne unresponsive to
conventional therapy. In most states the availability of products is restricted to
prescription by specialist physicians. Labels and product literature carry a warning that
"This product causes birth defects". Warning letters have been circulated to doctors and
pharmacists concerning necessary precautions. Government approved patient
information leaflets and patient consent forms have been issued.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, No.116, ,
Nov 1984)
USA Aug 1985 Having regard to its teratogenicity, isotretinoin should be used only for severe cystic acne
refractory to conventional therapies.
(Reference: (FDADB) FDA Drug Bulletin, (2), , 1985)
OMN 24 Dec 1985 Having regard to its teratogenicity, isotretinoin may only be used under the supervision
and control of a hospital dermatologist.
(Reference: (OMNMH) Ministry of Health, 5, , 1985)
MYS 1988 The Drug Control Authority has decided that the labelling of preparations containing
isotretinoin should bear a distinct warning regarding teratogenicity, emphasizing that
effective contraceptive measures must be instituted throughout treatment and for at least
four weeks thereafter, and additional reference is also required to the following adverse
effects: symptoms of hypervitaminosis-A; transient and reversible elevation of
transaminases and alkaline phosphatases; bone changes after long-term high dosage;
benign intracranial hypertension.
(Reference: (MYSPR) Ministry of Health Press Release, 2, 3, 1988)
BEL 1 Jan 1988 Preparations containing isotretinoin have been placed in List IV of the 'Arr^t, du R,gent' of
2 June 1946 and as such can be administered only on prescription. They must be kept in
a poisons cabinet and carry the skull and crossbones label. They must bear a warning
regarding the embryotoxicity and teratogenicity of the drug which contraindicates its use
during pregnancy.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
FRA Apr 1997 Having regard to the known teratogenic risks of isotretinoin, the Ministry of Health and the
Medicines Agency have decided to reinforce the prescription requirements to ensure that
patients are informed of the teratogenic risk and of the necessity for contraceptive
measure before, during and after treatment. The physician must ensure that pregnancy
tests are performed at indicated intervals.
(Reference: (FRAAMC) Communiqué de Presse, , , 11 Apr 1997)
EGY The Technical Committee for Drug Controls has issued a statement that preparations
containing isotretinoin should not be used during pregnancy. Product information must
include a warning that paronychia can develop during treatment.
ESP Contraindications to isotretinoin must include a boxed paragraph stating that the drug
may only be used in women of child-bearing age when an effective method of
contraception assures protection during and for at least four weeks after discontinuation
of treatment. Pregnancy must be excluded before initiation of treatment.
NLD The Ministry of Welfare, Public Health and Culture has stressed that isotretinoin should
be prescribed only for serious forms of acne resistant to other treatment. Pregnancy
should be excluded prior to treatment and conception prevented during treatment.
(Reference: (GENMB) Geneesmiddelenbulletin, 18(9), , 1984)
NZL Having regard to its teratogenicity, isotretinoin is indicated only in severe nodulo-cystic
acne resistant to other forms of therapy.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 232, , Feb 1985)
TUN Having regard to its teratogenicity, isotretinoin should be used only for its recommended
indications under the strict supervision of the prescribing doctor.
WHO Comment : Isotretinoin, a retinol derivative, was introduced in 1982

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 154

Product Name Isotretinoin

C.A.S. number 4759-48-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
exclusively for the treatment of severe acne. Its use in pregnant women has
resulted in major fetal abnormalities. The manufacturer's information emphasizes
that the drug is teratogenic and must not be given to women who are pregnant,
and that contraceptive measures must be maintained for at least four weeks after
discontinuation of treatment. In some countries, blood banks are advised not to
accept as donors persons who have taken isotretinoin within the previous four
weeks. See also under retinol (vitamin A).

Product Name Isoxicam

C.A.S. number 34552-84-6
Scientific and common names, and synonyms
2H-1,2-BENZOTHIAZINE-3-CARBOXIMIDE, 4-HYDROXY-2-METHYL-N-(5-METHYL-3- ISOXAZOLYL)-, 1,1-DIOXIDE
4-HYDROXY-2-METHYL-N-(5-METHYL-3-ISOXAZOLYL)-2H-1,2-BENZOTHIAZINE-3- CARBOXAMIDE 1,1-DIOXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Oct 1985 The Federal Health Office has suspended approval of preparations containing isoxicam
pending further evaluation of reported adverse reactions.
ITA Oct 1985 Following discussions with the National Health Council, the manufacturer has withdrawn
all preparations containing isoxicam pending further evaluation of the reported adverse
reactions.
FRA 11 Oct 1985 The French Health Authorities have suspended marketing of products containing
isoxicam following reports of rare but severe dermatological reactions.
@WD 31 Oct 1985 Marketing of the nonsteroidal antiinflammatory drug isoxicam was suspended worldwide
by the major manufacturer in October 1985 after it had been withdrawn in France on 11
October 1985 following reports of severe skin reactions, some of which were fatal.
OMN 8 Jan 1986 Import and sale of isoxicam have been prohibited.
(Reference: (OMNMH) Ministry of Health, 1, , 1986)
WHO Comment : Isoxicam, a nonsteroidal anti-inflammatory agent, was introduced
in 1983 for the treatment of rheumatic disorders. By 1985 its use had been
associated with serious adverse effects, including four deaths from rare skin
reactions. This led to its withdrawal in France followed immediately by the
voluntary suspension of marketing worldwide by the major manufacturer.

Product Name Kaolin

C.A.S. number 1332-58-7
Scientific and common names, and synonyms
ALBA
BOLUS

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IND 11 Feb 1991 The Central Government banned the manufacture and sale of combinations of fixed
doses of kaolin with any other drug.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 155

Product Name Kaolin

C.A.S. number 1332-58-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (INDC) Drugs Controller, , , Mar 1992)
LKA 1 Jan 1992 The Ministry of Health withdrew from sale all liquid preparations containing kaolin. Kaolin
has doubtful efficacy and its use may lead to increased salt and water loss.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
WHO Comment : Kaolin, a hydrated aluminium silicate, is an absorbent and has
been used to treat diarrhoea because of its ability to bind and inactivate bacterial
toxins. However, it has been shown to induce only a slight change in stool
consistency and there is no evidence that it can reduce the duration or the severity
of diarrhoeal disease. It does not reduce fluid and electrolyte losses. It cannot be
recommended in the treatment of diarrhoea.

Product Name Kebuzone

C.A.S. number 853-34-9
Scientific and common names, and synonyms
4-(3-OXOBUTYL)-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1985 Indications are restricted to inflammatory degenerative rheumatism, chronic polyarthritis,
ankylosing spondylitis, arthroses, neuritis and neuralgia such as lumbago and sciatica,
acute gout, soft tissue rheumatism, painful bruising or post-traumatic inflammation and
thrombophlebitis. A single course of treatment should not exceed three months.
Preparations are contraindicated in children under six years of age.
OMN Sep 1986 The Ministry of Health has prohibited the import of preparations containing kebuzone
except those intended for topical use.
AUT Indications restricted to exacerbations of gout and other arthritic conditions. Treatment
should not exceed seven days and doctors are advised not to prescribe this drug to
children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
WHO Comment : Kebuzone, a pyrazolone derivative with anti-inflammatory,
analgesic and antipyretic activity, was introduced in 1973 for the treatment of
rheumatic disorders. As it is structurally related to phenylbutazone it is subjected
to rigorously restricted indications by some national regulatory authorities. See
WHO comment for phenylbutazone.

Product Name Ketamine hydrochloride

C.A.S. number 1867-66-9
Scientific and common names, and synonyms
CN-52372-2
CL-581
KETAMINI HYDROCHLORIDUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 156

Product Name Ketamine hydrochloride

C.A.S. number 1867-66-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP The National Pharmaceutical Administration in the Ministry of Health has rescheduled
ketamine as a narcotic drug because of its high abuse potential.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Ketoconazole

C.A.S. number 65277-42-1
Scientific and common names, and synonyms
(+/-)-CIS-1-ACETYL-4-[P-[[2-(2,4-DICHLORPHENYL)-2-(IMIDAZOL-1-YLMETHYL)-1,3-DIOX-OLAN-4-
YL]METHOXYLPHENYL]PIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 04 Apr 1988 Products containing ketoconazole were allowed to be used only under the supervision of
a hospital physician.
(Reference: (OMNCR) Circular, 11/88, , Apr 1988)
WHO Comment : Ketoconazole, an imidazole antifungal agent, was introduced in
1978 for the topical and systemic treatment of a wide variety of fungal infections.
Its use by mouth has been associated with hepatotoxicity, including cases of
hepatitis, which have usually been reversible on discontinuation of the drug, but
some fatalities have also occurred. Ketoconazole is widely marketed.

Product Name Ketorolac

C.A.S. number 74103-06-3
Scientific and common names, and synonyms
H-PYRROLIZINE-1-CARBOXYLIC ACID, 5-BENZOYL-2,3-DIHYDRO, (+/-)-, COMPOUND WITH 2-AMINO-2-
(HYDROXYMETHYL)-1,3-PROPANEDIOL (1:1)
KETOROLAC TROMETHAMINE
KETOROLAC TROMETAMOL
1H-PYRROLIZINE-1-CARBOXYLIC ACID, 5-BENZOYL-2,3-DIHYDRO, (±)-, COMPOUND WITH2-AMINO-2-
(HYDROXYMETHYL)-1,3-PROPANEDIOL (1:1)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@EC Jun 1993 The Committee on Proprietary Medicinal Products recommended restrictions in dosage
and use pending further analysis of data concerning some 80 fatalities associated with its
use.
(Reference: (CPMPPO) Pharmacovigilance Opinion, No.15, , 16 June 1993)
DEU Jun 1993 The Federal Health Office in Germany withdrew the marketing authorization for the
nonsteroidal anti-inflammatory agent, ketorolac, on the basis of a high number of reports
of severe adverse reactions including renal failure, some of which were fatal.
(Reference: (DEUFHO) Communication from Federal Health Office, , , 17 June 1993)
GBR Jun 1993 The Committee on Safety of Medicines has revised the labelling for ketorolac to reduce
the recommended dose and duration of treatment, in accordance with the CPMP.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol. 19, , June 1993)
MYS Sep 1993 Following regulatory actions restricting the approved uses of ketorolac trometamol in

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 157

Product Name Ketorolac

C.A.S. number 74103-06-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
Canada, the United States and some other countries within the European Union, the
Drug Control Authority has decided to restrict the indications for the intramuscular
30mg/ml injectable formulation of this product and to revise the labelling for all products.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 7(3): 3, , Sep 1993)
FRA Dec 1993 The Ministry of Health in France suspended the marketing authorization for the
nonsteroidal anti-inflammatory agent, ketorolac, in view of the high frequency and
seriousness of adverse drug reactions reported from the National Commission for
Pharmacovigilance.
(Reference: (FRAAMC) Communiqué de Presse, , , 14 Jan 1994)
NZL Dec 1994 A parenteral dose of 120mg in 24 hours should not be exceeded in any patient, and this
dose should be halved in the mildly renally impaired and the elderly. Ketorolac is
contraindicated in patients with more severe renal impairment (serum creatinine > 180
µmol/L). The duration of use should be limited to two days for parenteral administration
or a total of seven days if a switch is made to oral use.
(Reference: (NZLPU) Prescriber Update, No.7, , Dec 1994)
JAM 1998 The Ministry of Health, Standards and Regulation did not approve registration of the non-
steroidal anti-inflammatory drug, ketorolac due to adverse effects.
(Reference: (JAMMHS) Communication to WHO, , , 26 Sep 2000)
WHO Comment : Ketorolac is a nonsteroidal anti-inflammatory agent used in the
management of moderate to severe acute post-operative pain. It remains on the
market in many countries with restrictions on its use.

Product Name Laetrile

C.A.S. number 29883-15-6
Scientific and common names, and synonyms
AMYGDALIN
VITAMIN B17
(O-(6-O-BETA-D-GLUCOPYRANOSYL-BETA-D-GLUCOPYRANOSIDE)-D-MANDELONITRILE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 20 Feb 1986 The Australian Drug Evaluation Committee has recommended that import of preparations
containing laetrile for use in cancer therapy be prohibited due to lack of efficacy, definite
serious toxicity and absence of knowledge of metabolism, excretion and serum levels. Its
use on an individual basis is under review.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, 122, 13,
1986)
USA 24 Mar 1987 Preparations containing laetrile have the same status as other unapproved drugs and as
such importation is prohibited.
WHO Comment : Laetrile, which consists mainly of amydgalin, a glycoside
extracted from the kernels of apricots, peaches and other fruits, has been available
for over 30 years in preparations purporting to be beneficial in the treatment of
cancer. Although there is no evidence that these are efficacious, preparations
continued to be widely used and, until the late 1970s, they were considered to be
harmless. However, oral dosage forms, which may be broken down in the gut to
hydrogen cyanide, have subsequently been shown to be potentially lethal. This has
resulted in restrictive regulatory measures in several countries.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 158

Product Name Lamivudine

C.A.S. number 134678-17-4
Scientific and common names, and synonyms
(-)-2?DEOXY-3?-THIACYTIDINE
3TC

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP The National Pharmaceutical Administration in the Ministry of Health has restricted the
use of lamivudine for the treatment of chronic hepatitis B to gastroenterologists only. This
decision has been taken because prolonged treatment may result in the emergence of
resistant strains. Furthermore post-treatment hepatitis that can be fatal in patients with
poor hepatic function or cirrhosis has been observed in patients after withdrawal of
therapy.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Lamotrigine

C.A.S. number 84057-84-1
Scientific and common names, and synonyms
1,2,4-TRIAZINE-3,5-DIAMINE, 6-(2,3-DICHLOROPHENYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Oct 1996 The Committee on Safety of Medicines issued a warning concerning serious skin
reactions, particularly in young children, associated with lamotrigine.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol.22, p.10, Oct 1996)
AUS 24 Oct 1997 The Adverse Drug Evaluation Committee has recommended that a boxed warning be
included in the labelling for the anticonvulsant, lamotrigine, stating that severe, potentially
life-threatening rashes have been reported in association with this product, particularly in
children, and that lamotrigine should be discontinued at the first sign of rash unless the
rash is clearly not drug related.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, Res No.
7255, , 24 Oct 1997)
WHO Comment : Lamotrigine is a relatively new antiepilepsy agent acting through
stabilization of neuronal membranes and preventing liberation of neurotransmitters.

Product Name Latamoxef

C.A.S. number 64952-97-2
Scientific and common names, and synonyms
5-OXA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID,7-((CARBOXY(4-HYDROXYPHENYL)ACETYL)AMINO)-7-
METHOXY-3-((1-METHYL-1H- TETRAZOL-5-YL)THIO)METHYL)-8-OXO-
LAMOXACTAM

MOXALACTAM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1 Jul 1984 Following reports of spontaneous bleeding and death in patients receiving preparations
containing latamoxef, indications will be restricted to serious and life threatening
infections such as sepsis and meningitis.
WHO Comment : Latamoxef, a cefamycin antibiotic, was introduced in 1982 for the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 159

Product Name Latamoxef

C.A.S. number 64952-97-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
treatment of serious infections. Its use has subsequently been associated with
reports of clinically important haemorrhage, sometimes fatal, and in some
countries routine co-administration of vitamin K is advised to minimize this risk.

Product Name Lead oxide and lead salts

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 21 Feb 1980 Lead oxide and lead salts have been withdrawn from cosmetics and topically
administered medicinal products having regard to the danger of percutaneous absorption
and their possible contribution to encephalopathy.
DNK 30 Jun 1983 As a result of recorded cases of lead poisoning caused by excessive topical application,
all pharmaceutical products containing lead compounds have been withdrawn.
SAU Prohibited for use in cosmetics and other topical uses, having regard for the danger of
percutaneous absorption.
VEN Not approved for use and/or sale in topical pharmaceutical products.
WHO Comment : Lead oxides and other lead salts were formerly available in
topical preparations which had soothing astringent properties. The toxicity of lead
salts by inhalation, ingestion and percutaneous absorption is now conclusively
established and the medicinal use of preparations containing lead salts is no
longer permitted in many countries.

Product Name Levacetylmethadol

C.A.S. number 34433-66-4
Scientific and common names, and synonyms
(-)-6(DIMETHYLAMINO)-4,4-DIPHENYL-3-HEPTANOL ACETATE (ESTER)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@EC 2001 The European Medicines Evaluation Agency (EMEA) has recommended the suspension
of the marketing authorization of levacetylmethadol (Orlaam) in view of its pro-arrhythmic
potential and the fact that a re-assessment of the risk-benefit profile showed no special
advantage for levacetylmethadol over existing alternatives.
(Reference: (EMEAPS) Public statement, EMEA/8776/01, , 19 Apr 2001)
USA 23 Aug 2003 Product to be withdrawn due to adverse cardiac events; safer alternatives to be adopted.
(Reference: (USARLI) "Dear Healthcare Professional " letter, , , 23 Aug 2003)

Product Name Levamfetamine

C.A.S. number 156-34-3
Scientific and common names, and synonyms
LEVAMPHETAMINE
(-)-ALPHA-METHYLPHENETHYLAMINE

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 160

Product Name Levamfetamine

C.A.S. number 156-34-3
Scientific and common names, and synonyms
(-)-ALPHA-METHYLBENZENEETHANAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1973 Anorectic drugs containing levamfetamine were withdrawn from the market by the Food
and Drug Administration due to evidence of abuse and high risk of dependence.
OMN May 1991 Import and marketing of products containing levamfetamine were prohibited.
(Reference: (OMNCR) Circular, 16/91, , May 1991)
ARE Pharmaceutical preparations containing levamfetamine are banned.
WHO Comment : Levamfetamine, an amfetamine derivative, is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances. See WHO
comment for amfetamine.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Levamisole hydrochloride

C.A.S. number 16595-80-5
Scientific and common names, and synonyms
L-TETRAMISOLE HYDROCHLORIDE
LEVAMISOLI HYDROCHLORIDUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
VTN Apr 2000 The Drug Administration of Viet Nam in the Ministry of Health has withdrawn the
registration of products with the anthelminthic, levamisole as the active ingredient. The
reason for withdrawal is that these products have adverse effects that cause encephalitis
and mortality.
(Reference: (VTNMHD) Directive, 13(2000), QD-QLD, 27 Apr 2000)

Product Name Levarterenol

C.A.S. number 51-41-2
Scientific and common names, and synonyms
NOREPINEPHRINE
NORADRENALINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1973 The National Drugs Advisory Board has withdrawn from the market all local anesthetic
preparations intended for infiltration anesthesia containing epinephrine 1:50,000 and
norepinephrine 1:50,000 alone or in combination. This decision, reached in agreement
with the Irish Dental Association, followed reports of serious cardiovascular and
cerebrovascular reactions.
SAU Following published reports of serious cardiovascular and cerebrovascular adverse
reactions, preparations for infiltration anaesthesia which contain epinephrine and
levarterenol, alone or in combination, are now under review.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 161

Product Name Levarterenol

C.A.S. number 51-41-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
VEN Not approved for use and/or sale for infiltration anesthesia, alone or in combination.
WHO Comment : Vasoconstrictor agents have been in use for many years to
prolong duration of action of local anaesthetics, particularly in dentistry.
Combination products containing epinephrine or levarterenol in concentrations of
1:80,000 or less remain widely available. See also WHO comment for epinephrine.

Product Name Lexipafant

C.A.S. number 139133-26-9
Scientific and common names, and synonyms
ETHYL-N-METHYL-N-[A-(2-METHYLIMIDAZOLE[4,5-C]PYRIDIN-1-YL)TOSYL]-L-LEUCINATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
EME May 1998 The European Agency for the Evaluation of Medicinal Products (EMEA) has refused
marketing authorization for lexipafant. The Committee for Proprietary Medicinal Products
reviewed the data submitted by the company and considered that lexipafant was not
approvable for the treatment of severe acute pancreatitis on the basis of the submitted
data.
(Reference: (EMEAPR) EMEA Press Release, , , 05 May 1998)

Product Name Lindane

C.A.S. number 58-89-9A
Scientific and common names, and synonyms
BENZENE HEXACHLORIDE, GAMMA
CYCLOHEXANE, 1,2,3,4,5,6-HEXACHLORO-,(1ALPHA,2ALPHA,3BETA,4ALPHA,5ALPHA,6BETA)-

GAMMA-1,2,3,4,5,6-HEXACHLOROCYCLOHEXANE
(1 ALPHA,2 ALPHA,3 BETA,4 ALPHA,5 ALPHA,6 BETA)-HEXACHLOROCYCLOHEXANE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD 17 Jan 1984 Products containing lindane are no longer accepted for the treatment of head-lice
infestation because of widespread development of resistant strains. They remain
available for the treatment of scabies and body or pubic lice.
DEU 18 Jul 1986 Use is limited to 0.3% with the exception of shampoo, which may contain up to 1% since
exposure time is limited to 4 minutes.
EGY 1987 The Technical Committee for Drug Control has restricted the use of lindane to topical
treatment of lice and scabies. Products should not contain concentrations greater than
0.3%.
(Reference: (EGYDI) Drug Information, 5(2), , 1987)
OMN May 1991 Import and marketing of external preparations containing lindane in concentrations
greater then 0.3% were prohibited. Use of more concentrated preparations is considered
to be less safe and no more effective.
(Reference: (OMNCR) Circular, 9, , Mar 1991)
BRA Feb 2001 The marketing authorization for products containing lindane was withdrawn because of

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 162

Product Name Lindane

C.A.S. number 58-89-9A
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
unacceptable potential to cause toxic effects.
(Reference: (BRARES) Resolucao n., 147/ANVISA, , 14 Aug 2001)
WHO Comment : Lindane has been available for more than 25 years and is widely
used as an agricultural and household pesticide.

Product Name Lipoic acid

C.A.S. number 1077-28-7
Scientific and common names, and synonyms
1,2-DITHIOLANE-3-PENTANOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARM Feb 2001 The Armenian Drug and Medical Technology Agency has not approved marketing of the
new immunomodulating agent on the grounds of unacceptable risk benefit ratio resulting
from serious adverse effects.
(Reference: (ARMCW) Communication to WHO, , , 31 Aug 2001)

Product Name Lobelia

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, this drug has been prohibited for
use. All prescription chemicals and galenical preparations not included in the latest
edition of the British Pharmacopeia or British Pharmaceutical Codex have been
prohibited for use.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
WHO Comment : Lobelia comprises the dried aerial parts of lobelia species, the
activity of which is due chiefly to the alkaloid lobeline. Although preparations
containing lobelia were formerly available for use in the symptomatic treatent of
asthma, they are now largely obsolescent as a result of their irritant properties and
the availability of more effective preparations.

Product Name Loperamide

C.A.S. number 53179-11-6
Scientific and common names, and synonyms
1-PIPERIDINEBUTANAMIDE, 4-(4-CHLOROPHENYL)-4-HYDROXY-N,N-DIMETHYL-ALPHA, ALPHA-DIPHENYL
4-(P-CHLOROPHENYL)-4-HYDROXY-N,N-DIMETHYL-ALPHA,ALPHA-DIPHENYL-1- PIPERIDINEBUTYRAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 163

Product Name Loperamide

C.A.S. number 53179-11-6
PHL Nov 1982 Restricted for use as an antidiarrhoeal drug. Contraindicated in children below two years
of age due to the risk of central nervous system damage.
@WD 1990 Drop formulations containing loperamide have been voluntarily withdrawn by the major
manufacturer.
(Reference: (LJJ) Letter to WHO from Johnson & Johnson, , , 21 June 1990)
LIY May 1990 Use of products containing loperamide in children was banned.
(Reference: (LIYRL) Resolution of the General People's Health Committee, 141, , May
1990)
PAK Jun 1990 Drop and syrup formulations of products containing loperamide were banned.
(Reference: (TURMH) Communication from the Ministry of Health, , , Nov 1991)
OMN Jul 1990 Drop and syrup formulations of products intended for paediatric use containing
loperamide were voluntarily withdrawn by the manufacturer.
(Reference: (OMNCR) Circular, 13/90, , July 1990)
PER Oct 1990 Registration of drop formulations of loperamide intended for paediatric use was
withdrawn. Syrup formulations of loperamide were required to carry a warning stating that
they should not be administered to children under 5 years of age.
(Reference: (PERMH) Ministry of Health, , , 27 Oct 1990)
IDN Nov 1990 Syrup and liquid formulations of products containing loperamide intended for the
treatment of diarrhoea in children were banned.
(Reference: (IDMH) Ministry of Health, , , 19 Nov 1990)
MEX Dec 1990 Registration of products containing loperamide intended for paediatric use was withdrawn.
(Reference: (MEXMH) Communication from the Ministry of Health, , , 28 Nov 1990)
FRA 18 Dec 1990 The approved information for paediatric formulations of the antidiarrhoeal substance
loperamide was amended to indicate that these products should not be administered, on
grounds of safety, to children less than two years of age.
(Reference: (FRARP) La Revue Prescrire, 11(108), 293, 1991)
NPL 1991 Liquid formulations of products containing loperamide either alone or in combination, and
intended for the treatment of diarrhoea in children, were banned.
(Reference: (NPLDDA) Communication from the Department of Drug Administration, , ,
27 Feb 1992)
PHL 1991 Registration of products containing loperamide intended for paediatric use was withdrawn.
(Reference: (MEXMH) Communication from the Ministry of Health, , , 28 Nov 1990)
KOR May 1991 Solid oral dosage forms of products containing loperamide were disallowed for use in
children under 7 years of age and syrup formulations were prohibited in infants under 24
months due to the severe toxic effects on the central nervous system.
(Reference: (KRMHSA) Ministry of Health and Social Affairs - Communication to WHO, ,
, 13 Dec 1991)
LBN Aug 1991 Use of products containing loperamide in children under 5 years of age was discontinued
and registration of paediatric preparations was withdrawn.
(Reference: (LBNMHD) Ministry of Health and Social Affairs Decree, 150/1, , Aug 1991)
TUR Sep 1991 Drop and syrup formulations of products containing loperamide were banned.
(Reference: (TURMH) Communication from the Ministry of Health, , , Nov 1991)
LKA Nov 1991 Manufacture, import or sale of drop and syrup formulations of loperamide were prohibited.
(Reference: (LKAGAZ) The Gazette of the Democratic Socialist Republic of Sri Lanka
(Extraordinary), 688/29, Part I-1, 15 Nov 1991)
WHO Comment : Loperamide, an inhibitor of intestinal peristalsis, was introduced
in 1975 for the treatment of acute and chronic diarrhoea. In many countries its use
was discouraged in young children. In late 1989, treatment of infants in Pakistan
was associated with 19 cases of paralytic ileus, 6 of which have been fatal. This
has subsequently led the major manufacturer to withdraw all drop formulations of

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 164

Product Name Loperamide

C.A.S. number 53179-11-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
the drug worldwide as well as the lower dose syrup forms from countries where
there is a programme for the control of diarrhoeal diseases. The WHO Control of
Diarrhoeal Diseases Programme recommends that loperamide should not be used
in children below five year of age.
(Reference: (LJJ) Letter to WHO from Johnson & Johnson, , , 21 June 1990)

Product Name Loxoprofen sodium

C.A.S. number 68767-14-6
Scientific and common names, and synonyms
P-[(2-OXOCYCLOPENTYL)METHYL]HYDRATROPATE DIHYDRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP The National Pharmaceutical Administration in the Ministry of Health has not approved
loxoprofen sodium because of reports of colonic ulceration and death associated with its
use.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name L-Tryptophan

C.A.S. number 73-22-3
Scientific and common names, and synonyms
L-2-AMINO-3-(INDOL-3-YL) PROPIONIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 17 Nov 1989 The marketing authorization for over-the-counter dietary supplements containing L-
tryptophan as the sole or major ingredient has been withdrawn.
(Reference: (HHSNS) HHS News: US Department of Health and Human Services, P89-
49, , 17 Nov 1989)
CHE Dec 1989 The marketing authorization for all pharmaceuticals containing L-trytophan has been
suspended.
(Reference: (CHBCM) Bulletin Mensuel, , , 27 Dec 1989)
GBR Dec 1989 Non-prescription dietary supplements containing L-tryptophan as the sole or major
ingredient and medicinesindicated for the treatment of depression have been withdrawn.
Multivitamin and multi-aminoacid supplements where tryptophan is a minor ingredient,
parenteral nutrition fluids and preparations for the treatment of phenylketonuria remain on
the market.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 244, 486, 1990)
(Reference: (GBRCSM) Committee on Safety of Medicines, Current problems, 27, , Dec
1989)
SWE 6 Dec 1989 Products containing L-tryptophan have been prohibited. An exemption has been granted
for parenteral nutrition preparations and oral low dose combinations.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, 14(6),
181, 1989)
AUT 1990 The marketing authorization for all products containing L-tryptophan, including high and

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 165

Product Name L-Tryptophan

C.A.S. number 73-22-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
low-dose formulations for oral administration, combination products and solutions for
infusion has been suspended.
(Reference: (AUTGB) Bundesgesetzblatt für die Republik Oesterreich, , , 18 Oct 1990)
BEL 1990 Food supplements containing L-tryptophan as the major ingredient have been withdrawn
from sale. All other products containing L-tryptophan, including extemporaneous
preparations, have been subjected to prescription control.
(Reference: (BELAP) Annales Pharmaceutiques belges, 2, 31, 1990)
(Reference: (BELAP) Annales Pharmaceutiques belges, 11, 64, 1990)
DEU 1990 The marketing authorization for all products intended for oral use containing L-tryptophan
has been suspended until 30 September 1991. An exemption has been granted for
nutritional preparations intended for patients either severely impaired digestion and
absorption or who are unresponsive to other therapy.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 145(44), 2951, 1990)
(Reference: (DEUPZ) Pharmazeutische Zeitung, 145(41), 2735, 1990)
(Reference: (DEUPZ) Pharmazeutische Zeitung, 145(40), 2629, 1990)
ESP 1990 Products containing L-tryptophan intended for oral use were withdrawn, following their
association with cases of eosinophilia-myalgia syndrome. Products intended for
parenteral use were allowed to remain on the market.
(Reference: (ESPITS) Información de la Terapeutica del Sistema Nacional de Salud,
14(12), 349, 1990)
NOR 1990 Products containing L-tryptophan as the therapeutic ingredient may only be prescribed
for patients alreadyunder treatment and at the special request of a psychiatrist.
Preparations containing tryptophan at natural levels, such as products for parenteral
nutrition, are exempted from this restriction.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 3, 7, 1990)
NZL Feb 1990 Capsules and tablets which result in a daily intake of 100 mg or more of L-tryptophan
have been recalled from retail outlets. Companies may continue to provide preparations
containing L-tryptophan to patients.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 257, , 15 Mar 1990)
FRA 11 Mar 1990 The manufacture, import, sale and distribution of all dietary supplements and
extemporaneous medicinal preparations containing L-tryptophan has been suspended.
This measure does not refer to other medicines or to special dietary preparations,
including dietary products for nursing infants and for young children with metabolic and
nutritional problems, hypoallergenic dietary products for infants and nutritive mixtures for
special liquid nourishment.
(Reference: (JORF) Journal Officiel de la Republique Francaise, , , 13 May 1990)
(Reference: (FMOPL) Le Moniteur des Pharmacies et des Laboratoires, 1892, 18, 1990)
OMN May 1990 Following reports of cases of eosinophilia-myalgia syndrome in the United States, import
and marketing of monocomponent and multi-ingredient medicinal preparations containing
L-tryptophan were prohibited. A certificate from the Ministry of Health was required for the
importation of dietary supplements.
(Reference: (OMNCR) Circular, 9/90, , May 1990)
JPN 14 May 1990 As a result of the epidemic of eosinophilia-myalgia syndrome reported from the USA, L-
tryptophan and all drugs and food products in which it is a constituent have been
withdrawn.
(Reference: (JPNPH) Pharma Japan, 1204, 1, 14 May 1990)
MYS Jul 1990 The marketing authorization for dietary supplements and medicines containing L-
tryptophan has been withdrawn. The decision does not apply to preparations intended for
parenteral nutrition or to enteral feed preparations used under medical supervision in
patients with specific conditions.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 166

Product Name L-Tryptophan

C.A.S. number 73-22-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (MYSDC) Malaysian Drug Control Authority, , , 26 July 1990)
WHO Comment : L-tryptophan, an essential aminoacid and precursor of serotonin,
was introduced into medicine in 1963 for the treatment of depression and sleep
disorders. Its effectiveness in these conditions has, however, never been
convincingly demonstrated. It is also widely used in dietary supplements,
parenteral nutrition preparations and dietary products for children with
phenylketonuria. In 1989, reports from the USA showed an association between the
consumption of L-tryptophan containing preparations and the development of
eosiniphilia-myalgia syndrome (EMS), a condition characterized by intense
eosinophilia, severe muscle and joint pain, swelling of the arms and legs, skin
rashes and possible fever. Some of the reported cases have been fatal. Since it is
not yet clear whether L-tryptophan itself or an unidentified contaminant is the
cause of the EMS, many drug regulatory authorities have suspended the marketing
authorization of products containing tryptophan pending further investigation,
whereas others have withdrawn these products or restricted their use.

Product Name Lynestrenol

C.A.S. number 52-76-6
Scientific and common names, and synonyms
LYNOESTRENOL
LYNENOL
19-NOR-17-ALPHA-PREGN-4-EN-20-YN-17-OL
19 NORPREGN-4-EN-20-YN-17-OL, (17ALPHA)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 1980 High dosage (2.5mg) lynestrenol products were withdrawn following demonstration of a
dose-related incidence of mammary tumours in the beagle bitch. It is acknowledged,
however, that this species may not offer a reliable model for predicting possible
carcinogenicity of progestogens in humans.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, No.90, , )
SAU Products now controlled by the authorities.
WHO Comment : Lynestrenol, a synthetic progestogen, was introduced in the early
1960s as a component in oral contraceptive preparations. In 1967, as a result of
new regulations required by the United States Food and Drug Administration,
lynestrenol was submitted to long-term toxicity studies and by the early 1970s it
was shown to be associated with an increased incidence of mammary tumours in
beagle bitches which led to its withdrawal by at least one regulatory authority.
Subsequently the validity of the beagle bitch model as a predictor of
carcinogenicity of steroid contraceptives has been contested by many national
regulatory authorities and lynestrenol remains available in some countries for
contraceptive and other purposes.
(Reference: (WHODI) WHO Drug Information, 1-3, 5-7, 1984)

Product Name Mazindol

C.A.S. number 22232-71-9
Scientific and common names, and synonyms

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 167

Product Name Mazindol

C.A.S. number 22232-71-9
Scientific and common names, and synonyms
5-(P-CHLOROPHENYL)-2,5-DIHYDRO-3H-IMIDAZOL[2,1-A]ISOINDOL-5-OL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 11 Jan 1987 Import and marketing of products containing mazindol were prohibited.
(Reference: (OMNCR) Circular, 2/87, , Jan 1987)
WHO Comment : Mazindol, an anorectic agent, was introduced into medicine in
1970 as an aid to weight reduction. It is controlled under Schedule IV of the 1971
Convention on Psychotropic Substances. It remains available in many countries
with highly evolved drug regulatory authorities.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Meclozine

C.A.S. number 569-65-3
Scientific and common names, and synonyms
MECLIZINE
PIPERAZINE, 1-((4-CHLOROPHENYL)PHENYLMETHYL)-4-((3-METHYLPHENYL)METHYL)-
1-(P-CHLORO-ALPHA-PHENYLBENZYL)-4-(M-METHYLBENZYL)PIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IDN 1 Jan 1963 The Ministry of Health has prohibited the importation, production, sale and distribution of
this drug.
(Reference: (IDMHD) Ministerial Decree, 682-PH-63B, , June 1963)
WHO Comment : Meclozine, an antihistamine with antiemetic activity, was
introduced in 1953 for the treatment of nausea. The action taken in Indonesia in
1963 resulted from concern regarding its possible teratogenic potential.
Subsequent epidemiological studies have been widely accepted, however, as
dispelling this suspicion. Meclozine remains widely available in both prescription
only and over-the-counter preparations and in some countries the licensed
indications include management of nausea of pregnancy.

Product Name Medifoxamine

C.A.S. number 32359-34-5
Scientific and common names, and synonyms
NN-DIMETHYL-2,2-DIPHENOXYETHYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MAR Jun 1999 The manufacturer has withdrawn medifoxamine from the market because of evidence of
hepatic injury.
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
FRA Mar 2000 The Medicines Agency has announced the withdrawal of the antidepressant,
medifoxamine from the market after a pharmacovigilance enquiry performed in France
revealed evidence of hepatic injury associated with the use of medifoxamine.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 168

Product Name Medifoxamine

C.A.S. number 32359-34-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (FRAAMI) Infofax - Pharmacovigilance, , , 30 June 1999)

Product Name Mefloquine

C.A.S. number 53230-10-7
Scientific and common names, and synonyms
4-QUINOLINEMETHANOL, ?-2-PIPERIDINYL-2,8-BIS(TRIFLUOROMETHYL)-, (R*, S*)-(±)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL May 1996 The Irish Medicines Board has contraindicated the use of mefloquine for prophylaxis in
patients with renal insufficiency or severe impairment of liver function; for prophylaxis in
patients with a history of psychoses and epilepsy; in patients with hypersensitivity to
mefloquine or related compounds; in concomitant use with halofantrine.
(Reference: (IRDDS) Drug Safety Newsletter, No.2, , May 1996)
GBR Jul 1996 The Committee on Safety of Medicines recommends that prophylactic use of mefloquine
is contraindicated in patients with a history of neuropyschiatric disturbance, and that
patients should be informed about adverse reactions that may occur in association with
mefloquine.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol.22, p. 6, 1996)
WHO Comment : Mefloquine was developed in response to proliferation of multi-
drug resistant strains of Plasmodium falciparum, and has been widely used since
the early 1980s. Provided the drug is used appropriately, the risks associated with
its prophylactic use are clearly outweighed by the benefits. Mefloquine is listed in
the WHO Model List of Essential Drugs.

Product Name Megestrol acetate

C.A.S. number 3562-63-8
Scientific and common names, and synonyms
PREGNA-4,6-DIENE-3,20-DIONE, 17-(ACETYLOXY)-6-METHYL
17-HYDROXY-6-METHYLPREGNA-4,6-DIENE-3,20-DIONE ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1976 Preparations for oral use have been withdrawn from the market.
NOR 1 Jan 1976 Oral contraceptives containing this substance have been withdrawn from the market and
use is now restricted to anti-cancer treatment.
DEU 1977 Following the discovery of increased incidence of breast tumours in beagle bitches during
long-term toxicity studies, contraceptive preparations containing megestrol acetate were
voluntarily withdrawn by the manufactuer. The drug remains available for treatment of
endometrial carcinoma.
GBR 1982 This substance is licensed only for the treatment of certain hormone-dependent
neoplasms but not for use in contraceptive preparations. This restriction was applied
because of reports of dose dependent mammary tumours in beagles. Such lesions have
not been reported in rats and monkeys.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 169

Product Name Megestrol acetate

C.A.S. number 3562-63-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL Voluntarily withdrawn from the market.
WHO Comment : Megestrol acetate, a synthetic progestogen, was introduced in the
early 1960s as a component in oral contraceptive preparations. In 1967, as a result
of new regulations required by the United States Food and Drug Administration,
megestrol acetate was submitted to long-term toxicity studies and by the early
1970s it was shown to be associated with an increased incidence of mammary
tumours in beagle bitches which led to its withdrawal by several regulatory
authorities. Subsequently the validity of the beagle bitch model as a predictor of
carcinogenicity of steroid contraceptives has been contested by many national
regulatory authorities and megestrol remains available in some countries for
contraceptive purposes. In other countries its use is restricted to anticancer
treatment.
(Reference: (WHODI) WHO Drug Information, 1-3, 5-7, 1984)

Product Name Melatonin

C.A.S. number 73-31-4
Scientific and common names, and synonyms
5-METHOXY-N-ACETYL TRYPTAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Sep 1995 The Medicines Control Agency has ordered suppliers to stop selling the hormone,
melatonin, until they have obtained a product licence. The MCA has now decided that
melatonin is "medicinal by function" and requires a licence.
(Reference: (GBRPHJ) The Pharmaceutical Journal, Vol.255, p.245, 16 Sep 1995)
NOR May 1996 The Medicines Control Authority has reclassified melatonin as a prescription medicine.
(Reference: (NORNL) Nytt om legemidler, 19(3): 56, , 1996)
DEU Jun 1996 The Federal Institute for Drugs and Medical Devices has decided that melatonin is a
medicinal product and therefore requires a marketing authorization.
(Reference: (DEUPM) Pressemitteilung, 5/96, , 14 June 1996)
NZL Aug 1997 Melatonin has been classified as a Prescription Medicine because the information on its
safety and efficacy is insufficient. Previously, melatonin was unclassified.
(Reference: (NZLPU) Prescriber Update, No.15, , Aug 1997)
WHO Comment : Melatonin is promoted as a cure for travel sickness, jet-lag and
insomnia and has recently been claimed in the United States to reverse the ageing
process. A synthetic version has been freely available from health food shops and
pharmacies as a "nutritional supplement" since 1993.

Product Name Mepacrine

C.A.S. number 83-89-6
Scientific and common names, and synonyms
ARRITHINUM
ANTIMALARINAE CHLORHYDRAS
CHINACRINA MEPACRINI HYDROCHLORIDIUM
QUINACRINE HYDROCHLORIDE

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 170

Product Name Mepacrine

C.A.S. number 83-89-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IND Aug 1998 The Government has issued a notification banning the import, manufacture, sale and
distribution of mepacrine (quinacrine) for use as a contraceptive or sterilisation agent.
Penalties include up to three years imprisonment and fines of up to Rs. 5,000. This
action has been taken following clinical trials undertaken by the Indian Council of Medical
Research that raised questions about the safety of the drug.
(Reference: (HINDU) Use of quinacrine as contraceptive banned, , , 18 Aug 1998)

Product Name Mephenesin

C.A.S. number 59-47-2
Scientific and common names, and synonyms
3-(O-METHYLPHENOXY)-1,2-PROPANEDIOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1976 This compound, promoted as a muscle relaxant, has been withdrawn because of lack of
substantial evidence of efficacy and safety.
SAU Registration of this drug has been postponed, and its distribution is prohibited.
WHO Comment : Mephenesin, a centrally acting muscle relaxant and sedative, was
introduced in 1948 and its use has subsequently been associated with some of the
undesirable features of barbiturate use. It is of limited efficacy since it is short-
acting and does not relieve the spasticity associated with chronic neurological
disorders. It has therefore been largely superseded by benzodiazepines but it
remains available in some countries.

Product Name Meprobamate

C.A.S. number 57-53-4
Scientific and common names, and synonyms
1,3-PROPANEDIOL, 2-METHYL-2-PROPYL-, DICARBAMATE
2-METHYL-2-PROPYL-1,3-PROPANEDIOL DICARBAMATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jan 1981 Meprobamate-containing appetite suppressants have been withdrawn from the market.
There is a lack of evidence of their value in long-term management of obesity, they have
the potential for abuse and despite warnings they are frequently used over unacceptably
prolonged periods.
WHO Comment : Meprobamate, a bis-carbamate ester, was introduced in 1955 for
the treatment of anxiety and was subsequently used as a sedative-hypnotic drug.
Psychological and physical dependence can occur and abuse has been reported.
Meprobamate is controlled under Schedule IV of the 1971 Convention on
Psychotropic Substances.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Mesna

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 171

C.A.S. number 19767-45-4

Scientific and common names, and synonyms
ETHANESULFONIC ACID, 2-MERCAPTO-, MONOSODIUM SALT
SODIUM 2-MERCAPTOETHANESULFONATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Apr 1991 Oral liquid dosage forms of preparations containing mesna were voluntarily withdrawn by
the manufacturer because their use had been associated with hypersensitivity reactions
of different degrees, including slight skin eruptions up to more serious anaphylactic
reactions, in patients with autoimmune conditions.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 131(17), VI, 1991)
WHO Comment : Mesna, an antidote used to protect patients treated with
cyclophosphamide or ifosfamide from haemorrhagic vesiculitis, was introduced on
the market in 1984. Shortly afterwards, its use became associated with allergic
reactions, which occurred mainly in patients treated with the oral solution. This led
to the withdrawal of this formulation in Germany, the only country where it was
marketed. An oral liquid dosage form is still registered, but not marketed, in the
Netherlands and products for intravenous injection remain available elsewhere.

Product Name Metamfetamine

C.A.S. number 537-46-2
Scientific and common names, and synonyms
METHYLAMPHETAMINE
METAMPHETAMINE
(+)-2-METHYLAMINO-1-PHENYLPROPANE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
OMN 10 May 1982 Import and marketing of products containing metamfetamine and its racemic form were
prohibited.
(Reference: (OMNCR) Circular, 11/82, , May 1982)
NGA 1988 All products containing metamfetamine have been banned.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
WHO Comment : Metamfetamine, an amfetamine derivative, is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances. See WHO
comment for amfetamine.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Metamizole sodium

C.A.S. number 68-89-3
Scientific and common names, and synonyms
ANALGIN
DIPYRONE
DIPYRON
METHANESULFONIC ACID, ((2,3-DIHYDRO-1,5-DIMETHYL-3-OXO-2-PHENYL-1H-PYRAZOL-4-YL)METHYLAMINO)-
,SODIUM SALT
METHANESULFONIC ACID

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 172

Product Name Metamizole sodium

C.A.S. number 68-89-3
Scientific and common names, and synonyms
METHAMPYRONE
NORAMIDOPYRINE METHANESULFONATE SODIUM
SULPYRINE
SULPYRIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 1965 The Department of Health has prohibited the importation of noramidopyrine
methanesulfonate sodium (metamizole sodium).
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, No.9, , )
NOR Jul 1976 Withdrawn from the market.
PHL 1977 Used only as a last resort in serious and life-threatening situations when other less toxic
antipyretic drugs and other measures have failed and are not tolerated, and only with
proper supervision and monitoring. The package inserts are required to carry extensive
warning information, especially regarding the risk of fatal agranulocytosis with the usage
of this drug. The drug is available only on prescription.
(Reference: (PHADO) Administrative Order, 330, , 1977)
USA 27 Jun 1977 An analgesic, antipyretic drug, found to be effective at reducing fever but withdrawn from
the market and prohibited for export by the Food and Drug Administration on the basis of
reports of agranulocytosis, a sometimes fatal blood condition, associated with its use.
The Director of the Bureau of Drugs found that agranulocytosis cannot be effectively
prevented by frequent examination of treated patients since this condition can occur
within a few hours following administration of the drug to a sensitive individual. In its
decision, the FDA cited the availability of effective orally administered drug products (e.g.
acetylsalicylic acid or paracetamol) and concluded that the risks associated with this drug
far outweigh any benefit derived from its use, including use in Hodgkin's disease and
similar malignant diseases.
(Reference: (FEREAC) Federal Register, 42(117), 30893, 1977)
KWT Dec 1978 All dosage forms are no longer allowed with the exception of injectable preparations
which may be used only in an emergency.
(Reference: (KTMD) Ministerial Decree, 556/78, , 1978)
ITA 1979 Injectable preparations with dosages higher than 1 gram and intravenous preparations in
combination with other compounds have been withdrawn. The label for currently
marketed preparations now carries a warning regarding fatal accidents due to
hypersensitivity.
DNK Apr 1979 Preparations containing metamizole were banned for systemic use due to the potential
risk of fatal agranulocytosis.
(Reference: (UGLAAD) Ugeskrift for Laeger, 873, , Mar 1979)
SAU 1980 All preparations containing metamizole were prohibited due to several reports of
anaphylactic shock.
ARE 9 Jun 1981 Pharmaceutical preparations containing metamizole sodium are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
SDN 1982 The Ministry of Health no longer allows registration of metamizole sodium with the
exception of parenteral preparations for limited use.
BGD Jun 1982 Banned in oral drops and tablet form due to high incidence of adverse effects and
availability of safer alternatives. A single ingredient injection remains available for
terminal care as a restricted drug for specialized use.
EGY Jul 1983 Following reports of anaphylactic shock, no registration licence is to be granted for
injectable preparations containing more than 1 gram of this compound.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 173

Product Name Metamizole sodium

C.A.S. number 68-89-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISR 1 Dec 1985 Fixed dose combinations of metamizole sodium are not approved for registration.
Parenteral preparations of metamizole sodium (single-dose product) may be
administered only in hospitals and clinics where there are suitable facilities for
resuscitation (in cases of anaphylactic shock). Enteral preparations of metamizole
sodium (single-dose product) may be dispensed without prescription.
BEL 1987 Preparations containing metamizole sodium have been placed in List IV of the 'Arr^t, du
R,gent' of 2 June 1946 and as such can be administered only on prescription. They must
be kept in a poisons cabinet and carry the skull and crossbones label. Metamizole in
combination with a spasmolytic may be dispensed a maximum of five times against a
renewable prescription for a period of six months.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
MYS Jan 1987 All products containing metamizole sodium have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.6, , Oct 1986)
DEU 27 Apr 1987 Subsequent to the regulatory action taken in January 1983 (see Pyrazolones) the Federal
Health Office has further restricted the use of preparations containing metamizole
sodium. As from 1 January 1987 all preparations have been subjected to prescription
control and combination products have been withdrawn.
(Reference: (FRGGH) Bundesgesundheitsamt Pressedienst, 18, , Apr 1987)
PAK 1988 All combination products containing metamizole sodium were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
ESP 1989 The indications of products containing metamizole sodium have been restricted to acute
post-traumatic or post-surgical pain, abdominal colic and high fever unresponsive to
other antipyretics. All fixed combination products containing metamizole have been
withdrawn, except those in which it is associated with a spasmolytic.
(Reference: (ESPINS) Información Terapéutica de la Seguridad Social, 13(1), 6, 1989)
GHA 1 Sep 1989 Products containing metamizole sodium of its salts have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
NLD 1990 Having regard to reports of agranulocytosis, the manufacturers have agreed to the
voluntary withdrawal of metamizole sodium from combination preparations.
(Reference: (NPHWB) Pharmaceutisch Weekblad, 125(3), 82, 1990)
CHE 1 Jan 1992 Products containing metamizole sodium were subjected to prescription control.
(Reference: (CHBCM) Bulletin Mensuel, 10, 686, 1991)
LKA 1 Jan 1992 The Ministry of Health withdrew from sale pharmaceutical products containing
metamizole sodium (injectable formulation). This action was based on the potential of
these products to induce suppression of the bone marrow.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
THA Feb 1994 The Ministry of Public Health has revised the product information for pharmaceutical
products containing the pyrazalone analgesic, metamizole sodium (dipyrone) to include a
warning on possible agranulocytosis and impairment of the immune system and to
restrict its use to severe pain and lack of response to aspirin or paracetamol. The drug
has been rescheduled and may now be obtained only on prescription. It has also been
prohibited for use in combination products, i.e. antispasmodic and cold remedy
preparations.
(Reference: (THAFDA) Communication to WHO, , , 08 Feb 1994)
NPL 21 Jul 1997 The health authorities have banned the importation, manufacture, sale, distribution and
storage of metamizole sodium alone or in combination. This action has been taken on

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 174

Product Name Metamizole sodium

C.A.S. number 68-89-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
the basis of safety concerns relating to this product.
(Reference: (NPLGZ) Nepal Gazette, Part 47(15), Notice 2, 21 July 1997)
SYR 1998 The Suprim Technical Committee and the Ministry of Health has instructed all local drug
factories to stop manufacturing metamizole sodium (dipyrone) ampoules with immediate
effect.
(Reference: (SYRAFD) Announcement from the Directorate, No: 1784, , 02 Feb 1998)
YEM 1998 The Supreme Board of Drugs and Medical Appliances has withdrawn all formulations of
metamizole sodium because of its potential to cause anaphylactic shock and
agranulocytosis.
(Reference: (YEMCW) Communications to WHO, , , 10 Oct 1998)
ZWE 1998 The Medicines Control Authority has cancelled the registration of all metamizole sodium
(dipyrone)- containing products due to the potential risk of metamizole sodium causing
fatal agranulocytosis.
(Reference: (ZWEDIB) Drug Information Bulletin, Vol.2 No.1, , Mar 1998)
SWE 1999 The Medical Products Agency has suspended the marketing authorization for metamizole
sodium with effect from 28 April 1999. The decision is based on a larger than expected
number of reports of agranulocytosis in Sweden since 1996 (1 in 1,700).
(Reference: (SWEMPA) EU/EEA Rapid Alert, , , 28 Apr 1999)
MAR May 2000 The Minister of Public Health has decided to suspend the marketing authorization for
products containing metamizole sodium on the recommendation of the National Advisory
Commission for Pharmacovigilance. This recommendation followed an official survey
which showed severe adverse reactions associated with this product.
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
COL Jun 2000 The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia,
Colombian Ministry of Health has restricted the use of metamizole either alone or in
combination. These products should be available only if other combination. These
products should be available only if other therapeutic management is insufficient.
(Reference: (COLVMA) Letter from INVIMA to WHO, Res. 259048, , 22 June 2000)
LTH Sep 2000 The marketing authorization for tablets was not renewed for safety reasons.
(Reference: (LTHCW) Communication to WHO, , , 24 Aug 2001)
ARM The Drug and Medical Technology Agency has suspended the marketing authorization of
metamizole sodium (tablets and solution). The decision is based on a large number of
reports on agranulocytosis in Sweden since 1996 and other dangerous adverse effects.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
BHR Preparations containing metamizole sodium have been withdrawn.
GRC Preparations containing metamizole have been withdrawn from the market, with the
exception of injectable preparations containing up to 1 gram, because of concern about
agranulocytosis associated with the drug's use.
IRL Products containing metamizole have been withdrawn.
MEX Due to toxicity, not accepted for use in pediatric preparations (elixir, solution, suspension,
suppositories). Alternatives must be sought.
PER The package and/or label for this product advises that the drug is intended for
prescription use only and may cause agranulocytosis.
SGP Metamizole sodium and related salts have been banned for importation.
SWE Preparations containing metamizole sodium were withdrawn from the market by the
manufacturers after mutual discussions due to adverse reactions such as
agranulocytosis.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 175

Product Name Metamizole sodium

C.A.S. number 68-89-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
VEN Not approved for use and/or sale.
WHO Comment : Metamizole sodium, a pyrazolone derivative with analgesic,
antipyretic and anti-inflammatory activity, was introduced in 1921 and has since
been widely available in over-the-counter products. By the early 1970s its use had
been associated, as with some other pyrazolones, with serious and sometimes
fatal adverse reactions, notably cases of blood dyscrasias including
agranulocytosis, which led to its withdrawal by some regulatory authorities (see
full list). Although preparations of metamizole sodium are prohibited in certain
countries, they remain widely available in others and, in some cases, in over-the-
counter products.

Product Name Metformin

C.A.S. number 657-24-9
Scientific and common names, and synonyms
IMIDODICARBONIMIDIC DIAMIDE-, N,N-DIMETHYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL Apr 1998 Metformin is contraindicated in chronic hepatic disease, hypoxia (e.g., recent myocardial
infarction, cardiac failure, pulmonary disease), dehydration and in the period from
immediately prior to surgery until the patient is again eating and drinking normally.
(Reference: (NZLPU) Prescriber Update, No.16, , Apr 1998)

Product Name Methanol

C.A.S. number 67-56-1
Scientific and common names, and synonyms
METHYL ALCOHOL
METHANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Products containing this ingredient may not be registered.
WHO Comment : Methanol has been subjected to abuse by consumption as a
substitute for ethanol. Its toxic metabolites cause irreversible blindness and severe
metabolic acidosis, and are ultimately fatal. Methanol continues to be used as an
industrial solvent.

Product Name Methapyrilene

C.A.S. number 91-80-5
Scientific and common names, and synonyms
1,2-ETHANEDIAMINE, N,N-DIMETHYL-N'-2-PYRIDINYL-N'-(2-THIENYLMETHYL)
2((2-(DIMETHYLAMINO)ETHYL)-2-THENYLAMINO)PYRIDINE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 176

Product Name Methapyrilene

C.A.S. number 91-80-5
Country Effective Description of action taken
Date Grounds for decision
DEU 1979 Withdrawn following experimental evidence of carcinogenicity in rodents.
DOM 1979 Withdrawn following experimental evidence of carcinogenicity in rodents.
GBR 1979 Withdrawn following experimental evidence of carcinogenicity in rodents.
ITA 1979 Withdrawn from the market owing to suspected carcinogenicity.
CAN 28 Jun 1979 Approval for registration of products containing methapyrilene, or any of its salts was
withdrawn. Action was based on data received by the Health Protection Branch
identifying methapyrilene as a potent carcinogen in rats.
(Reference: (CANGZ) Canada Gazette, 113/II(13), 2530, 1979)
SGP Oct 1979 Medicinal products containing methapyrilene and/or its salts have been banned for
importation.
HKG 17 Dec 1979 The Pharmacy and Poisons Committee no longer allows the registration, sale or
distribution of products containing methapyrilene.
AUS 1980 All preparations withdrawn following demonstration of carcinogenic potential in rats.
EGY 1980 Products containing methapyrilene were withdrawn having regard to its carcinogenic
potential.
PAN 9 May 1980 The Ministry of Health has banned the sale of pharmaceuticals and cosmetics containing
methapyrilene.
(Reference: (PANMR) Ministry of Health Resolution, 882, , May 1980)
BRA 30 Jun 1980 Products containing methapyrilene are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, No.08, , 1980)
PHL Sep 1980 This compound has been banned in antihistamines. It has been found to be carcinogenic
in animals.
ARE 9 Jun 1981 Pharmaceutical preparations containing methapyrilene hydrochloride are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
IND 1983 Prohibited for manufacture and sale for reasons of health risks associated with use
and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
OMN 27 Jul 1992 Marketing of products containing methapyrilene was prohibited.
(Reference: (OMNCR) Circular, 28/92, , July 1992)
CHL Withdrawn following experimental evidence of carcinogenicity in rodents.
NZL Voluntarily withdrawn from the market.
USA This antihistamine was withdrawn in the United States of America, and subsequently in
several other countries, following experimental evidence of carcinogenicity in rodents.
VEN Withdrawn from market.
WHO Comment : Methapyrilene, an antihistamine with moderate sedative activity,
was introduced in 1947 for the treatment of various allergic conditions and was
subsequently incorporated in many over-the-counter sleeping aids. In the early
1970s it was identified as a carcinogen in rats and, although there was no direct
evidence that it constitutes a health hazard to man, it was withdrawn in many
countries.
(Reference: (WHODI) WHO Drug Information, 2, 4, 1979)

Product Name Methaqualone

C.A.S. number 72-44-6

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 177

Product Name Methaqualone

C.A.S. number 72-44-6
Scientific and common names, and synonyms
2-METHYL-3-O-TOLYL-4(3H)-QUINAZOLINONE
4(3H)-QUINAZOLINONE, 2-METHYL-3-(2-METHYLPHENYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1979 Withdrawn from the market.
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
OMN 10 May 1982 Import and marketing of products containing methaqualone were prohibited.
(Reference: (OMNCR) Circular, 11/82, , May 1982)
ZWE Nov 1984 Prohibited for use.
(Reference: (ZWESI) Statutory Instrument, 366, , Nov 1984)
PAK 1988 Products containing methaqualone were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
GHA 1 Sep 1989 Products containing methaqualone or its salts have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
ARE Pharmaceutical preparations containing methaqualone are banned.
WHO Comment : Methaqualone, a quinazolone derivative, was introduced in 1965
for use as a sedative-hypnotic drug. It is widely abused and is associated with
severe withdrawal symptoms. Methaqualone is controlled under Schedule IV of the
1971 Convention of Psychotropic Substances.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Methiodal sodium

C.A.S. number 126-31-8
Scientific and common names, and synonyms
METHANESULFONIC ACID, IODO-, SODIUM SALT
SODIUM IODOMETHANESULFONATE
SODIUM IODOMETHANE SULPHONATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1 Jan 1975 Methiodal sodium was reported to have induced muscle spasms in some patients
subjected to myelography, presumably because of an irritant action on motor nerve roots.
Registration was withdrawn when a safer X-ray contrast medium was introduced on the
market.
WHO Comment : Methiodal sodium, a radio-opaque medium, was formerly used for
the examination of the urinary tract. Its use was associated with muscle spasms
presumed to result from irritation of motor nerve roots in the spinal canal. This led
to its withdrawal in Sweden in 1975 when a safer alternative became available.
Preparations containing methiodal sodium were subsequently withdrawn
worldwide by the manufacturer.

Product Name Methylphenidate

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 178

C.A.S. number 113-45-1

Scientific and common names, and synonyms
METHYL ALPHA-PHENYL-2-PIPERIDINEACETATE
2-PIPERIDINEACETIC ACID, ALPHA-PHENYL-, METHYL ESTER, (R*,R*)-(+/-)
2-PHENYL-2-(2-PIPERIDYL)ACETIC ACID, METHYL ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
OMN 10 May 1982 Import and marketing of products containing methylphenidate were prohibited.
(Reference: (OMNCR) Circular, 11/82, , May 1982)
NGA 1988 All products containing methylphenidate have been banned.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
WHO Comment : Methylphenidate, a piperidine derivative with mild central
stimulant activity, was introduced in 1956. Its pharmacological properties resemble
those of amfetamines and it shares their abuse potential. Methylphenidate retains a
place as an adjunct in the treatment of hyperkinetic syndromes in both children
and adults. It is controlled under Schedule II of the 1971 Convention on
Psychotropic Substances.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Methylrosanilinium chloride

C.A.S. number 548-62-9
Scientific and common names, and synonyms
CRYSTAL VIOLET
CL BASIC VIOLET
GENTIAN VIOLET
METHYLROSANILINE CHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS Apr 1998 The Drug Control Authority decided to cancel the registration of all existing products
containing methylrosanilinium chloride following reports of adverse reactions and toxicity
such as buccal ulceration, stomatitis, kerato-conjunctivitis, irritation and sensitivity
reactions encountered with the use of products containing this dye. Studies have shown
methylrosanilinium chloride to be a carcinogen in mice and it has been labelled as a
mutagen, a mitotic poison and a clastogen.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), Vol.12 No.2, , Aug 1998)

Product Name Methyprylon

C.A.S. number 125-64-4
Scientific and common names, and synonyms
PIPERIDINEDIONE
2,4-PIPERIDINEDIONE, 3,3-DIETHYL-5-METHYL-
3,3-DIETHYL-5-METHYL-2,4-PIPERIDINEDIONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 179

Product Name Methyprylon

C.A.S. number 125-64-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ZWE Nov 1984 Prohibited for use.
(Reference: (ZWESI) Statutory Instrument, 366, , Nov 1984)
WHO Comment : Methyprylon, a piperidine derivative, was introduced in 1955 for
use as a sedative-hypnotic drug. Habituation, tolerance, physical dependence and
addiction can occur and methyprylon is controlled under Schedule IV of the 1971
Convention on Psychotropic Substances.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Metoclopramide (paediatric)

C.A.S. number 364-62-5
Scientific and common names, and synonyms
AHR-3070-C
METOCLOPRAMIDI HYDROCHLORIDIUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SYR 1999 The Suprim Technical Committee and the Ministry of Health has prohibited the use of
metoclopramide in children less than 20 kg of weight because of reports of sensitivity
reactions. .
(Reference: (SYRAFD) Announcement from the Directorate, No. 5615/3/15, , 1999)

Product Name Metofoline

C.A.S. number 2154-02-1
Scientific and common names, and synonyms
ISOQUINOLINE,1-(2-(4-CHLOROPHENYL)ETHYL)-1,2,3,4-TETRAHYDRO-6,7-DIMETHOXY-2-METHYL-
METHOPHOLINE
1-(P-CHLOROPHENETHYL)-1,2,3,4-TETRAHYDRO-6,7-DIMETHOXY-2- METHYLISOQUINOLINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Mar 1965 Withdrawn from the market and prohibited for export by the Food and Drug
Administration on the basis of findings of eye changes and corneal opacities in chronic-
toxicity studies in dogs.
WHO Comment : Metofoline, an analgesic, was introduced in the early 1960s for
the treatment of mild to moderate acute and chronic pain. It was never available
outside the USA.

Product Name Metrodin HP

C.A.S. number 2004-0-0007

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 180

Product Name Metrodin HP

C.A.S. number 2004-0-0007
Country Effective Description of action taken
Date Grounds for decision
GBR 10 Feb 2003 Metrodin High Purity (HP), a product used in the treatment of infertility and manufactured
from urine sourced from Italy, is being withdrawn in the UK by the Committee on Safety
of Medicines (CSM), following confirmation of a case of variant Creutzfeldt-Jakob
Disease (vCJD) in Italy.
(Reference: (GBRMRS) Media Release, , , 10 Feb 2003)

Product Name Mianserin

C.A.S. number 24219-97-4
Scientific and common names, and synonyms
DIBENZO(C,F)-PYRAZINO(1,2-A)AZEPINE, 1,2,3,4,10,14B-HEXAHYDRO-2- METHYL
1,2,3,4,10,14B-HEXAHYDRO-2-METHYLDIBENZO(C,F)-PYRAZINO(1,2-A)AZEPINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 27 Nov 1986 Having regard to reported adverse effects, the Central Drug Committee has prohibited
import and marketing of pharmaceutical products containing mianserin.
WHO Comment : Mianserin, a serotonin antagonist with antidepressant and
antihistaminic activity, was introduced in 1975 for the treatment of depressive
illness. Its use has since been associated with cases of severe blood dyscrasias,
particularly in elderly patients, including agranulocytosis, leucopenia and
granulocytopenia. Several drug regulatory authorities have reacted by stipulating
that blood counts should be monitored regularly during the first few months of
treatment and that administration should be discontinued immediately should any
signs possibly indicative of dyscrasia develop.

Product Name Mibefradil

C.A.S. number 116644-53-2
Scientific and common names, and synonyms
(1S,2S)-(2-{[3-(2-BENZINIDAZOYLYL)PROPYL]METHYLAMINE}-ETHYL-6-FLUORO-1,2,3,4-TETRAHYDRO-1-ISOPROPYL-
2-NAPHTHYL METHOXYACETATE DIHYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PER 1998 La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of
Health withdrew marketing authorization for mibefradil (Posicor) following reports of
serious adverse effects caused by the interaction with other medicines.
(Reference: (PERDGM) Alerta DIGEMID, No. 04-98, , 1998)
USA 1998 Roche laboratories announced the voluntary market withdrawal of the antihypertensive
and antianginal medication mibefradil (Posicor). This action was taken because of
information on a number of drug interactions, some of them serious that occur when
mibefradil is taken together with other medications.
(Reference: (USADDL) Dear Doctor letter, , , 08 June 1998)
ZAF 1998 The South African Medicines Control Council has withdrawn products containing
mibefradil because of safety concerns in relation to potential for serious drug interactions.
(Reference: (ZAFPS) Information from the Pharmaceutical Services, , , )
JAM Feb 1998 The calcium channel blocking agent, mibefradil was voluntarily withdrawn from the
market by Hoffman La Roche.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 181

Product Name Mibefradil

C.A.S. number 116644-53-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (JAMMHS) Communication to WHO, , , 26 Sep 2000)
GBR Jul 1998 Mibefradil was voluntarily withdrawn from the market by the manufacturer worldwide due
to an increasing number of reports of serious interactions with a wide range of drugs. .
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)
DEU Aug 1998 The Federal Institute for Drugs and Medical Devices has suspended the marketing
authorization for mibefradil because it considers that mibefradil has a negative
benefit/risk ratio. In particular, it has a life-threatening potential to induce cardiac
arrhythmias (including torsades de pointes) especially when taken concomitantly with
other medications.
(Reference: (DEUCFI) Communication, , , 21 Aug 1998)
BGR Apr 1999 The Bulgarian Drug Agency in the Ministry of Health withdrew the calcium channel
blocking agent, mibefradil (Posicor) because of serious adverse reactions worldwide.
(Reference: (BGRBDA) Communication to WHO, , , )
ARM Jul 2000 Mibefradil has been voluntarily withdrawn on the basis of a large number of reports of life-
threatening interactions of the drug: extremely low heart rates and a risk of muscle injury.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)

Product Name Mifepristone

C.A.S. number 84371-65-3
Scientific and common names, and synonyms
11BETA-[P-(DIMETHYLAMINO)PHENYL]-17BETA-HYDROXY-17-(1-PROPYNYL)ESTRA-4,9-DIEN-3-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Apr 1991 Following reports of cardiovascular adverse effects, the approved product information for
mifepristone was amended to contraindicate its use, in conjunction with a prostaglandin,
as an abortifacient in women who have smoked regularly for more than 2 years and in all
women over 35 years of age.
(Reference: (FRAMSS) Ministry of Social Affairs and Solidarity, , , 19 Apr 1991)
WHO Comment : Mifepristone, an antiprogesterone used in combination with a
prostaglandin for the termination of early pregnancy, was introduced in 1990. Use
of the combination has been associated with episodes of coronary spasm that are
attributed to administration of the prostaglandin and which have resulted in several
cases of cardiac infarction and ventricular fibrillation. At least one of these
incidents has been fatal.

Product Name Miglustat

C.A.S. number 72599-27-0
Scientific and common names, and synonyms
1,5-(BUTYLIMINO)-1,5-DIDEOXY-D-GLUCITOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISR 2002 Miglustat has been temporarily withdrawn in Israel as a precaution pending investigation
of an unexplained cognitive dysfunction in a patient previously treated with the drug.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 182

Product Name Miglustat

C.A.S. number 72599-27-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (ISRMDR) Media Release, , , 24 Apr 2002)

Product Name Minocycline

C.A.S. number 10118-90-8
Scientific and common names, and synonyms
2-NAPHTACENECABOXAMIDE,4,7-BIS(DIMETHYLAMINO)-1,-4,4A,5,5A,6,11,12A-OCTAHYDRO-3,10,12,12A-
TETRAHYDROXY-1,-11-DIOXO,[4S-(4ALPHA,4AALPHA,5AALPHA,12AALPHA]-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1989 Products containing minocycline have been refused for registration, on the grounds that
the associated adverse reactions tend to be more severe than those resulting from other
tetracycline antibiotics.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, 13, 1989)
WHO Comment : Minocycline, a semi-synthetic tetracycline derivative was
introduced in 1967. It is used today in the treatment of bacterial, rickettsial and
amoebic infections. Symptoms described as dizziness or vertigo have been
recognized in association with minocycline administration, however, these
symptoms are usually not severe. Minocycline is registered in many countries and
the World Health Organization is not aware that registration has been refused
elsewhere.

Product Name Misoprostol

C.A.S. number 59122-46-2
Scientific and common names, and synonyms
SC-29333. METHYL 7-{1R,2R,3R)-3-HYDROXY-2-[(E)-(4RS)-4-HYDROXY-4-METHYLOCT-1-ENYL]-5-
OXOCYCLOPENTYL}HEPTANOATE
(11 ALPHA, 13E)-11, 16-DIHYDROXY-16-METHYL-9-OXOPROST-13-EN-1-OIC ACID METHYL ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN Apr 2000 The Directorate General of Pharmaceutical Affairs & Drug Control has rescheduled
misoprostol as a non-psychotropic restricted controlled item because of international data
concerning its potential abuse and risk of dependence.
(Reference: (OMNCR) Circular, No. 25/2000, , 25 Apr 2000)
THA Oct 2000 This drug has been severely restricted for use in hospitals only.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)

Product Name Mofebutazone

C.A.S. number 2210-63-1
Scientific and common names, and synonyms
4-BUTYL-1-PHENYL-3,5-PYRAZOLIDINEDIONE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 183

Product Name Mofebutazone

C.A.S. number 2210-63-1
Country Effective Description of action taken
Date Grounds for decision
DEU 1985 Indications are restricted to symptomatic treatment of acute exacerbations of arthroses
including chronic articular rheumatism, periarthritis, tendinitis, ankylosing spondylitis and
superficial thrombophlebitis.
OMN 1986 The Ministry of Health has prohibited the import of preparations containing mofebutazone
except those intended for topical use.
AUT Indications restricted to exacerbations of gout and other arthritic conditions. Treatment
should not exceed seven days and doctors are advised not to prescribe this drug to
children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
WHO Comment : Mofebutazone, a pyrazolone with anti-inflammatory, analgesic
and antipyretic activity, was introduced in 1962 for the treatment of rheumatic
disorders. As it is structurally related to phenylbutazone it is subjected to
rigorously restricted indications by some national regulatory authorities. See WHO
comment for phenylbutazone.

Product Name Moxisylyte

C.A.S. number 54-32-0
Scientific and common names, and synonyms
THYMOXAMINE
4-(2-DIMETHYLAMINOETHOXY)5-ISOPROPYL-2-METHYLPHENYL ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 28 Jun 1993 The manufacturer of moxisylyte has decided to withdraw the product from the market in
France. The action was taken in the light of evidence of dose-dependent hepatotoxicity
and after discussion with the National Pharmacovigilance Commission. Although
patients have recovered after withdrawal of therapy, the benefit/risk ratio for this product
is considered unfavourable.
(Reference: (FRAARN) Adverse Reaction Newsletter, No.2, p.9, June 1993)
WHO Comment : Moxisylyte was introduced in the late 1980s. It belongs to the
group of a-adrenergic blocking agents. In France it is indicated for the treatment of
manifestations of benign prostatic hypertrophy. It is also marketed in the UK at
lower dosages for the treatment of peripheral vascular disorders (Raynaud's
disease).

Product Name Mucopolysaccharide polysulfuric acid ester

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHE May 1988 The Intercantonal Office for Drug Control has suspended indefinitely the marketing
authorization for products containing mucopolysaccharide polysulfuric acid ester.
FRA 1992 Acting on the advice of the National Commission for Pharmacovigilance, the Ministry of
Health suspended for one year the marketing authorization for a mixture of aqueous calf
cartilage and bone marrow extract indicated as a chondroprotective agent. The decision
was taken having regard to reports of allergic reactions.
(Reference: (FRARP) La Revue Prescrire, 12(121), 415, 1992)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 184

Product Name Mucopolysaccharide polysulfuric acid ester

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PRT 02 Jul 1992 The Ministry of Health suspended the marketing authorization for a product containing
mucopolysaccharide polysulfuric acid ester indicated as a chondroprotective agent
pending a thorough evaluation of reported adverse reactions.
(Reference: (PRTMH) Ministry of Health, , , 02 July 1992)
AUT 07 Jul 1992 The Ministry of Health suspended a product indicated as a chondroprotective agent and
containing mucopolysaccharide polysulfruic acid ester (Ateparon(R): Luitpold) pending
the results of further investigations. The decision was taken after two deaths associated
with the use of this product were reported in Germany. The product containing
mucopolysaccharide polysulfuric acid ester was initially suspended at the begining of
1988 after reports of serious adverse reactions including cerebral bleeding which gave
rise to concern about its safety. It was reintroduced in 1989 since results did not confirm
a causal relationship at the time.
(Reference: (AUTMH) Ministry of Health, , , 07 July 1992)
DEU 28 Jul 1992 The Federal Health Office amended the product information for a topical
mucopolysaccharide polysulfuric acid ester indicated as treatment for thrombophlebitis,
varicose veins, haematoma, and oedema to alert prescribers to cases of skin irritation
and allergy. The contraindications have been extended to patients known to be
hypersensitive to any component of the product. The manufacturer of a product
containing mucopolysaccharide polysulfuric acid ester and indicated as a
chondroprotective agent voluntarily withdrew the product from the market.
(Reference: (DEUCDC) Communication, , , 28 July 1992)
(Reference: (BGHBL) Bundesgesundheitsblatt, 2/92, 109, Feb 1992)
WHO Comment : Mucopolysaccharide polysulfuric acid ester is a heparinoid used
in the treatment of rheumatoid arthritis.Those formulations of mucopolysaccharide
polysulfuric acid esters indicated for topical application have been associated with
adverse drug reactions in the form of skin irritations. In 1992 contraindications for
the topical mucopolysaccharide polysulfuric acid ester (Huridoid R) were altered to
include all patients known to be hypersensitive to any component of the product.

Product Name Muzolimine

C.A.S. number 55294-15-0
Scientific and common names, and synonyms
3H-PYRAZOL-3-ONE, 5-AMINO-2-(1-(3,4-DICHLOROPHENYL)ETHYL)-2,4-DIHYDRO-
3-AMINO-1-(3,4-DICHLORO-ALPHA-METHYLBENZYL)-2-PYRAZOLIN-5-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1987 Following discussions with the Federal Health Office, the manufacturer has voluntarily
suspended the sale of products containing muzolimine.
FRA 1987 Following discussions with the Directorate of Pharmacy and Medicines, the manufacturer
has voluntarily suspended the sale of products containing muzolimine.
(Reference: (FMOPL) Le Moniteur des Pharmacies et des Laboratoires, 1762(10), ,
1987)
NOR 1987 Muzolimine is not approved for registration on grounds of positive carcinogenicity tests
and because the risk of carcinogenic effect in man is not excluded.
WHO Comment : Reports of neurological adverse effects, including paraesthesiae
and paralyses, associated with prolonged use of high dosages of muzolimine, were
received shortly after its introduction in 1984.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 185

Product Name Muzolimine

C.A.S. number 55294-15-0

Product Name Nabilone

C.A.S. number 51022-71-0
Scientific and common names, and synonyms
9H-DIBENZO(B,D)PYRAN-9-ONE, 3-(1,1-DIMETHYLHEPTYL)-6,6A,7,8,10,10A- HEXAHYDRO-1-HYDROXY-6,6-
DIMETHYL, TRANS-, (+/-)
(+/-)-3-(1,1-DIMETHYLHEPTYL-6,6A BETA,7,8,10,10A ALPHA-HEXAHYDRO-1- HYDROXY-6,6-DIMETHYL-9H-
DIBENZO(B,D)PYRAN-9-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Apr 1987 The Drug Enforcement Administration of the Department of Justice has placed nabilone
under Schedule II of the Controlled Substances Act.
(Reference: (FEREAC) Federal Register, 52(66), 11042-3, 1987)
WHO Comment : Nabilone is a structural analogue of dronabinol (delta-9-
tetrahydrocannabinol), the major active component of cannabis.

Product Name Naftidrofuryl (parenteral formulations)

C.A.S. number 31329-57-4
Scientific and common names, and synonyms
NAFRONYL OXALATE
2-FURANPROPANOIC ACID, TETRAHYDRO-?-(1-NAPHTHALENYLMETHYL)-, 2-(DIETHYLAMINO)ETHYL
ESTER,ETHANEDIOATE (1:1)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Feb 1995 The Committee on Safety of Medicines, after having received 63 reports of adverse
reactions associated with naftidrofuryl, considers that naftidrofuryl must not be given as a
bolus and the rate of infusion should not exceed 200mg in 90 minutes, as indicated in the
current data sheet.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol.21, , Feb 1995)
FRA May 1995 The infusion formulation of naftidrofuryl has been withdrawn after a review showing that
the risks of cardiac and neurological toxicity outweigh the benefit of intravenous
administration. The oral form remains available for use.
(Reference: (FRARP) La Revue Prescrire, Vol. 15(151), p.348, May 1995)
DEU 26 Jan 1996 The Federal Institute for Drugs and Medical Devices has revoked the marketing approval
for the injectable formulation of the vasodilator, naftidrofuryl, after reports of two fatal
cases of hypersensitivity reactions associated with its use. Subsequently cases of other
serious adverse reactions were reported in other countries, including severe hepatic and
cardiac reactions.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 141(6): 432, , 1996)
WHO Comment : Naftidrofuryl is a vasoactive spasmolytic used to treat peripheral
vascular disease. It also improves the oxygen utilization in tissues.

Product Name Nandrolone decanoate (injectable)

C.A.S. number 360-70-3
Scientific and common names, and synonyms
ESTR-4-EN-3-ONE, 17-((1-OXODECYL)OXY)-, (17BETA)
NORTESTOSTERONE DECYLATE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 186

Product Name Nandrolone decanoate (injectable)

C.A.S. number 360-70-3
Scientific and common names, and synonyms
NORTESTERONE DECYCLATE
17BETA-HYDROXYESTR-4-EN-3-ONE DECANOATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, low-strength preparations were
banned following unacceptable promotion encouraging their use in children suffering from
malnutrition.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
FRA Apr 1998 The Medicines Agency has withdrawn from the market all injectable formulations of the
anabolic steroid, following a routine re-evaluation of the benefit/risk ratio showing a lack
of clinical data to support the efficacy of the product in the claimed indication (confirmed
osteoporosis in postmenopausal women.
(Reference: (FRAAMC) Communiqué de Presse, , , 03 Apr 1998)
WHO Comment : Nandrolone decanoate, an anabolic steroid, was introduced in
1962. In 1982, low dosage preparations were prohibited in Bangladesh due to
inadmissible promotion of products containing anabolic steroids for malnourished
children. Higher dosage preparations of nandrolone decanoate remain available in
many countries, including Bangladesh, for several highly specific but limited
indications that apply to patients with chronic debilitating and emaciating
diseases, particularly associated with neoplasia and some types of aplastic
anaemia.

Product Name Nandrolone phenylpropionate (injectable)

C.A.S. number 62-90-8
Scientific and common names, and synonyms
ESTR-4-EN-3-ONE, 17-(1-OXO-3-PHENYLPROPOXY)-, (17BETA)-
NORTESTOSTERONE PHENYLPROPIONATE
NANDROLONE PHENPROPIONATE
17BETA-HYDROXYESTR-4-EN-3-ONE HYDROCINNAMATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, low-strength preparations were
banned following unacceptable promotion encouraging their use in children suffering from
malnutrition.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
WHO Comment : Nandrolone phenylpropionate, an anabolic steroid, was
introduced in 1959. In 1982, low dosage preparations were prohibited in
Bangladesh due to inadmissible promotion of products containing anabolic
steroids for malnourished children. Higher dosage preparations of nandrolone
phenylpropionate remain available in many countries, including Bangladesh, for
several highly specific but limited indications that apply to patients with chronic
debilitating and emaciating diseases, particularly associated with neoplasia and
some types of aplastic anaemia.

Product Name Nebacumab

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 187

Product Name Nebacumab

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 1993 The manufacturer of the human monoclonal HA-1A antibody, nebacumab, has withdrawn
the product worldwide following preliminary results of a trial conducted in the United
States of America which showed that there was no reduction in mortality in patients
treated with nebacumab who had Gram-negative bacteraemia. Furthermore, mortality
was increased among patients who did not have Gram-negative bacteraemia receiving
nebacumab than among those receiving placebo.

Product Name Nefazodone

C.A.S. number 2004-0-0008

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP 01 Mar 2003 Nefazodone suspended due to life-threatening hepatotoxicity.
(Reference: (ESPSMA) Communication to WHO, , , 01 Mar 2003)
TUR 21 Mar 2003 The Directorate General of Pharmaceuticals and Pharmacy has decided to suspend the
license for nefazodone hydrocholride preparations (Serzone) held by Bristol Meyers
Squibb Drugs Inc. in Turkey since the latest data received by the Turkish Ministry of
Health as well as worldwide developments that suggest acute hepatic failure associated
with nefazodone use.
(Reference: (TURDPC) Communication to WHO, , , 21 Mar 2003)
CAN 27 Nov 2003 Sale of nefazodone has been discontinued in Canada due to adverse hepatic events.
(Reference: (CANBMS) "Dear Healthcare Professional " letter, , , 02 Oct 2003)
SGP 01 Mar 2004 Withdrawn from the market.
(Reference: (SGPHSA) Communication to WHO, , , 01 Mar 2004)

Product Name Neomycin sulfate

C.A.S. number 1405-10-3

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, this product has been banned
since it has been shown to cause malabsorption in children and to be of little or no
therapeutic value.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
PHL Jul 1982 All anti-diarrhoeal preparations for oral administration containing this product have been
banned. Most cases of diarrhoea have been found to be resistant to the drug and its
constant use promotes pseudomembranous colitis in infants and children. Neomycin can
cause other serious adverse effects including renal damage, neuro-muscular blockage
and ototoxicity, possibly leading to deafness in some patients.
(Reference: (PHADO) Administrative Order, 24, , July 1982)
NGA 1983 Because of the risk of bacterial resistance arising from the use of anti-diarrhoeals
containing neomycin in small amounts, these products have been withdrawn.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
WHO Comment : Neomycin sulfate, a broad-spectrum antibiotic, was first isolated
in 1949 and has subsequently been included in topical, oral and parenteral

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 188

Product Name Neomycin sulfate

C.A.S. number 1405-10-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
preparations. Its value in the treatment of diarrhoea is widely questioned although
it is still contained in a number of widely available antidiarrhoeal preparations. In
some countries the officially approved indications for oral preparations are
restricted to the preparation of the bowel prior to surgery and the management of
hepatic coma.

Product Name Nevirapine

C.A.S. number 129618-40-2
Scientific and common names, and synonyms
11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO[3,2-B:2 1,3 1-E][1,4]DIAZEPIN-6-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Feb 2001 Precautionary note added about hepatotoxicity.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)

Product Name Nialamide

C.A.S. number 51-12-7
Scientific and common names, and synonyms
ISONICOTINIC ACID 2-((2-BENZYLCARBAMOYL)ETHYL)HYDRAZIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Nov 1974 The Ministry of Health and Welfare withdrew all products containing isocarboxazid and
nialamide on the grounds that they lack substantial evidence of efficacy and safety.
IND 1983 Prohibited for manufacture and sale for reasons of health risks associated with use
and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
CUB Prohibited from use by the National Formulary Commission (1982) on grounds of
reported toxicity and in view of the availability of other less toxic drugs.
DNK Withdrawn from the market by the manufacturer.
SAU Products now controlled by the authorities.
THA Products have been banned.
VEN Banned for use and/or sale.
WHO Comment : Nialamide, a monoamine oxidase inhibitor (MAOI), was
introduced in 1959 for the treatment of depressive illness. Subsequently concern
regarding potentially serious interactions between MAOIs and foods containing
tyramine inspired much restrictive regulatory action. However, MAOIs still retain a
place in the treatment of serious depressive illness although there is no
international consensus on which compounds should be preferred. Thus nialamide
remains available in several countries.

Product Name Nifedipine

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 189

C.A.S. number 21829-25-4

Scientific and common names, and synonyms
3,5-PYRIDINEDICARBOXYLIC ACID, 1,4-DIHYDRO-2,6-DIMETHYL-4-(2-NITROPHENYL)-, DIMETHYL ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS 11 Mar 1996 In agreement with the Australian Drug Evaluation Committee, the manufacturer has
withdrawn the 10mg capsule formulation of nifedipine, since the tablet formulation has
now been approved. This action was based on reports of serious adverse effects related
to the more rapid release and higher peak serum concentrations from the capsule
formulation. The Committee has deferred its decision on the 5mg capsule for twelve
months.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, Res No.
5969, , 11 Mar 1996)
IRL May 1996 Following review and evaluation of data at a national level, the Irish Medicines Board
recommends that, regarding ischaemic heart disease the use of nifedipine should be
restricted to the prophylaxis of stable angina. Its use is contraindicated in patients with
unstable angina.
(Reference: (IRDDS) Drug Safety Newsletter, No.2, , May 1996)
JPN Jul 1996 The Pharmaceutical Affairs Bureau has revised the data sheet for nifedipine, which is
now contraindicated in patients with acute myocardial infarction and care is
recommended in its administration in patients with unstable angina pectoris.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.138, , July 1996)
DEU 1 Jul 1997 See under calcium channel blockers.
WHO Comment : Nifedipine is a dihydropyridine calcium channel blocker. It is
listed in the WHO Model List of Essential Drugs. The 10mg tablet is retained on the
list for short-term treatment of hypertension. Sustained-release preparations are
advised for long-term treatment.

Product Name Nimesulide

C.A.S. number 51803-78-2
Scientific and common names, and synonyms
N-(4-NITRO-2-PHENOXYPHENYL)METHANESULFONAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP May 2002 The Spanish Committee on Safety of Medicines has recommended the temporary
suspension of nimesulide pending evaluation of reports of hepatotoxicity with the drug by
the European Agency for the Evaluation of Medicinal Products.
(Reference: (ESPCDR) Communication on Drug Risks, No.2002/03, , 03 May 2002)
BGD 11 Jun 2003 The manufacture, distribution, sale and use of all dosage forms of nimesulide paediatric
preparations were officially banned in Bangladesh.
(Reference: (BGDDDA) Communication to WHO, , , 11 June 2003)

Product Name Nitrefazole

C.A.S. number 21721-92-6
Scientific and common names, and synonyms
2-METHYL-4-NITRO-1-(4-NITROPHENYL)IMIDAZOLE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 190

Product Name Nitrefazole

C.A.S. number 21721-92-6
Country Effective Description of action taken
Date Grounds for decision
DEU 1 Jun 1984 The Federal Health Office has withdrawn nitrefazole following reports of hepatotoxicity.
AUT Jul 1984 The Federal Ministry of Health and Environmental Protection has withdrawn nitrefazole
following reports of hepatotoxicity.
WHO Comment : Nitrefazole, which is used in the treatment of alcoholism, was
introduced in the early 1980s. By 1984 its use had been associated with
hepatotoxic reactions, some of which were fatal. This led to its withdrawal in at
least two countries. WHO has no information to suggest that preparations
containing nitrefazole remain commercially available.

Product Name Nitrendipine

C.A.S. number 39562-70-4
Scientific and common names, and synonyms
(+/-)-ETHYLMETHYL-1,4-DIHYDRO-2,6-DIMETHYL-4-(M-NITROPHENYL)-3,5- PYRIDINEDICARBOXYLATE,
3,5-PYRIDINEDICARBOXYLIC ACID, 1,4-DIHYDRO-2,6-DIMETHYL-4-(3- NITROPHENYL)-, ETHYL METHYL ESTER, (+/-)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS Registration refused on grounds of inadequate data on pharmacokinetics, absolute
bioavailability and toxicity, and insufficient clinical data on long-term safety, use in
patients with a history of angina and concomitant use with angiotensin-converting
enzyme blocking agents and other drugs likely to be taken by the target population.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, 133, 06,
1968)

Product Name Nitrofural

C.A.S. number 59-87-0
Scientific and common names, and synonyms
5-NITRO-2-FURALDEHYDE SEMICARBAZONE
HYDRAZINECARBOXAMIDE, 2-((5-NITRO-2-FURANYL)METHYLENE)-
NITROFURAZONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 A nitrofuran compound withdrawn from all marketed preparations in Japan on the
grounds that it had been superseded by safer and more effective preparations.
ITA 1983 The following warning has been inserted on the label: "Experimental data on animals
recommend the use of the product for systemic route only for short periods and under the
physician's guidance".
DEU May 1992 The indications for products containing nitrofural were restricted to the treatment of
furuncles, carbuncles, abscesses, burns, chronic ulcers, mastitis and skin transplants;
the use of the drug in trivial infections was approved only when alternative therapeutic
interventions had failed and for no longer than is required to assure a satisfactory
response.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(21), VIII, 1992)
WHO Comment : Nitrofural, a nitrofuran derivative with broad-spectrum
antibacterial activity, was introduced in the early 1940s for the topical treatment of

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 191

Product Name Nitrofural

C.A.S. number 59-87-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
various skin conditions. It has also been used systemically for the treatment of
African trypasonomiasis. Following recent findings of in vitro mutagenicity and of
carcinogenicity in experimental animals, use of topical preparations containing this
substance was restricted in Germany. Nitrofural remains registered in several
countries and the World Health Organization is not aware of restrictive action
having been taken elsewhere.

Bibliographical references
IARC MONOGRAPH, 50, 195, 1990
WHO FOOD ADD., 31, 125, 1993

Product Name Nitrofurantoin

C.A.S. number 67-20-9
Scientific and common names, and synonyms
2,4-IMIDAZOLIDENEDIONE, 1-[[5-NITRO-2-FURANYL)METHYLENE]AMINO]-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 23 Nov 1993 The Drug Commission of the German Medical Profession recommended that the use of
preparations containing the nitrofuran derivative, nitrofurantoin, be restricted to cases of
acute, superficial and uncomplicated infections of the bladder and the urinary tract. This
recommendation is based both on evidence of limited efficacy and severe adverse
reactions associated with use of these products, including neuropathy, lung reactions and
hepatitis. Nitrofurantoin is contraindicated in patients with impaired renal function and in
all persons over 60 years of age. Either creatinine serum levels or creatinine clearance
should be measured before starting therapy with nitrofurantoin. Fixed combinations of
nitrofurantoin with other drugs should be avoided.
(Reference: (DEUCDC) Communication, , , 23 Nov 1993)

Product Name Nitroxoline

C.A.S. number 4008-48-4
Scientific and common names, and synonyms
5-NITRO-8-QUINOLINOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1973 The National Drugs Advisory Board has withdrawn nitroxoline from the market. No
serious adverse reactions have been reported in human beings, but cataracts have
developed in rats in prolonged dosage studies.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, 19, , 1973)
THA Jan 1975 Registration permit has been revoked for pharmaceutical preparations containing this
ingredient.
VEN Not approved for use and/or sale.
WHO Comment : Nitroxoline, a urinary antiseptic, was introduced in the mid-1960s.
By the early 1970s long-term animal studies revealed the development of cataracts
in rats and, although no serious adverse effects had been reported in man, the
drug was withdrawn in at least two countries. Preparations containing nitroxoline

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 192

Product Name Nitroxoline

C.A.S. number 4008-48-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
remain widely available.

Product Name Nomifensine

C.A.S. number 24526-64-5
Scientific and common names, and synonyms
8-ISOQUINOLINAMINE, 1,2,3,4,-TETRAHYDRO-2-METHYL-4-PHENYL,
8-AMINO-1,2,3,4-TETRAHYDRO-2-METHYL-4-PHENYLISOQUINOLINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Jan 1986 The antidepressant nomifensine has been withdrawn worldwide by the major
manufacturer following reports of cases of haemolytic anaemia associated with its use,
some of which were fatal.
DEU Jan 1986 Withdrawn from the market by the major manufacturer following reports of cases of
haemolytic anaemia associated with its use.
GBR Jan 1986 Withdrawn from the market by the major manufacturer following reports of cases of
haemolytic anaemia associated with its use.
WHO Comment : Nomifensine, an antidepressant indicated for the treatment of a
wide range of depressive illness, was introduced in 1976. Subsequently rare cases
of haemolytic anaemia - sometimes fatal - thrombocytopenia, hepatotoxicity and
fever were associated with the use of the drug. Following discussions with
regulatory authorities in the United Kingdom and the Federal Republic of Germany
the major manufacturer withdrew all preparations containing nomifensine
worldwide in January 1986.

Product Name Norethisterone enantate (injectable)

C.A.S. number 3836-23-5
Scientific and common names, and synonyms
NORETHINDRONE
19-NORPREGN-4-EN-20-YN-3-ONE, 17-HYDROXY-, (17ALPHA)-
17-HYDROXY-19-NOR-17ALPHA-PREGN-4-EN-20-YN-3-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1983 The use of injectable steroid preparations for contraceptive purposes has been restricted
to use by women with a normal menstrual cycle who do not tolerate other forms of
contraception. Pregnancy must be excluded before treatment is started and it is
contraindicated during lactation. The label must bear a warning about adverse effects
including menstrual disturbances and headaches.
WHO Comment : Norethisterone enantate was introduced in 1978 for use as a long-
acting injectable contraceptive. Risk-benefit judgements differ significantly from
country to country, having regard to differing national circumstances.
Norethisterone enantate is, however, widely available and is included as a
complementary drug in the WHO Model List of Essential Drugs.
(Reference: (WHODI) WHO Drug Information, 2(1), , 1988)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 193

Product Name Norethisterone enantate (injectable)

C.A.S. number 3836-23-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Noscapine

C.A.S. number 128-62-1
Scientific and common names, and synonyms
NARCOTINE
1(3H)-ISOBENZOFURANONE, 6,7-DIMETHOXY-3-(5,6,7,8-TETRAHYDRO-4-METHOXY-6-METHYL-1,3-DIOXOLO[4,5-G]-
ISOQUINOLIN-T-YL), [S-(R*,S*)]

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1990 The National Drugs Advisory Board has recommended that antitussives containing the
opioid, noscapine, should not be approved for use in children.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , 27, 1990)
DEU 1991 The approved information of products containing noscapine was amended to state that
pregnancy must be excluded before treatment is instituted; conception should be avoided
during treatment; and breastfeeding should be discontinued until 24 hours after
treatment. These amendments were made in view of the mutagenic potential of
noscapine.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 131(36), VI, 1991)
GBR 1991 Cough mixtures containing noscapine were voluntarily withdrawn by the manufacturer
and all other noscapine products were placed under prescription control, following
concern that the drug may be genotoxic. In addition, the manufacturer reformulated
preparations containing papaveretum to exclude noscapine.
(Reference: (GBRPHJ) The Pharmaceutical Journal, , 783, 14 Dec 1991)
(Reference: (GBRCSM) Committee on Safety of Medicines, Current problems, 31, ,
June 1991)
NLD 1991 Following discussions with the Board for the Evaluation of Medicines, manufacturers and
importers discontinued marketing of products containing noscapine, having regard to
their mutagenic potential. Extemporaneous preparations containing noscapine remained
available on medical prescription and with an absolute contraindication for pregnant
women.
(Reference: (GENMB) Geneesmiddelenbulletin, 25/9, 34, 1991)
MYS Jan 1992 The Drug Control Authority has issued a warning to all prescribers that noscapine has
been shown to exerta mutagenic effect in vitro. Its use is contraindicated in women of
childbearing potential.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 6(2):2, , 1992)
WHO Comment : Noscapine, a centrally-acting cough suppressant and one of
several alkaloids present in papaveretum (opium concentrate) was introduced into
medicine many years ago. Subsequently, it was shown to increase the number of
chromosomes in mammalian cell lines maintained in vitro. Although the clinical
significance of this finding is uncertain, restrictive action was taken in a few
countries since the possibility of a genotoxic effect cannot be excluded. On 4
December 1992 the European Committee on Proprietary Medicinal Products
concluded that the available evidence does not indicate that use of noscapine
holds any significant hazard. The Swedish Medical Products Agency also
concluded that there is no justification to restrict the use of noscapine in women of
childbearing age.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 194

Product Name Novobiocin

C.A.S. number 303-81-1
Scientific and common names, and synonyms
BENZAMIDE,N-(7-((3-O-(AMINOCARBONYL)-6-DEOXY-5-C-METHYL-4-O-METHYL-BETA-L-LYXO-
HEXOPYRANOSYL)OXY)-4-HYDROXY-8-METHYL-2-OXO-2H-1-BENZOPYRAN-3-YL)-4-HYDROXY-3-(3-METHYL-2-
BUTENYL)-
STRETONOVICIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS Jul 1987 All products containing novobiocin may not be registered.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.11, , July 1987)
WHO Comment : Novobiocin, an antibiotic with a narrow spectrum of activity, was
introduced in 1956. Its use was subsequently associated with serious adverse
effects including blood dyscrasias. In view of its toxicity there are no current valid
indications for its use. Although preparations containing novobiocin may remain
available in some countries it has largely lapsed into disuse.

Product Name Omeprazole

C.A.S. number 73590-58-6
Scientific and common names, and synonyms
1H-BENZIMIDAZOLE, 5-METHOXY-2-[[(4-METHOXY-3,5-DIMETHYL-2-PYRIDINYL)METHYL]SULFINYL]-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 11 Aug 1995 The German Federal Health Office has suspended marketing authorization for bolus
injection formulations of pharmaceutical products containing the proton pump inhibitor,
omeprazole, from 2 August 1994. The revocation of marketing authorization took effect
from 31 July 1995. The other parenteral dosage formulation (infusion) and the oral
dosage formulation may still be marketed with revised product information listing visual
and auditory adverse reactions.
(Reference: (DEUCFI) Communication, 2-Aug-94, 31-May-9, 11 Aug 1995)
WHO Comment : Omeprazole was introduced in the 1980s. It belongs to a group of
agents that have an inhibitory effect on the secretion of hydrochloric acid in the
stomach (gastric acid proton pump inhibitors) and is used in the treatment of
upper gastrointestinal tract disorders. The Committee for Proprietary Medicinal
Products of the European Commission has concluded that a causal association
between the reactions reported in Germany and the use of omeprazole had not
been established. Nevertheless oral administration should be preferred.
(Reference: (CPMPPO) Pharmacovigilance Opinion, No.16 , , 25 July 1994)

Product Name Opium in antitussive preparations

C.A.S. number 8008-60-4

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD Jun 1982 Banned in tincture and spirit form due to its liability for addiction and misuse.
ITA This substance for use as an antitussive has been removed from the market owing to an
unfavourable risk-benefit ratio and lack of substantial evidence of efficacy.
WHO Comment : Opium, which is extracted from the unripe seed capsules of the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 195

Product Name Opium in antitussive preparations

C.A.S. number 8008-60-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
poppy plant, has been used throughout recorded history both in a medicinal and
recreational context. Of the pharmacologically active constituents, several
alkaloids, including morphine, codeine, papaverine and noscapine, have wide
clinical use. Opium produces both physical and psychological dependence and is
controlled under Schedule I of the 1961 Single Convention on Narcotic Drugs.
(Reference: (UNSND) United Nations Single Convention on Narcotic Drugs I, , ,
1972)

Product Name Oral rehydration salts

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NPL 2 Jul 1986 Import, sale and distribution of oral rehydration salts which do not comply with WHO
recommendations are prohibited.
OMN Aug 1988 Import and marketing of oral rehydration salts which do not comply with the
WHO/UNICEF formula were prohibited.
(Reference: (OMNCR) Circular, 21/88, , June 1988)

Product Name Orgotein

C.A.S. number 9016-01-7
Scientific and common names, and synonyms
BOVINE SUPEROXIDE DISMUTASE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHE May 1990 The marketing authorization for products containing orgotein has been withdrawn, on the
grounds that a great number of anaphylactic reactions associated with their use has been
reported, particularly in the Federal Republic of Germany, and that they are of
questionable efficacy in some of the indications claimed by the manufacturers.
(Reference: (CHBCM) Bulletin Mensuel, 8, , 24 Sep 1990)
DEU 25 Mar 1994 The Federal Health Office has suspended as from 25 March 1994 the marketing
authorization for pharmaceutical products containing orgotein on the grounds that
unjustifiable risk outweighs the benefits. The Agency has received about 400 reports of
adverse reactions - 90 of these reports describe serious hypersensitivity reactions, some
of which were fatal.
(Reference: (DEUPD) BGA Pressedienst, 19/1994, , 30 Mar 1994)
PRT 20 May 1994 The Ministry of Health has suspended the marketing authorization for medicines
containing orgotein (bovine superoxide dismutase) for a period of 90 days. The
products, which are indicated for the treatment of rheumatic conditions, radiation-induced
cystitis and interstitial cystitis, have been associated with severe adverse effects,
including hypersensitivity reactions.
(Reference: (PRTOC) Official Communication: Suspension of medicines containing
orgotein, , , 20 May 1994)
WHO Comment : Orgotein, bovine superoxide dismutase with anti-inflammatory
activity, was introduced in 1968 for the management of rheumatic disorders and for

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 196

Product Name Orgotein

C.A.S. number 9016-01-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
the amelioration of side-effects of radiotherapy. Although not widely registered, it
remains available in other countries.

Product Name Oxeladin

C.A.S. number 468-68-1
Scientific and common names, and synonyms
2-(2-DIETHYLAMINOETHOXY)ETHYL 2-ETHYL-2-PHENYLBUTYRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 14 Mar 1994 The Institute has issued a Rapid Alert to all the pharmaceutical companies concerned
requesting their comments on a graduated plan of withdrawal of marketing authorizations
for all medicinal products containing oxaledin pending further studies on the
carcinogenicity of the product.
(Reference: (DEURFI) Rapid Alert - Pharmacovigilance, , , 14 Mar 1995)
FRA 19 Apr 1995 Since the results of the German study on the potential carcinogenicity of oxeladin were
disseminated, the Medicinal Products Agency has recalled all batches of pharmaceutical
products containing, oxeladin (Paxeladine®: Beaufour).
(Reference: (FRAAMN) Notification, , , 19 Apr 1995)

Product Name Oxeladin citrate

C.A.S. number 52432-72-1
Scientific and common names, and synonyms
2-(2-DIETHYLAMINOETHOXY)ETHYL 2 ETHYL-2-PHENYLBUTARATE DIHYDROGEN CITRATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARM Jul 2000 The Drug and Medical Technology Agency rejected the registration of oxeladin since
studies in Germany have shown potential carcinogenicity of the drug.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)

Product Name Oxyphenbutazone

C.A.S. number 129-20-4
Scientific and common names, and synonyms
BUTANOVA
HYDROXYPHENYLBUTAZONE
HYDROXYPHENBUTAZONE
OXAZOLIDIN
3,5-PYRAZOLIDINEDIONE, 4-BUTYL-1-(4-HYDROXYPHENYL)-2-PHENYL-
4-BUTYL-1-(P-HYDROXYPHENYL)-2-PHENYL-3,5-PYRAZOLIDINEDIONE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 197

Product Name Oxyphenbutazone

C.A.S. number 129-20-4
Country Effective Description of action taken
Date Grounds for decision
JPN Jul 1977 Indications are restricted to acute exacerbations of rheumatoid arthritis and osteoarthritis.
Doctors are advised to prescribe this drug only to adults and for periods of no longer than
one week.
AUT 1984 Indications are restricted to exacerbations of gout and other arthritic conditions.
Treatment should not exceed seven days and doctors are advised not to prescribe this
drug to children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
CYP 1984 Withdrawn from the market due to the potential to cause serious adverse reactions.
Exemption applies for products intended for local ophthalmic use.
FIN 1984 Oral and rectal preparations have been withdrawn from the market.
IRL 1984 Approved indications for phenylbutazone and oxyphenbutazone revised: now restricted to
cases of acute gout, ankylosing spondylitis, and chronic arthritis in patients unsuited to
alternative therapy. Treatment of acute gout should not extend beyond 7-10 days and the
lowest effective dose should be used. Treated arthritic patients should remain under
regular surveillance and specialist supervision. Doctors are advised not to prescribe
these drugs for children or pregnant women and to reduce the dose in elderly patients.
Certain contraindications include previous or existing gastrointestinal disease, blood
dyscrasias, hepatic or renal dysfunction, cardiac or pulmonary insufficiency, thyroid or
salivary gland disorders or hypersensitivity. Combination products with other active
ingredients have been withdrawn from use.
TUN 1984 All preparations of oxyphenbutazone have been banned for use.
ARE 19 Mar 1984 Pharmaceutical preparations containing oxyphenbutazone are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.480, , 1984)
KWT Apr 1984 Approved indications have been restricted to ankylosing spondylitis and acute gout and
oxyphenbutazone should not be dispensed without a prescription.
(Reference: (KTMD) Ministerial Decree, 160/84, , 1984)
BRB 25 Jun 1984 Indications for oxyphenbutazone are limited to active ankylosing spondylitis, gout and
pseudo-gout. It may also be used to treat acute exacerbations of rheumatoid arthritis and
osteoarthritis and acute non-articular rheumatoid disease unresponsive to other non-
steroidal anti-inflammatory drugs.
ZWE Jul 1984 The Drugs Control Council requested manufacturers to withdraw preparations containing
oxyphenbutazone from the market and to exhaust stocks by June 1985.
(Reference: (ZWDCC) Drugs Control Council, News Bulletin, , , 1985)
ESP 15 Jul 1984 Approved indications have been restricted to inflammatory arthritic conditions, active
ankylosing spondylitis and other inflammatory spondylopathies, acute attacks of gout and
pseudo-gout, acute exacerbations of rheumatoid arthritis and other polyarthritic
conditions. Parenteral preparations have been restricted to hospital use only.
JOR 1 Oct 1984 Registration of all pharmaceutical products containing oxyphenbutazone has been
withdrawn.
(Reference: (JORMH) Ministry of Health Resolution, No.4/2/1559, , Apr 1984)
BGD Nov 1984 Use has been banned due to reported severe adverse reactions.
DEU 1985 Indications are restricted to severe exacerbations of rheumatism and acute gout.
Duration of oral treatment should not exceed one week. Parenteral preparations are
indicated only for initiating therapy. A single injection only is recommended because local
tissue damage may occur. Preparations are contraindicated in children under 14 years of
age.
ETH 1985 Banned from the market due to reported serious adverse reactions.
GRC 1985 Withdrawn from the market.
NLD 1 Jan 1985 Parenteral dosage forms and combination products containing oxyphenbutazone have

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 198

Product Name Oxyphenbutazone

C.A.S. number 129-20-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
been withdrawn from the market. The approved indications have been restricted to the
treatment of spondyloarthritis unresponsive to other non-steroidal anti-inflammatory
agents.
(Reference: (NETJAN) Nederlands Tijdschrift voor Geneeskunde, 128(50), , 1984)
SWE 1 Jan 1985 Withdrawn from the market after joint discussions between the National Board of Health
and Welfare and the importer on the grounds of serious blood dyscrasias associated with
its use.
NZL Apr 1985 Voluntarily withdrawn from the market.
CHL 4 Jun 1985 Preparations containing oxyphenbutazone have been prohibited.
(Reference: (CHLRS) Resolution of the Minister of Health, No. 2660, , Apr 1984)
GHA 1986 Use of oxyphenbutazone has been banned.
OMN 1986 Oxyphenbutazone for internal use (tablets, injections, syrups and suppositories) should
neither be imported nor marketed after the stock in the local market has been used.
TUR 1 Mar 1986 The Ministry of Health has prohibited the manufacture and sale of preparations
containing oxyphenbutazone for oral, rectal and topical use.
MYS Jan 1987 All products containing oxyphenbutazone have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.6, , Oct 1986)
HKG 1 Sep 1987 The Pharmacy and Poisons Committee no longer allows the registration, sale or
distribution of products containing oxyphenbutazone.
BEL 1 Jan 1988 Preparations containing oxyphenbutazone have been placed in List IV of the Arr^t, du
R,gent of 2 June 1946 and as such can be administered only on prescription. They must
be kept in a poisons cabinet and carry the skull and cross-bones label.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
LKA 1 Jan 1992 The Ministry of Health withdrew from sale pharmaceutical products containing
oxyphenbutazone (tablet formulation). This action was based on the potential of these
products to induce suppression of the bone marrow.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 41(1), , 1992)
BHR Preparations containing oxyphenbutazone have been withdrawn.
COG Injectable preparations have been withdrawn from the market. Oral preparations have
indications restricted to the treatment of ankylosing spondylitis, gout and periarticular
rheumatism.
GBR All product licences for preparations containing oxyphenbutazone have been revoked
with the exception of those for eye ointments.
HUN Indications are restricted to ankylosing spondylitis and related diseases, acute gout
attacks, acute exacerbations of rheumatoid arthritis and inflamed osteoarthritis. The
duration of treatment is restricted to 14 days. There is only one registered preparation
containing oxyphenbutazone; its dispensing is restricted to individual cases authorized by
the Ministry of Health at special request.
ISR The pharmaceutical administration of the Ministry of Health withdrew from use all
preparations containing oxyphenbutazone.
WHO Comment : Oxyphenbutazone, a pyrazolone derivative with anti-inflammatory,
analgesic and antipyretic activity, was introduced in 1955 for the treatment of
rheumatic disorders. It is one of the active metabolites of phenylbutazone and has
a similar spectrum of activity including an association with serious and sometimes
fatal adverse reactions, notably cases of aplastic anaemia and agranulocytosis.
Many national drug regulatory authorities consider that more recently introduced

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 199

Product Name Oxyphenbutazone

C.A.S. number 129-20-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
drugs offer a safer alternative for most, if not all, patients requiring
antiinflammatory agents. Although oxyphenbutazone has been widely withdrawn it
remains available in some countries.

Product Name Oxyphenisatine acetate

C.A.S. number 115-33-3
Scientific and common names, and synonyms
ACETPHENOLISATIN
BISATIN
DIPHESATIN
DIASATIN
DIACETYLDIPHENOLISATIN
DIACETOXYDIPHENYLISATIN
ISAPHENIN
OXYPHENISATIN DIACETATE
PHENLAXINE
2H-INDOL-2-ONE,3,3-BIS(4-ACETYLOXY)PHENYL)-1,3-DIHYDRO-
3,3-BIS(P-HYDROXYPHENYL)-2-INDOLINONE DIACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CUB 1970 Banned for use following reports of hepatotoxicity.
AUS 1972 The Department of Health of the Commonwealth withdrew from the market all
preparations containing oxyphenisatine acetate (diacetoxydiphenolisatin) and
triacetyldiphenolisatin. This recommendation was based on an increasing number of
reports, including one fatality, implicating these compounds as a cause of acute and
chronic liver disease.
USA Feb 1972 Preparations for oral or rectal use withdrawn by the Food and Drug Administration (oral
preparations withdrawn 2/72; rectal preparations withdrawn 3/73) on grounds of safety
considerations. After a review of the clinical evidence, the FDA concluded that in view of
the hazards associated with the use of these drugs, including hepatitis and jaundice, and
the availability of alternative drugs having a wider margin of safety, the benefit/risk ratio
did not justify their continued marketing.
(Reference: (FEREAC) Federal Register, 38, 6419, Mar 1973)
JPN Mar 1972 Banned by the Pharmaceutical Affairs Bureau in over-the-counter drugs, due to hepatic
damage (e.g. jaundice) observed with long-term use.
NOR 1974 Withdrawn from the market.
DNK Oct 1975 Registration for these products has been cancelled.
(Reference: (DENBH) Danish National Board of Health, Circular Letter, , , July 1985)
DEU 1976 Withdrawn following a review of published cases of acute and chronic liver disease.
ITA 1976 Preparations for oral, rectal and topical use have been withdrawn from the market due to
the risk of sensitization.
AUT Mar 1977 Withdrawn by the Federal Ministry of Health and Environmental Protection following
reports of cases of acute and chronic liver disease associated with this drug.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 200

Product Name Oxyphenisatine acetate

C.A.S. number 115-33-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1978 All products containing this substance have been withdrawn except for rectal
suppositories for single-dose use.
CAN 1 Jul 1978 All preparations containing this substance have been withdrawn from sale.
(Reference: (CANGZ) Canada Gazette, 113/(10), , 1979)
FRA 30 Mar 1979 The Commission on Drug Monitoring of the Ministry of Health has called for the exclusion
of oxyphenisatine from proprietary laxative products, having regard to the established
relationship between this substance and chronic hepatic damage.
KWT Jan 1980 The importation of oxyphenisatine and related compounds is prohibited.
BEL 14 Jan 1981 Pharmaceutical preparations containing oxyphenisatine acetate are prohibited.
(Reference: (BELAR) Arrêté Royal, , , Jan 1981)
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
ESP 1 Mar 1985 Products containing oxyphenisatine have been withdrawn from the market because of its
potential to induce hepatitis.
(Reference: (ESPMC) Programa Selectivo de Revisión de Medicamentos, , , 1985)
CYP Products containing oxyphenisatine acetate have been withdrawn having regard to the
risk of liver damage in patients receiving this drug.
NLD Products containing oxyphenisatine have been withdrawn from the market.
NZL Voluntarily withdrawn from the market.
VEN Not approved for use and/or sale.
WHO Comment : Oxyphenisatine acetate was widely used as a laxative after its
cathartic activity was first described in 1925. In 1969 its use was first associated
with cases of acute and chronic liver disease. This association is considered by
some, but not all, national drug regulatory authorities to warrant the withdrawal
from the market of preparations containing oxyphenisatine and its derivatives.

Product Name Oxytocin

C.A.S. number 50-56-6
Scientific and common names, and synonyms
L-CYSTEINYL-L-TYROSYL-L-ISOLEUCYL-L-GLUTAMINYL-L-ASPARGINYL-L-CYSTEINYL-L-PROLYL-
LEUCYLGLYCINAMIDE CYCLIC (1 6) -DISULFIDE -
LEUCYLGLYCINAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS Oxytocin injections have been restricted for use only in public and private hospitals with
maternity units and will no longer be available in retail pharmacies.

Product Name Pangamic acid

C.A.S. number 13149-68-3
Scientific and common names, and synonyms

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 201

Product Name Pangamic acid

C.A.S. number 13149-68-3
Scientific and common names, and synonyms
GLUCONIC ACID 6-BIS(N-DI-ISOPROPYLAMINO)ACETATE
VITAMIN B15

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1984 Withdrawn from the market having regard to its low benefit to risk ratio (mutagenicity).
WHO Comment : Pangamic acid, which is extracted from apricot kernels and rice
bran, has been described as Vitamin-B15. Although there is no evidence that it is a
vitamin, it remains available in some preparations sold in health food stores.

Product Name Paracetamol

C.A.S. number 103-90-2
Scientific and common names, and synonyms
ACETAMINOPHEN
ACETAMIDE, N-(4-HYDROXYPHENYL)-
P-(ACETYLAMINO)PHENOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Feb 1994 The Ministry of Public Health has revised the product information for pharmaceutical
products containing paracetamol to include a warning on hepatotoxicity if used over the
recommended doses or prolonged use of more than five days. Patients with impaired
hepatic or kidney function should consult their doctors of pharmacists before receiving
the drug.
(Reference: (THAFDA) Communication to WHO, , , 04 Feb 1994)
MYS Nov 1996 The Drug Control Authority has decided to cancel the registration of all paracetamol 500-
mg/5ml liquid preparations due to cases of overdosage in children associated with the
use of paracetamol 500-mg/5ml instead of the 120-mg/5ml preparation.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 10(3): 11, , 1996)
GBR Apr 1997 The Medicines Control Agency has proposed to restrict pack sizes of paracetamol and
set a maximum that pharmacists are allowed to sell, because of the risk of overdosage.
No changes are proposed for packs of effervescent tablets, granules or liquid products
for general sale.
(Reference: (GBRPHJ) The Pharmaceutical Journal, Vol.256, p.785, 30 Nov 1996)
THA Feb 2001 Precautions in children's dosage for paracetamol drop formulation have been revised.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)
WHO Comment : Paracetamol, a widely used analgesic and antipyretic is known, in
case of overdose, to cause liver damage, frequently with fatal outcome. In
recommended dosages this risk does not occur. Paracetamol is listed in the WHO
Model List of Essential Drugs.

Product Name Paromomycin

C.A.S. number 7542-37-2
Scientific and common names, and synonyms
D-STREPTAMINE,O-2-AMINO-2-DEOXY-ALPHA-D-GLUCOPYRANOSYL-1(1-->4)-O-[O-2,6-DIAMINO-2,6-DIDEOXY-BETA-
L-IDOPYRANOSYL-(1-->3)-BETA-D-RIBOFURANOSYL-(1-->5)]-2-DEOXY-

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 202

Product Name Paromomycin

C.A.S. number 7542-37-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP 1989 All parenteral forms of preparations containing paromomycin have been withdrawn,
having regard to their unacceptably high toxicity.
(Reference: (ESPINS) Información Terapéutica de la Seguridad Social, 13(1), 7, 1989)
WHO Comment : Paromomycin, an aminoglycoside antibiotic was introduced into
medicine in 1959 for the treatment of protozoal, helminthic and bacterial infections.
It has been associated, particularly when used by parenteral route, with severe
adverse effects including renal damage, neuromuscular blockage and ototoxicity,
possibly leading to deafness in some patients. This route of administration is now
considered obsolete. However, parenteral dosage forms of paromomycin may still
remain available in certain countries.

Product Name Paroxetine

C.A.S. number 2004-0-0010

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 10 Jun 2003 The CSM has advised that paroxetine should not be used in children and adolescents
under the age of 18 years to treat depressive illness, due to its unfavourable risk benefit
ratio.
(Reference: (GBRLFC) Letter from the Chairman, , , 10 June 2003)

Product Name Pectin

C.A.S. number 9000-69-5

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
LIY May 1990 The use of pectin for children was banned.
(Reference: (LIYRL) Resolution of the General People's Health Committee, 141, , 21 May
1990)
IND 11 Feb 1991 The Central Government banned the manufacture and sale of combinations of fixed
doses of pectin with any other drug.
(Reference: (INDC) Drugs Controller, , , Mar 1992)
LKA 1 Jan 1992 The Ministry of Health withdrew from sale all liquid preparations containing pectin. Pectin
is of doubtful efficacy in the management of diarrhoea and its use may lead to increased
salt and water loss.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
WHO Comment : Pectin is a purified carbohydrate product isolated from the rinds
of citrus fruits or green apples. Its major constituent is polygalacteronic acid, and it
is almost completely digested and absorbed in the intestine. Pectin became
popular as a simple remedy for diarrhoea in the early 1900s. It does not affect the
frequency of stool or stool weight. Use of such products diverts attention away
from more important aspects of treatment, such as rehydration, proper nutrition
and in the case of cholera and dysentery, appropriate antibiotics.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 203

Product Name Pemoline

C.A.S. number 2152-34-3
Scientific and common names, and synonyms
4(5H-)-OXAZOLONE, 2-AMINO-5-PHENYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARG Nov 1996 The Administración Nacional de Medicamentos, Alimentos y Technologia Medica has
restricted the use of pemoline to special prescription control. Pemoline in combination
with other agents will be supplied under official prescription. The action has been taken
because pemoline has been used for a variety of indications without medical supervision.
(Reference: (ARGBO) Boletín oficial, No.28.516, , 06 Nov 1996)
USA Mar 1997 The manufacturer of the central stimulant, pemoline, has revised the product labelling to
include a boxed warning describing liver failure and to indicate that pemoline should not
ordinarily be considered as a first-line drug therapy for attention-deficit hyperactivity
disorder.
(Reference: (FDAMB) FDA Medical Bulletin, , p.6, Mar 1997)
WHO Comment : Pemoline was introduced in 1975 for the treatment of attention-
deficit disorder. Because of its central stimulating effects it has also been used in
weight control in combination with anorectic agents, laxatives.

Product Name Pentazocine

C.A.S. number 359-83-1
Scientific and common names, and synonyms
(2R*,6R*,11R*)-1,2,3,4,5,6-HEXAHYDRO-6,11-DIMETHYL-3-(3-METHYL-2- BUTENYL)-2,6-METHANO-3-BENZAZOCIN-8-
OL
2,6-METHANO-3-BENZAZOCIN-8-OL, 1,2,3,4,5,6-HEXAHYDRO-6,11-DIMETHYL-3-( 3-METHYL-2-BUTENYL)-,
(2ALPHA,6ALPHA-11R*)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT Subjected to control at national level analogous to that provided by Schedule I of the
1961 Single Convention on Narcotic Drugs.
WHO Comment : Pentazocine, which has both agonist and weak opioid antagonist
activity, was introduced in 1967 for the treatment of moderate and severe pain. The
risk of drug dependence is lower with pentazocine than with morphine-like drugs
and pentazocine has been controlled under Section III of the 1971 Convention on
Psychotropic Substances since 1984. The risk of dependence is now widely
acknowledged to exist in vulnerable individuals and at least one country has
applied controls analogous to those of Schedule I of the 1961 Single Convention
on Narcotic Drugs.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Pentobarbital

C.A.S. number 76-74-4
Scientific and common names, and synonyms
5-ETHYL-5-(1-METHYLBUTYL)BARBITURIC ACID
PENTOBARBITONE
2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-ETHYL-5-(1-METHYLBUTYL)-

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 204

Product Name Pentobarbital

C.A.S. number 76-74-4
Country Effective Description of action taken
Date Grounds for decision
SWE Jul 1985 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing pentobarbital.
WHO Comment : Pentobarbital is a short-acting barbiturate which is controlled
under Schedule III of the 1971 Convention on Psychotropic Substances. See WHO
comment for barbiturates.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Pentosan polysulfate sodium

C.A.S. number 116001-96-8
Scientific and common names, and synonyms
SODIUM XYLANPOLYSULPHATE
SODIUM PENTOSAN POLYSULPHATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Aug 1994 The Medicines Agency has withdrawn the product licences for injectable and tablet
formulations of the antithrombotic agent, pentosane polysulfate sodium, citing its
unfavourable risk/benefit profile, and particularly reports of thrombocytopenia associated
with its use.
(Reference: (FRAAMN) Notification, , , Aug 1994)

Product Name Pexiganan

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Mar 2000 The Food and Drug Administration has not approved marketing of the topical anti-
infective agent pexiganan acetate on the grounds that efficacy has not been sufficiently
demonstrated.
(Reference: (USADAC) The US FDA's Anti-infective Drugs Advisory Committee, , , 04
Mar 2000)

Product Name Phenacetin

C.A.S. number 62-44-2
Scientific and common names, and synonyms
ACETOPHENETIDIN
ACETOPHENETHIDINE
ACETAMIDE, N-(4-ETHOXYPHENOL)-
N-(4-ETHOXYPHENYL) ACETAMIDE
P-ACETOPHENETIDIDE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 205

Product Name Phenacetin

C.A.S. number 62-44-2
Country Effective Description of action taken
Date Grounds for decision
FIN 1965 Prohibited due to the well-documented association between its long-term use and
nephropathy.
CAN 1973 No manufacturer or importer shall sell a drug that contains phenacetin in combination
with any salt or derivative of salicylic acid.
(Reference: (CANGZ) Canada Gazette, , , June 1973)
ITA 1973 Withdrawn from the market due to suspected liver and kidney toxicity.
KWT 1973 Preparations containing phenacetin in combination with salicylates are no longer allowed.
(Reference: (KTMD) Ministerial Decree, No.53, , 1973)
NZL 1974 Phenacetin was scheduled as a prescription drug in 1974, and was subsequently
voluntarily withdrawn.
NGA Mar 1978 Prohibited for import, distribution and sale based on a survey and review of the literature,
and clinical and experimental data regarding toxic effects on the kidney and liver.
CYP 1979 The Drug Council decided to withdraw all products containing phenacetin and its
derivatives having regard to the risk of liver damage in patients receiving this drug.
YEM 1979 Preparations containing phenacetin have been withdrawn.
PHL Jun 1980 Phenacetin-containing drugs are no longer registrable due to the risk of developing
methaemoglobinaemia.
GBR 27 Mar 1980 The Phenacetin Prohibition Order has prohibited the sale, supply or importation of any
medicinal product containing phenacetin. Certain exemptions may apply.
(Reference: (GBPHA) Phenacetin Prohibition Order, 1181, , 1979)
ISR 1981 The sale of analgesic combination products containing phenacetin has been prohibited.
Paracetamol has been recommended as a substitute for phenacetin.
NOR 1981 Withdrawn from the market.
ARE 9 Jun 1981 Pharmaceutical preparations containing phenacetin are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
BRA 27 Nov 1981 Products containing phenacetin are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, No.23, , Nov 1981)
ROM 1982 The Minister of Health has recommended the gradual reduction in the use of this product
until it has been phased out of use completely.
TUR 1982 Preparations containing phenacetin in combination with analgesics and antipyretics have
been withdrawn by the Ministry of Health with the recommendation that such formulations
be changed, due to the risk of nephropathy from long-term use. Export of this product is
prohibited.
BGD Mar 1982 Under the provisions of the Drugs (Control) Ordinance, this product has been banned,
since the phenacetin component is toxic and liable to be abused.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
SWE Jul 1982 Banned for use and/or sale for domestic purpose due to the risk of carcinogenicity and
renal damage on long-term use and the presence of alternative therapy. Although
Sweden has no legal powers to prohibit export, no export of this product occurs.
HKG 1 Jul 1982 The Pharmacy and Poisons Committee no longer allows the registration, sale or
distribution of products containing phenacetin.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 206

Product Name Phenacetin

C.A.S. number 62-44-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Aug 1982 The Ministry of Health and Welfare banned phenacetin in proprietary drugs because of its
propensity to cause renal damage and its carcinogenicity.
IND 1983 Prohibited for manufacture, sale and import for reasons of health risks associated with
use and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
NPL 1983 Preparations containing phenacetin have been banned from use.
THA Feb 1983 Registration permit has been revoked for pharmaceutical preparations containing this
ingredient.
RWA 1 Oct 1983 Products containing phenacetin have been banned following established evidence of
adverse effects of these preparations.
USA 4 Nov 1983 Withdrawn from the market and prohibited for export by the Food and Drug
Administration due to its high potential for abuse and its unfavourable benefit-to-risk ratio
with excessive chronic use. Risks cited include kidney damage and the possibility of
haemolytic anaemia and methaemoglobinaemia resulting from abuse.
(Reference: (FEREAC) Federal Register, 48(194), 45466, 1983)
CHL 1984 Products containing phenacetin have been withdrawn from the market in view of the risk
of renal damage and methaemoglobinaemia with use.
ETH 1984 Withdrawn from the market due to the association of long-term use and nephropathy.
GRC 1984 Withdrawn from the market.
DNK 31 Dec 1984 Products containing phenacetin have been withdrawn from the market due to their
potential risks of carcinogenicity and nephrotoxicity.
(Reference: (UGLAAD) Ugeskrift for Laeger, 3769, , Nov 1984)
PAN 16 Sep 1985 The Ministry of Health has banned the import and sale of pharmaceuticals containing
phenacetin.
(Reference: (PANMR) Ministry of Health Resolution, No.7-DG, , June 1985)
DEU 1 Apr 1986 Preparations containing phenacetin have been withdrawn from the market and will no
longer be considered for registration.
MYS Nov 1986 All products containing phenacetin have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.4, , Aug 1986)
OMN 1 Jan 1987 The Ministry of Health has prohibited the import and marketing of products containing
phenacetin.
AUT 1 Jan 1988 The distribution and use of medicines containing phenacetin are prohibited.
(Reference: (AUTGB) Bundesgesetzblatt für die Republik Oesterreich, No.284, , 1987)
BEL 1 Jan 1988 Preparations containing phenacetin have been placed in List IV of the 'Arr^t, du R,gent' of
2 June 1946 and as such can be administered only on prescription. They must be kept in
a poisons cabinet and carry the skull and crossbones label.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
BHR Preparations containing phenacetin have been withdrawn.
EGY The Technical Committee for Drug Control has instructed manufacturers to reformulate
products to exclude this substance due to its potential to cause cumulative kidney
damage.
IRL Products containing phenacetin have been withdrawn.
NLD Products containing phenacetin have been banned.
SAU Not approved, having regard to the risk of liver damage as well as nephropathy.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 207

Product Name Phenacetin

C.A.S. number 62-44-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SUR Registration of all pharmaceutical products containing phenacetin has been withdrawn.
WHO Comment : Phenacetin, an aniline derivative, was introduced into medicine
as an antipyretic over a century ago. It subsequently gained recognition as an
analgesic and was available in many proprietary analgesic preparations. However,
in the 1940s its habitual use was first implicated as the cause of
methaemoglobinaemia and chronic haemolysis. Since 1950 there have been many
reports published indicating that abusive use is associated with cumulative renal
damage. Evidence also exists to suggest that it may have a carcinogenic potential.
The drug has been withdrawn in many countries but may remain available in others.
(Reference: (WHODI) WHO Drug Information, 1, 5, 1980)

Product Name Phenazone

C.A.S. number 60-80-0
Scientific and common names, and synonyms
AZOPHENUM
ANTIPYRINE
1,2-DIHYDRO-1,5-DIMETHYL-2-PHENYL-3H-PYRAZOLE-3-ONE
2,3-DIMETHYL-1-PHENYL-3-PYRAZOLIN-5-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARE 9 Jun 1981 Pharmaceutical preparations containing phenazone are banned.
(Reference: (UAEMD) Ministry of Health Decree, 694, , 1981)
MYS Nov 1986 All products containing phenazone have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.4, , Nov 1986)
BHR Preparations containing phenazone have been withdrawn.
WHO Comment : Phenazone is a pyrazolone derivative chemically related to
aminophenazone. Some regulatory authorities have imposed restrictions on its use
on these grounds. However, a recent international study showed no statistically-
based evidence of an association with agranulocytosis or aplastic anaemia. Nor
does it share with aminophenazone the propensity to produce potentially
carcinogenic nitrosamines.

Product Name Phenazopyridine

C.A.S. number 94-78-0
Scientific and common names, and synonyms
2,6-PYRIDINEDIAMINE, 3-(PHENYLAZO)
2,6-DIAMINO-3-(PHENYLAZO)PYRIDINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1984 Withdrawn from the market having regard to its unacceptable benefit to risk ratio
(carcinogenic potential).

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 208

Product Name Phenazopyridine

C.A.S. number 94-78-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : Phenazopyridine, an azo dye, was introduced in the 1950s as a
urinary antiseptic. It was withdrawn in Greece in 1984 on grounds that it has a
carcinogenic potential but it remains available in other countries, most frequently
as a constituent of combination products.

Product Name Phendimetrazine

C.A.S. number 634-03-7
Scientific and common names, and synonyms
MORPHOLINE, 3,4-DIMETHYL-2-PHENYL-, (2S-TRANS)-
PHENIMETHOXAZINE
(2S,3S)-3,4-DIMETHYL-2-PHENYLMORPHOLINE
(+)-3,4-DIMETHYL-2-PHENYLMORPHOLINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
WHO Comment : Phendimetrazine, a sympathomimetic amine, was introduced in
1961 for use as an anorexic agent. It retains a place in the treatment of obesity.
However, since it has been subject to abuse and because dependence can occur,
phendimetrazine is controlled under Schedule IV of the 1971 Convention on
Psychotropic Substances.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Phenformin

C.A.S. number 114-86-3
Scientific and common names, and synonyms
IMIDODICARBONIMIDIC DIAMIDE, N-(2-PHENYLETHYL)-
PHENFORMIN HYDROCHLORIDE
1-PHENETHYLBIGUANIDE HCL
1-PHENETHYLBIGUANIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 1970 Due to published evidence of occasional fatal cases of lactic acidosis from this
substance, the Ministry of Health has withdrawn all products containing phenformin and
used metformin as a replacement. Export of this product is prohibited.
CAN 1977 Voluntarily withdrawn from sale as a result of concern regarding lactic acidosis.
Metformin remains available for use.
CHE 1977 Withdrawn following reports of occasional but sometimes fatal cases of lactic acidosis
among diabetics receiving biguanides.
(Reference: (UGLAAD) Ugeskrift for Laeger, 140, 181, 1978)
NOR 1977 Phenformin was withdrawn following a review of the published evidence relating to the
development of lactic acidosis in diabetics treated with this drug. In the view of the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 209

Product Name Phenformin

C.A.S. number 114-86-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
specialities board adequate alternative treatment is available that does not involve a
comparable risk.
NZL 1977 Voluntarily withdrawn from the market.
SGP Aug 1977 Banned for importation.
BRA 14 Dec 1977 Combination products containing phenformin are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, No.30, , Dec 1977)
DNK 1978 Withdrawn following reports of occasional but sometimes fatal cases of lactic acidosis
among diabetics receiving biguanides.
(Reference: (UGLAAD) Ugeskrift for Laeger, 140, 181, 1978)
FIN 1978 Withdrawn from the market by the manufacturers since it has been shown to cause lactic
acidosis among diabetics receiving biguanides.
ITA 1978 Warnings and contraindications have been added to currently marketed products with
this ingredient. It has been recommended that dosages lower than 100 mg/day be
followed due to the risk of lactic acidosis.
DEU Mar 1978 Withdrawn from the market because of occurrence of lactic acidosis.
FRA 31 May 1978 Withdrawn following reports of occasional but sometimes fatal cases of lactic acidosis
among diabetics receiving biguanides.
(Reference: (UGLAAD) Ugeskrift for Laeger, 140, 181, 1978)
AUT Sep 1978 In conformity with the decision taken in several other countries, and following reports of
occasional lactic acidosis, all products containing phenformin and buformin have been
withdrawn. Metformin remains available for limited indications.
SWE Oct 1978 Withdrawn from domestic use due to several cases of lactic acidosis, some of which
have been fatal. This product is no longer manufactured in Sweden. Although Sweden
has no legal powers to prohibit export, no export of this product occurs.
THA Nov 1978 Registration permit has been revoked for pharmaceutical preparations containing this
ingredient.
USA 15 Nov 1978 Withdrawn from the market and prohibited for export by the Food and Drug
Administration following reports of cases of lactic acidosis. Special arrangements have
been made to allow doctors to obtain, on request, supplies of phenformin for the
treatment of specific patients in whom the "benefits of the drug are considered to
outweigh the risks.".
(Reference: (FEREAC) Federal Register, 44(68), 20966, 1979)
CYP 1979 The Drug Council withdrew all products containing phenformin following a review of
published literature relating to the development of fatal acidosis in diabetics treated with
this drug.
ETH 1979 Withdrawn from the market following reports of fatal lactic acidosis.
IRL 1979 Phenformin and buformin were withdrawn from the market as a result of concern
regarding lactic acidosis.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, 14, , 1979)
YEM 1979 Withdrawn following reports of fatal lactic acidosis.
KWT Jan 1980 Prohibited for import.
GBR 1982 Withdrawn from the market by the manufacturer owing to evidence of lactic acidosis with
its use.
HKG 14 Oct 1985 The Pharmacy and Poisons Committee no longer allows the registration, sale or
distribution of products containing phenformin.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 210

Product Name Phenformin

C.A.S. number 114-86-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IND Currently available on the market. Precautionary information is required to be given with
this drug.
MUS The Committee on Safety of Drugs has issued a circular letter to all doctors informing
them of contraindications to phenformin and the precautions to be observed when the
drug is used.
NLD Withdrawn from the market.
SAU Prohibited following reports of lactic acidosis.
VEN Subject to restricted use and/or sale.
WHO Comment : Phenformin, a biguanide with oral hypoglycaemic activity, was
introduced in 1957 for the management of diabetes mellitus. By 1970 its use had
been associated with incidences of lactic acidosis and by 1976 clinical studies had
conclusively demonstrated that the hazards of phenformin treatment outweighed
the benefits. Preparations containing phenformin were withdrawn in several
countries and their use restricted in others. Elsewhere, however, proprietary
preparations containing this drug may remain available. The related biguanide,
buformin, has been also associated with lactic acidosis and has been subjected to
similar restrictions as phenformin, whereas there is some evidence that metformin
is less liable to induce lactic acidosis.
(Reference: (WHODI) WHO Drug Information, 2, 4, 1977)

Product Name Phenicarbazide

C.A.S. number 103-03-7
Scientific and common names, and synonyms
1-PHENYLSEMICARBAZIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL Having regard to the serious nature of the adverse effects, products containing
phenicarbazide have been withdrawn.
WHO Comment : Phenicarbazide, which has analgesic and antipyretic activity, was
introduced in the 1970s. It has been withdrawn in at least one country on grounds
of its adverse effect profile and it appears to have fallen into disuse in others.

Product Name Phenmetrazine

C.A.S. number 134-49-6
Scientific and common names, and synonyms
MORPHOLINE, 3-METHYL-2-PHENYL
3-METHYL-2-PHENYLMORPHOLINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 6 Sep 1982 Banned for production, import, export, sale and use.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 211

Product Name Phenmetrazine

C.A.S. number 134-49-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 10 May 1982 Import and marketing of products containing phenmetrazine were prohibited.
(Reference: (OMNCR) Circular, 11/82, , May 1982)
NGA 1988 All products containing phenmetrazine have been banned.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
WHO Comment : Phenmetrazine, a sympathomimetic amine, was introduced in
1956 for use as an anorexic agent. Although preparations remain available, the use
of phenmetrazine is no longer indicated for the treatment of obesity. Moreover,
since it has been subject to abuse, and because dependence can occur, it is now
controlled under Schedule II of the 1971 Convention on Psychotropic Substances.
(Reference: (UNCPS2) United Nations Convention on Psychotropic Substances (II),
, , 1971)

Product Name Phenobarbital

C.A.S. number 50-06-6
Scientific and common names, and synonyms
5-ETHYL-5-PHENYLBARBITURIC ACID
PHENOBARBITONE
PHENEMALUM
2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-ETHYL-5-PHENYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jul 1985 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing phenobarbital.
ARG Dec 1996 The Administración Nacional de Medicamentos, Alimentos y Technologia Medica
(ANMAT) has restricted the use of phenobarbital to special prescription control including
a requirement for record-keeping.
(Reference: (ARGBO) Boletín oficial, No.28.552, 6019/96, 27 Dec 1996)
MUS 2001 Based on the regulatory decision taken by the Agence Francaise de Securite des
Produits de Sante on 21 February 2001 on phenobarbitone preparations used as mild
sedatives, all phenobarbital preparations other than those used as anti-epileptic products
are being phased out of the market in Mauritius. Further import permits have not been
issued.
(Reference: (MUSCW) Communication to WHO, , , 27 Aug 2002)
FRA Apr 2001 Phenobarbital has been suspended due to reports of rare but severe cutaneous and
mucosal reactions including Lyell Syndrome and Stevens-Johnson syndrome.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)
WHO Comment : Phenobarbital is a long-acting barbiturate which is controlled
under Schedule IV of the 1971 Convention on Psychotropic Substances.
Phenobarbital is of value in the treatment of epilepsy and preparations for such
use are included in the WHO Model List of Essential Drugs. See also WHO
comment for barbiturates.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 212

Product Name Phenol

C.A.S. number 108-95-2
Scientific and common names, and synonyms
HYDROXYBENZENE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DOM 1983 Domestic manufacturers and importers have been requested to eliminate this ingredient
from their marketed products since studies worldwide have shown that its antiseptic
benefits do not outweigh the risks associated with use.
LTH Dec 2000 Phenol aerosol was not granted marketing authorization on the grounds that other safer
antiseptics are now available.
(Reference: (LTHCW) Communication to WHO, , , 24 Aug 2001)
WHO Comment : Phenol became widely used as an antiseptic following
demonstration of its germicidal activity in 1867. It is an intensely corrosive
substance and percutaneous absorption can produce serious systemic toxicity. It
has been withdrawn from pharmaceutical preparations by at least one national
regulatory authority. However, it is still used widely in concentrations of the order
of 1.4% in proprietary preparations for the relief of soreness of the mouth and
throat.

Bibliographical references
IPCS ENVIRONMENTAL HEALTH CRITERIA, 161, , 1994
IPCS HEALTH AND SAFETY GUIDE, 88, , 1994

Product Name Phenolphthalein

C.A.S. number 77-09-8
Scientific and common names, and synonyms
1(3H)-ISOBENZOFURANONE, 3,3-BIS(4-HYDROXYPHENYL)
2(3H)-ISOBENZOFURANONE, 3,3-BIS(4-HYDROXYPHENYL)-
3,3-BIS-(P-HYDROXYPHENYL)PHTHALIDE
3,3-BIS(4-HYDROXYPHENYL)-1(3H)-ISOBENZOFURANONE
3,3-BIS(4-HYDROPHENYL)-PHTHALIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1979 Withdrawn from the market.
YEM 1979 All products containing phenolphthalein have been withdrawn.
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, this product has been banned due
to evidence of insufficient therapeutic value.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
GRC 1985 Withdrawn from the market.
CAN 30 Sep 1997 After reviewing the benefits and risks associated with the use of phenolphthalein-
containing laxatives, Health Canada has concluded that there is a risk that
phenolphthalein may cause cancer in humans; therefore the authority to sell and
distribute these products has been revoked.
(Reference: (CANPR) Press Release, 1997-54, , 30 Sep 1997)
FRA Oct 1997 Following the opinion of the CPMP that the availability of phenolphthalein- containing
laxatives should be restricted in view of the potential carcinogenicity of phenolphthalein,
the Agence du Médicament has decided to suspend the marketing authorization of
products containing phenolphthalein.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 213

Product Name Phenolphthalein

C.A.S. number 77-09-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (FRAAMC) Communiqué de Presse, , , 03 Oct 1997)
MAR Nov 1997 The Direction du médicament et de la pharmacie has suspended marketing authorization
for phenolphthalein.
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
OMN Dec 1997 The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the
registration, import and sale of phenolphthalein in all laxative preparations, including
candies or chewing gum, because of a potential risk of carcinogenicity.
(Reference: (OMNPN) Pharmaceutical Newsletter, 5(4): 8, , 1997)
@EC 17 Dec 1997 At a Pharmacovigilance Working Party meeting in September 1997, it was indicated that
national competent authorities were either considering immediate suspension of
phenolphthalein or were discussing with the relevant marketing authorization holders the
withdrawal on a voluntary basis. If voluntary action was not agreed by marketing
authorization holders, the national competent authorities concerned would consider
suspension of the products.
(Reference: (CPMPPP) Position paper on the genotoxic and carcinogenic potential of
phenolphthalein, , , 17 Dec 1997)
OMN 1998 The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the
registration, import and sale of phenolphthalein in all laxative preparations, including
candies or chewing gum, because of a potential risk of carcinogenicity.
(Reference: (OMNPN) Pharmaceutical Newsletter, 5(4): 8, , 1997)
JPN 27 Jan 1998 Manufacturers have voluntarily withdrawn products containing phenolphthalein from the
market.
(Reference: (JPNPMB) Communication, , , 27 Jan 1998)
SAU Jun 1999 The Ministry of Health has withdrawn from the market laxative products containing
phenolphthalein because of a potential risk of carcinogenicity.
(Reference: (SAUCW) Notification, , , 20 June 1999)
BHR Preparations containing phenolphthalein have been withdrawn.
SGP The National Pharmaceutical Administration in the Ministry of Health has rescheduled
phenolphthalein to a Prescription- Only-Medicine due to its genotoxic and carcinogenic
potential.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)
WHO Comment : Phenolphthalein has been widely used as a laxative since its
cathartic activity was first described in 1902. Because it undergoes enterohepatic
circulation it is eliminated slowly and it has been associated with adverse effects,
notably skin reactions, potassium loss and atonia. This has led to the withdrawal
of phenolphthalein from pharmaceutical preparations in several countries.
Elsewhere, it remains available, often in over-the-counter preparations.

Product Name Phenoxybenzamine

C.A.S. number 59-96-1
Scientific and common names, and synonyms
BENZENEMETHANAMINE, N-(2-CHLOROETHYL)-N-(1-METHYL-2-PHENOXYETHYL)
N-(2-CHLOROETHYL)-N-(1-METHYL-2-PHENOXYETHYL)BENZYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 214

Product Name Phenoxybenzamine

C.A.S. number 59-96-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUS Jul 1984 The Australian Drug Evaluation Committee has recommended that phenoxybenzamine
should be restricted to use in phaeochromocytoma and neurogenic retention of urine
having regard to reported carcinogenicity and mutagenicity in animal studies.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, 114, , July
1984)
WHO Comment : Phenoxybenzamine, a long-acting alpha-adrenoreceptor
antagonist, was introduced in 1953 and has been used in a variety of peripheral
vascular disorders. In 1982 it was shown to have mutagenic activity and in 1985 it
was found to be carcinogenic in the rat. Its approved use was subsequently
restricted by several regulatory authorities and phenoxybenzamine is currently
used to manage hypertensive episodes associated with phaeochromocytoma, as
an adjunct to the short-term management of urinary retention due to neurogenic
bladder, in the short-term treatment of benign prostatic hypertrophy in patients
awaiting surgery, and in inoperable benign prostatic hypertrophy.

Product Name Phentermine

C.A.S. number 122-09-8
Scientific and common names, and synonyms
ALPHA,ALPHA-DIMETHYLPHENETHYLAMINE

A,A-DIMETHYLPHENETHYLAMIN
BENZENEETHANAMINE, ALPHA,ALPHA-DIMETHYL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jan 1981 Phentermine-containing appetite suppressants have been withdrawn from the market.
There is a lack of evidence of their value in long-term management of obesity, they have
the potential for abuse and despite warnings they are frequently used over unacceptably
prolonged periods.
ARE 9 Jun 1981 Pharmaceutical preparations containing phentermine are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
OMN 11 Jan 1987 Import and marketing of products containing phentermine were prohibited.
(Reference: (OMNCR) Circular, 2/87, , Jan 1987)
GBR Apr 2000 The Medicines Control Agency has banned the anorectic agent, phentermine on the
basis of a European Commission decision stating that risks outweigh the benefits. (Ref:
Communication to WHO, 30 August 2000 from the Medicines Control Agency,
Department of Health, United Kingdom.)
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)
VEN Phentermine is not approved for use and/or sale.
WHO Comment : Phentermine, a sympathomimetic amine, was introduced in 1959
for use as an anorexic agent. It retains a place in the treatment of obesity. However,

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 215

Product Name Phentermine

C.A.S. number 122-09-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
since it has been subject to abuse and because dependence can occur,
phentermine is controlled under Schedule IV of the 1971 Convention on
Psychotropic Substances.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Phentolamine mesilate

C.A.S. number 65-28-1
Scientific and common names, and synonyms
PHENTOLAMINI MESILAS. 3-[N-(2-IMIDAZOLIN-2-YLMETHYL)-P-TOLUIDINO]PHENOL METHANESULPHONATE
PHENTOLAMINE METHANESULPHONATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SGP The National Pharmaceutical Administration in the Ministry of Health has not approved
phentolamine mesylate, a drug used for the treatment of erectile dysfunction because of
abnormal findings in rat carcinogenicity studies.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Phenylbutazone

C.A.S. number 50-33-9
Scientific and common names, and synonyms
BUTADIONE
3,5-PYRAZOLIDINEDIONE, 4-BUTYL-1,2-DIPHENYL-
4-BUTYL-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Indications are restricted to acute exacerbations of rheumatoid arthritis, ankylosing
spondylitis and acute gout. Doctors are advised to prescribe these drugs only to adults
and for periods of no longer than one week.
HUN 1984 Indications are restricted to ankylosing spondylitis and related diseases, acute gout
attacks, acute exacerbations of rheumatoid arthritis and inflamed osteoarthritis. The
duration of treatment is restricted to 14 days.
(Reference: (BNIPH) Bulletin of the National Institute of Pharmacy, 34(6), 186, 1984)
IRL 1984 Approved indications for phenylbutazone and oxyphenbutazone revised: now restricted to
cases of acute gout, ankylosing spondylitis, and chronic arthritis in patients unsuited to
alternative therapy. Treatment of acute gout should not extend beyond 7-10 days and the
lowest effective dose should be used. Treated arthritic patients should remain under
regular surveillance and specialist supervision. Doctors are advised not to prescribe
these drugs for children or pregnant women and to reduce the dose in elderly patients.
Certain contraindications include previous or existing gastrointestinal disease, blood
dyscrasias, hepatic or renal dysfunction, cardiac or pulmonary insufficiency, thyroid or
salivary gland disorders or hypersensitivity. Combination products with other active
ingredients have been withdrawn from use.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 216

Product Name Phenylbutazone

C.A.S. number 50-33-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUN 1984 Injectable and topical preparations are prohibited. Tablets and suppositories are
restricted to the treatment of ankylosing spondylitis and gout.
ARE 19 Mar 1984 Pharmaceutical preparations containing phenylbutazone are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.480, , 1984)
KWT Apr 1984 Approved indications have been restricted to ankylosing spondylitis and acute gout and
phenylbutazone should not be dispensed without a prescription.
(Reference: (KTMD) Ministerial Decree, No.160, , 1984)
BRB 25 Jun 1984 Indications for phenylbutazone are limited to active ankylosing spondylitis, gout and
pseudo-gout. It may also be used to treat acute exacerbations of rheumatoid arthritis and
osteoarthritis and acute non-articular rheumatoid disease unresponsive to other non-
steroidal antiinflammatory drugs.
ZWE Jul 1984 Approved indications are restricted to ankylosing spondylitis. The duration of therapy
should not exceed seven days. Labelling must contain a warning that adverse
haematological effects may occur and that the blood count should be monitored before
and during therapy. Topical products have been withdrawn.
(Reference: (ZWDCC) Drugs Control Council, News Bulletin, , , Aug 1985)
ESP 15 Jul 1984 Approved indications have been restricted to inflammatory arthritic conditions, active
ankylosing spondylitis and other inflammatory spondylopathies, acute attacks of gout and
pseudo-gout, acute exacerbations of rheumatoid arthritis and other polyarthritic
conditions. Parenteral preparations have been restricted to hospital use only.
COG 1 Aug 1984 Indications for phenylbutazone have been restricted to ankylosing spondylitis.
JOR 1 Oct 1984 Registration of all pharmaceutical products containing phenylbutazone has been
withdrawn.
(Reference: (JORMH) Ministry of Health Resolution, 4/2/1559, , Apr 1984)
BGD Nov 1984 Use has been banned due to reported severe adverse reactions.
DEU 1985 Indications have been restricted to exacerbations of rheumatism and acute gout.
Duration of oral treatment should not exceed one week. Parenteral preparations are
indicated only for initiating therapy. A single injection only is recommended because local
tissue damage may occur. Preparations are contraindicated in children under 14 years of
age.
ETH 1985 Banned from the market due to reported serious adverse reactions.
GRC 1985 Indications have been restricted.
NLD 1 Jan 1985 Parenteral dosage forms and combination products containing phenylbutazone have
been withdrawn from the market. The approved indications have been restricted to the
treatment of spondyloarthritis unresponsive to other non-steroidal antiinflammatory
agents.
(Reference: (NETJAN) Nederlands Tijdschrift voor Geneeskunde, 128(50), , 1984)
SWE Feb 1985 Indications for use have been restricted to acute gout and morbus Bechterew on the
grounds of serious blood dyscrasias associated with its use.
NZL Apr 1985 Indications for phenylbutazone have been restricted.
CHL 4 Jun 1985 Preparations containing phenylbutazone have been prohibited.
(Reference: (CHLRS) Resolution of the Minister of Health, No.2660, , Apr 1984)
OMN 22 Sep 1985 Phenylbutazone is available in small quantities only in government hospitals for the
treatment of patients unresponsive to other therapy. The Ministry of Health has prohibited
import of preparations containing phenylbutazone except combinations containing
phenylbutazone and clofexamide (clofezone) intended for topical use.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 217

Product Name Phenylbutazone

C.A.S. number 50-33-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (OMNMH) Ministry of Health, 3, , 1985)
HKG 2 Oct 1985 The use of preparations containing phenylbutazone has been restricted.
PAN 1 Jan 1986 The Ministry of Health has suspended the import and sale of pharmaceuticals containing
phenylbutazone with the exception of parenteral preparations for which use will be
confined to hospitals.
(Reference: (PANMR) Ministry of Health Resolution, No.9/III-DG, , )
TUR 12 Mar 1986 Production and sale of preparations containing phenylbutazone have been banned with
the exception of topical preparations.
MYS Jan 1987 All products containing phenylbutazone have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.6, , Oct 1986)
BEL 1 Jan 1988 Preparations containing phenylbutazone have been placed in List IV of the 'Arr^t, du
R,gent' of 2 June 1946 and as such can be administered only on prescription. They must
be kept in a poisons cabinet and carry the skull and crossbones label.
(Reference: (BELAR) Arrêté Royal, , , June 1987)
GHA 1 Sep 1989 Products containing phenylbutazone, its salts or derivatives have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
LKA 1 Jan 1992 The Ministry of Health withdrew from sale pharmaceutical products containing
phenylbutazone. This action was based on the potential of these products to induce
suppression of the bone marrow.
(Reference: (LKADIB) Drug Information Bulletin, University of Peradeniya and Ministry of
Health, 4(1), , 1992)
ARM The Drug and Medical Technology Agency has suspended the marketing authorization of
phenylbutazone for oral, parenteral and topical use because of its toxicity.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
AUS Indications are restricted to seronegative spondyloarthropathies, acute gout and
rheumatoid arthritis not responding to other non-steroidal anti-inflammatory drugs.
AUT Indications are restricted to exacerbations of gout and other arthritic conditions.
Treatment should not exceed seven days and doctors are advised not to prescribe this
drug to children under 14 years of age or elderly patients.
(Reference: (WIMAM) Wichtige Mitteilung ueber Arzneimittel, (1), , 1984)
BHR Preparations containing phenylbutazone have been withdrawn.
CYP All combination products withdrawn from the market due to the potential to cause serious
adverse reactions. The indications for monocomponent products have been restricted to
ankylosing spondylitis.
GBR Approved indications are restricted to ankylosing spondylitis. Use is restricted to hospitals.
ISR The Pharmaceutical Administration of the Ministry of Health has notified the World Health
Organization of its intention to withdraw from use all preparations containing
oxyphenbutazone and to restrict the approved indication for preparations containing
phenylbutazone to ankylosing spondylitis.
ITA Indications have been restricted to the acute phase of ankylosing spondylitis, acute gout
and the acute phase of pelvispondylitis and psoriatic polyarthritis. Use should only be
considered when alternative treatment is ineffective or inappropriate. No course of
treatment should exceed seven to ten days.
PHL Due to its risk of toxicity, phenylbutazone is recommended for use only when other
agents fail.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 218

Product Name Phenylbutazone

C.A.S. number 50-33-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : Phenylbutazone, a pyrazolone derivative with anti-inflammatory,
analgesic and antipyretic activity, was introduced in 1949 for the treatment of
rheumatic disorders. Its use was subsequently associated with serious and
sometimes fatal adverse reactions, notably cases of aplastic anaemia and
agranulocytosis. Many national drug regulatory authorities consider that more
recently introduced drugs offer a safer alternative for most, if not all, patients
requiring anti-inflammatory agents. Phenylbutazone has thus been either
withdrawn at the national level or retained with rigorously restricted indications for
patients unresponsive to other therapy. These restrictions also apply, in general, to
combination products containing phenylbutazone.

Product Name Phenylephrine

C.A.S. number 59-42-7
Scientific and common names, and synonyms
BENZENEMETHANOL, 3-HYDROXY-ALPHA-((METHYLAMINO)METHYL)
(-)-M-HYDROXY-ALPHA-((METHYLAMINO)METHYL)BENZYL ALCOHOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Jun 1987 The Department of Health and Social Security has refused to extend the product licence
for eyedrops containing phenylephrine having regard to the possibility that use in the eye
may result in delayed healing, reactive hyperaemia and the precipitation of closed angle
glaucoma.

Product Name Phenylpropanolamine

C.A.S. number 14838-15-4
Scientific and common names, and synonyms
BENEZENEMETHANOL, ALPHA-(1-AMINOETHYL)-,(R*,S*)-, (+/-)

DL-ERYTHRO-2-AMINO-1-PHENYL-1-PROPANOL
(+/-)-NOREPHEDRINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Nov 1985 The Committee on the Review of Medicines has recommended that preparations
containing phenylpropanolamine for treatment of cough and cold (other than nasal sprays
and drops) should be subjected to prescription control if the recommended dosage
exceeds, for slow-release forms, 50 mg (single dose), 100 mg (daily dose); or for
immediate release dosage forms, 25 mg (single dose), 100 mg (daily dose). Slow-release
preparations are contraindicated in children and all formulations are contraindicated in
hypertensive patients and those currently receiving (or within two weeks of stopping)
therapy with monoamine oxidase inhibitors.
(Reference: (GBMIL) Medicines Act Information Letter, 45, , Nov 1985)
HKG Nov 1985 The Pharmacy and Poisons Committee has issued guidelines restricting the use of
phenylpropanolomine.
DEU 1987 Approval of products containing phenylpropanolamine as appetite suppressants and for
the symptomatic treatment of the common cold was withdrawn, because of their

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 219

Product Name Phenylpropanolamine

C.A.S. number 14838-15-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
association with hypertensive episodes in susceptible individuals, particularly when taken
together with coffee, alcohol, antihistamines or neuroleptics.
(Reference: (BGHBL) Bundesgesundheitsblatt, 30(5), 187, 1987)
BRA Nov 2000 The National Health Surveillance Agency stopped the sale of all products containing
phenylpropanolamine due to the potential of these products to induce several adverse
reactions including cerebral haemorrhage.
(Reference: (BRARES) Resolucao n., 96/ANVISA, , 10 Nov 2000)
LTH Nov 2000 The classification status of all medicinal products containing phenylpropanolamine was
changed from over-the-counter (OTC) to prescription-medicines-only (PMO).
Restrictions in dosage (not to exceed 100 mg daily dose) and contraindications (not to be
used in patients with arterial hypertension, atherosclerosis of cerebral arteries and in
patients on concurrent anticoagulant therapy) and dosage adjustment in children were
recommended. Usage in children below 12 years of age was banned.
(Reference: (LTHPHB) LSMCA bulletin "Pharmacon", No. 24, 2000, , 17 Aug 2001)
(Reference: (LTHMCA) Order of State Medicines Control Agency, order no. 136, , 16 Nov
2000)
MYS Nov 2000 The Ministry of Health suspended the registration of all medicines containing
phenylpropanolamine (PPA) following a US report of increased risk of haemorrhagic
stroke in people taking medicines containing PPA.
(Reference: (MYSCW) Communication to WHO, , , 05 Oct 2001)
SGP Nov 2000 Manufacturers were asked to withdraw all products containing phenylpropanolamine
(PPA) from the market following reports of increased risk of haemorrhagic stroke.
Manufacturers have been advised to re-formulate their products without PPA.
(Reference: (SGPCW) Communication to WHO, , , 19 Sep 2001)
USA Nov 2000 All phenylpropanolamine (PPA ) containing products were withdrawn due to risk of
haemorrhagic stroke after a research study by scientists at Yale University showed a
significant increase in the risk for haemorrhagic strokes among women who had taken
PPA as an appetite suppressant.
(Reference: (USAPHA) Public Health Advisory, , , 06 Nov 2000)
GBR Dec 2000 The Committee on Safety of Medicines (CSM) concluded that the evidence of a like
between haemorrhagic stroke and phenylpropanolamine (PPA) is weak and recommend
that the Medicines Control Agency should work closely with manufacturers to improve
existing product information on the packs and patient information leaflets for PPA
containing products with more prominent warnings.
(Reference: (GBRSMU) Safety Message Update, , , )
OMN Dec 2000 The registration of all products containing phenylpropanolamine has been cancelled in
Oman.
(Reference: (OMNCR) Circular, 64/2000, , 02 Oct 2001)
CAN 2001 Health Canada has directed the removal of all phenylpropanolamine containing products
from the Canadian market due to the risk of serious haemorrhagic strokes with
phenylpropanolamine.
(Reference: (CANWHC) Warnings/Advisories, , , May 2001)
IDN Apr 2001 The National Agency fro Drug and Food Control (NADFC) in Indonesia has allowed the
marketing of phenylpropanolamine containing products with restrictions on the maximum
strength per unit dose and maximum daily dose (adult 15 mg/unit dose; 60 mg per day;
children 7.5 mg/unit dose; 30 mg per day).
(Reference: (IDNCW) Communication to WHO, , , 13 Sep 2001)
CUB May 2001 The Centre for State Control of Drug Quality (CECMED) issued a resolution banning the
use of phenylpropanolamine products in Cuba.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 220

Product Name Phenylpropanolamine

C.A.S. number 14838-15-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (CUBCDQ) CECMED Resolution, No. 7/2001, , 16 May 2001)
CHL Oct 2001 The Public Health Institute of Chile has modified the labels of products containing
phenylpropanolamine, warning against their use in children under the age of 12 years
and advising patients to immediately report to their physicians all adverse reactions
experienced with phenylpropanolamine products.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)
JPN 15 Aug 2003 The Ministry of Health, Labour and Welfare (MHLW) has asked manufacturers of
products containing phenylpropanolamine (PPA) to include new warnings on
cardiovascular risks. The move follows several reports of cerebral haemorrhage and
other problems associated with the use of PPA containing products.
(Reference: (JPNSWP) Scrip World Pharmaceutical News, No.2876, , 15 Aug 2003)
WHO Comment : Phenylpropanolamine, a symopathomimetic amine, has been
widely available in over-the-counter preparations since 1941. It is one of the most
frequently used nasal decongestants and it is a common ingredient in preparations
for weight reduction, although doubts have been raised about its usefulness in this
indication. It is also used in stress incontinence. Its use has been associated with
occasional excessive elevation of blood pressure, especially in hypersensitive
individuals.

Product Name Phthalylsulfathiazole

C.A.S. number 85-73-4
Scientific and common names, and synonyms
6'-(THIAZOLYLAMINOSULFAMOYL)PHTHALANILIC ACID
BENZOIC ACID, 2-(((4-((2-THIAZOLYLAMINO)SULFONYL)PHENYL)AMINO)-CARBONYL)-
4'-(2-THIAZOLYLSULFAMOYL)PHTHALANILIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, this product has been banned. It
has been found to be of little or no therapeutic value, its side effects can be harmful, and
it is subject to misuse.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
WHO Comment : Phthalylsulfathiazole, a sulfonamide anti-infective agent, was
introduced in 1946 for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing bacterial
resistance and their replacement by antibiotics which are generally more active
and less toxic. Although phthalylsulfathiazole, which is poorly absorbed from the
gastrointestinal tract, is no longer recommended in some countries, it continues to
be used in others for the treatment of local intestinal infections, including bacterial
dysentery, and for pre-operative bowel preparation.

Product Name Pipamazine

C.A.S. number 84-04-8
Scientific and common names, and synonyms
10-(3-(4-CARBAMOYLPIPERIDINO)PROPYL)-2-CHLOROPHENOTHIAZINE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 221

Product Name Pipamazine

C.A.S. number 84-04-8
Country Effective Description of action taken
Date Grounds for decision
USA Jul 1969 Withdrawn from the market and prohibited for export by the Food and Drug
Administration due to the lack of proof of efficacy and safety for use as an antinauseant
and antiemetic for pregnant women.
WHO Comment : Pipamazine, which is pharmacologically similar to
chlorpromazine, was introduced in 1959 for the treatment of nausea and vomiting.
Although it was withdrawn in 1969 by the United States FDA on grounds of lack of
proof of efficacy and safety, it remains available in some countries.

Product Name Pipenzolate

C.A.S. number 13473-38-6
Scientific and common names, and synonyms
1-ETHYL-3-HYDROXY-1-METHYLPIPERIDINIUM BENZILATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PAK Jun 1990 Paediatric formulations of antidiarrhoeal products containing pipenzolate were banned.
WHO Comment : Pipenzolate, an anticholinergic agent, was introduced in 1960 for
the treatment of spastic conditions of the gastro-intestinal tract. It has never been
widely used for the treatment of diarrhoea, and WHO is not aware of any such
preparations that remain available.

Product Name Piperazine

C.A.S. number 110-85-0
Scientific and common names, and synonyms
BUTADIONE
3,5-PYRAZOLIDINEDIONE, 4-BUTYL-1,2-DIPHENYL-4-BUTYL-1,2-DIPHENYYL-3,5,PYRAZOLIDINEDIONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 1977 Products with anthelminthic indications have been withdrawn due to an unfavourable
risk/benefit balance. Since 1975, warnings have been added to the labels concerning the
possibility of neurotoxic effects with high dosages. In 1979, the label was revised to
advise use on an empty stomach and for short periods of time with long intervals, in order
to avoid interaction with nitrites.
SWE 1983 In the light of the carcinogenic and mutagenic potential of piperazine demonstrated in
recent studies, discussions between the manufacturers and the Department of Drugs
have led to the withdrawal of registration for this drug.
DNK 2 Jul 1984 Following recent evidence leading to the possibility that carcinogenic nitroso-derivatives
may be generated in vivo, preparations containing piperazine have been placed under
prescription control.
(Reference: (UGLAAD) Ugeskrift for Laeger, 1949, , June 1984)
NLD 1 Jan 1985 The Board of Evaluation of Drugs has concluded that other anthelminthics have a more
favourable risk-benefit ratio than piperazine, which may also give rise to potentially
carcinogenic nitroso-derivatives. Manufacturers have been requested to withdraw
products containing piperazine.
(Reference: (NETJAN) Nederlands Tijdschrift voor Geneeskunde, 128(41), , 1984)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 222

Product Name Piperazine

C.A.S. number 110-85-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS 1996 The Drug Control Authority withdrew registration of products containing the anthelminthic,
piperazine, because of reports of severe neurotoxicity and hypersensitivity reactions.
Moreover, the mononitrasation of piperazine in the stomach can produce the potential
carcinogen N-mononitrosopiperazine.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 10(1): 4, , 1996)
ARM Jul 2000 The Drug and Medical Technology Agency withdrew registration of the anthelminthic
product, piperazine because of reports of questionable safety with detection of
neurotoxicity, hypersensitivity and nitrosamine-generating ability.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
THA The use of pharmaceutical preparations containing piperazine is severely restricted.
WHO Comment : Piperazine was first used as a treatment for gout earlier this
century and its anthelminthic activity was discovered in 1949. It is also
considerably cheaper than other anthelminthic drugs. In some countries where
ascariasis is not endemic and where piperazine was used predominantly for the
treatment of pinworm it has been withdrawn from use on the grounds that other
more effective and less toxic drugs are now available (see full list). In other such
countries, however, piperazine remains available in over-the-counter preparations.
Clinical dosages occasionally induce transient neurological signs and concern has
been expressed that in some circumstances the drug may generate small amounts
of nitrosamine in the stomach. However, it is widely considered that these trace
doses are unlikely to give rise to a significant carcinogenic potential.
(Reference: (WHODIB) WHO Drug Information Bulletin, 1: 5, , 1983)

Product Name Pipradrol

C.A.S. number 467-80-7
Scientific and common names, and synonyms
ALPHA,ALPHA-DIPHENYL-2-PIPERIDINEMETHANOL
1,1-DIPHENYL-1-(2-PIPERIDYL)-METHANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 6 Sep 1982 Banned for production, import, export, sale and use.
DNK Withdrawn from the market by the manufacturer.
VEN Not approved for use and/or sale.
WHO Comment : Pipradrol, a central nervous system stimulant, was introduced in
1955 for use as an anorexic agent. Pipradrol is controlled under Schedule IV of the
1971 Convention on Psychotropic Substances.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Pirprofen

C.A.S. number 31793-07-4
Scientific and common names, and synonyms
BENZENEACETIC ACID,3-CHLORO-4-(2,5-DIHYDRO-1H-PYRROL-1-YL)-ALPHA-METHYL-
2-(3-CHLORO-4-(3-PYOLIN-1-YL)PHENYL) PROPIONIC ACID

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 223

Product Name Pirprofen

C.A.S. number 31793-07-4
Scientific and common names, and synonyms
3-CHLORO-4-(3-PYRROLIN-1-YL) HYDRATROPIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 30 Sep 1990 Products containing pirprofen have been voluntarily discontinued by the manufacturer.
(Reference: (CGPR) Press release from Ciba-Geigy, , , 15 Mar 1990)
WHO Comment : Pirprofen, a nonsteroidal anti-inflammatory agent, was introduced
in 1982 primarily for the treatment of rheumatic diseases, as well as for use in post-
traumatic and post-operative inflammatory conditions, acute gout and
dysmenorrhoea. Reports of serious adverse effects, in particular cases of liver
toxicity, some of which were fatal, led the manufacturer, in 1985 and in 1989, to
amend the approved product information of the drug, limiting duration of treatment
and lowering the recommended doses. In the light of these successive restrictions,
which have considerably reduced the field of application of pirprofen and in view of
available alternatives, the manufacturer has decided to discontinue the drug
worldwide.

Product Name Pituitary-chorionic gonadotropin (injectable)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Jul 1972 Gonadotropins of animal origin have been withdrawn from use and prohibited for export
by the Food and Drug Administration on grounds of safety and efficacy. In its decision the
FDA cited the risk of eliciting antibodies to animal protein, leading to allergic reactions,
and the availability of safer and more effective alternatives.
(Reference: (FEREAC) Federal Register, 37(130), 13284, 1972)
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing pituitary chorionic gonadotropin or to
indicate that preparations are still commercially manufactured.

Product Name Placental tissue derived medicine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 23 Jul 1992 The Directorate of Pharmacy has suspended the marketing authorization of certain
medicinal products derived from human placental tissue: Placentafil, injectable and tipical
formulations and Placenta Soca, ointment (Laboratoire gerda). This does not necessarily
include other products made from placental tissue.
(Reference: (FRAMHH) Ministry of Health and Humanitarian Action, , , 23 July 1992)
WHO Comment : Placental derived products, both topical and injectable, have been
used to treat arthritis, eczema, acne vulgaris and numerous other ailments. In 1989
the European Community raised concerns regarding the risk of viral infection and
it was this that stimulated restrictive regulatory action. Other placental products
including some preparations of albumin remain on the market. Indeed, worldwide,
placental tissue continues to be a prime source of albumin.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 224

Product Name Podophyllum resin

Scientific and common names, and synonyms

PODOPHYLLIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 1970 Withdrawn from the market owing to the risk of teratogenicity.
FRA 30 Mar 1979 Having regard to the presumed teratogenic risk, the Commission on Drug Monitoring of
the Ministry of Health recommended that podophyllin be removed from all medicinal
products intended for internal use.
EGY 1984 Preparations containing podophyllum will not be considered for registration, having
regard to the potential risk of teratogenicity.
CUB Restricted to hospital use for the treatment of cutaneous lesions only. Oral and parenteral
preparations are banned.
SAU Available medicinal products containing this drug are intended for topical use only.
WHO Comment : Podophyllum resin, which is extracted from Indian podophyllum,
is highly irritant to the skin and mucous membranes and its use in purgatives is
now obsolescent. However, topical preparations remain available for the treatment
of venereal and other warts and the drug is included in the WHO Model List of
Essential Drugs for this purpose. Podophyllin extracts have been demonstrated to
have a teratogenic potential which has led to their withdrawal in some countries
and restriction of use in others. They are best avoided during pregnancy.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Polidexide sulfate

C.A.S. number 56227-39-5
Scientific and common names, and synonyms
DEXTRAN 2-(DIETHYLAMINO)ETHYL 2-((2-(DIETHYLAMINO)ETHYL)DIETHYLAMMONIO) ETHYL ETHER SULFATE,
EPICHLOROHYDRIN CROSSLINKED
DEAE-SEPHADEX
POLY(2-(DIETHYLAMINO)ETHYL)POLYGLYCERYLENE)DEXTRAN
PDX-CHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1977 This substance, except for the intravenous preparation, has been withdrawn by the
company following evidence of oculo-mucocutaneous syndrome.
WHO Comment : Polidexide sulfate, an anion-exchange resin, was formerly used in
the treatment of hypercholesterolaemia. The drug, which was marketed only in the
United Kingdom, was withdrawn in the mid-1970s on the basis of new safety
findings.

Product Name Polyoxyethylated castor oil

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 225

Product Name Polyoxyethylated castor oil

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 1984 The Italian Ministry of Health has suspended the marketing authorization of two
anaesthetic preparations containing polyoxyethylated castor oil.
@WD Jun 1984 The manufacturer of an anaesthetic agent containing polyoxyethylated castor oil has
withdrawn the product worldwide.
EGY 26 Mar 1985 Preparations containing polyoxyethylated castor oil will no longer be approved for
registration and the substance should be withdrawn from all pharmaceutical and
cosmetic products.
WHO Comment : Polyoxyethylated castor oil is a non-ionic emulsifying agent
produced by reacting ethylene oxide with castor oil. It has been used for over 20
years to prepare stable injectable liquid preparations of drugs with low aqueous
solubility. By the mid-1970s, its use had been associated with cases of severe
anaphylactoid reactions and haematological changes including hyperlipidaemia,
altered blood viscosity and erythrocyte aggregation. For the formulation of certain
lipophilic substances such as ciclosporin there is currently no viable alternative to
this pharmaceutical aid. It continues to be approved in some countries whereas its
use is restricted or banned in others. One manufacturer has withdrawn worldwide
all products containing polyoxyethylated castor oil.

Product Name Polyvidone

C.A.S. number 9003-39-8
Scientific and common names, and synonyms
PVP
POVIDONE
POLYVINYLPYRROLIDONE
1-VINYL-2-PYRROLIDINONE POLYMER
2-PYRROLIDINONE, 1-ETHENYL-, HOMOPOLYMER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1983 All injectable products containing PVP with a molecular weight of approximately 12000
have been reformulated or withdrawn. PVP content of remaining products and an
appropriate warning regarding their risks must be widely displayed on the labelling. PVPs
have been widely used as stabilisers in injectable products, but the Federal Health Office
considers that safer substances are now available for this purpose. It is now recognized
that PVPs of high molecular weight are sequestered in the body. Their accumulation may
cause pain at the site of injection and granulomatous lesions have developed that have
been mistaken for neoplastic tumors.
PAK 1988 Plasma expanders containing polyvidone were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
EGY Registration of injectable preparations containing polyvidone with a molecular weight
greater than 12000 are not approved because such preparations can cause painful
granulomatous lesions at the site of administration. Currently registered products were
reformulated to exclude this product.
WHO Comment : Polyvidone, a polymer of vinylpyrrolidinone, is an excipient used
as a suspending and dispersing agent. Injectable preparations containing polymers
with a molecular weight in the order of 12,000 have caused painful local

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 226

Product Name Polyvidone

C.A.S. number 9003-39-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
granulomatous lesions. This has led to the withdrawal of polyvidone from such
preparations in some countries. Polyvidone was formerly also used as a plasma
expander but, because it was sequestered within the liver and spleen, this use has
been discontinued. However, it remains widely used as a vehicle for ophthalmic
preparations, and as the major component of artificial tears.

Product Name Potassium canrenoate

C.A.S. number 2181-04-6
Scientific and common names, and synonyms
ALDADIENE POTASSIUM
PREGNA-4,6-DIENE-21-CARBOXYLIC ACID, 17-HYDROXY-3-OXO, POTASSIUM SALT ( 17ALPHA)-
POTASSIUM 17-HYDROXY-3-OXO-17ALPHA-PREGNA-4,6-DIENE-21-CARBOXYLATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Sep 1986 The indications for preparations containing potassium canrenoate are restricted having
regard to the possible carcinogenic risk associated with long-term use. All combination
products containing potassium canrenoate have been withdrawn.
(Reference: (DEUAB) Deutsches Aertzteblatt, 83, , 1986)
WHO Comment : Potassium canrenoate, which has no intrinsic aldosterone
antagonist activity, owes its therapeutic effect to the enzymatic interconversion in
the body to canrenone. Evidence that long-term administration of high doses are
tumorigenic in the rat has recently led to restriction of its use by some national
regulatory authorities. See also WHO comments for canrenone and spironolactone.

Product Name Potassium chloride

C.A.S. number 7447-40-7

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BEL 1982 Having regard to their association with ulceration of the gastrointestinal tract, fast-acting
tablet formulations of potassium salts, including potassium chloride, are prohibited.
Sustained-release tablets, tablets intended to be dissolved and liquid formulations remain
available.
FRA 31 Mar 1989 Fast-acting tablets containing potassium chloride have been withdrawn, in the light of
evidence that rapid release of potassium can induce intestinal perforation.
(Reference: (FRARP) La Revue Prescrire, 9(82), 59, 1989)
WHO Comment : Potassium chloride has been used for many years to correct
potassium deficiency. The use of fast-acting tablets has been associated with
lesions of the gastro-intestinal mucosa, which have led to their general withdrawal.

Product Name Potassium nitrate

C.A.S. number 7757-79-1
Scientific and common names, and synonyms

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 227

Product Name Potassium nitrate

C.A.S. number 7757-79-1
Scientific and common names, and synonyms
NITRE
SALTPETRE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jan 1981 Having regard to their obsolescence in clinical medicine and the potential carcinogenic
risk attached to excessive use of nitrates, medicinal preparations of potassium nitrate
were withdrawn from the market.
EGY Mar 1984 No registration licence is to be granted for oral pharmaceutical preparations containing
potassium nitrate to avoid any carcinogenic risk resulting from excessive use of nitrates.
VEN Not approved for use and/or sale.
WHO Comment : Potassium nitrate was formerly used as a diuretic. Its use for this
purpose is now considered obsolete but it is still available in at least one country
for the correction of potassium deficiency. It is aslo widely permitted at
concentrations of the order of 5% in proprietary toothpastes. In some countries the
drug has been banned due to a potential carcinogenic risk arising from the
excessive use of nitrates and their transformation to nitrosamines.

Product Name Practolol

C.A.S. number 6673-35-4
Scientific and common names, and synonyms
ACETAMIDE, N-(4-(2-HYDROXY-3-((1-METHYLETHYL)AMINO)PROPOXY)PHENYL)-
4'-(2-HYDROXY-3-(ISOPROPYLAMINO)-PROPOXY)ACETANILIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FIN 1975 Restricted for use only in cases of cardiac dysrhythmias due to the oculo-mucocutaneous
syndrome. The only available preparation is a solution for intravenous use.
GRC 1975 Withdrawn from the market.
TUR 1975 Withdrawn from the market by the Ministry of Health due to published evidence of its
harmful effects on hearing and on the eyes and skin. Export of this product is prohibited.
NZL Mar 1975 Voluntarily withdrawn from the market.
SWE 1 May 1975 An intravenous preparation remains on the market for treatment of selected cardiac
dysrhythmias.
DNK 1 Jul 1975 Registration has been cancelled for the product in tablet form. Administration by injection
is allowed.
(Reference: (UGLAAD) Ugeskrift for Laeger, 137, 1016, Apr 1975)
THA Dec 1975 Products containing this ingredient have been banned.
SGP Jul 1976 Banned for importation.
GBR 1977 This substance except for the intravenous preparation has been withdrawn from use by
the company following evidence of oculo-mucocutaneous syndrome.
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 228

Product Name Practolol

C.A.S. number 6673-35-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IND 1983 Prohibited for manufacture and sale for reasons of health risks associated with use
and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
DEU 25 Mar 1994 The Federal Health Office has suspended the marketing authorization for pharmaceutical
products containing orgotein on the grounds that unjustifiable risk outweighs the benefits.
The Agency has received about 400 reports of adverse reactions - 90 of these repors
describe serious hypersensitivity reactions, some of which were fatal.
(Reference: (DEUPD) BGA Pressedienst, 19/1994, , 30 Mar 1994)
NOR 1995 Preparations for oral use were withdrawn from the market in 1975. Preparations for
parenteral use have been withdrawn from the market.
VEN Banned due to undesirable effects.
WHO Comment : Practolol, a beta-adrenoreceptor antagonist, was introduced in
1970 for the treatment of angina and cardiac dysrhythmias. By 1974 long-term use
had been associated with serious delayed idiosyncratic reactions (oculo-
mucocutaneous syndrome) and this led to the withdrawal of oral preparations by
the major manufacturer on a worldwide basis. There is no evidence to suggest that
other beta-adrenoreceptor antagonist are associated with this risk. Intravenous
preparations of practolol remain available in many countries for the emergency
treatment of selected cardiac dysrhythmias.

Product Name Prasterone

C.A.S. number 53-43-0
Scientific and common names, and synonyms
DHEA
DEHYDROEPIANDROSTERONE
DEHYDROANDROSTERONE
3BETA-HYDROXYANDROST-5-EN-17-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1985 The Food and Drug Administration has withdrawn products containing prasterone on
grounds of lack of information on efficacy and safety of long-term use. These products,
which were available without prescription, were promoted for weight reduction, enhanced
sexual function and extension of life.
(Reference: (HHSNS) HHS News: US Department of Health and Human Services, , ,
Apr 1985)
WHO Comment : The World Health Organization has no information further to the
above regarding preparations containing prasterone or to indicate that such
preparations remain available.

Product Name Prenylamine

C.A.S. number 390-64-7
Scientific and common names, and synonyms
BENZENEPROPANAMINE, N-(1-METHYL-2-PHENYLETHYL)-GAMMA-PHENYL-
N-(3,3-DIPHENYLPROPYL)-ALPHA-METHYLPHENETHYLAMINE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 229

Product Name Prenylamine

C.A.S. number 390-64-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 31 Mar 1989 Following reports of polymorphic ventricular tachycardia that led to withdrawal of
prenylamine in the United Kingdom and the Federal Republic of Germany, the
manufacturer has decided to withdraw the product from the market worldwide from 31
March 1989.
WHO Comment : Prenylamine is a calcium-channel blocking agent which was
introduced in 1960. It has been widely used for the prophylaxis of angina pectoris
and long-term treatment of coronary heart disease. Concern about its propensity to
induce dangerous cardiac dysrhythmias led the company to withdraw it from the
market.

Product Name Progabide

C.A.S. number 62666-20-0
Scientific and common names, and synonyms
BUTANAMIDE, 4-(((4-CHLOROPHENYL)(5-FLUORO-2-HYDROXYPHENYL)METHYLENE) AMINO)-
4-((ALPHA-(P-CHLOROPHENYL)-5-FLUOROSALICYLIDENE)AMINO)BUTYRAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 17 Mar 1986 Following the development of icteric hepatitis in patients taking progabide, the major
manufacturer advised doctors that its use should be restricted to patients unresponsive
to other anticonvulsants.
WHO Comment : Progabide, an anticonvulsant, was introduced in France in 1985
for the treatment of epilepsy. Its use has occasionally been associated with
clinically evident signs of icteric hepatitis developing within the first six months of
treatment. These signs are generally reversible on withdrawal of the drug but
continuation of treatment has been associated with three reported fatalities (two of
which are doubtfully related to the drug). The manufacturer revised the data sheet
in March 1986 advising that use of progabide should be reserved for patients
unresponsive to other anticonvulsants.

Product Name Promethazine

C.A.S. number 60-87-7
Scientific and common names, and synonyms
10H-PHENOTHIAZINE-10-ETHANAMINE, N,N,?-TRIMETHYL-, MONOHYDROCHLORIDE
10H-PHENOTHIAZINE-10-ETHANAMINE, N,N,ALPHA-TRIMETHYL-.
10-[2-(DIMETHYLAMINO)PROPYL]-PHENOTHIAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Oct 1994 The section on contraindications in the data sheet for the antihistamine, promethazine
will now state: "Not for use in children under two years of age because safety of such
use has not been established".
(Reference: (GBRPHJ) The Pharmaceutical Journal, 253: 512, , 08 Oct 1994)
MAR May 2000 The National Commission form Pharmacovigilance has restricted the administration of
this product for children over 2 years of age.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 230

Product Name Promethazine

C.A.S. number 60-87-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
WHO Comment : Introduced in 1946, promethazine, a phenothiazine derivative has
a variety of pharmacological properties. At present it is mainly used as an
antihistamine and anti-motion-sickness drug. Promethazine is listed in the WHO
Model List of Essential Drugs.

Product Name Propafenone

C.A.S. number 54063-53-5
Scientific and common names, and synonyms
1-PROPANONE, 1-[2-[2-HYDROXY-3-(PROPYLAMINO)PROPOXY]PHENYL]-3-PHENYL-
2'-[HYDROXY-3-(PROPYLAMINO)PROPOXY]-3-PHENYLPROPIOPHENONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Sep 1990 Products containing propafenone were restricted to the treatment of patients unsuitable
for or unresponsive to other antiarrhythmic agents, on the grounds that they had been
associated with cases of ventricular tachycardia and fibrillation, some of which were fatal.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, 104, , Sep 1990)
MYS Feb 1991 The indications for products containing propafenone were restricted to the suppression of
life-threatening ventricular arrhythmias, including sustained ventricular tachycardia, on
the grounds that their potential to induce adverse effects must be assumed to be similar
to that of encainide and flecainide.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 5(1):2, , 1991)
WHO Comment : Propafenone, a membrane-stabilizing antiarrhythmic agent, was
introduced into medicine in the mid 1980s. Shortly afterwards, its use became
associated with cases of severe cardiac arrhythmias, which led to notable
restrictions in the drug's indications in at least two countries. See also WHO
comment for flecainide.

Product Name Propionic acid

C.A.S. number 79-09-4
Scientific and common names, and synonyms
PROPANOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1987 Having regard to proliferative lesions associated with administration of high dosages of
propionic acid to experimental animals, the Federal Health Office restricted its use as a
preservative and prohibited its use in bread.
(Reference: (BGHBL) Bundesgesundheitsblatt, 30(10), 370, 1987)

Product Name Propofol

C.A.S. number 2078-54-8
Scientific and common names, and synonyms

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 231

Product Name Propofol

C.A.S. number 2078-54-8
Scientific and common names, and synonyms
DISOPROFOL
2,6-DI-ISOPROPYLPHENOL
2,6-BIS(1-METHYLETHYL)PHENOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISR 1992 The Ministry of Health has not approved propofol for use in children.
(Reference: (ISRMH) Ministry of Health, Israel, , , 29 June 1992)
NOR 06 Apr 1992 The use of propofol for long term sedation in children was not approved in Norway. The
drug authorities in Norway strongly advised Norwesgian hospitals not to use propofol in
children.
(Reference: (NORMCA) Norwegian Medicines Control Authority, , , 06 Apr 1992)
GBR Jun 1992 The Committee on Safety of Medicines reminded doctors that the use of propofol for
sedation in children has not been evaluated and, in light of serious and sometimes fatal
reactions, such use is not recommended.
(Reference: (GBRCSM) Committee on Safety of Medicines, Current problems, 34, ,
June 1992)
LTH Mar 2001 The State Medicines Control Agency of Lithuania (SMCA) has further extended the
restrictions on the use of propofol. The agency has advised that propofol is not a
recommended drug and should not be used for sedation in children below the age of 16
years.
(Reference: (LTHPHB) LSMCA bulletin "Pharmacon", No. 5-6, 2001, , 17 Sep 2001)
(Reference: (LTHMCA) Order of State Medicines Control Agency, order no. 43, , 23 Mar
2001)
WHO Comment : Propofol, a short acting injectable anaesthetic, was introduced in
1987. In April 1992, the Norwegian Medicines Control Board reported that
prolonged use of propofol had been associated with two fatalities in children
characterized by metabolic acidosis, liver enlargement, and cerebral oedema. The
UK Committee on the Safety of Medicines has received 5 reports of deaths
occurring in children who had received propofol while in intensive care.

Product Name Propylhexedrine

C.A.S. number 3595-11-7
Scientific and common names, and synonyms
CYCLOHEXANEETHANAMINE, N,ALPHA-DIMETHYL-(+/-)
(+/-)-N,ALPHA-DIMETHYLCYCLOHEXANEETHYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Jul 1981 Administration of centrally active appetite inhibiting preparations containing
propylhexedrine has been restricted to four weeks. A warning concerning the risk of
dependence has been included in the package leaflet.
WHO Comment : Propylhexedrine, a sympathomimetic amine, has been widely
available since 1949 in over-the-counter inhalants for nasal decongestion and in
oral anorexic preparations. As dependence can occur and because abuse has been
reported, propylhexedrine was subjected in 1986 to control under Schedule IV of
the 1971 Convention on Psychotropic Substances.
(Reference: (WHTAC2) 2nd Report of the WHO Expert Committee on Drug
Dependence (IV), 729, , 1985)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 232

Product Name Propylhexedrine

C.A.S. number 3595-11-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Propyphenazone

C.A.S. number 479-92-5
Scientific and common names, and synonyms
ISOPROPYLANTIPYRINE
4-ISOPROPYL-2,3-DIMETHYL-1-PHENYL-3-PYRAZOLIN-5-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR Jan 1986 Banned for production and sale having regard to severe adverse reactions.
ITA 1989 Having regard to the adverse effects associated with their long-term use, products
containing propyphenazone may now be indicated only for the short-term treatment of
severe pain or pyrexia.
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, 13(2), 5, 1989)
ARE Pharmaceutical preparations containing propyphenazone are banned.
BHR Preparations containing propyphenazone have been withdrawn.
IRL Following the occurrence of a case of fatal aplastic anaemia in a patient taking a
propyphenazone-containing product for a prolonged period, the regulatory authority
requested that the product be reformulated to exclude this ingredient.
WHO Comment : Propyphenazone, a pyrazolone derivative with anti-inflammatory,
analgesic and antipyretic activity, was introduced in 1951 for the treatment of
rheumatic disorders. As it is structurally related to aminophenazone it has been
associated with severe blood dyscrasias. However, it cannot be transformed into
potentially carcinogenic nitrosamines and has therefore been widely used as a
replacement drug for aminophenazone. In certain countries, products containing
propyphenazone have now been restricted in their indications, whereas in others
they are still available, sometimes as over-the-counter preparations. See also WHO
comment for aminophenazone.

Product Name Proxibarbal

C.A.S. number 2537-29-3
Scientific and common names, and synonyms
5-ALLYL-5-(2-HYDROXYPROPYL)BARBITURIC ACID
PROXIBARBITAL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Apr 1998 The Medicines Agency has withdrawn proxibarbal from the market after a benefit/risk
evaluation showed that it may induce immunoallergic thrombocytopenia with potentially
severe consequences. Proxibarbal was indicated for the treatment of minor signs of
anxiety and hot flushes of the menopause and migraine. The company has already
withdrawn proxibarbal in Italy, Spain, Portugal and Turkey. It is still marketed in Hungary
and Poland.
(Reference: (FRAAMC) Communiqué de Presse, , , 16 Apr 1998)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 233

Product Name Proxibarbal

C.A.S. number 2537-29-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Apr 1998 The manufacturer has voluntarily withdrawn proxibarbal in France after an evaluation by
the Medicines Agency concluded that the risk-benefit ratio of proxibarbal is unfavourable
given the identified risk of immunoallergic thrombopenia.
(Reference: (FRAAMC) Communiqué de Presse, , , 16 Apr 1998)

Product Name Pumactant

Scientific and common names, and synonyms

ARTIFICIAL LUNG EXPANDING COMPOUND

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Apr 2000 Pumactant was voluntarily withdrawn from the market by the licence holder following the
results of a randomized clinical trial which showed unexpectedly higher mortality rate in
neonates given pumactant.
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)

Product Name Pyridoxine (Vitamin B6)

C.A.S. number 65-23-6
Scientific and common names, and synonyms
3,4-PYRIDINEDIMETHANOL, 5-HYDROXY-6-METHYL-, HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Jul 1997 The Committee on the Safety of Medicines has advised that vitamin B6 in daily dose
above 50mg should be available on prescription only, and that the general sales supply
of vitamin B6 should be restricted to products providing a daily dose of 10mg or less.
This action has been taken because of reports of peripheral neuropathy after daily doses
of 50-mg.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 259 : 46, , 12 July 1997)
WHO Comment : Pyridoxine (vitamin B6) is listed in theWHO Model List of
Essential Drugs.

Product Name Pyrithione zinc

C.A.S. number 13463-41-7
Scientific and common names, and synonyms
ZINC PYRIDINETHIONE, SKIN-CA
ZINC 2-PYRIDINETHIOL 1-OXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ARE 1997 The Ministry of Health has withdrawn the marketing approval for pyrithione zinc that is
indicated for the treatment of dandruff or psoriasis. This follows concern raised by the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 234

Product Name Pyrithione zinc

C.A.S. number 13463-41-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FDA and Canada after closer analysis of the product revealed that it contained an
(unlabelled) prescription strength corticosteroid (clobetasol).
(Reference: (UAEDIB) Drug Information Bulletin, No. 3, p.2, 1997)
ARM Aug 1999 The Drug and Medical Technology Agency has restricted the indications for pyrithione
zinc to seborrhoeic dermatitis.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)

Product Name Pyritinol

C.A.S. number 1098-97-1
Scientific and common names, and synonyms
PYRITHIOXINE
3,3'-(DITHIODIMETHYLENE)BIS(5-HYDROXY-6-METHYL-4-PYRIDINEMETHANOL)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, this product has been banned due
to evidence of insufficient therapeutic value and risk of misuse.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
WHO Comment : Pyritinol, which is claimed to promote the uptake of glucose in
the brain, is used in the treatment of cerebrovascular disorders. However, WHO is
not aware of controlled experimental data to show that it has any therapeutic effect.

Product Name Pyrrolizidine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office has decided to withdraw certain medicines containing
pyrrolizidine alkaloids with a 1,2 unsaturated necine structure which occur in the cells of
many plant species on the grounds that they are potentially carcinogenic and hepatotoxic.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 137(32):2400, , 1992)
BEL 02 Sep 1992 The Minister of Social Integration, Public Health and the Environment decided to prohibit
the use of medicinal products derived from plants containing pyrrolizidine alkaloids
having regard to the potential of these substances to induce veno-occlusive liver disease,
pulmonary and central nervous system toxicit, as well as their potential carcinogenicity,
mutagenicity and teratogenicity.
(Reference: (BELMD) Ministerial Decree, , , 02 Sep 1992)
GBR 20 Mar 1993 Tablet and capsule formulations of comfrey containing pyrrolizidine alkaloids have been
voluntarily withdrawn from the market following reports of liver toxicity.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 377, , 20 Mar 1993)
WHO Comment : Plants containing pyrrolizidine alkaloids have traditionally been
made into teas in the Caribbean and South-East Asia and several of these active
substances have been incorporated into medicines for use in treatment for a
variety of illnesses. The decision to prohibit use of these products was based on
their association with a variety of adverse effects and on their hepatotoxic and

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 235

Product Name Pyrrolizidine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
carcinogenic potential as seen in both laboratory animals and in communities that
commonly use plants containing these compounds to prepare teas and other
beverages.

Product Name Quinine sulfate

C.A.S. number 804-63-7
Scientific and common names, and synonyms
CINCHONAN-9-OL, 6'-METHOXY-, (8?, 9R)-, SULFATE (2:1) (SALT)
CHININI SULFAS

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 22 Aug 1994 After reviewing the available information concerning over-the-counter drug products for
the treatment and/or prevention of nocturnal leg muscle cramps, the Food and Drug
Administration has concluded that the risk associated with use of quinine sulfate, in the
absence of evidence of its effectiveness, outweighs any potential benefit in treating
and/or preventing this benign, self-limiting condition. Moreover, in doses used to treat or
prevent this condition, quinine sulfate has caused adverse events such as transient
visual and auditory disturbances, dizziness, fever, nausea, vomiting and diarrhoea.
Quinine sulfate has been reported to cause unpredictable serious and life-threatening
hypersensitivity reactions requiring medical intervention and hospitalization, including
fatalities.
(Reference: (FEREAC) Federal Register, 59(161) , p. 43234, 1994)
USA 20 Mar 1998 The Food and Drug Administration has issued a final rule revoking approval for over-the-
counter sale of products containing quinine for the treatment and/or prevention of malaria
because the treatment of malaria requires medical supervision. Additionally, the agency
is concerned about the possible misuse of quinine for the treatment or prevention of
night-time leg muscle cramps, an indication that has been revoked (see other entry).
(Reference: (FEREAC) Federal Register, 63(54) , p. 13526, 1998)
WHO Comment : Quinine is an important drug in the treatment of multi- drug-
resistant forms of malaria. Its use in nocturnal leg muscle cramps, a benign and
self-limiting condition, is connected with unjustified risks. Quinine is listed in the
WHO Model List of Essential Drugs for treatment of malaria.

Product Name Remifentanil

C.A.S. number 132875-61-7
Scientific and common names, and synonyms
1-PIPERIDINEPROPANOIC ACID, 4-(METHOXYCARBONYL)-4-[(1-OXOPROPYL)PHENYLAMINO]-, METHYL
ESTER,MONOHYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Nov 1996 The Drug Enforcement Administration has rescheduled the narcotic analgesic,
remifentanil and its salts, into Schedule II of the Controlled Substances Act, thus
subjecting it to the corresponding regulatory controls and criminal sanctions governing its
manufacture, distribution, dispensing, importation and exportation.
(Reference: (FEREAC) Federal Register, 61(222) , p. 58471, 1996)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 236

Product Name Remifentanil

C.A.S. number 132875-61-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

WHO Comment : Remifentanil is defined as an opioid narcotic with an addiction-

forming and addiction-sustaining liability similar to morphine.

Product Name Remoxipride

C.A.S. number 117591-79-4
Scientific and common names, and synonyms
BENZAMIDE, 3-BROMO-N-[(1-ETHYL-2-PYRROLIDINYL)METHYL]-2,6-DIMETHOXY-, (S)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 14 Mar 1994 The manufacturer of the antipsychotic dopamine antagonist, remoxipride, has decided to
withdraw the product licence worldwide following concern about an association with its
use and aplastic anaemia. It will, however, remain available on a compassionate basis
for named patients.
(Reference: (ASTRA) Communication from Astra, , , 14 Mar 1994)

Product Name Retinol

C.A.S. number 68-26-8
Scientific and common names, and synonyms
AXEROPHTHOCUM
VITAMIN A
3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2,4,6,8-NONATETRAEN-1-OL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1 Apr 1989 Oral dosage forms of products containing vitamin A (retinol) are required to bear the
following warnings: 1) preparations bearing a maximum recommended daily dosage of
more than 25000 IU: "Because of danger of congenital malformations, not allowed during
pregnancy nor for women of childbearing age." 2) preparations bearing a maximum
recommended daily dosage of 10000 IU to 25000 IU: "Contraindicated during pregnancy
because of danger of congenital malformations." 3) preparations bearing a maximum
recommended daily dosage of 10000 IU: "Pregnant women should not exeed the
recommended daily dosage except on medical advice."
(Reference: (DAZ) Deutsche Apotheker Zeitung, 128(41), 85, 1988)
AUS 1996 The Adverse Drug Reactions Advisory Committee has reminded prescribers of the need
to advise patients who are pregnant or likely to become pregnant not to exceed the
recommended daily allowance of vitamin A (retinol) from all sources because of the risk
of birth defects. The label should also bear the following warning statement: "
WARNING - Taking more than 25,000 IU a day during pregnancy may cause birth
defects".
(Reference: (AUSADR) Australian Adverse Drug Reactions Bulletin, 15(4):14, , 1996)
IRL May 1996 Following the review of a study that concluded that high dietary intake of Vitamin A
(retinol) appears to be teratogenic, the Irish Medicines Board requested marketing
authorization holders to update product authorization documents for these products
accordingly and stresses that women who are pregnant or likely to become pregnant
should be aware of the potential risks associated with high doses of Vitamin A both from

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 237

Product Name Retinol

C.A.S. number 68-26-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
dietary and supplementary sources (more than 10,000 units per day).
(Reference: (NEJOM) New England Journal of Medicine, 333:1369-73, , 1995)
(Reference: (IRDDS) Drug Safety Newsletter, No. 2, , May 1996)
WHO Comment : Vitamin A, a fat-soluble vitamin, is used in the treatment and
prevention of vitamin A deficiency resulting from inadequate dietary intake. It has
been demonstrated to be teratogenic at high doses (more than 25,000 IU per day).
Daily dosages of less than 10000 IU seem to be free of this risk. Retinol (vitamin A)
is listed in the WHO Model List of Essential Drugs.

Product Name Rituximab

C.A.S. number 174722-31-7
Scientific and common names, and synonyms
IDEC-102

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Feb 1999 The Medicines Control Agency has severely restricted the use of the monoclonal
antibody used in the treatment of non- Hodgkin?s lymphoma. Treatment should now only
be undertaken in a hospital environment under the close supervision of a specialist
oncologist/haematologist who has access to full resuscitation facilities. This is because of
a number of cases of serious infusion-related reactions reported worldwide including 8
with a fatal outcome.
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)

Product Name Rubiae tinctorum radix

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 29 Apr 1992 The Federal Health Office has decided to revoke the marketing authorization of all
medicinal products containing derivatives of Rubiae tinctorum radix, including lucidin and
other derivatives of anthraquinone.
(Reference: (DEUFHO) Communication from Federal Health Office, , , 29 Apr 1992)
WHO Comment : Extracts of Rubiae tinctorum radix have traditionally been used as
treatment for a variety of diseases. Regulatory action has been taken because
insufficient evidence has been gathered about its efficacy. Lucidin (1,2-
dihydroxyanthraquinone), a component of Rubia tinctorum, has been shown in
animal experiments to induce both benign and malignant tumours in the gastric
and intestinal mucosa. Lucidin is positive for the Ames test indicating possible
genotoxicity.

Product Name Santonin

C.A.S. number 481-06-1

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 238

Product Name Santonin

C.A.S. number 481-06-1
Country Effective Description of action taken
Date Grounds for decision
SGP Oct 1978 Importation prohibited.
WHO Comment : Santonin, a crystalline lactone obtained from flowerheads of
species of Artemisia, was formerly used as an anthelminthic. Its use was
associated with a range of adverse effects, mainly involving the sense organs and
the central nervous system, some of which were fatal. It has been superseded by
other less toxic and more effective anthelminthics.

Product Name Scopolamine

C.A.S. number 51-34-3
Scientific and common names, and synonyms
6BETA,7BETA-EPOXY-1ALPHAH,5ALPHAH-TROPAN-3ALPHA-OL(-)-TROPATE (ESTER)

BENZENEACETIC ACID, ALPHA-(HYDROXYMETHYL)-,9-METHYL-3-OXA-9-AZATRICYCLO[3.3.1.0.???]NON-7-YL

ESTER,[7(S)-(1ALPHA,2BETA,4BETA,5ALPHA,7BETA]-
HYSOCINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1 Mar 1988 Depot plasters containing scopolamine have been subjected to prescription control, on
the grounds of adverse effects including visual disturbances, hallucinations and
glaucoma.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 2, 8, 1988)
WHO Comment : Scopolamine, an alkaloid with anticholinergic activity extracted
from solanaceous plants, was introduced into medicine in 1888. It is used as a
mydriatic, as an anti-emetic for the control of motion sickness, and for
premedication in general anaesthesia. Shortly after their introduction in the early
1980's, transdermal delivery systems containing scopolamine that were indicated
for the prevention of motion sickness were associated with visual disorders (e.g.
mydriasis, glaucoma) and hallucinations. The action taken in Norway is in
accordance with the legislation in several other countries where these preparations
have always been subjected to prescription control.

Product Name Secobabital

C.A.S. number 76-73-3
Scientific and common names, and synonyms
5-ALLYL-5-(1-METHYLBUTYL) BARBITURIC ACID
QUINALBARBITONE
2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-(1-METHYLBUTYL)-5-(2-PROPENYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GHA 1 Sep 1989 Products containing secobarbital have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
NZL 1990 In agreement with the Department of Health, products containing secobarbital sodium
have been withdrawn bythe manufacturer.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 258, , 16 July 1990)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 239

Product Name Secobabital

C.A.S. number 76-73-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN May 1991 Import and marketing of products containing secobarbital were prohibited.
(Reference: (OMNCR) Circular, 16/91, , May 1991)
WHO Comment : Secobarbital is a short to intermediate-acting barbiturate which is
controlled under Schedule III of the 1971 Convention on Psychotropic Substances.
See WHO comment for barbiturates.
(Reference: (UNCPS3) United Nations Convention on Psychotropic Substances (III),
, , 1971)

Product Name Selegiline

C.A.S. number 14611-51-9
Scientific and common names, and synonyms
BENZENEETHANAMINE, N,?-DIMETHYL-N-2-PROPYNYL-, HYDROCHLORIDE, (R)-
DEPRENYL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Feb 1995 The Food and Drug Administration modified the data sheet for selegiline to reflect the
risk of severe adverse events when the drug is used in patients taking antidepressants or
selective serotonin receptor antagonists.
(Reference: (FDAMB) FDA Medical Bulletin, 25(1), p.6, Feb 1995)
USA Mar 1997 The Food and Drug Administration modified the data sheet for selegiline to note that a
few reports of hypertensive reactions associated with the ingestion of tyramine-containing
foods have occurred in patients receiving the product at the recommended dose (5 mg,
twice daily).
(Reference: (FDAMB) FDA Medical Bulletin, 27(1), p.5, Mar 1997)
USA Mar 1997 The Food and Drug Administration refused marketing approval for selegiline citrate for
the treatment of Alzheimer's disease.
(Reference: (FEREAC) Federal Register, 59(96) , p. 26239, 19 May 1994)
WHO Comment : Selegiline was introduced in the early 1990s. It is a monoamine
oxidase inhibitor and is used in the management of Parkinson's disease. A
symptomatic effect of selegiline in Parkinson's disease has been shown, but longer
follow-up failed to provide any definitive evidence of ability to retard the loss of
dopaminergic neurons (Parkinson's Study Group, 1993).

Product Name Sertindole

C.A.S. number 106515-24-9
Scientific and common names, and synonyms
LU-23-174
1-(2-{4-[5-CHLORO-1-(P-FLUOROPHENYL)INDOL-3-YL]PIPERIDINE}ETHYL)2-IMIDAZOLIDINONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Dec 1998 The manufacturer of the antipsychotic medication, sertindole (serdolect) voluntarily
suspended the availability of serdolect. This is because of concerns about reports of

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 240

Product Name Sertindole

C.A.S. number 106515-24-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
cardiac arrhythmias and sudden cardiac death associated with its use.
(Reference: (GBRCW) Communication, , , 02 Dec 1998)
BGR The Bulgarian Drug Agency in the Ministry of Health withdrew the atypical antipsychotic
agent sertindole (serdolect) because of serious adverse reactions worldwide.
(Reference: (BGRBDA) Communication to WHO, , , )

Product Name Sibutramine

C.A.S. number 106650-56-0
Scientific and common names, and synonyms
BTS-54524 (SIBUTAMINE HYDROCHLORIDE)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1998 The Drug Enforcement Administration has placed sibutramine for the management of
obesity, in Schedule IV of the Controlled Substances Act. This scheduling is based on
the low potential for abuse of sibutramine and the fact that it has a currently accepted
medical use in treatment in the United States.
(Reference: (FEREAC) Federal Register, 63(28) , p. 6862, 1998)

Product Name Sildenafil

C.A.S. number 139755-83-2
Scientific and common names, and synonyms
1-[[3-(4,7-DIHYDRO-1-METHYL-7-OXO-3-PROPYL-1-H-PYRAZOLO[4,3-D]PYRIMIDIN-5-YL)-4-
ETHOXYPHENYL]SULFONYL]-4-METHYLPIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHL Sep 2001 The Public Health Institute of Chile modified the labels to include the information that a
medical evaluation is needed before administering this medication.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)

Product Name Silver acetate

C.A.S. number 563-63-3
Scientific and common names, and synonyms
ARGENTI ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CYP 23 Oct 1992 The Drugs Council rejected a marketing application for a lozenge preparation containing
silver acetate intended as a smoking deterrent.
(Reference: (CYPPS) Pharmaceutical Services, Ministry of Health, , , 23 Oct 1992)
WHO Comment : Silver acetate has been used as a disinfectant and as an anti-
smoking aid. It was refused registration in Cyprus on the grounds that prolonged

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 241

Product Name Silver acetate

C.A.S. number 563-63-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
use of silver salts can cause permanent argyria and that no well-controlled trials
have been performed to establish the safety and efficacy of the preparation. It
remains registered as an aid to stopping smoking in Canada and the United States.

Product Name Sodium dibunate

C.A.S. number 14992-59-2
Scientific and common names, and synonyms
SODIUM 2,6-DI-TERT-BUTYL-1(OR 3)-NAPHTHALENESULFONATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Apr 1982 Withdrawn from use as an antitussive following demonstration of central nervous system
toxicity in experimental mice. Prolonged administration in humans results in reduction in
granular leukocytes.

Product Name Sodium hydrogen bicarbonate (paediatric)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NPL 21 Jul 1997 The health authorities have banned the importation, manufacture, sale, distribution and
storage of sodium hydrogen bicarbonate in liquid formulations intended for paediatric
use. This action has been taken on the basis of safety concerns relating to this product.
(Reference: (NPLGZ) Nepal Gazette, Part 47(15), Notice 1, 21 July 1997)

Product Name Somatropin (pituitary-derived)

C.A.S. number 12629-01-5
Scientific and common names, and synonyms
GROWTH HORMONE, HUMAN
HGH
STH
SOMATOTROPIN
SOMATOTROPHIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CYP 1985 Voluntarily withdrawn by Kabi Vitrum following reports of deaths associated with its use.
IRL 1985 Some preparations containing growth hormone derived from human pituitary have been
withdrawn while use of others is severely restricted.
ISR 1985 The Ministry of Health has decided that no patients should be newly placed on growth
hormone therapy unless they are suffering from associated hypoglycaemia.
(Reference: (ISRDB) Israel Drug Information Bulletin, , , Feb 1987)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 242

Product Name Somatropin (pituitary-derived)

C.A.S. number 12629-01-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL 1985 Preparations of somatropin (growth hormone) extracted from human pituitary glands have
been withdrawn by the Department of Health following reports of Creutzfeldt-Jakob
disease associated with their use.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, , , )
BEL May 1985 The National Commission for Pitutiary Dwarfism has advised doctors not to prescribe
somatropin (human growth hormone) following reports of Creutzfeldt-Jakob disease
associated with their use.
(Reference: (BFOLP) Folia Pharmacotherapeutica, 12(6), 46, 1985)
GBR May 1985 Withdrawn following reports of deaths associated with its use.
NLD May 1985 The use of products containing pituitary-derived human growth hormone (somatropin)
was discontinued following reports of Creutzfeldt-Jakob disease associated with their use.
EGY 9 Jul 1985 Withdrawn from the market.
USA Aug 1985 The Food and Drug Administration has withdrawn the licence of the National Pituitary
Agency for manufacture of human growth hormone preparations following reports of
death associated with their use.
(Reference: (FDADB) FDA Drug Bulletin, 15(2), 17-18, 1985)
DEU Sep 1985 The Federal Health Office has informed doctors to restrict the use of human somatropin
(growth hormone) to the treatment of pituitary dwarfism with hypoglycaemic reactions or
before the end of the growth period. Preparations must bear a warning that some patients
contracted Creutzfeldt-Jakob disease after treatment. No more than three batches should
be used for each patient.
TUR Oct 1985 Banned for production, import, export, sale and use having regard to severe adverse
reactions.
OMN 16 Jan 1986 Import of pharmaceutical preparations containing somatropin (human growth hormone)
has been prohibited following reports of Creutzfeldt-Jakob disease associated with their
use.
(Reference: (OMNMH) Ministry of Health, 2, , 1986)
ITA The manufacture and use of somatropin (human growth) hormone have been restricted
following reports of Creutzfeldt-Jakob disease associated with its use.
THA Preparations containing somatropin are not approved for use.
WHO Comment : Somatropin, a pituitary-derived human growth hormone, has been
used in the treatment of hypopituitary dwarfism for over twenty years. In 1985 it
became known that Creutzfeldt-Jakob disease, a potentially fatal form of brain
degeneration resulting from a slow neurotropic viral infection, had developed in
several patients who had received preparations of somatropin in the late
1960s/early 1970s. This led to the withdrawal of these preparations in many
countries. An international collaborative effort was maintained to identify newly-
diagnosed cases. By 1990 a total of 30 such cases had been notified. More efficient
purification procedures introduced during the 1970s greatly reduced the risk of
viral contamination, but products containing pituitary-derived somatropin have
been superseded by biosynthetically-manufactured preparations produced using
recombinant techniques.

Product Name Sotalol

C.A.S. number 3930-20-9
Scientific and common names, and synonyms
METHANESULFONAMIDE, N-[4-[1-HYDROXY-2-[(1-METHYLETHYL)AMINO]ETHYL]-PHENYL]-,MONOHYDROCHLORIDE

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 243

Product Name Sotalol

C.A.S. number 3930-20-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Jul 1996 The Committee on Safety of Medicines has restricted the indications of sotalol to the
treatment of ventricular arrhythmias or prophylaxis of supraventricular arrhythmias.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, 22:6-7, , July 1996)
WHO Comment : Sotalol is a non-selectiveß-adrenoreceptor antagonist. It should
be noted that when stopping sotalol the dose should be reduced gradually.

Product Name Sparfloxacin

C.A.S. number 110871-86-8
Scientific and common names, and synonyms
5-AMINO-1-CYCLOPROPYL-7-(CIS-3,5-DIMETHYLPIPERAZIN-1-YL)-6,8-DIFLUORO-4-OXOQUINOLINE-3-CARBOXYLIC
ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN 1995 The Pharmaceutical Affairs Bureau has decided to include a warning statement in the
data sheet for sparfloxacin about photosensitivity and rash related to exposure to sunlight.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.127, , July 1994)
FRA Jun 1995 The Medicines Agency has announced that in view of a large number of reports of
phototoxicity associated with the use of sparfloxacin, the indications for the use of
sparfloxacin have been restricted to: acute bacterial pneumonia, diagnostically
confirmed by X-ray, and to acute bacterial sinusitis with documented evidence of
pneumococcus with reduced sensitivity to penicillin.
(Reference: (FRAAMC) Communiqué de Presse, , , 06 June 1995)
WHO Comment : Sparfloxacin is a quinolone antimicrobial agent. See also under
quinolone and fluoroquinolone antimicrobial agents.

Product Name Spironolactone

C.A.S. number 52-01-7
Scientific and common names, and synonyms
PREGN-4-ENE-21-CARBOXYLIC ACID, 7-(ACETYLTHIO)-17-HYDROXY-3-OXO,GAMMA- LACTONE, (7ALPHA,17ALPHA)-
17-HYDROXY-7ALPHA-MERCAPTO-3-OXO-17ALPHA-PREGN-4-ENE-21-CARBOXYLIC ACID, GAMMA-LACTONE
ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Oct 1986 Having regard to the possible carcinogenic risk associated with long-term use of
spironolactone, the approved indications of products containing spironolactone are now
restricted to cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome,
the diagnosis and treatment of primary hyperaldosteronism, and congestive heart failure.
WHO Comment : Spironolactone, an aldosterone antagonist, has been widely used
for over 25 years in the treatment of hypertension and in the management of
refractive oedema. Evidence that long-term administration of high doses are
tumorigenic in the rat has recently led to restriction of its use by some national
regulatory authorities although the significance of this finding with respect to
clinical use is not certain. In 1987 spironolactone was transferred from the main list
to the complementary list of the WHO Model List of Essential Drugs. (See also

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 244

Product Name Spironolactone

C.A.S. number 52-01-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO comments for canrenone and potassium canrenoate).
(Reference: (WHODI) WHO Drug Information, 2(1), , 1988)

Product Name Streptomycin

C.A.S. number 57-92-1
Scientific and common names, and synonyms
D-STREPTAMINE, O-2-DEOXY-2-(METHYLAMINO)-ALPHA-L-GLUCOPYRANOSYL-(1->2)-O-5-DEOXY-3-C-FORMYL-
ALPHA-L-LYXOFURANOSYL-(1->4)-N,N'-BIS(AMINOIMINOMETHYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
KOR May 1991 Antidiarrhoel products containing streptomycin were not accepted for registration.
(Reference: (KRMHSA) Ministry of Health and Social Affairs - Communication to WHO, ,
, 13 Dec 1991)
LBN 03 Aug 1991 Liquid formulations of products containing streptomycin indicated for the treatment of
diarrhoea in children were withdrawn.
(Reference: (LBNMHD) Ministry of Health and Social Affairs Decree, 150/1, , Aug 1991)
WHO Comment : Oral preparations of streptomycin, an aminoglycoside antibiotic
isolated from streptomyces griseus in 1944, were formerly widely used to treat
intestinal infections. There is no evidence that streptomycin is effective in this
indication and its widespread use promotes the emergence of resistant strains of
bacteria. The World Health Organization recommends that streptomycin should not
be used for the treatment of diarrhoea.
(Reference: (WHORUD) The Rational Use of Drugs, , , 1990)

Product Name Strychnine and salts

C.A.S. number 57-24-9
Scientific and common names, and synonyms
STRYCHNIN (DEU)
STRYCHNIDIN-10-ONE
STRICNINA (ITA)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CAN 1979 The Health Protection Branch has considered the value of strychnine in drugs for human
use and concluded that this substance has no established therapeutic significance. S.C.
01.038 of the Food and Drug Act states that "A drug for human use is adulterated if it
contains: a) strychnine or any of its salts, b) extracts or tinctures of 1) Strychnos nux-
vomica 2) Strychnos ignatii or 3) Strychnos species containing strychnine, other than
those species mentioned in sub paragraph 1) and 2)".
BRA 17 Jul 1980 Products containing strychnine are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, (12), , 1980)
BGD Mar 1982 Under the provisions of the Drugs (Control) Ordinance, this product has been banned.
Authorities feel that "Strychnine should only be used as a rodenticide".

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 245

Product Name Strychnine and salts

C.A.S. number 57-24-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
JPN 1987 Preparations containing strychnine have been withdrawn.
PAK Jan 1987 The Registration Board of the Ministry of Health has directed manufacturers to
reformulate all preparations containing strychnine so as to delete this ingredient.
BRA Feb 2001 Registration of combination products containing strychnine are banned because of the
potential to cause convulsions.
(Reference: (BRARES) Resolucao n., 147/ANVISA, , 14 Aug 2001)
ARE Pharmaceutical preparations containing strychnine are banned.
PHL Products containing strychnine are banned for use and sale.
WHO Comment : Strychnine, the principal alkaloid present in nux vomica, was first
used in medicine several centuries ago. However, it has no demonstrated
therapeutic value and there is no current justification for its presence in any
medication. It continues to be used as a rodenticide though such use is severely
restricted in many countries since accidental ingestion can be lethal.

Product Name Sulfacarbamide

C.A.S. number 547-44-4
Scientific and common names, and synonyms
SULFANILYLUREA

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office withdrew products containing sulfacarbamide from the market.
This decision is based on a review carried out by the Advisory Panel for the Evaluation of
Medicines which concluded that the benefit/risk ratio for these products is negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
WHO Comment : Sulfacarbamide, a sulfonamide anti-infective agent, was
introduced in the 1940's for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing bacterial
resistance and their replacement by antibiotics which are generally more active
and less toxic. The Sulfacarbamide are known to cause serious adverse effects
such as renal toxicity, sometimes fatal exfoliative dermatitis and erythema
multiforma and dangerous adverse reactions affecting blood formation such as
agranulocytosis and haemolytic or aplastic anaemia. Sulfacarbamide still remains
available in at least one country for the treatment of urinary infections.

Product Name Sulfadicramide

C.A.S. number 115-68-4
Scientific and common names, and synonyms
3-METHYL-N-SULPHANILYLCROTONAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 246

Product Name Sulfadicramide

C.A.S. number 115-68-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office has withdrawn products containing sulfanilamide from the
market. This decision is based on a review carried out by the Advisory Panel for the
Evaluation of Medicines which concluded taht the benefit/risk ratio for these products is
negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
WHO Comment : Sulfadicramide, a sulfonamide anti-infective agent, was
introduced in 1942 for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing resistance and
their replacement by antibiotics which are generally more active and less toxic. The
sulfonamides are known to cause serious adverse effects such as renal toxicity,
sometimes fatal exfoliative dermatitis and erythema multiforma and dangerous
adverse reactions affecting blood formation such as agranulocytosis and
haemolytic or aplastic anaemia. Sulfadicramide is still used in some countries as a
15% ointment for application to the eye.

Product Name Sulfadimidine

C.A.S. number 57-68-1
Scientific and common names, and synonyms
SULFAMETHAZINE
SULFADIMIDINUM
SULFADIMEZINIUM
SULFADIMETHYLPYRIMIDINE
SULFADIMERAZINE

4-(4,6-DIMETHYLPRIMIDINE-2-YL)SULPHANILIMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office has withdrawn products containing sulfadimidine from the
market. This decision is based on a review carried out by the Advisory Panel for the
Evaluation of Medicines which concluded that the benefit/risk ratio for these products is
negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
WHO Comment : Sulfadimidine, a sulfonamide anti-infective agent, was introduced
in 1942 for the treatment of bacterial infections. The importance of sulfonamides
has subsequently decreased as a result of increasing resistance and their
replacement by antibiotics which are generally more active and less toxic. The
sulfonamides are known to cause serious adverse effects such as renal toxicity,
sometimes fatal exfoliative dermatitis and erythema multiforma and dangerous
adverse reactions affecting blood formation such as agranulocytosis and
haemolytic or aplastic anaemia. Sulfadimidine is still used in some countries as a
injectable or oral antimicrobial for susceptible infections.

Product Name Sulfaguanidine

C.A.S. number 57-67-0
Scientific and common names, and synonyms

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 247

Product Name Sulfaguanidine

C.A.S. number 57-67-0
Scientific and common names, and synonyms
BENZENESULFONAMIDE, 4-AMINO-N-(DIAMINOMETHYLENE)-
N-AMIDINOSULPHANILAMIDE MONOHYDRATE
N1-(DIAMINOMETHYLENE)SULFANILAMIDE
SULGIN

SULGINUM
SOLFAGUANIDINA
SULFAMIDINUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DOM Jun 1971 Prohibited for import, manufacture, distribution, storage, sale or medical prescription. It
has been found to be ineffectual in the treatment of acute bacterial dysentery and in
therapeutic use with colon surgery in reducing hospitalization. Furthermore, it has been
shown that most strains of Shigella have developed a resistance against this drug in vivo.
IRN 1972 The Ministry of Health has prohibited the importation and production of all drugs
containing sulfaguanidine.
THA Jan 1975 May only be used in the treatment of diarrhoea.
TUR 4 Mar 1985 Banned for production and sale having regard to severe adverse reactions.
PAK 1988 Tablets containing sulfaguanidine were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
NPL 1991 Products containing sulfaguanidine either alone or in combination, and intended for the
treatment of diarrhoea in children, were banned.
(Reference: (NPLDDA) Communication from the Department of Drug Administration, , ,
27 Feb 1992)
DEU 1992 The Federal Health Office has withdrawn products containing sulfaguanidine from the
market. This decision is based on a review carried out by the Advisory Panel for the
Evaluation of Medicines which concluded that the benefit/risk ratio for these products in
negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
ARM Jul 2000 The Drug and Medical Technology Agency withdrew registration of the antidiarrhoeal
drug sulgin because of increasing resistance to sulfonamides and also because
nonabsorbable sulfonamides containing antidiarrhoeal products are not recommended in
the treatment of diarrhoea.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)
DNK Withdrawn from the market by the manufacturer.
VEN Not approved for use and/or sale. Compound currently under study.
WHO Comment : Sulfaguanidine, a sulfonamide anti-infective agent, was
introduced in 1941 for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing bacterial
resistance and their replacement by antibiotics which are generally more active
and less toxic. The sulfonamides are known to cause serious adverse effects such
as renal toxicity sometimes fatal exfoliative dermatitis and erythema multiforma
and dangerous adverse reactions affecting blood formation such as
agranulocytosis and haemolytic or aplastic anaemia. Although sulfaguanidine,
which is poorly absorbed from the gastrointestinal tract, is no longer
recommended in some countries, it continues to be used in others for the
treatment of local intestinal infections, including bacterial dysentery, and for pre-

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 248

Product Name Sulfaguanidine

C.A.S. number 57-67-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
operative bowel preparation.

Product Name Sulfamerazine sodium

C.A.S. number 127-58-2
Scientific and common names, and synonyms
SULFAMERAZINUM NATRICUM
SOLUBLE SULPHERAMERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office has withdrawn products containing sulfamerazine sodium from
the market. This decision is based on a review carried out by the Advisory Panel for the
Evaluation of Medicines which concluded that the benefit/risk ratio for these products is
negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
WHO Comment : Sulfamerazine sodium, a sulfonamide anti-infective agent, was
introduced several decades ago for the treatment of bacterial infections. The
importance of sulfonamides has subsequently decreased as a result of increasing
resistance and their replacement by antibiotics which are generally more active
and less toxic. The sulfonamides are known to cause serious adverse effects such
as renal toxicity, sometimes fatal exfoliative dermatitis and erythema multiforma
and dangerous adverse reactions affecting blood formation such as
agranulocytosis and haemolytic or aplastic anaemia. Sulfamerazine is still used in
some countries usually in combination with other sulfonamides.

Product Name Sulfamethizole

C.A.S. number 144-82-1
Scientific and common names, and synonyms
BENZENESULFONAMIDE, 4-AMINO-N-(5-METHYL-1,3,4-THIADIAZOL-2-YL)-
N1-(5-METHYL-1,3,4-THIADIAZOL-2-YL)SULPHANILAMIDE
N1-(5-METHYL-1,3,4-THIADIAZOL-2-YL)-SULFANILAMIDE
SULPHAMETHIZOLE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1 Feb 1984 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. A combination of adverse reactions and low sales led to this
decision.
WHO Comment : Sulfamethizole, a sulfonamide anti-infective agent, was
introduced in 1953 for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing bacterial
resistance and their replacement by antibiotics which are generally more active
and less toxic. However sulfamethizole, which is rapidly eliminated, retains a place
in the treatment of urinary infections in some countries whereas in others its use

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 249

Product Name Sulfamethizole

C.A.S. number 144-82-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
has been discontinued.

Product Name Sulfamethoxypyridazine

C.A.S. number 80-35-3
Scientific and common names, and synonyms
N1-(6-METHOXYPYRIDAZIN-3-YL)SULPHANILAMIDE
N1-(6-METHOXY-3-PYRIDAZINYL)SULFANILAMIDE
SULPHAMETHOXYPYRIDAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1 Feb 1984 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. A combination of adverse reactions and low sales led to this
decision.
PAK 1988 Products containing sulfamethoxypyridazine were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
ARE Pharmaceutical preparations containing sulfamethoxypyridazine are banned.
WHO Comment : Sulfamethoxypyridazine, a sulfonamide anti-infective agent, was
introduced in 1957 for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing bacterial
resistance and their replacement by antibiotics which are generally more active
and less toxic. The sulfonamides are known to cause serious adverse effects such
as renal toxicity, sometimes fatal exfoliative dermatitis and erythema multiforma
and dangerous adverse reactions affecting blood formation such as
agranulocytosis and haemolytic or aplastic anaemia. Commercial manufacture of
the drug has been discontinued by at least one major manufacturer but supplies
can still be obtained on special request, particularly for patients with dermatitis
herpetiformis in which condition it has been claimed to be beneficial.

Product Name Sulfanilamide

C.A.S. number 63-74-1
Scientific and common names, and synonyms
SULFANILAMIDUM
SULFAMINUM
STREPTOCIDIN
SOLFAMMIDE
4-AMINOBENZENESULPHONAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office has withdrawn products containing sulfanilamide from the
market. This decision is based on a review carried out by the Advisory Panel for the
Evaluation of Medicines which concluded that the benefit/risk ratio for these products is

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 250

Product Name Sulfanilamide

C.A.S. number 63-74-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
WHO Comment : Sulfanilamide, a sulfonamide anti-infective agent, was introduced
in 1936 for the treatment of bacterial infections. The importance of sulfonamides
has subsequently decreased as a result of increasing resistance and their
replacement by antibiotics which are generally more active and less toxic. The
sulfonamides are known to cause serious adverse effects such as renal toxicity,
sometimes fatal exfoliative dermatitis and erythema multiforma and dangerous
adverse reactions affecting blood formation such as agranulocytosis and
haemolytic or aplastic anaemia. Sulfanilamide is still used in some countries as a
pessaries or as vaginal cream.

Product Name Sulfathiazole

C.A.S. number 72-14-0
Scientific and common names, and synonyms
BENZENESULFONAMIDE, 4-AMINO-N-2-THIAZOLYL
NORSULFAZOLUM

N1-2-THIAZOLYLSULFANILAMIDE
N1-(THIAZOL-2-YL)SULPHANILAMIDE
SULFONAZOLUM
SULFANILAMIDOTHIAZOLUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Sep 1970 Sulfathiazole has been withdrawn as an ingredient in products for systemic use due to
the known serious hazards associated with this compound. The Food and Drug
Administration has determined that the benefit/risk ratio associated with this compound is
unfavourable especially in the light of the availability of other sulfonamides with
equivalent benefits and less risk. Prohibited for export.
(Reference: (FEREAC) Federal Register, 35, 16190, Oct 1970)
PHL May 1971 The use of this drug as an antidiarrhoeal has been withdrawn due to the risk of
crystalluria.
DOM Mar 1982 Preparations containing sulfathiazole or its sesquihydrate or monohydrate as the active
ingredient have been prohibited for use and/or sale since they have been associated with
serious side effects and shown to be of questionable efficacy.
WHO Comment : Sulfathiazole, a sulfonamide anti-infective agent, was introduced
more than 25 years ago for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing bacterial
resistance and their replacement by antibiotics which are generally more active
and less toxic. The sulfonamides are known to cause serious adverse effects such
as renal toxicity, sometimes fatal exfoliative dermatitis and erythema multiforma
and dangerous adverse reactions affecting blood formation such as
agranulocytosis and haemolytic or aplastic anaemia. Although preparations remain
available, use of the drug has been discontinued in many countries.

Bibliographical references
WHO FOOD ADD., 25, 95, 1991

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 251

Product Name Sulfisomidine

C.A.S. number 515-64-0
Scientific and common names, and synonyms
N-(2,6-DIMETHYLPYRIMIDIN-4-YL)SULPHANILAMIDE
SULFASOMIDINE
SULFAISODIMIDINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1992 The Federal Health Office has withdrawn products containing sulfisomide from the
market. This decision isbased on a review carried out by the Advisory Panel for the
Evaluation of Medicines which concluded that the benefit/risk ratio for these products is
negative.
(Reference: (DWM) Wichtige Mitteilungen, 18, , 1992)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 132(11), , 1992)
WHO Comment : Sulfisomide, a sulfonamide anti-infective agent, was introduced
several decades ago for the treatment of bacterial infections. The importance of
sulfonamides has subsequently decreased as a result of increasing resistance and
their replacement by antibiotics which are generally more active and less toxic. The
sulfonamides are known to cause serious adverse effects such as renal toxicity,
sometimes fatal exfoliative dermatitis and erythema multiforma and dangerous
adverse reactions affecting blood formation such as agranulocytosis and
haemolytic or aplastic anaemia. Sulfisomide is still used topically in some
countries for vaginal infection.

Product Name Sulfonamides (topical preparations)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHL Pharmaceutical preparations for topical use containing sulfonamide and its derivatives
are prohibited.
(Reference: (CHLRS) Resolution of the Minister of Health, No.10154, , Oct 1986)

Product Name Suloctidil

C.A.S. number 54767-75-8
Scientific and common names, and synonyms
BENZENEMETHANOL, 4-((1-METHYLETHYL)THIO)-ALPHA-(1-(OCTYLAMINO)ETHYL-, ( R*,S*)-
ERYTHRO-P-(ISOPROPYLTHIO)-ALPHA-(1-(OCTYLAMINO)ETHYL)BENZYL ALCOHOL
1-(4-ISOPROPYLTHIOPHENYL)-2-OCTYLAMINOPROPAN-1-OL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 1985 Suloctidil, a vasodilator, was voluntarily withdrawn worldwide by the manufacturer
following several reports of hepatitis associated with its use, some of which were fatal.
DEU Jul 1985 The Federal Office of Health has not renewed its approval for suloctidil following reports
of hepatitis. Meanwhile the manufacturer stopped the sale of this drug and recalled all
distributed packages.
AUT Oct 1985 The Federal Ministry of Health and Environmental Protection prohibited the use of
preparations containing suloctidil following reports of hepatotoxic effects.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 252

Product Name Suloctidil

C.A.S. number 54767-75-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CYP Voluntarily withdrawn by the manufacturer following reports of hepatitis.
WHO Comment : Suloctidil, a peripheral vasodilator, was introduced in 1975 for the
treatment of arterial disease. By 1985 its use had been associated with serious
adverse effects, including deaths from hepatitis. In July 1985 renewal for approval
was refused in the Federal Republic of Germany. This was followed by the
voluntary withdrawal of the drug by the manufacturer firstly in several European
countries and ultimately on a worldwide basis.

Product Name Sulprostone

C.A.S. number 60325-46-4
Scientific and common names, and synonyms
[1R-[1ALPHA(Z),2BETA(1E,3R*),3ALPHA]]-7-[3-HYDROXY-2-(3-HYDROXY-4-PHENOXY-1-BUTENYL)-5-
OXOCYCLOPENTYL]-N-(METHYLSULFONYL)-5-HEPTENAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Apr 2001 Severely restricted prescription drug to be used in hospitals only.
(Reference: (THACW) Communication to WHO, , , 28 Sep 2001)

Product Name Sultopride

C.A.S. number 53583-79-2
Scientific and common names, and synonyms
N-[(1-ETHYL-2-PYRROLIDINYL)METHYL]-5-(ETHYLSULFONYL)-O-ANISAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Oct 1991 The Ministry of Health extended the contraindications for products containing sultopride
to patients with bradycardia and hypokalaemia; to those receiving drugs that may induce
bradycardia, hypokalaemia, impairment of intracardiac conduction and ventricular
arrhythmias; and to breastfeeding women. The association of sultopride with other
phenothiazines was also discouraged. A warning was required in the product information
stating that patients with severe cardiovascular disorders are at risk of hypotension and
cardiac arrhythmias. These amendments to the approved product information were made
following reports of ventricular arrhythmias in patients treated with sultopride.
(Reference: (FRAMHH) Ministry of Health and Humanitarian Action, , , 11 Dec 1992)
WHO Comment : Sultopride, a neuroleptic indicated for the treatment of acute and
chronic psychoses, was introduced on the market in 1976. In the early 1990s, its
use was associated with cardiac arrhythmias, some of which were fatal. This led
the regulatory authority in France to take restrictive action on the product.
Sultopride continues to be marketed in several other countries.

Product Name Sumatriptan

C.A.S. number 103628-48-4
Scientific and common names, and synonyms
1H-INDOLE-5-METHANESULFONAMIDE, 3-[2-(DIMETHYLAMINO)ETHYL]-N-METHYL-, BUTANEDIOATE (1:1)

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Product Name Sumatriptan

C.A.S. number 103628-48-4

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BEL 1993 The Ministry of Health has modified the approved data sheet for products containing the
serotonin receptor agonist, sumatriptan, to include the following precautions: at least one
hour should elapse between any two injections; treatment is contraindicated in persons
suffering from coronary vasospasm or other cardiovascular disorders; the effects of
sumatriptan may be potentiated by ergotamine.
(Reference: (BELARD) 1993 Annual Report, , , May 1994)
DEU Feb 1994 The Federal Health Office has amended the data sheet for pharmaceutical products
containing the serotonin receptor agonist, sumatriptan (Imigran: Glaxo), to include all
degrees of hypersensitivity including shock in the listed adverse effects associated with
treatment.
(Reference: (BGHBL) Bundesgesundheitsblatt, No. 2/94, p.94, Feb 1994)
DEU May 1994 The Federal Health Office proposed to revise the product information for pharmaceutical
products containing sumatriptan (Avessa, Imigran: Glaxo) to state that patients should
not be treated concomitantly with sumatriptan and medicinal products which influence the
serotonin metabolism (MAO inhibitors, inhibitors of serotonin re-uptake, clomipramine,
lithium), and that the use of sumatriptan is contraindicated in patients with migraine
accompanied by unilateral weakness or paralysis, paralysis of the eye muscles
(hemiplegic migraine), or temporary disturbance of vision resulting in double images or
blind spots (ophthalmoplegic migraine). Sumatriptan is also contraindicated in patients
who suffer from heart diseases and it shall be given with caution and only after careful
evaluation to asymptomatic patients with clinically important risk factors for coronary
heart disease (hyperlipidemia, obesity, diabetes mellitus, smoking).
(Reference: (DEUFHO) Communication from Federal Health Office, , , 25 May 1994)
DEU Oct 1994 The manufacturer of the serotonin receptor agonist, sumatriptan (Imigran: Glaxo) has
revised the prescribing information for this product in the light of severe adverse
reactions which have been ascribed to the incorrect use of sumatriptan, some of which
were fatal. Sumatriptan should only be used for the treatment of migraine or confirmed
cluster headache. Sumatriptan should not be administered to patients who develop
unexplained thoracic symptoms (e.g. angina-like symptoms) until cardiovascular disease
can be excluded. Sumatriptan should be administered only after cardiovascular disease
has been excluded to patients with existing heart disease or asymptomatic patients with
risk factors for coronary heart disease (older than 40 years, high blood pressure,
smoking, diabetes mellitus, obesity, long-term use of high-dose ergotamine preparations).
(Reference: (DEUFHO) Communication from Federal Health Office, , , 25 May 1994)
FRA Feb 1995 Following a request from the manufacturer of the serotonin receptor agonist, sumatriptan
(Imigran: Glaxo), the French Commission of Pharmacovigilance has revised the product
information for this product as follows. Concurrent use with monoamine oxidase
inhibitors, serotonin receptor antagonists and ergot derivatives is now contraindicated. A
previous history of allergy to sulfonamides will be mentioned in this section because of
serious cross-reactions due to a sulfonamide group in the sumatriptan molecular
structure. The warnings section will carry a reminder that sumatriptan should be
administered only after a diagnosis of migraine or facial vascular algia has been clearly
established and that if the first injection is ineffective, the diagnosis has to be
reconsidered before a second dose is administered in case the headache may be a
symptom of another condition. A reminder will be included concerning cardiovascular
risk factors and the section on precautions for use will state that in patients with a history
of convulsions or epilepsy, the occurrence of seizures must be taken into account. The
section adverse effects will include allergic reactions and convulsions.
(Reference: (FRAAMC) Communiqué de Presse, , , 02 Feb 1995)
GBR Feb 1995 The manufacturer of the serotonin receptor agonist, sumatriptan (Imigran: Glaxo) has
revised the prescribing information for this product on the basis of adverse cardiac
effects from post-marketing safety monitoring data and with the aim of promoting its
appropriate use. The existing warnings and precautions section has been strengthened

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 254

Product Name Sumatriptan

C.A.S. number 103628-48-4
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
to ensure that there is a clear diagnosis of migraine/cluster headache before
administration of sumatriptan; patients in whom unrecognized coronary disease is likely
(postmenopausal women, men over 40 or patients with other cardiovascular risk factors)
do not receive sumatriptan until an appropriate evaluation has been performed to exclude
underlying heart disease since extremely rare cases of cardiac arrhythmias, transient
ischaemic ECG changes or myocardial infarction have been reported; if symptoms
consistent with ischaemic heart disease occur, an appropriate evaluation should be
carried out. The list of contraindications now includes concomitant use of derivatives of
ergotamine as well as ergotamine, and the list of adverse effects additionally lists
tachycardia and palpitations.
(Reference: (GLAXO) Communication, , , 03 Feb 1995)
USA Aug 1995 The manufacturer of sumatriptan (Imitrex : Glaxo) has issued a "Dear Health
Professional" letter stating that sumatriptan should be prescribed only when a clear
diagnosis of migraine has been established. It should not be given to patients in whom
unrecognized coronary artery disease is likely without a prior evaluation for underlying
cardiovascular disease.
(Reference: (FDAMB) FDA Medical Bulletin, 25(2), p. 6, Aug 1995)

Product Name Suprofen

C.A.S. number 40828-46-4
Scientific and common names, and synonyms
BENZENACETIC ACID, ALPHA-METHYL-4-(2-THIENYLCARBONYL)-
PARA-2-THENOYLHYDRATROPIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD The manufacturer has suspended sales worldwide.
WHO Comment : Suprofen, a nonsteroidal anti-inflammatory agent, was introduced
in 1983 for use as an analgesic for the symptomatic relief of mild to moderate pain
and for primary dysmenorrhoea. By 1986 it had become evident that its use was
occasionally associated with flank pain sometimes accompanied by evidence of
decreased renal function. The Arthritis Advisory Committee of the United States
Food and Drug Administration met in December 1986 to review the situation and
decided against withdrawing suprofen from the market. However, in May 1987 the
Committee for Proprietary Medicinal Products of the European Community
recommended that all marketing authorizations should be suspended. The
manufacturer subsequently decided to suspend sale worldwide on the grounds
that sales had diminished to the point where the product was no longer
economically viable.

Product Name Suxamethonium chloride

C.A.S. number 71-27-2
Scientific and common names, and synonyms
ETHANAMINIUM, 2,2'-[(1,4-DIOXO-1,4,-BUTANEDIYL)BIS(OXY)]BIS[N,N,N,-TRIMETHYL-], DICHLORIDE
SUCCINYLCHOLINE CHLORIDE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 255

Product Name Suxamethonium chloride

C.A.S. number 71-27-2
Country Effective Description of action taken
Date Grounds for decision
DEU Feb 1995 The Federal Institute for Drugs and Medical Devices revised the product information to
include a warning concerning possible irreversible cardiac arrest in children and
adolescents. Because of the life-threatening nature of the adverse reaction, it is
recommended that administration of suxamethonium chloride to children and
adolescents, even if they appear to be healthy, should be considered only when
immediate intubation is planned or where there are facilities for maintaining the airway in
emergency.
(Reference: (DEURFI) Rapid Alert - Pharmacovigilance, , , 03 Feb 1995)
WHO Comment : Suxamethonium chloride is a short-acting muscle relaxant. It is
used in surgery. Suxamethonium chloride is listed in the WHO Model List of
Essential Drugs.

Product Name Suxibuzone

C.A.S. number 27470-51-5
Scientific and common names, and synonyms
4-BUTYL-(4-HYDROXYMETHYL)-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE HYDROGEN SUCCINATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1977 Indications are restricted to severe exacerbations of rheumatoid arthritis, osteoarthritis
and ankylosing spondylitis. Doctors are advised to prescribe this drug only to adults and
for periods of no longer than one week.
DEU 1985 Indications are restricted to severe exacerbations of rheumatism and acute gout.
Duration of oral treatment should not exceed one week. Parenteral preparations are
indicated only for initiating therapy. A single injection only is recommended because local
tissue damage may occur. Preparations are contraindicated in children under 14 years of
age.
OMN Sep 1986 The Ministry of Health has prohibited the import of preparations containing suxibuzone
except those intended for topical use.
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
WHO Comment : Suxibuzone, a pyrazolone derivative with anti-inflammatory,
analgesic and antipyretic activity, was introduced in 1974 for the treatment of
rheumatic disorders. As it is structurally related to phenylbutazone, it is subjected
to rigorously restricted indications by some national regulatory authorities. See
WHO comment for phenylbutazone.

Product Name Tamoxifen

C.A.S. number 10540-29-1
Scientific and common names, and synonyms
ETHANAMINE, 2-[4-(1,2-DIPHENYL-1-BUTENYL)PHENOXY]-N,N-DIMETHYL, (Z)-, 2-HYDROXY-1,2,3-
PROPANETRICARBOXYLATE (1:1)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Dec 1995 The Federal Institute for Drugs and Medical Devices has decided that the following
warnings should be included in the product information for pharmaceutical products

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 256

Product Name Tamoxifen

C.A.S. number 10540-29-1
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
containing tamoxifen: "Investigations in different in vivo and in vitro systems prove that
tamoxifen has a genotoxic potential following hepatic activation; clinical reports yield
signs of an increased risk of developing endometrial tumours".
(Reference: (DEURFI) Rapid Alert - Pharmacovigilance, , , 23 Dec 1995)
ZAF Jun 1996 The Medicines Control Council has revised the package insert for pharmaceutical
products containing tamoxifen to include a warning about an increased incidence of
endometrial changes, including hyperplasia, polyps and cancer reported in association
with tamoxifen treatment.
(Reference: (ZAFMCC) Communication, , , 22 June 1996)
WHO Comment : Tamoxifen is an anti-estrogen agent used mainly to treat breast
cancer. Tamoxifen is listed in the WHO Model List of Essential Drugs.

Product Name Tartrazine

C.A.S. number 1934-21-0
Scientific and common names, and synonyms
COLOUR INDEX NO. 19140
CI FOOD YELLOW 4
E 102
FD&C YELLOW NO.5
TRISODIUM 5-HYDROXY-1-(4-SULPHONATOPHENYL)-4-(4-SULPHONATOPHENYLAZO) PYRAZOLE-3-CARBOXYLATE
TARTRAZOL YELLOW

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1984 Not allowed in antihistamines and bronchodilators. All other products must bear a
warning about allergic reactions.
NZL Aug 1984 The inclusion of tartrazine in medicines for internal use will be phased out over the next
two years having regard to its allergenic potential. It can be used in products for external
use.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 224, , Jan 1984)
IRL 1985 Products intended for the management of allergic states and for prolonged use should be
reformulated to exclude tartrazine. Use of tartrazine should be discouraged in all other
preparations and where it is present it should be declared on the label.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , , 1985)
HUN 31 Mar 1990 Tartrazine is no longer accepted as a colouring agent in pharmaceutical products
submitted for registration. In registered products it must be replaced by 31 December
1992 and, in the meantime, these products must bear the warning: "This preparation
contains tartrazine which may cause allergic reactions in sensitized individuals".
(Reference: (HUNIP) National Institute of Pharmacy, , , 08 Feb 1990)
OMN Mar 2002 The Directorate General of Pharmaceutical Affairs and Drug Control has banned the use
of Tartrazine FD&C Yellow No. 5 in pharmaceutical products, in any pharmaceutical form,
following similar restrictions worldwide due to a spectrum of side effects such as
allergies, thyroid tumors, lymphocytic lymphomas, chromosomal damage, asthma
attacks, urticaria and hyperactivity.
(Reference: (OMNCR) Circular, 50/2001, , 12 Nov 2001)
WHO Comment : Tartrazine is widely used as a permitted colouring agent in food

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 257

Product Name Tartrazine

C.A.S. number 1934-21-0
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
and pharmaceutical preparations. Its use has been associated with allergic
reactions some of which have been severe. Several national drug regulatory
authorities now require a warning on labels of products containing tartrazine and
some manufacturers have voluntarily withdrawn this compound from their
products.

Product Name Temafloxacin

C.A.S. number 108319-06-8
Scientific and common names, and synonyms
(+/-)-(2,4-DIFLUOROPHENYL)-6-FLUORO-1,4-DIHYDRO-7-(3-METHYL-1-PIPERAZINYL)-4-OXO-3-
QUINOLINECARBOXYLIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Jun 1992 Products containing temafloxacin were withdrawn worldwide by the manufacturer, having
regard to severe adverse reactions associated with their use, some of which were fatal.
(Reference: (HHSNS) HHS News: US Department of Health and Human Services, P92-
16, , 05 June 1992)
OMN 22 Jun 1992 Products containing temafloxacin will not be allowed for import and marketing.
(Reference: (OMNCR) Circular, 25/92, , June 1992)
WHO Comment : Temafloxacin, a quinolone antimicrobial, was introduced in 1991.
Shortly afterwards, its use became associated with severe adverse effects,
including hypoglycaemia, haemolytic anaemia, renal failure, hepatitis and
anaphylactic reactions. This led to its worldwide withdrawal by the manufacturer.

Product Name Temazepam

C.A.S. number 864-50-4
Scientific and common names, and synonyms
7-CHLORO-3-HYDROXY-1-METHYL-5-PHENYL-1,4-BENZODIAZEPIN-2-ONE
3-HYDROXYDIAZEPAM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Sep 1995 The authorities in the United Kingdom have announced that temazepam is to be
subjected to stricter regulations and is to be transferred from Schedule 4 of the Misuse of
Drugs Regulations 1985 to Schedule 3, however with some exemptions. These
measures are being taken in an attempt to prevent misuse of temazepam.
(Reference: (GBRPR) Press Release, , , 12 Sep 1995)
WHO Comment : Temazepam is a widely used benzodiazepine derivative. As with
other drugs in this class, cases of misuse and drug dependence are known.

Product Name Terbinafine

C.A.S. number 91161-71-6
Scientific and common names, and synonyms

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 258

Product Name Terbinafine

C.A.S. number 91161-71-6
Scientific and common names, and synonyms
1-NAPHTHALENEMETHANAMINE, N-(6,6-DIMETHYL-2-HEPTEN-4-YNYL)-N-METHYL-, (E)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 25 Jan 1995 The National Commission of Pharmacovigilance has revised the product information to
include serious adverse effects associated with the use of the antifungal agent,
terbinafine (Lamisil®), including severe cutaneous disorders, haematological and hepatic
risks, and possible taste disorders in the section on "Adverse effects".
(Reference: (FRAAMN) Notification, , , 25 Jan 1995)

Product Name Terconazole

C.A.S. number 67915-31-5
Scientific and common names, and synonyms
CIS-1-[P-((2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL]-4-
ISOPROPYLPIPERAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Dec 1988 The marketing authorization of vaginal suppositories containing 160 mg terconazole has
been suspended, having regard to reports of fever, shivering, headace and circulatory
reactions associated with their use. Lower dose formulations remain available.
(Reference: (BGHBL) Bundesgesundheitsblatt, 12, 492, 1988)
SWE Jul 1991 The marketing authorization for vaginal suppositories containing 80 mg and 160 mg
terconazole was withdrawn, after these preparations had been associated with febrile
reactions, often accompanied by influenza-like symptoms.
(Reference: (SWEILS) Information från Läkemedelsverket, 2(3), 158, 1991)
WHO Comment : Terconazole, an antifungal agent, was introduced into medicine in
1980. It is indicated for the treatment of vaginal candidiasis. It is not yet clear
whether the adverse effects associated with high dose formulations are due to
terconazole itself, to an excipient in the preparation or to fungal constituent.

Product Name Terfenadine

C.A.S. number 50679-08-8
Scientific and common names, and synonyms
A-[4-(1,1-DIMETHYLETHYL)PHENYL]-4-(HYDROXYDIPHENYLMETHYL)-1-PIPERIDINEBUTANOL

1-PIPERIDINEBUTANOL, ?-[4-(1,1-DIMETHYLETHYL)PHENYL]-4-(HYDROXYDIPHENYLMETHYL)-
1-PIPERIDINEBUTANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FIN Sep 1994 The National Agency for Medicines has withdrawn from OTC sale and placed under
prescription control products containing terfenadine. Adverse reactions have been
reported in cases where terfenadine was used concomitantly with ketoconazole and
macrolide antibiotics; the possibility that such reactions might occur when terfenadine is
used for self-medication cannot be excluded.
(Reference: (FINNAM) Notice, , , 21 Sep 1994)
JPN Feb 1995 The Pharmaceutical Affairs Bureau has decided to include in the labelling of terfenadine

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 259

Product Name Terfenadine

C.A.S. number 50679-08-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
a boxed warning drawing attention to the fact that the metabolism of terfenadine is
inhibited either by concomitant medication of imidazole antifungal agents or macrolide
antibiotics, or in patients with serious liver damage, or in patients liable to QT
prolongation. This may lead to serious cardiovascular adverse reactions.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.130, , Feb 1995)
NZL Oct 1996 Terfenadine has been reclassified to Restricted Medicine (an OTC classification, but may
only be sold personally by a pharmacist).
(Reference: (NZLPU) Prescriber Update, No.13, , Oct 1996)
OMN 1997 The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the
registration, import and sale of terfenadine due to reported serious cardiac adverse
effects associated with its inappropriate use.
(Reference: (OMNPN) Pharmaceutical Newsletter, 5(4): 8, , 1997)
FRA Feb 1997 The French Health Authority has suspended the marketing authorization for terfenadine
for one year because of the risk of rare but serious ventricular arrhythmias following
overdosage and the risk of hepatic damage and cardiac reaction when taken
concomitantly with imidazole antifungal agents.
(Reference: (FRAAMP) Press Release, , , 13 Feb 1997)
JPN Feb 1997 The Pharmaceutical Affairs Bureau has expanded its warnings in the labelling for
terfenadine by adding the possibility of dangerous interactions with some antiarrhythmic
drugs, diuretics, psychotropic drugs and probucol.
(Reference: (JPNMHC) Communication to WHO, , , 13 Feb 1997)
MAR Feb 1997 The National Advisory Commission for Pharmacovigilance has reviewed the overall risk-
benefit of terfenadine and decided to withdraw terfenadine from the market because of
the risk of cardiac arrhythmia associated with the administration of terfenadine.
(Reference: (MARDMP) Letter to WHO, , , 24 Aug 1999)
GBR 16 Sep 1997 The Committee on Safety of Medicines has decided that as from 16 September 1997,
terfenadine will only be available on prescription. In addition to conditions for use of
terfenadine issued in other countries the CSM advises patients not to drink grapefruit
juice while taking terfenadine.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol.23, , Sep 1997)
OMN Dec 1997 The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the
registration, import and sale of terfenadine due to reported serious cardiac adverse
effects associated with its inappropriate use.
(Reference: (OMNPN) Pharmaceutical Newsletter, 5(4): 8, , 1997)
USA 1998 Hoechst, Marion Roussel and Baker Norton Pharmaceuticals have voluntarily
discontinued distribution and marketing of all terfenadine-containing antihistamine
products in the United States. Terfenadine-containing products have been associated
with rare, but serious heart problems when taken with certain antibiotics and antifungals.
The FDA reminded consumers and health care providers that equally safe and effective
alternative drugs are available.
(Reference: (FDATPW) FDA Talk Paper www.fda.gov/bbs/topics/ANSWERS/ANS00853.
html, , , )
MUS Dec 1998 The Ministry of Health and Quality of Life has withdrawn terfenadine from the market
following reports of fatal drug interactions with commonly use drugs. .
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)
FRA 1999 The Agence du Médicament has withdrawn the antihistamine, terfenadine from the
market because the risk of ventricular arrhythmias does not justify the continuation of
terfenadine on the market.
(Reference: (FRACCE) Décision, , , 22 Sep 1998)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 260

Product Name Terfenadine

C.A.S. number 50679-08-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISL Jan 1999 The State Committee on Pharmaceuticals in Iceland withdrew the marketing
authorization for 120 mg tablets of terfenadine and 60 mg tablets were switched from
OTC to POM status in January 1998 due to the occurrence of serious adverse effects.
(Reference: (ISLSCP) Communication to WHO, , , 17 Oct 2000)
SAU Jun 1999 The Ministry of Health has withdrawn from the market products containing the histamine
H1-receptor antagonist, terfenadine, because of reports of a potentially fatal heart
condition associated with its use.
(Reference: (SAUCW) Notification, , , 20 June 1999)
BRA Jul 2000 Withdrawn from the Brazilian market due to the increased risk of producing cardiac
arrhythmias.
CHL Mar 2001 The Public Health Institute of Chile has banned the use of terfenadine due to serious
cardiotoxic effects reported in conjunction with other drugs.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)
ARG 19 Aug 2003 The Food, Drug and Medical Devices agency in Argentina, ANMAT, has withdrawn the
marketing authorization for all products containing terfenadine. This measure follows
associations of life-threatening ventricular arrhythmias with terfenadine.
(Reference: (ARGFDM) Communication from ANMAT, , , 19 Aug 2003)
SGP The National Pharmaceutical Administration in the Ministry of Health has banned
terfenadine because of its association with rare but serious heart problems when taken
with certain drugs, including antibiotics and antifungal drugs.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)
WHO Comment : The first clinically interesting histamine H-receptor1 antagonists
were introduced in the late 1940s and early 1950s. Several H-antihistaminics have
a similar cardiac effect to that seen with astemizole1 and terfenadine. Serious
cardiovascular adverse reactions have been reported when used concomitantly
with imidazole antifungals and macrolide antibiotics. See also under astemizole.

Product Name Terodiline

C.A.S. number 15793-40-5
Scientific and common names, and synonyms
BENZENEPROPANAMINE, N-(1,1-DIMETHYLETHYL)-ALPHA-METHYL-GAMMA-PHENYL-
N-TERT-BUTYL-1-METHYL-3,3-DIPHEYLPROPYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 1992 Products containing terodiline were withdrawn from the market worldwide by the
manufacturer, following reports of cardiac adverse reactions, including ventricular
tachycardia, heart block and bradycardia associated with their use.
(Reference: (DCCKB) Drug company communication - Kabi Pharmacia, , , 26 Sep 1991)
WHO Comment : Terodiline, an anticholinergic and calcium-channel blocking
agent, was first introduced into medicine in the mid 1960s for the treatment of
angina pectoris. In 1986, it was registered for the indication of urinary
incontinence. In 1991, its use in urinary incontinence was reported to be
associated with severe cardiac arrhythmias. This led to a temporary withdrawal in a
few Member States in 1991, followed by a final withdrawal by the manufacturer in
1992.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 261

Product Name Testosterone propionate (injectable)

C.A.S. number 57-85-2
Scientific and common names, and synonyms
ANDROST-4-EN-3-ONE, 17-(1-OXOPROPOXY)-, (17BETA)-
TESTOSTERONE PROPIONATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, low dosage forms (100mg
ampoules) were banned on grounds of inadmissable promotion and misuse. Higher
dosage forms (250mg ampoules) remain available for use in selected patients under
medical supervision.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
WHO Comment : In 1982, low dosage preparations of testosterone propionate, a
synthetic ester of the naturally-occurring androgen, testosterone, were prohibited
in Bangladesh following their inadmissable promotion as anabolic agents for use
in malnourished children. Higher dosage preparations of testosterone propionate
remain available in many countries, including Bangladesh, for several highly
specific but limited indications including hypogonadism and the palliative
treatment of inoperable breast cancer.

Product Name Tetracycline (paediatric)

C.A.S. number 60-54-8
Scientific and common names, and synonyms
2-NAPHTHACENECARBOXAMIDE, 4-(DIMETHYLAMINO)-1,4,4A,5,5A,6,11,12A- OCTAHYDRO-3,6,10,12,12A-
PENTAHYDROXY-6-METHYL-1,11-DIOXO- (4S-(4ALPHA,4AALPHA,5AALPHA,6BETA,12AALPHA))
4-(DIMETHYLAMINO)-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-3,6,10,12,12A- PENTAHYDROXY-6-METHYL-1,11-DIOXO-2-
NAPHTHACENECARBOXAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JOR 1973 The Ministry of Health withdrew syrup formulations of tetracyclines (mixtures, suspension
or drops) particularly intended for pediatric use on the grounds that tetracyclines interfere
with the growth of bones and teeth in infants.
PER 1974 The package insert and/or label for this product requires a warning that its use may be
dangerous in nursing infants, children under 3 years of age and pregnant women, due to
the drug's well known effects on bone formation.
ITA 1975 Preparations for rectal use have been withdrawn from the market owing to their non-
constant absorption. Since 1979, labels of concentrated liquid preparations have warned
about possible dischromic effects on tooth enamel.
PHL 1978 Preparations containing chlortetracycline, oxytetracycline, tetracycline, demeclocycline,
rolitetracycline, methacycline, doxycycline, minocycline, and other tetracycline derivatives
in the form of syrup (mixture or suspension) or drops particularly intended for pediatric
use are no longer acceptable.
(Reference: (PHADO) Administrative Order, 342, , 1978)
USA 2 Jan 1979 Tetracycline drops intended for pediatric use have been withdrawn from the market.
Doctors have been advised that liquid preparations of tetracycline and its congeners
should not be administered to pregnant women or children under 9 years of age.
(Reference: (FEREAC) Federal Register, 43(211), 50676, 1978)
GHA 1980 Paediatric preparations have been banned.
ARE 9 Jun 1981 Tetracyclines in syrups and paediatric drops are banned.
(Reference: (UAEMD) Ministry of Health Decree, No.694, , 1981)

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 262

Product Name Tetracycline (paediatric)

C.A.S. number 60-54-8
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, tetracycline syrups have been
banned as they are harmful to children and pregnant mothers; they disturb bone growth
of children up to 12 years of age and discolour teeth.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)
SDN 1982 The Ministry of Health no longer allows registration of tetracycline syrups. Syrups will only
be available to government health units for specific treatment.
IND 1983 Liquid oral dosage preparations have been prohibited for manufacture and sale for
reasons of health risks associated with use and/or questionable therapeutic value.
(Reference: (GAZIE) The Gazette of India: Extraordinary, II-3i, , 23 July 1986)
OMN Sep 1985 Tetracycline pediatric suspension has been prohibited for import, selling and marketing.
PAK 1988 Products containing tetracyclines for paediatric use, including tetracycline,
oxytetracycline and doxycycline were withdrawn.
(Reference: (PAKMH) Ministry of Health, Special Education and Social Welfare, , , Aug
1988)
CHL 31 Aug 1990 All products containing tetracycline, demeclocycline, doxycycline, metacycline,
exytetracycline or other tetracycline derivatives were required to bear a warning stating
that they should not be administered to children under 8 years of age, or to pregnant or
lactating women.
(Reference: (BMCHL) Boletin Informativo Sobre Medicamentos, 8(1), 14, 1991)
NPL 1991 Liquid oral preparations containing tetracycline, and intended for the treatment of
diarrhoea in children, were banned.
(Reference: (NPLDDA) Communication from the Department of Drug Administration, , ,
27 Feb 1992)
AUS The Australian Drug Evaluation Committee has recommended that all pediatric
formulations of tetracyclines should be withdrawn from the market in view of their
propensity to stain teeth and retard bone growth.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, No.71, , )
BEL Preparations containing tetracyclines intended for internal use must carry a warning
stating that the preparation should not be administered to children under eight years of
age or to pregnant women after the fourth month of pregnancy except on medical advice.
NZL Pediatric preparations have been voluntarily withdrawn.
SAU Following reports indicating interference with bone growth and teeth in infants the use of
all tetracycline preparations is prohibited in pregnant women and children below twelve
years of age.
WHO Comment : The first tetracycline antibiotic, chlortetracycline, was introduced
in 1948 and subsequently several semisynthetic derivatives have been used as
antibacterial, antiamoebic and antirickettsial agents. All tetracyclines accumulate in
the developing bones and teeth of the foetus and young children which can result
in retarded bone growth and dental staining. Preparations intended specifically for
children have been withdrawn in some countries, whereas in others warnings are
required on the label advising against administration of tetracyclines to young
children and pregnant women. Non-paediatric dosage forms of tetracycline remain
in the WHO Model List of Essential Drugs.
(Reference: (WHTAC1) The Use of Essential Drugs, 2nd Report of the WHO Expert
Committee, 722, , 1985)

Product Name Thalidomide

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 263

C.A.S. number 50-35-1

Scientific and common names, and synonyms
?-(N-PHTHALIMIDO)GLUTARIMIDE
ALPHA-(N-PHTHALIMIDO)GLUTARIMIDE
N-(2,6-DIOXO-3-PIPERIDYL)PHTHALIMIDE
1H-ISOINDOLE-1,3(2H)-DIONE, 2-(2,6-DIOXO-3-PIPERIDINYL)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BEL 1963 Pharmaceutical preparations containing thalidomide were prohibited in 1963. In 1983
they were reintroduced for limited use in special circumstances.
FIN 1963 Prohibited due to its well-known teratogenic effects.
IDN 1963 Prohibited for importation, production, sale and distribution by the Ministry of Health.
CAN Jul 1984 Total ban under S.15 of the Food and Drugs Act has been revoked. Thalidomide is now
available on a limited basis, upon specific authorization for emergency purposes only.
BRA 4 Jul 1994 The Ministry of Health has issued an Order prohibiting the prescription of thalidomide for
women of childbearing age. This action has been taken in consideration of the risks of
teratogenic effects of thalidomide associated with indiscriminate use of the product.
(Reference: (BRASVS) Secretaria de Vigilancia Sanitaria, Portaria 63, , 04 July 1994)
BRA 04 Jul 1994 The Ministry of Health has issued an Order prohibiting the prescription of thalidomide for
women of childbearing age. This action has been taken in consideration of the risks of
teratogenic effects of thalidomide associated with indiscriminate use of the product.
(Reference: (BRACVS) Centro de Vigilancia Sanitaria, 63, , 04 July 1994)
ARG Jul 1996 The Ministry of Health and Social Affairs has restricted the use of thalidomide to ensure
that it is not accessible to pregnant women.
(Reference: (ARGANM) Communication, , , 19 July 1996)
DNK Prohibited for import, production, sale and distribution by the Ministry of Health.
IND Prohibited for import due to the lack of substantial evidence of safety and/or efficacy,
except for specially authorized use in leprosy patients in leprosy hospitals excluding
women patients of childbearing age.
NZL This product is a controlled drug and is available on a very restricted basis.
SGP Banned for importation.
VEN Not approved for use and/or sale.
WHO Comment : Notwithstanding the highly potent teratogenic action of
thalidomide, this drug retains a place in the treatment of reactional lepromatous
leprosy and several serious dermatological conditions refractory to other
treatment. In many countries, the competent authorities have granted exemption
from licensing requirements to enable doctors to obtain limited supplies of
thalidomide under strictly controlled circumstances for use in named patients.
Arrangements have also been made by some national drug regulatory authorities
for thalidomide to be used in institutions concerned with the treatment of leprosy.

Product Name Thenalidine

C.A.S. number 86-12-4
Scientific and common names, and synonyms
THENOPHENOPIPERIDINE

1-METHYL-4-N-2-THENYLANILINOPIPERIDINE

Legislative or regulative action

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 264

Product Name Thenalidine

C.A.S. number 86-12-4
Country Effective Description of action taken
Date Grounds for decision
USA 17 Jul 1958 Thenalidine was withdrawn in the United States of America after four cases of severe
neutropenia, two of which were fatal, were reported in patients treated continuously over
periods of several months.
GBR 1961 Thenalidine was withdrawn in the United States of America after four cases of severe
neutropenia, two of which were fatal, were reported in patients treated continuously over
periods of several months. It was subsequently withdrawn in the United Kingdom.
SWE Apr 1976 Withdrawn following reports of neutropenia associated with its use.
FRA 16 Jun 1978 Voluntarily withdrawn following reports of neutropenia associated with its use.
CYP 1980 Products containing thenalidine were withdrawn following reports of neutropenia
associated with their use.
AUS Voluntarily withdrawn following reports of neutropenia associated with its use.
FIN Voluntarily withdrawn following reports of neutropenia associated with its use.
NOR Withdrawn following reports of neutropenia associated with its use.
VEN Not approved for use and/or sale.
WHO Comment : Thenalidine, a piperidine antihistamine, was introduced in 1953
for the management of dermatologic and allergic conditions. By 1958 its use had
been associated with cases of severe neutropenia, two of them fatal, which led to
its withdrawal in the United States of America and subsequently in the United
Kingdom. Over the next fifteen years, continued reports of its association with
cases of neutropenia resulted in further withdrawals in many countries. It is
apparently still available, however, in some combination products.
(Reference: (WHODI) WHO Drug Information, 1, 5, 1979)

Product Name Thiomersal

C.A.S. number 56-64-8
Scientific and common names, and synonyms
ETHYL(2-MERCAPTOBENZOATO-S)MERCURY
MERCURY, ETHYL(4-MERCAPTOBENZOATO-S)-, SODIUM SALT
THIMEROSAL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS The Drug Control Authority in Malaysia has directed manufacturers to discontinue the use
of thiomersal as a preservative in vaccines and to replace it with other permitted
preservatives.
MYS Sep 1995 The Drug Control Authority has rejected an application for registration of contact lens
products and ophthalmological preparations containing thiomersal on the grounds that
mercury is absorbed from such preparations in significant amounts. Thiomersal can also
cause sensitization after repeated use.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 9(3): 3, , Sep 1995)
BRA Jun 2001 Products containing thiomersal are prohibited except those intended for vaccine
conservation.
(Reference: (BRARES) Resolucao n., 528/ANVISA, , 06 Aug 2001)

Product Name Tianeptine sodium

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 265

C.A.S. number 30123-17-2

Scientific and common names, and synonyms
TIANEPTINE. 7-[(3-CHLORO-6,11?DIHYDRO-6-METHYLDIBENZO[C,F][1,2] THIAZEPIN-11-YL)AMINO]HEPTANOIC ACID
S,S DIOXIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BHR The Drug Control Directorate has classified tianeptine sodium under the 'special-drugs-
under-controlled prescriptions' category due to increasing reports of misuse and abuse
by patients.
SGP The National Pharmaceutical Administration in the Ministry of Health has restricted the
use of tianeptine sodium to psychiatrists due to its abuse potential.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Tiaprofenic acid

C.A.S. number 33005-95-7
Scientific and common names, and synonyms
5-BENZOYL-?-METHYL-2-THIOPHENEACETIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Aug 1994 In view of the high number of reports of cystitis, the Committee on Safety of Medicines
recommends that tiaprofenic acid should not be given to patients with pre-existing urinary
tract disorders and that if urinary tract symptoms develop tiaprofenic acid should be
stopped.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, 20: 11, , Aug 1994)
DEU Oct 1994 The manufacturer of the nonsteroidal anti-inflammatory agent, tiaprofenic acid revised
the product information to include a reference to the potential of this product to induce
cystitis, which is initially reversible on discontinuation of treatment and to stress the need
to interrupt therapy with tiaprofenic acid as soon as urinary disturbances are reported by
the patient.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 139(40): 3401, , 1994)
MYS Dec 1995 In view of reports from other countries of cystitis in patients receiving the nonsteroidal
anti-inflammatory agent, tiaprofenic acid, the Drug Control Authority has decided to revise
the product information to include the following precautionary statement: Urinary
symptoms (bladder pain, dysuria and frequency), haematuria or cystitis may occur. In
certain exceptional cases, the symptoms have become severe on continued treatment.
Should urinary symptoms occur, treatment with tiaprofenic acid must be stopped.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 9(4): 2, , 1995)
WHO Comment : See comment under "Nonsteroidal anti-inflammatory agents".

Product Name Ticlopidine

C.A.S. number 55142-85-3
Scientific and common names, and synonyms
5-(O-CHLOROBENZYL)-4,5,6,7-TETRAHYDROTHIENO-(3,2-C)PYRIDINE
THIENO(3,2-C)PYRIDINE, 5-((2-CHLOROPHENYL)METHYL)-4,5,6,7-TETRAHYDRO-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1983 Registered solely for the treatment of haemodialysis patients, with shunt complications,
who are intolerant to acetylsalicylic acid. A full blood count should be made before

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 266

Product Name Ticlopidine

C.A.S. number 55142-85-3
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
treatment and every 14 days, then subsequently every month throughout treatment.
GRC 1984 Use is restricted to patients with severe renal damage who do not tolerate acetylsalicylic
acid having regard to the occurrence of severe blood reactions.
ITA Approved indications for use have been restricted to antithrombotic therapy in
haemodialysis, peripheral obliterating arteriopathy, thrombosis of the central retinal vein,
maintenance of extracorporeal circulation and aortic-coronary by-pass. Haematological
monitoring is advised throughout treatment.
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, (3), , 1984)
WHO Comment : Ticlopidine, an inhibitor of platelet aggregation, was introduced in
1978 for use as an antithrombotic agent. By 1982 its use had been associated with
cases of agranulocytosis, severe leucopenia and impaired haemostasis. The drug
remains available in most countries in which it was approved with appropriate
warnings in the product information.

Product Name Tienilic acid

C.A.S. number 40180-04-9
Scientific and common names, and synonyms
ACETIC ACID, (2,3-DICHLORO-4-(2-THIENYLCARBONYL)PHENOXY)-
TICRYNAFEN
(2,3-DICHLORO-4-(2-THIENYLCARBONYL)PHENOXY)-ACETIC ACID
(2,3-DICHLORO-4-(2-THENOYL)-PHENOXY)ACETIC ACID
4-(2-THENOYL)-2,3-DICHLOROPHENOXYACETIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1980 The Ministry of Health and Welfare has withdrawn this product from domestic use.
(Reference: (GRAGA) Ministry of Health Decision, 12946, , Dec 1980)
PHL Jan 1980 Withdrawn by the manufacturer after reports from other countries that prolonged use in
some patients resulted in deaths due to liver dysfunction.
USA 30 Jan 1980 Withdrawn from the market following reports of liver toxicity.
BRA 31 Jan 1980 Products containing tienilic acid are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, (01), , Nov 1980)
DEU Dec 1980 Voluntarily withdrawn from the market following cases of hepatic failure some of which
were fatal.
PAN 10 Apr 1981 The Ministry of Health has banned the sale of pharmaceuticals and cosmetics containing
tienilic acid.
(Reference: (PANMR) Ministry of Health Resolution, 28, , Apr 1981)
FRA 1991 Voluntarily withdrawn from the market by the manufacturer, following reports of hepatitis
associated with its use.
(Reference: (FRARP) La Revue Prescrire, 12(114), 28, 1992)
IND Not approved for marketing after withdrawal in the United States following reports of liver
toxicity.
VEN Not approved for use and/or sale.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 267

Product Name Tienilic acid

C.A.S. number 40180-04-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : Tienilic acid, a diuretic agent with uricosuric and antihypertensive
activity, was introduced in 1976. By 1979 its use had been associated with cases of
hepatic toxicity, some of which were fatal, which led to the withdrawal of the drug
in most countries in which it was marketed. In France, however, precautions
regarding the use of tienilic acid were issued by the Pharmacovigilance
Commission and the drug remained available for another decade. In 1991, it was
eventually also withdrawn there since cases of hepatitis, some of which were
fulminant, had continued to occur.

Product Name Tilbroquinol

C.A.S. number 7175-09-9
Scientific and common names, and synonyms
7-BROMO-5-METHYL-8-QUINOLINOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jul 1997 The Agence du Médicament has decided to suspend the marketing authorization for
tilbroquinol (Intetrix® P) and batches were recalled on 5 July 1997. This decision was
reached in view of the absence of efficacy data for the treatment of infectious diarrhoeas
and because of the risk of liver toxicity. [See also tilbroquinol/tiliquinol in Combination
products].
(Reference: (FRAAMI) Infofax - Pharmacovigilance, , , 04 July 1997)
MAR Nov 1997 The Direction du médicament et de la pharmacie has suspended marketing authorization
for the paediatric formulation of tilbroquinol and the therapeutic indications for the adult
formulation were restricted to the treatment of intestinal amoebiasis.
(Reference: (MARDMP) Letter to WHO, , , 08 Sep 2000)
FRA 1999 The Agence du Médicament has withdrawn the antiprotozoal, tilbroquinol from the market
because the hepatoxicity of the drug outweighs the potential benefit.
(Reference: (FRADRA) Décision de retrait de l'autorisation de mise sur le marché
d'Intetrix P granulés, , , 05 July 1999)
SAU Jun 1999 The Ministry of Health has withdrawn from the market products containing tilbroquinol
and a combination product containing tilbroquinol/tiliquinol because of a risk of
hepatotoxicity associated with their use.
(Reference: (SAUCW) Notification, , , 20 June 1999)

Product Name Tocainide

C.A.S. number 41708-72-9
Scientific and common names, and synonyms
PROPANAMIDE, 2-AMINO-N-(2,6-DIMETHYLPHENYL)-
2-AMINO-2',6'-PROPIONOXYLIDIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IRL 1985 Use of tocainide has been limited to named patients under the supervision of a
consultant, having regard to cases of agranulocytosis associated with its use.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 268

Product Name Tocainide

C.A.S. number 41708-72-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , , 1985)
NLD 1986 Having regard to reports of blood dyscrasias associated with its use, indications are
restricted to the symptomatic treatment of ventricular dysrhythmias when other
treatments fail or are contraindicated.
(Reference: (NPHWB) Pharmaceutisch Weekblad, 121, 167, 1986)
WHO Comment : Tocainide, an antidysrhythmic agent, was introduced in 1981 for
the treatment of ventricular dysrhythmias. By 1984 its use was associated with
cases of agranulocytosis, aplastic anaemia and thrombocytopenia, some of which
were fatal. This led some regulatory authorities to restrict the indications for its
use. The major manufacturer has subsequently restricted its use on a worldwide
basis to the treatment of symptomatic ventricular dysrhythmias not responding to
other therapy, or when other therapy is contraindicated.

Product Name Tolcapone

C.A.S. number 134308-13-7
Scientific and common names, and synonyms
3,4-DIHYDROXY-5-NITROPHENYL (4-METHYLPHENYL)METAHANONE
3,4-DIHYDROXY-4 ?-METHYL-5 NITROBENZOPHENONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
EME Nov 1998 The European Agency for the Evaluation of Medicinal Products has recommended the
suspension of the marketing authorization for tolcapone. This follows several reports of
severe and unpredictable hepatic reactions including fatal fulminant hepatitis.
(Reference: (EMEAPR) EMEA Press Release, , , 17 Nov 1998)
GBR Nov 1998 The manufacturer of the antiparkinsonism drug, tolcapone has voluntarily withdrawn it
from the market. This follows a review of the hepatotoxic effects by the European
Committee for Proprietary Medicinal Products (CPMP) which found that the overall
balance of risks and benefit was no longer favourable. .
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)
ISL Nov 1998 The State Committee on Pharmaceuticals in Iceland withdrew the marketing
authorization for tolcapone due to serious adverse effects. Since then the product has
been available to specialist neurologists for the treatment of severe cases of
Parkinson?s disease.
(Reference: (ISLSCP) Communication to WHO, , , 17 Oct 2000)
LTH Dec 1998 The State Medicines Control Agency has withdrawn from the market tablets of tolcapone.
(Reference: (LTHMCA) Order of State Medicines Control Agency, No. 123, , 15 Dec 1998)
AUS Feb 1999 Following overseas reports of serious and unpredictable hepatotoxicity associated with
the use of the catechol-O-methyl transferase inhibitor, tolcapone (TamarR), including 3
fatalities, its registration has been withdrawn in Australia.
(Reference: (AUSADR) Australian Adverse Drug Reactions Bulletin, 18(1), , Feb 1999)
BGR Apr 1999 The Bulgarian Drug Agency in the Ministry of Health withdrew the antiparkisonism agent,
tolcapone because of serious adverse reactions worldwide.
(Reference: (BGRBDA) Communication to WHO, , , )
SGP The National Pharmaceutical Administration in the Ministry of Health has restricted the
use of tolcapone to neurologists as there are concerns over reports of severe

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 269

Product Name Tolcapone

C.A.S. number 134308-13-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
hepatotoxicity associated with the use of the drug.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

Product Name Tolrestat

C.A.S. number 82964-04-3
Scientific and common names, and synonyms
GLYCINE, N-[[6-METHOXY-5-(TRIFLUOROMETHYL)-1-NAPHTHALENYL]THIOXOMETHYL]-N-METHYL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Nov 1996 In October 1996 the manufacturer withdrew tolrestat from the market worldwide following
a case of hepatic necrosis and death notified to the National Pharmacovigilance System
in Argentina in 1995 and of two additional deaths from hepatic necrosis associated with
the use of tolrestat in Canada and Italy.
(Reference: (LANCET) Foppiano M & Lombardo G. Worldwide pharmacovigilance
systems and tolrestat withdrawal, Lancet 349, p.399 , 08 Feb 1997)
(Reference: (ARGANM) Communication, , , 05 Nov 1996)

Product Name Tramadol

C.A.S. number 27203-92-5
Scientific and common names, and synonyms
CYCLOHEXANOL,2-((DIMETHYLAMINO)METHYL))-1-(3-METHOXYPHENYL)-, TRANS-( +/-)

CG-315
(+/-)-TRANS 2-((DIMETHYLAMINO)METHYL)-1-(M-METHOXYPHENYL)CYCLOHEXANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT 1 Oct 1985 The drug substance and finished preparations are subject to control at national level
analogous to that provided by Schedules I and III of the 1961 Single Convention on
Narcotic Drugs.
BHR 2000 The Ministry of Health has restricted the prescription of medicines containing tramadol as
controlled medicines that should be dispensed only on special prescriptions issued by the
Directorate of Pharmacy and Drug Control at the Ministry of Health with effect from 2 May
2000.
(Reference: (BHRCW) Communication with WHO, , , 27 June 2000)
MUS Oct 2000 The Ministry of Health and Quality of Life has moved the product tramadol from
Prescription-only status to Psychotropic in Schedule III of the New Dangerous Drugs Act
based on 1988 Convention Classification. This is because of widespread 1988
Convention Classification. This is because of widespread abuse resulting from
unsupervised sales in pharmacies.
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)

Product Name Tranylcypromine

C.A.S. number 155-09-9

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 270

Product Name Tranylcypromine

C.A.S. number 155-09-9
Scientific and common names, and synonyms
CYCLOPROPANAMINE, 2-PHENYL-, TRANS-(+/-)-
TRANSAMINE SULPHATE
(+/-)-TRANS-2-PHENYLCYCLOPROPYLAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 1964 Withdrawn from the market by the Ministry of Health.
BEL 1965 The Ministry of Health has withdrawn drugs containing tranylcypromine.
SAU Products with this ingredient are now under strict control.
VEN Not approved for use and/or sale.
WHO Comment : Tranylcypromine, a monoamine oxidase inhibitor (MAOI), was
introduced in 1961 for the treatment of depressive illness. By 1964 its use had been
associated with transient hypertensive crises and other adverse effects when taken
together with certain cheeses and other foods containing tyramine. This led to the
withdrawal of the drug in several countries and the suspension of marketing on a
worldwide basis by the major manufacturer pending review of these adverse
reactions. Subsequently, in response to requests from the medical profession,
tranylcypromine was resubmitted for registration with appropriate warnings in the
product information and it is now marketed in more than 30 countries.

Product Name Trazodone

C.A.S. number 19794-93-5
Scientific and common names, and synonyms
1,2,4-TRIAZOLO(4,3-A)PYRIDIN-3(2H)-ONE, 2-(3-(4-(3-CHLOROPHENYL)-1- PIPERAZINYL)PROPYL)-
2-(3-(4-(M-CHLOROPHENYL)-1-PIPERAZINYL)PROPYL)-S-TRIAZOLO(4,3-A) PYRIDIN-3(2H)-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1985 Not approved for registration because the results of a two-year study in rats gave rise to
suspicion of a carcinogenic effect, and carcinogenic studies in another animal species
were not submitted.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, (1), , 1985)
WHO Comment : Trazodone, an antidepressant indicated for the treatment of a
wide range of depressive illness, was introduced in 1973. Although it is registered
for use in many countries with highly evolved regulatory authorities, approval for
registration was not granted in Norway because of a suspicion of carcinogenicity
in a two-year rat study.

Product Name Tretinoin

C.A.S. number 302-79-4
Scientific and common names, and synonyms
ALL-TRANS-RETINOIC ACID
RETINOIC ACID

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 271

Product Name Tretinoin

C.A.S. number 302-79-4
Country Effective Description of action taken
Date Grounds for decision
OMN 24 Dec 1985 Having regard to its teratogenicity, tretinoin may only be used under the supervision and
control of a hospital dermatologist.
(Reference: (OMNMH) Ministry of Health, No.5, , 1985)
DEU 29 Mar 1988 Tretinoin may no longer be included as an ingredient in cosmetic products, having regard
to its teratogenic potential.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 128(21), 35, 1988)
NZL 4 Nov 1993 Tretinoin in topical preparations for the treatment of acne has been reclassified from
Restricted Medicine (an OTC classification, but may only be sold personally by a
pharmacist) to Prescription Medicine because of its teratogenic potential.
(Reference: (NZLPU) Prescriber Update, No.5, , May 1994)
DEU 28 Jul 1994 The Federal Institute for Drugs and Medical Devices has revised the product information
for topical formulations containing the retinoid, tretinoin. The section on toxicological
properties will state that in animal experiments teratogenicity has been demonstrated
both after systemic and local administration. As a consequence, the product is now
contraindicated during pregnancy.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 139(30): 2379, , 1994)
WHO Comment : Tretinoin, a retinol derivative, was introduced in 1973 exclusively
for the topical treatment of severe acne. Preparations of tretinoin are indicated for
topical use only since oral administration has been associated with risk of toxicity
from hypervitaminosis-A and subsequently of teratogenicity.

Product Name Triacetyldiphenolisatin

C.A.S. number 18869-73-3
Scientific and common names, and synonyms
PHENISATINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1976 Withdrawn following a review of published cases of acute and chronic liver disease. The
action was consonant with decisions previously taken in a number of countries including
Australia and the United States. Some other national authorities have chosen to place
products containing this compound under prescription control.
ITA 1976 Preparations for oral, rectal and topical use have been withdrawn from the market due to
the risk of sensitization.
CAN 1978 All preparations containing this substance were withdrawn from sale in Canada.
(Reference: (CANGZ) Canada Gazette, , , May 1978)
CYP Products containing triacetyldiphenolisatin have been withdrawn having regard to the risk
of liver damage in patients receiving this drug.
NZL Voluntarily withdrawn from the market.
VEN Not approved for use and/or sale.
WHO Comment : Triacetyldiphenolisatin is a derivative of oxyphenisatine. See
WHO comment for oxyphenisatine acetate.

Product Name Triazolam

C.A.S. number 28911-01-5
Scientific and common names, and synonyms

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 272

Product Name Triazolam

C.A.S. number 28911-01-5
Scientific and common names, and synonyms
8-CHLORO-6-(O-CHLOROPHENYL)-1-METHYL-4H-S-TRIAZOLO(4,3-A)(1,4) BENZODIAZEPINE
CLORAZOLAM
4H-(1,2,4)TRIAZOLO(4,3-A)(1,4)BENZODIAZEPINE, 8-CHLORO-6-(2- CHLOROPHENYL)-1-METHYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MUS 9 Mar 1982 Under the Pharmacy and Poisons (Prohibitions of Harmful Drugs) Regulations, this drug
is deemed "harmful" by the Ministry of Health and is prohibited for import, manufacture,
storage, distribution, sale, possession, use, export or other transaction.
(Reference: (MPPHD) Pharmacy & Poisons (Prohibitions of Harmful Drugs) Regulations,
, , Mar 1982)
AUS 11 Apr 1986 Tablets containing 0.50mg and 0.25mg triazolam were not approved by the Australian
Drug Evaluation Committee, having regard to the risk of adverse effects due to
inappropriate use. Tablets containing 0.125mg triazolam were approved for the treatment
of insomnia.
(Reference: (AUDEC) Report of the Australian Drug Evaluation Committee, 123, , Apr
1986)
ITA 9 Mar 1987 The marketing authorization of tablets containing 0.50 mg triazolam was withdrawn by
Ministerial Decree on the basis of evidence that use of 0.50 mg tablets had caused
incidents of anterograde amnesia, mental confusion and behavioural disorders. The
package insert must state that the recommended dose of 0.25 mg should only be
exceeded in very exceptional cases to treat particularly resistant insomnia.
(Reference: (ITAMD) Ministerial Decree, No.7639/R, , Mar 1987)
DEU Apr 1988 The Federal Health Office has decided to withdraw the registration of tablets containing
0.5 mg triazolam and the indications for tablets containing 0.25 mg have been restricted
to short-term treatment of sleep disturbances.
CHL 14 Mar 1989 Products containing 0.125 mg and 0.250 mg triazolam have been subjected to
prescription control and must carry the following warning: "This product may only be
administered under strict medical control and supervision." These measures were taken
on the grounds of reports of serious adverse psychiatric effects.
(Reference: (CHLMS) Letter to WHO from the Ministerio de Salud, , , Sep 1990)
(Reference: (BMCHL) Boletin Informativo Sobre Medicamentos, 6(1), 13, 1989)
@EC 16 Oct 1991 The Committee for Proprietary Medicinal Products recommended that the indications for
products containing triazolam should be restricted to the treatment of severe disabling
sleeping disorders or to insomnia causing extreme distress; duration of treatment should
not exceed 2-3 weeks; the lowest effective dose should be used and a dose of 0.250 mg
should not be exceeded; for the elderly, debilitated patients and patients with disturbed
liver/kidney function, the dose should not exceed 0.125 mg; the compound should not be
administered to patients with major psychiatric disorders; packs of not more than seven
tablets should be made available.
(Reference: (CPMPPS) Position Statement, , , Oct 1991)
ESP Dec 1991 The marketing authorization for tablets containing 0.250 mg triazolam was suspended by
the manufacturer, because of association with serious psychiatric adverse reactions,
particularly anterograde amnesia.
FRA 30 Dec 1991 The marketing authorization for tablets containing 0.250 mg triazolam was suspended,
because this high dosage formulation was considered to present risks, especially
amnesia, that outweigh the therapeutic benefits. Duration of treatment for tablets
containing 0.125 mg was restricted to two weeks and the package size was limited to
seven tablets. Tablets containing 0.5 mg triazolam had been withdrawn in the late 1980s.
(Reference: (FRAMS) Ministry of Social Affairs and Integration, , , 30 Dec 1991)
PAK Jan 1992 The Drug Registration Board decided that triazolam tablets should bear a warning that
they are contraindicated in patients with a major psychiatric disorder.

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 273

Product Name Triazolam

C.A.S. number 28911-01-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (PAKDI) Pakistan Drug Information, 3, , Jan 1992)
NOR Feb 1992 Following their initial suspension from the market on 4 October 1991, products containing
triazolam were withdrawn because of their association with serious psychiatric adverse
effects, including memory disturbances, anxiety, depression and agressivity.
(Reference: (NORMCA) Norwegian Medicines Control Authority, , , Oct 1992)
JPN Mar 1992 The Pharmaceutical Affairs Bureau decided to reduce the recommended dosage regimen
for triazolam. It is proposed that treatment should be initiated at a nightly dose of 0.125
mg or less, and that under no circumstances should the dose exceed 0.5 mg.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, 113, , Mar 1992)
BRA Jun 1992 The Centre for Pharmacovigilance of the State of Sao Paulo prohibited the sale and use
of pharmaceutical products containing triazolam. The National Secretariat for
Pharmacovigilance suspended indefinitely the manufacture and marketing of such
products with effect from 5 June 1992.
(Reference: (BRAPT) Portaria do Servico Publico Federal, 59, , June 1992)
(Reference: (BRADMS) Diario Oficial Ministerio da Saude, , , June 1992)
(Reference: (BRACVS) Centro de Vigilancia Sanitaria, , , June 1992)
CYP 23 Oct 1992 The Drug Council withdrew the marketing licence for tablets containing 0.5 mg of
triazolam and revised the product information for lower dose formulations. These
products are now indicated exclusively for sleeping disorders that are "severe, disabling
or cause extreme distress".
(Reference: (CYPPS) Pharmaceutical Services, Ministry of Health, , , 23 Oct 1992)
OMN Nov 1992 The Directorate General of Pharmaceutical Affairs and Drug Control has decided to
suspend the sale of pharmaceutical products containing triazolam as a precautionary
measure. This decision will be reviewed when further information concerning the safety of
triazolam is available.
(Reference: (OMNDGP) Directorate General of Phamaceutical Affairs, , , Nov 1992)
FIN 13 Jan 1993 Following the initial suspension of registration of products containing triazolam pending a
reassessment of their benefits and risks, these products were reintroduced to the market
with restricted indications. Tablets of 0.125mg and 0.25mg and buccal tablets 0.2mg only
are available. The indications are restricted to transient but disabling short-term insomnia.
(Reference: (FINAWH) National Agency for Welfare and Health, , , 13 Jan 1993)
GBR 09 Jun 1993 Products containing triazolam were withdrawn in 1991 because of their association with
serious, though reversible psychiatric adverse effects, particularly loss of memory and
depression. After several appeals to this decision, the United Kingdom Licensing
Authority decided to uphold its decision to revoke the licence of all products containing
triazolam.
(Reference: (DCCUJC) Upjohn News Release, , , 09 June 1993)
WHO Comment : Triazolam, a benzodiazepine derivative with sedative and
hypnotic activity, was introduced in 1978 for themanagement of insomnia. It is
controlled under Schedule IV of the 1971 Convention of Psychotropic Substances.
Concern regarding the psychotropic effects of triazolam was first raised in the
Netherlands in 1979 when this compound was suspended for sale and
subsequently withdrawn by the Committee for the Evaluation of Medicines on the
basis of reports of a reversible complex of symptoms including paranoia,
depersonalization, nightmares, suicidal tendency and hyperaesthesia in patients
receiving the drug. The basis for this decision was later successfully contested by
the manufacturer and the drug was reregistered in early 1990 with a revised
product information. However, concern was regenerated elsewhere that higher
doses are associated with an unacceptable incidence of unwanted effects and the
manufacturer has eventually withdrawn 0.5 mg tablets on a worldwide basis. In

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 274

Product Name Triazolam

C.A.S. number 28911-01-5
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
1991 the issue of the safety of triazolam was again reopened by reports of
retrograde amnesia and depression among patients taking the decreased
recommended dosages. The product information has been revised by the United
States FDA to include more rigorous cautions regarding dosage. In the Member
States of the European Communities the products have been suspended pending
further review by the EC Committee on Proprietary Medicinal Products.
(Reference: (UNCPS4) United Nations Convention on Psychotropic Substances (IV),
, , 1971)

Product Name Trimipramine

C.A.S. number 739-71-9
Scientific and common names, and synonyms
DIMETHYL-{3-(3-(10,11-DIHYDRO-5H-DIHENZ[B,F]AZEPIN-5-YL-2-METHYL)PROPYL}AMINE
TRIMEPRIMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1992 The Medicines Control Authority has decided that the 50 mg tablet formulation of
trimipramine may be prescribed only in hospitals and specialized clinics because of the
toxic potential of these products and the risk of overdosage and suicide with the high
dose formulla.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, 9, 1992)
WHO Comment : Trimipramine, a tricyclic antidepressant was introduced in 1961
for the management of endogenous depression. Much of the adverse effects are
caused by its antimuscarinic actions. These include dry mouth, cardiac
arrhythmias, central nervous system disturbances, blood disorders and risk of
suicide. The risk of suicide and dangers related to overdosage led Norwegian
Medicines Control Authority to put the higher strength formulation under
prescribing restriction in 1992. The risk of death following overdosage is
apparently higher for products containing tricyclic compounds as compared with
nontricyclic products.

Product Name Troglitazone

C.A.S. number 97322-87-7
Scientific and common names, and synonyms
(±)-ALL-RAC-5-[P-[(6-HYDROXY-2,5,7,8-TETRA-METHYL-2-CHROMANYL)METHOXY]BENZYL]-2,4-THIAZOLIDINEDIONE
2,4-THIAZOLIDINEDIONE, 5-[[4-[3,4-DIHYDRO-6-HYDROXY-2,5,7,8-TETRAMETHYL-2H-BENZOPYRAN-2-YL)METHOXY]-
PHENYL]METHYL]-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Dec 1997 In relation with hepatic reactions including cases of severe hepatocellular damage,
hepatic necrosis and hepatic failure, troglitazone has now been voluntarily withdrawn
from the UK by the companies concerned.
(Reference: (GBRMCA) Communication to WHO, , , 01 Dec 1997)
JPN Dec 1997 The product information for troglitazone has been revised to include a warning about

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 275

Product Name Troglitazone

C.A.S. number 97322-87-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
significant hepatic dysfunction and doctors have been required to monitor liver function of
patients periodically (at least once a month.
(Reference: (JPNPMB) Communication, , , 01 Dec 1997)
USA Dec 1997 The FDA has issued new advice about the use of troglitazone. Patients taking
troglitazone should be monitored at least once a month for signs of injury to the liver
during the first six months of treatment, and periodically thereafter. In addition, warning
information about potential liver toxicity will be more prominently featured in the drug's
labelling.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T97-61, , 01 Dec 1997)
JAM 2 Feb 1998 The Ministry of Health, Standards and Regulation did not approve registration of the
antidiabetic agent troglitazone (Rezulin) due its hepatotoxicity.
(Reference: (JAMMHS) Communication to WHO, , , 26 Sep 2000)
USA Jun 1999 The FDA and the manufacturer of troglitazone (RezulinR: Parke-Davis) - a drug used to
treat type 2 diabetes mellitus (non-insulin dependent diabetes mellitus, or adult onset
diabetes) has notified significant new changes to the labelling and recommended uses
for this product. These changes are being made because new safety information (i.e.,
further evidence of serious and sometimes fatal liver injury in patients treated with
troglitazone) indicates that its use should be limited to patients not adequately controlled
by other therapy and should not be used as initial single agent therapy in the treatment of
type 2 diabetes. The labelling changes also include recommendations for more extensive
monitoring of liver function in patients using troglitazone.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T99-28, , 16 June 1999)
PER May 2000 La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of
Health has communicated to health professionals that Warner Lambert Peru S.A. has
voluntarily withdrawn the antidiabetic agent troglitazone from the market because of
severe hepatic adverse effects associated with the use of this medicine.
(Reference: (PERDGM) Alerta DIGEMID, No. 6-2000, , 26 May 2000)
CHL Oct 2000 Use in formulations has been banned by the Public Health Institute of Chile; the
marketing authorization has been cancelled.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)

Product Name Trolamine

C.A.S. number 102-71-6
Scientific and common names, and synonyms
ETHANOL, 2,2',2'-NITRILOTRIS-
TRIETHANOLAMINE
2,2',2'-NITRILOTRIETHANOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHE 30 Jun 1992 Trolamine and its salts can no longer be contained in products intended for oral use,
because under certain circumstances this emulsifying agent can be concerted in the
stomach into carcinogenic N-nitrosamines. In products for external and parenteral use
trolamine may still be used, but in strictly limited amounts.
(Reference: (CHBCM) Bulletin Mensuel, 11, 760, 1990)
WHO Comment : Trolamine is widely used as an emulsifier in combination with
fatty acids in pharmaceutical and cosmetic products. The World Health

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 276

Product Name Trolamine

C.A.S. number 102-71-6
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
Organization is not aware of restrictive action having been taken elsewhere.

Product Name Trovafloxacin mesilate

C.A.S. number 147059-72-1
Scientific and common names, and synonyms
CP-99219-27
TROVAFLOXACIN MESYLATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SYR 1999 The Suprim Technical Committee and the Ministry of Health has withdrawn the licensing
approval for trovafloxacin and cancelled it from the national essential drug list.
(Reference: (SYRAFD) Announcement from the Directorate, 4/2/1989, , 02 Sep 1999)
EME May 1999 The European Agency for the Evaluation of Medicinal Products (EMEA) has
recommended that marketing authorization for products containing trovafloxacin or
alatrofloxacin be suspended. This follows reports of serious adverse hepatic events.
(Reference: (EMEAPS) Public statement, No.17438/99, , May 1999)
ESP Jun 1999 The Spanish Medicines Agency has suspended the use of medicinal products contain the
fluoroquinolone antibiotic, trovafloxacin and the intravenous formulation of the drug,
alatrofloxacin
(Reference: (ESPAES) Communication, , , 15 June 1999)
MAR Jun 1999 The National Advisory Commission for Pharmacovigilance has decided to restrict the use
of trovafloxacin and alatrofloxacin only to university hospitals under professional control
and after a total examination of hepatic function. In the meantime, the Commission has
launched a survey among prescribers in order to evaluate the risk/benefit balance of this
product.
(Reference: (MARDMP) Letter to WHO, , , 24 Aug 1999)
VTN Jul 1999 The Drug Administration of Viet Nam in the Ministry of Health has not approved the
registration of trovafloxacin (Trovan) solution for injection 5 mg/ml and tablet 200 mg on
the basis that these products have a potential for hepatotoxicity.
(Reference: (VTNMHD) Directive, 2785, QLD, 15 July 1999)
PHL Jan 2000 The Department of Health Bureau of Food and Drugs have banned and withdrawn
trovafloxacin since it is associated with hepatic adverse reactions.
(Reference: (PHADO) Administrative Order, (1) s. 2000, , 03 Jan 2000)
SGP The National Pharmaceutical Administration in the Ministry of Health has not approved
trovafloxacin since it is associated with hepatic adverse reactions.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)
USA The Food and Drug Administration has restricted the indications for products containing
trovafloxacin or alatrofloxacin to patients having nosocomial infections or complicated
intra-abdominal infections that are serious or life- threatening. This is due to concerns
over the risks of serious liver toxicity.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T99-26, , June 1999)

Product Name Trypsin

C.A.S. number 9002-07-7

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Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 277

Product Name Trypsin

C.A.S. number 9002-07-7
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SLV Jun 2001 Injections for intramuscular use were not approved because of incomplete data on safety
and efficacy.
(Reference: (SLVCW) Communication to WHO, , , 24 Aug 2001)

Product Name Urethane

C.A.S. number 51-79-6
Scientific and common names, and synonyms
CARBAMIC ACID, ETHYL ESTER
ETHYLURETHANE
ETHYL CARBAMATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BRA 16 Sep 1963 Products containing urethane are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, No.13, , Sep 1963)
CUB 1964 The use of urethane both as a solvent and an antineoplastic agent was prohibited due to
the availability of less toxic and more effective drugs.
DNK 1967 Registration has been cancelled.
(Reference: (UGLAAD) Ugeskrift for Laeger, 136, 2093, Sep 1974)
EGY 1975 Products containing urethane were withdrawn having regard to the carcinogenic potential
of the drug.
JPN Jul 1975 Banned as a co-solvent in drugs by Pharmaceutical Affairs Bureau, for reasons of
carcinogenicity.
THA Dec 1975 Use as a stabilizer or solubilizer in drug preparations is prohibited.
USA Mar 1977 Withdrawn from use and/or sale by the Food and Drug Administration as an ingredient in
pharmaceutical products due to its carcinogenic nature. Prohibited for export in
pharmaceutical products.
ITA 1979 Withdrawn from the market owing to suspected carcinogenicity.
GRC 1980 Withdrawn as an excipient in pharmaceutical preparations.
DEU Jan 1982 Registration for all products containing urethane was cancelled due to the carcinogenic
potential of the drug.
VEN Not approved for use and/or sale in pharmaceutical products.
WHO Comment : Urethane was formerly used as an antineoplastic agent in the
treatment of chronic myeloid leukaemia. It is also a mild hypnotic which has been
used as an anaesthetic for veterinary practice. It has been reported to have both a
carcinogenic and mutagenic potential. Although urethane continues to be used as
an industrial solvent, WHO has no information to suggest that it remains
commercially available in pharmaceutical preparations.

Bibliographical references
IARC MONOGRAPH, 7, 111, 1974

Product Name Vaccines for mumps, measles, and rubella

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 278

Product Name Vaccines for mumps, measles, and rubella

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD 16 Sep 1992 In agreement with regulatory agencies SmithKline Beecham decided to discontinue
marketing all vaccines which contain the Urabe Am 9 strain of the mumps virus in those
countries where an alternative vaccine containing other strains of the mumps virus is
available. This decision is based on the reported incidence of meningeal reactions (1:
11,000) associated with this strain of virus.
(Reference: (DCCSKB) Drug company communication - Smith Kline Beecham, , , 16 Sep
1992)
GBR 19 Sep 1992 The Department of Health restricted future purchasing of mumps, measles and rubella
vaccine to MMR-II which is marketed by Wellcome Medical Division and contains the
Jeryl Lynn (B level) strain of the mumps virus.
(Reference: (GBRPHJ) The Pharmaceutical Journal, 358, , 19 Sep 1992)
CYP 23 Oct 1992 The Drug Council in Cyprus withdrew the marketing licence for SmithKline Beecham
triple vaccine Pluserix,the mumps/measles vaccine Rimparix, the mumps vaccine
Pariorix and two other MMR vaccines, Trimovax and Imovax (Pasteur Merieux).
(Reference: (CYPPS) Pharmaceutical Services, Ministry of Health, , , 23 Oct 1992)
WHO Comment : Mumps, measles and rubella vaccine is a mixed preparation
containing live attenuated strains of the measles, mumps and rubella virus. There
are different strains of the mumps virus and it is suggested that meningitis may
occur marginally more frequently with vaccine containing the Urabe Am 9 strain of
the mumps virus than the Jeryl Lynn strain. However, a number of regulatory
authorities still accept the Urabe Am 9 strain of the mumps virus on the grounds
that no permanent damage arises from the aseptic meningitis.

Product Name Valproic acid

C.A.S. number 99-66-1
Scientific and common names, and synonyms
2-PROPYLPENTANOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHL Nov 2001 The Public Health Institute of Chile has modified the labels to include warnings about the
adverse reactions (pancreatitis and its symptoms) associated with the drug.
(Reference: (CHLCW) Communication to WHO, , , 26 Sep 2001)

Product Name Vigabatrin

C.A.S. number 60643-86-9
Scientific and common names, and synonyms
GAMMA-VINYL AMINOBUTYRIC ACID
GAMMA VINYL-GABA
4-AMINOHEX-5-ENOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1991 The Medicines Control Authority has refused an application of registration of the
anticonvulsant, vigabatrin, on grounds that the product is not medically justified.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 279

Product Name Vigabatrin

C.A.S. number 60643-86-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, 1, 27, 1991)
WHO Comment : Vigabatrin, an irreversible inhibitor of GABA-transaminase was
introduced in 1989 as a anticonvulsant for management of epilepsy unresponsive
to other antiepilepsy agents. In 1991 it was refused registration in Norway because
it induced toxic changes, including microvacuolation in the brain of two animal
species, at doses that are close to therapeutic dosage levels in man. It is still
marketed in Sweden and the United Kingdom.

Product Name Vinarol and viga (dietary supplements)

C.A.S. number 2004-0-0011

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 04 Apr 2003 Two dietary supplement products (Vinarol and Viga) are being voluntarily recalled by the
respective companies due to the unlabeled presence of sildenafil.
(Reference: (USAMSA) Medwatch Safety Alert, , , 23 May 2003)
(Reference: (USAMSA) Medwatch Safety Alert, , , 04 Apr 2003)

Product Name Vinbarbital

C.A.S. number 125-42-8
Scientific and common names, and synonyms
5-ETHYL-5-(1-METHYLBUT-1-ENYL)BARBITURIC ACID
VINBARBITONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE Jul 1984 Withdrawn following discussions between the manufacturer and the National Board of
Health and Welfare. Fatal intoxications and abuse are associated with use of
preparations containing vinbarbital.
WHO Comment : Vinbarbital is an intermediate-acting barbiturate. See WHO
comment for barbiturates.

Product Name Vincamine

C.A.S. number 1617-90-9
Scientific and common names, and synonyms
METHYL(3ALPHA,16ALPHA)-14,15-DIHYDRO-14BETA-HYDROXYEBURNAMENINE-14- CARBOXYLATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
HUN 1980 Intravenous administration of preparations containing vincamine was prohibited, following
association with cardia arrhythmias.
(Reference: (HUNIP) National Institute of Pharmacy, , , 21 Aug 1980)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 280

Product Name Vincamine

C.A.S. number 1617-90-9
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1987 The Federal Health Office has withdrawn herbal preparations containing vincamine on
grounds of inadequate evidence of efficacy and risk of blood dyscrasias.
(Reference: (DEUPD) BGA Pressedienst, No.38, , July 1987)
WHO Comment : Vincamine, an alkaloid derived from Vinca minor, is claimed to
increase cerebral circulation and utilization of oxygen. It is used in a variety of
cerebral disorders and is widely marketed for this purpose.

Product Name Voglibose

C.A.S. number 83480-39-9
Scientific and common names, and synonyms
3,4-DIDEOXY-4-[[2-HYDROXY-1-(HYDROXYMETHYL)ETHYL]AMINO]-2-C-(HYDROXYMETHYL)-D-EPI-INOSITOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Dec 1996 The product information for voglibose has been revised to state that hypoglycaemic
symptoms were observed following monotherapy, in particular in patients with severe
hepatic dysfunction when no other antidiabetics were administered. [See also acarbose.]
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.140, , Dec 1996)
WHO Comment : Acarbose and voglibose area-glucosidase inhibitors and delay
digestion/absorption of carbohydrates as well as improving postprandial
hyperglycaemia.

Product Name Warfarin

C.A.S. number 81-81-2
Scientific and common names, and synonyms
2H-1-BENZOPYRAN-2-ONE,4-HYDROXY-3-(3-OXO-1-PHENYLBUTYL)-
3-(ALPHA-ACETONYLBENZYL)-4-HYDROXYCOUMARIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
EGY 1988 Products containing warfarin must bear a warning advising against the use during the first
trimester of pregnancy, having regard to their teratogenic potential.
(Reference: (EGYDI) Drug Information, 6(4), 1, 1988)
WHO Comment : Warfarin, a coumarin anticoagulant, was introduced into medicine
in 1950 for the prevention and managementof thrombo-embolic disorders. Its use
during the first trimester of pregnancy has been associated with birth
malformations, particularly in relation to cranial and limb development, and there
have been reports of foetal death due to haemorrhage following administration of
the drug during the late stages of pregnancy. The decision of the Egyptian agency
to requrie a warning regarding teratogenicity to be included in the approved
information of products containing warfarin beings the text of the package insert in
line with those approved in other countries. Warfarin is included in the WHO Model
List of Essential Drugs.
(Reference: (WHTAC4) The Use of Essential Drugs, 4th Report of the WHO Expert
Committee, 796, , 1990)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 281

Product Name Xenazoic acid

C.A.S. number 1174-11-4
Scientific and common names, and synonyms
P-((ALPHA-ETHOXY-P-PHENYLPHENACYL)AMINO)BENZOIC ACID
XENALMINE
XENALAMINE
4-(2-(BIPHENYL-4-YL)-1-ETHOXY-2-OXOETHYLAMINO)BENZOIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BEL 1965 The Ministry of Health has suspended the sale of drugs containing xenazoic acid.
FRA 1965 The Ministry of Health withdrew approval of xenazoic acid since liver damage had been
noted during administration of this drug.
VEN Not approved for use and/or sale.
WHO Comment : Xenazoic acid, an antiviral agent, was introduced in the early
1960s. Its use was associated with hepatic toxicity which resulted in its withdrawal
from the market in at least two countries in 1965. WHO has no information to
suggest that xenazoic acid remains commercially available.

Product Name Zimeldine

C.A.S. number 56775-88-3
Scientific and common names, and synonyms
(Z)-3-(1-P-BROMOPHENYL)-3-(DIMETHYLAMINO)PROPENYL)-PYRIDINE
2-PROPEN-1-AMINE, 3-(4-BROMOPHENYL)-N,N-DIMETHYL-3-(3-PYRIDINYL-, (Z)-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Jul 1983 This antidepressant drug was withdrawn worldwide by the manufacturer following
consultations with the Swedish Department of Drugs. This action was taken in
consequence of reports of hypersensitivity reactions which, in a few instances, were
accompanied by neurological complications.
WHO Comment : Zimeldine, an inhibitor of serotonin uptake, was introduced in
1982 for the treatment of depressive illness. By 1983 its use had been associated
with incidences of hypersensitivity of varying severity and serious neurological
side effects including the Guillain-Barr, syndrome. Following discussions with the
National Board of Health and Welfare of Sweden, the major manufacturer decided
to withdraw the drug on a worldwide basis.

Product Name Zipeprol

C.A.S. number 34758-83-3
Scientific and common names, and synonyms
ALPHA-(ALPHA-METHOXYBENZYL)-4-(BETA-METHOXYPHENETHYL)-1- PIPERAZINEETHANOL

1-METHOXY 3-(4-(BETA-METHOXYPHENETHYL)-PIPERAZIN-1-YL)-1-PHENYLPROPAN- 2-OL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Jun 1982 Withdrawn from use as an antitussive since toxicological studies with rhesus monkeys
have shown respiratory arrest after administration.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 282

Product Name Ziperol

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BRA Oct 1993 The Brazilian Ministry of Health has withdrawn Ziperol from the market and prohibited its
importation or production due to several cases of deaths among street children.
(Reference: (BRASDP) Centro Brasileiro de Informacoes Sobre Drogas Psicotropicas, , ,
05 Oct 1993)

Product Name Zomepirac

C.A.S. number 33369-31-2
Scientific and common names, and synonyms
5-(P-CHLOROBENZOYL)-1,4-DIMETHYLPYRROLE-2-ACETIC ACID
5-(P-CHLOROBENZOYL)-1,4-DIMETHYLPYRROLE-2-ACETATE
1H-PYRROLE-2-ACETIC ACID, 5-(4-CHLOROBENZOYL)-1,4-DIMETHYL-

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
@WD Mar 1983 The US Food and Drug Administration has informed the World Health Organization that
this nonsteroidal anti-inflammatory drug has been withdrawn voluntarily from the market
by the manufacturers following reports of serious allergic reactions, including five deaths
from anaphylaxis. The drug was approved for marketing within the USA in October 1980.
In April 1982 the labelling was revised to warn of the occurrence of allergic reactions, but
because of the subsequent increase in the incidence of anaphylactoid reactions and
reports of four deaths in the first three months of 1983, the company advised the FDA
that it was temporarily withdrawing zomepirac worldwide pending further evaluation.
WHO Comment : Zomepirac, a nonsteroidal anti-inflammatory agent, was
introduced in 1979 for the treatment of rheumatic disorders and the management of
moderate to severe pain. By 1983 its use had been associated with serious allergic
reactions, including five deaths from anaphylaxis. This led to voluntary withdrawal
of the drug from markets worldwide by the major manufacturer.

Product Name Zopiclone

C.A.S. number 43200-80-2
Scientific and common names, and synonyms
ZOPICLONUM
27267-RP
4-METHYL-1-PIPERAZINECARBOXYLIC ACID ESTER WITH 6-(5-CHLORO-2-PYRIDYL)- 6,7-DIHYDRO-7-HYDROXY-5H-
PYRROLO(3,4-B)PYRAZIN-5-ONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ISL 25 Feb 1986 Zopiclone is not approved for registration on grounds of positive findings in
carcinogenicity tests in animals and adverse effects in humans.
NOR 1987 Zopiclone is not approved for registration on grounds that animal studies have disclosed
thyroid disorders and neoplasms.
MUS May 2000 The Ministry of Health and Quality of Life has rescheduled the antipsychotic agent
zopiclone into Schedule III of the consolidated Dangerous Drugs Act 2000 following
observations of irrational use and emerging abuse.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (MONOCOMPONENT PRODUCTS) 283

Product Name Zopiclone

C.A.S. number 43200-80-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (MUSMHQ) Letter to WHO, , , 27 Dec 2000)
WHO Comment : Zopiclone was introduced as a sedative in 1985. It remains
registered in several countries and the World Health Organization is not aware of
any other country that has refused registration.

Legislative or regulation action

 Pharmaceuticals(Combination and Group Products)
Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 284

Product Name ACE-Inhibitors

Scientific and common names, and synonyms

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Sep 1988 The Federal Health Office re-emphasized that products containing ACE-inhibitors are
contraindicated during pregnancy. Exposure to enalapril or captopril in utero has resulted
in a state of potentially reversible anuria in newly born infants.
(Reference: (BGHBL) Bundesgesundheitsblatt, 31/9, 369, 1988)
GBR Dec 1989 The product information of ACE-inhibitors including captopril, enalapril, lisinopril and
quinapril was amended to emphasize that these products are contraindicated in
pregnancy, following thier association with shortage of amniotic fluid in mothers and
abnormal skull ossification, hypotension, renal failure and anuria in exposed infants.
(Reference: (GBRCSM) Committee on Safety of Medicines, Current problems, 27, , Dec
1989)
ITA Jul 1990 Use of products containing ACE-inhibitors was contraindicated during pregnancy,
following their association with shortage of amniotic fluid in mothers and imcomplete
cranial ossification in neonates.
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, XIV(7):4, , 1990)
MYS 1992 Manufacturers and importers of products containing ACE-inhibitors were notified by the
Drug Control Authority to include a warning that ACE-inhibitors have been shown to be
fetotoxic in animal studies and their use in women in the later stages of pregnancy has
been associated with an increased incidence of serious fetal/neonatal conditions.
(Reference: (MYSDN) Berita Ubat-Ubatan (Drug Newsletter), 6(2):2, , 1992)
NZL 1992 Having regard to reports of foetal damage, including kidney failure and face or skull
deformities attributed to angiotensin-converting enzyme inhibitors, women in New
Zealand who become pregnant while receiving such a product have been advised to
consult their doctor in order that an alternative treatment may be prescribed.
(Reference: (NZCSL) Clinical Services Letter, Department of Health, 266, , 28 Aug 1992)
PRT 1992 The Ministry of Health revised the product information for angiotensin-converting enzyme
(ACE) inhibitorsto contraindicate their use during pregnancy.
(Reference: (PRTIT) Informacao terapeutica, 1(1), , May 1992)
SWE 1992 The Medical Product Agency recommended that treatment with ACE-inhibitors be
discontinued immediately should the patient become pregnant.
(Reference: (SWEILS) Information från Läkemedelsverket, 2(3):89, , 1992)
USA Mar 1992 Product containing ACE-inhibitors, including captopril, fosinopril, benazepril, ramipril,
lisinopril, enalapril, enalaprilat and quinapril were required to carry a boxed warning
regarding risks of exposure during the later stages of pregnancy, following reports of
kidney failure, and abnormalities in the face and cranium of the foetus.
(Reference: (HHSNS) HHS News: US Department of Health and Human Services, P92-8,
, 13 Mar 1992)
ESP 21 Apr 1992 The Directorate General of Pharmacy and Health Products of the Ministry of Health and
Consumer Affairs decided that ACE-inhibitors treatment during pregnancy should be
contraindicated.
(Reference: (ESPOR) Ministerio de Sanidad y Consumo, , , 02 July 1992)
THA Feb 1994 The Ministry of Public Health has decided to add a warning to the labelling of products
containing angiotensin-converting enzyme (ACE) inhibitors stating that the drug should
not be used in pregnancy, that it may increase blood potassium level, provoke kidney
failure, angioneurotic oedema and other adverse effects.
(Reference: (THAFDA) Communication to WHO, , , 08 Feb 1994)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 285

Product Name ACE-Inhibitors

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : The tolerability profile of ACE-inhibitors (including captopril,
enalapril, lisinopril, quinapril, ramipril etc.) is by now well established. Captopril is
listed in the WHO Model List of Essential Drugs.

Product Name Acetylsalicylic acid/antacid

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Apr 1994 The Food and Drug Administration proposed to revise the labelling of products containing
acetylsalicylic acid (including buffered acetylsalicylic) alone or in combination with an
antacid to include the following statement: ?IMPORTANT: See your doctor before taking
this product for your heart or for other new uses of aspirin [acetylsalicylic acid], because
serious side effects could occur with self-treatment? .
(Reference: (FEREAC) Federal Register, 58(201) , p. 54224, 1993)
WHO Comment : See under Acetylsalicylic acid.

Product Name Acetylsalicylic acid/codeine

Scientific and common names, and synonyms

CODEINE/ACETYLSALICYLIC ACID

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1 Jan 1990 All fixed combination preparations containing acetylsalicylic acid 500 mg + codeine
phosphate 10 mg have been withdrawn, on the grounds that the low dose of codeine in
these preparations does not contribute to the analgesic effect, but may cause adverse
effects and induce dependence.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, 15(2),
59, 1990)

Product Name Acetylsalicylic acid/phenacetin/caffeine (APC)

Scientific and common names, and synonyms

APC
CAFFEINE/PHENACETIN/ACETYLSALICYLIC ACID
PHENACETIN/ACETYLSALICYLIC ACID/CAFFEINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA 1983 Banned for manufacture. Preparations must be reformulated to contain only
acetylsalicylic acid.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 286

Product Name Allopurinol and benzbromarone

C.A.S. number 2003-1-1001

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Feb 2001 This anti-gout preparation has been withdrawn in France due to associations of adverse
hepatic effects with benzbromarone and toxic skin and hypersensitivity reactions with
allopurinol.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)

Product Name Amoxicillin/clavulanic acid

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 8 Jun 1995 The injectable form of the combination antibiotic was suspended after reports of cases of
severe allergic reactions were received.
(Reference: (GRANDO) Communication, , , 08 June 1995)
GBR May 1997 The Committee on Safety of Medicines has restricted the indications for the combination
antibiotic, amoxicillin/clavulanic acid, to bacterial infections likely or known to be caused
by amoxicillin-resistant beta-lactamase producing strains. This action has been taken
after reports were received of cholestatic jaundice occurring during or shortly after the
use of this product.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol. 23, p.6, May 1997)
WHO Comment : The amoxicillin/clavulanic acid combination should be reserved
for infections likely or known to be caused by amoxicillin- resistant beta-lactamase
producing strains. Amoxicillin/clavulanic acid is listed in the WHO Model List of
Essential Drugs.

Product Name Ampicillin/cloxacillin

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS Jun 1995 The Drug Control Authority has cancelled the registration of fixed-dose combination
products containing ampicillin and cloxacillin because this combination does not meet the
criteria set for combination products.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 9(2): 3, , June 1995)
WHO Comment : Ampicillin and cloxacillin are listed separately in theWHO Model
List of Essential Drugs.

Product Name Analgesics in combination

Scientific and common names, and synonyms

ANALGESICS/BENZODIAZEPINES
ANALESICS/MEPROBAMATE

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 287

Product Name Analgesics in combination

Country Effective Description of action taken

Date Grounds for decision
DEU 1991 The marketing authorization for products containing analgesics in combination with
benzodiazepines or neprobamate was withdrawn, because sedative components in
analgesic preparations create unnecessary risks of abuse, dedation and subsequently
adverse effects due to chronic misuse of the analgesics.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 136/8, 402, 1991)
JPN 28 Sep 1995 The Central Pharmaceutical Affairs Council issued an alert concerning analgesics and
cold remedies containing antifever agents including acetylsalicylic acid, paracetamol and
ibuprofen available for sale over- the- counter (OTC), after over 40 reports were received
of severe adverse reactions necessitating hospitalization. In most cases, the patient had
a history of hypersensitivity but ignored the warning in the package insert.
(Reference: (JPNPAC) Central Pharmaceutical Affairs Council, , , 28 Sep 1995)
WHO Comment : There is a growing awareness of serious health risks associated
with indiscriminate use of these drugs. Acetylsalicylic acid, ibuprofen and
paracetamol are listed as individual agents in the WHO Model List of Essential
Drugs.

Product Name Anorectic drugs

Scientific and common names, and synonyms

AMFETAMINE-LIKE COMPOUNDS
DEXFENFLURAMINE
FENFLURAMINE
PHENTERMINE
PHENDIMETRAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BRA 18 Aug 1994 The Ministry of Health has issued an order prohibiting the manufacture, distribution and
sale of anorectic substances promoted as "anti-obesity" drugs. The substances at issue
are: fepramone, dexfenfluramine, fenfluramine, levofenfluramine, fenproporex and
mazindol either as single ingredient drugs or in combination with other anorectic agents.
(Reference: (BRASVS) Secretaria de Vigilancia Sanitaria, Portaria 87, , 18 Aug 1994)
FRA May 1995 Because of cases of pulmonary hypertension, the French Medicines Agency has made
the following restrictions in the use of amfetamine-based anorectic agents: they are
indicated only for the treatment of severe obesity in patients whose body mass index is
over 30, which constitutes a severe cardiovascular risk factor; duration of treatment
(cumulative) is limited to three months; they are contraindicated in combination with
other drugs.
(Reference: (FRAAMC) Communiqué de Presse, , , 12 May 1995)
@EC 18 Jul 1996 The Committee on Proprietary Medicinal Products recommends the inclusion of a boxed
warning in the Summary Product Characteristics that clearly sets out the risks of
pulmonary hypertension that is associated with anorectic agents, including the
serotonergic compounds dexfenfluramine and fenfluramine; and the ?amfetamine-like?
compounds: amfepramone, clobenzorex, fenbutrazate, fenproporex, mazindol,
mefenorex, cathine (norpseudoephedrine), phendimetrazine, phenmetrazine,
phentermine and propylhexedrine. The Committee concluded that the risk-benefit
balance is favourable provided that the products are used under strict supervision by
specialist in carefully selected patients.
(Reference: (CPMPAR) PMP Assessment Report for Anorectic Agents, , , 18 July 1996)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 288

Product Name Anorectic drugs

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PRT Sep 1999 The Portuguese Medicines Evaluation Committee has recommended to the Board of
INFARMED the suspension of marketing authorizations for all medicinal products
containing clobenzorex and fenproporex. This recommendation follows the final opinions
of the Committee on Proprietary Medicinal Products that recommends the withdrawal of
the marketing authorizatons for medicinal products containing amfepramone,
phentermine, clobenzorex, fenproporex, mefenorex, norpseudoephedrine and
phendimetrazine based on the lack of therapeutic efficacy of these products leading to an
unfavourable benefit/risk balance and the withdrawal of the marketing authorizations for
fenfluramine and dexfenfluramine containing medicinal products, based on an
unacceptable safety profile under normal conditions of use and limited therapeutic
efficacy, leading to an unfavourable benefit/risk balance.
(Reference: (PRTIFM) Communication, , , 14 Sep 1999)
FRA Oct 1999 The Agency Française de Sécurité Sanitaire des Produits de Santé (AFSSPS) has
suspended the marketing authorizations for medicinal products containing the anorectic
agents amfepramone, clobenzorex, dexfenfluramine, fenfluramine, fenproporex and
mefenorex because of their implication in the occurrence of arterial pulmonary
hypertension.
(Reference: (FRARP) La Revue Prescrire, Vol. 19(199), , Oct 1999)
OMN Apr 2000 The Directorate General of Pharmaceutical Affairs & Drug Control has banned the
registration and import of the following anorectic agents: Clobenzorex, mefenorex,
phedimetrazine, fenproporex, nor pseudoehedrine, febutazate and propylhexedrine. This
action was taken because of lack of therapeutic efficacy leading to an unfavourable
benefit/risk balance. .
(Reference: (OMNCR) Circular, No. 26/2000, , 26 Apr 2000)

Product Name Anorectic dugs in combinations

Scientific and common names, and synonyms

AMFEPRAMONE,BENZFETAMINE,BENFLUOREX,FENFLURAMINE,PHENDIMETRAZINE,PHENTERMINE/TIRATRICOL/TH
YROID HORMONE/METFORMIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ITA 26 May 1987 Extemporaneous preparation of products in which anorectic agents including
amfepramone, benzfetamine, benfluorex, fenfluramine, phendimetrazine and
phentermine are combined with tiratricol, thyroid hormone or metformin has been
prohibited. Prohibition of manufacture of preparations containing anorectics in
combination with other active principles.
(Reference: (ITADMS) Decree of the Ministero della Sanita, , , 26 May 1987)
WHO Comment : Anotectics have been introduced many years ago for use as
adjuncts to dietary control in the short-term management of obesity. Their use in
combination with other drugs such as thyroid hormone, tiratricol or metformin to
increase weight loss is considered inappropriate and dangerous. Although they
may lead to weight loss, thyroid hormone and tiratricol should only be used in
obese patients with a proven thyroid deficiency and metformin should only be
administered to overweight patients suffering from diabetes. Moreover, all three
drugs are associated with serious adverse effects. Extemporaneous preparations
of products containing anorectics in combination with other active ingredients has
been prohibited in Italy. In some other countries, although discouraged, it still
remains a common practice.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 289

Product Name Anorectic dugs in combinations

Product Name Antidiarrhoeal combinations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 1989 Import and marketing of antidiarrhoeal preparations containing antibiotics or antimicrobial
agents were prohibited.
(Reference: (OMNCR) Circular, 31/89, , 1989)
(Reference: (OMNCR) Circular, 15/89, , 1989)
LBN 03 Aug 1991 Registered only as a wood preservative for a very specific use.
IDN Oct 1991 Solid and liquid formulations of preparations containing streptomycin, kanamycin,
neomycin, non-absorbable sulfonamides, hydroxyquinolines, antihistamines or vitamins
intended for the treatment of diarrhoea in children were banned.
(Reference: (IDMH) Ministry of Health, , , 19 Nov 1991)
BRA 14 Sep 1994 The Ministry of Health has issued an order withdrawing a number of paediatric
formulations of antidiarrhoeal preparations on the grounds of low or unproven efficacy.
For another group of substances the order requires that the product information include
the phrase: "Not indicated in acute or persistent diarrhoea in children".
(Reference: (BRASVS) Secretaria de Vigilancia Sanitaria, Portaria 106, , 14 Sep 1994)
IND Apr 1995 The Drug Controller of India has banned the manufacture and sale of six antidiarrhoeal
products on the grounds that they do not have any therapeutic justification and are likely
to involve a risk for patients, especially in children for whom oral rehydration therapy is
preferred.
(Reference: (INDEPH) The Eastern Pharmacist, , , Apr 1995)
MYS Jun 1995 The Drug Control Authority has withdrawn the registration for liquid oral forms of
antidiarrhoeal preparations containing loperamide and diphenoxylate for use in young
children.
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 9(2): 7, , June 1995)
WHO Comment : The list of agents concerned is very long. Refer to original
references. The aminoglycoside antibiotics streptomycin, kanamycin and
neomycin, non-absorbable sulfonamides (i.e. sulfaguanidine, succinyl-
sulfathiazole, phthalylsulfathiazole) and halogenated hydroxyquinolines (e.g.
clioquinol, broxyquinoline, chlorquinaldol) have been used as antidiarrhoeal
agents. However, there is no satisfactory evidence that they are effective, they have
occasionally been associated with severe adverse reactions and some promote the
emergence of bacterial resistance. The World Health Organization recommends
that they should not be used for the management of diarrhoea in children.
(Reference: (WHTAC5) The rational use of drugs in the management of acute
diarrhoea in children, , , 1990)

Product Name Antirheumatic combinations with glucocorticosteroids

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
AUT Jan 1986 Enteral preparations have been withdrawn and parenteral preparations may only be used
for very limited indications and under strict medical supervision.
DEU 1 Jan 1986 Fixed combinations have been withdrawn since concurrent administration of such drugs
potentiates adverse effects without increasing benefit.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 290

Product Name Antirheumatic combinations with glucocorticosteroids

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Product Name Atropine in combination

C.A.S. number 51-55-8
Scientific and common names, and synonyms
BENZENEACETIC ACID, ALPHA-(HYDROXYMETHYL)-8-METHYL-8-AZABICYLO[3.2.1]OCT-3-YL ESTER, ENDO(+/-)-
1ALPHA H, 5ALPHA H-TROPAN-3ALPHA-OL (+/-)-TROPATE (ESTER)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Sep 1976 Combinations of atropine sulfate with difenoxylate, furazolidone and dimethylpolysiloxane
were withdrawn because of potential adverse reactions including dysuria (from atropine
and furazolidone), tachycardia, palpitation and blurring of vision.
KOR Dec 1991 Products containing atropine indicated for the treatment of acute diarrhoea were banned
because there are many preparations which are safer and more effective.
(Reference: (KRMHSA) Ministry of Health and Social Affairs - Communication to WHO, ,
, 13 Dec 1991)
WHO Comment : Atropine, an alkaloid with anticholinergic activity extracted from
Atropa belladonna, has been widely used in medicines for centuries for its
antispasmodic and mydriatic properties. It is also used for premedication prior to
anaesthesia. Preparations containing atropine remain available and the substance
is included in the WHO Model List of Essential Drugs.
(Reference: (WHTAC4) The Use of Essential Drugs, 4th Report of the WHO Expert
Committee, 796, , 1990)

Product Name Azatadine maleate/pseudoephedrine sulfate

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NLD May 1994 The marketing authorization of a combination tablet formulation containing azatadine
maleate and pseudoephedrine sulfate indicated for treatment of congestion associated
with the common cold was withdrawn because of doubtful efficacy and greater risk of
adverse effects with products intended for systemic use rather than topical use.
(Reference: (NPHWB) Pharmaceutisch Weekblad, 28(5):126, , 1994)

Product Name Barbiturates in asthma preparations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ZAF 1998 The South African Medicines Control Council has withdrawn asthmatic preparations
containing barbiturates because of the unacceptable risk-benefit profile which is not in
the interest of public health.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 291

Product Name Barbiturates in asthma preparations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (ZAFPS) Information from the Pharmaceutical Services, , , )

Product Name Barbiturates in combination

Scientific and common names, and synonyms

ATRIUM

ANTIASTHMATICS/BARBITURATES
ANTACIDS/BARBITURATES
ANALGESICS/BARBITURATES
BARBITURATES/ANTIASTHMATICS
BARBITURATES/ANTACIDS
BARBITURATES/ANALGESICS
1-(3-BUTOXY-2-HYDROXYPROPYL)-5-ETHYL-5-PHENYLBARBITURIC ACID CARBAMATE ESTER/1,3-BIS-(3-BUTOXY-2-
HYDROXYPROPYL)-5-ETHYL-5-PHENYLBARBITURIC ACID DICARBAMATE ESTER/ 5-ETHYL-5-PHENYLBARBITURIC
ACID DICARBAMATE ESTER

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
TUR 1982 Combination products with barbiturates and analgesics have been withdrawn by the
Ministry of Health due to the lack of substantial evidence of efficacy and the risk of
dependence. Export of these products is prohibited.
DEU 1 Jun 1986 The Federal Health Office has withdrawn approval for the inclusion of barbiturates in
analgesic and antirheumatic preparations since their inclusion in such products serves no
purpose and creates unnecessary risks of abuse and sedation.
MYS Nov 1986 All combination products containing barbiturates have been withdrawn.
(Reference: (MYSDC) Malaysian Drug Control Authority, No.4, , Nov 1986)
DEU Jun 1994 The Federal Institute for Drugs and Medical Devices has restricted the indications for
barbiturates to focal (partial) epileptic fits or generalized epileptic fits, and anaesthesia or
pre-anaesthesia. Marketing authorization for these medicinal products was revoked for
all other indications.
(Reference: (DEUCFI) Communication, , , 20 June 1994)
FRA 4 Apr 1997 The marketing authorization of the 100-mg formulation of Atrium®, a combination product
containing febarbamate, difebarbamate and phenobarbital indicated for the treatment of
minor anxiety, has been withdrawn following an evaluation which concluded that the
benefit/risk ratio is unfavourable, and in view of the potential risk of liver damage
occurrence. The indication for the 300-mg formulation of Atrium® is restricted to the
treatment of alcoholic withdrawal syndrome with a maximum treatment duration of four
weeks.
(Reference: (FRAAMA) Pharmacovigilance Alert, , , 04 Apr 1997)
SAU Jun 1999 The Ministry of Health has withdrawn from the market a fixed combination barbiturate
product containing phenobarbital, febarbamate and difebarbamate because of reports of
hepatotoxicity.
(Reference: (SAUCW) Notification, , , 20 June 1999)
GBR Barbiturates and antacids in combination have been withdrawn from the market by
manufacturers, for general safety reasons in relation to barbiturates. Combination
products with barbiturates and antiasthmatics have been withdrawn by manufacturers
because barbiturates may depress respiration.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 292

Product Name Barbiturates in combination

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
WHO Comment : Barbiturates were introduced at the beginning of the 20th century
and have been extensively used as sedative-hypnotic drugs. Their use in the
treatment of sleep disorders and anxiety has been largely superseded by the
benzodiazepines since the former have a greater liability for abuse and
development of tolerance and withdrawal syndrome, a lower therapeutic index and
a higher incidence of drug interactions and adverse effects possibly including
carcinogenic, mutagenic and teratogenic effects. Although many preparations
containing barbiturates remain available, some regulatory authorities have severely
restricted their approved indications and withdrawn product licences for
combination products containing these substances (see full list). The type of
product, its dose and duration of use are in this context of great importance.
Several barbiturates are controlled under the 1971 Convention on Psychotropic
Substances. The long-acting barbiturates phenobarbital and methylphenobarbital
are of value in the treatment of epilepsy and several short-acting barbiturates are
still used in anaesthesia.
(Reference: (UNCPS) United Nations Convention on Psychotropic Substances, , ,
1971)

Product Name Benzbromarone and Benziodarone

C.A.S. number 2004-1-1001

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP 10 Feb 2004 Following reports of hepatotoxicity, the Spanish Safety Committee has withdrawn the
marketing authorizations for benziodarone and benzbromarone-allopurinol fixed dose
combination products. Benzbromarone has been brought under restricted use, to be
prescribed by specialists in hospitals, for treating hyperuricaemia in allopurinol-intolerant
patients with gout polyarticular or gout tophaceous, renal failure and renal transplantation.
(Reference: (ESPSMA) Communication to WHO, Ref: 2004/02, , 10 Feb 2004)

Product Name Boric acid and borates

C.A.S. number 10043-35-3
Scientific and common names, and synonyms
BORIC ACID (H3BO3)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BRA Apr 2001 Boric acid and borax have been eliminated from preparations for topical administration in
infants.
(Reference: (BRARES) Resolucao n., 552/ANVISA, , 30 Apr 2001)

Product Name Calcium bromidum and chloral hydrate

C.A.S. number 2003-1-1002

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 293

Product Name Calcium bromidum and chloral hydrate

C.A.S. number 2003-1-1002
Country Effective Description of action taken
Date Grounds for decision
FRA Aug 2001 Withdrawn due to the mutagenic and carcinogenic potential of chloral hydrate.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)

Product Name Calcium channel blockers

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL Oct 1996 Monotherapy with short-acting calcium channel blockers (nifedipine) is no longer
recommended for patients with angina or clinical evidence of coronary artery disease.
(Reference: (NZLTN) Therapeutic Notes, No.22, , Oct 1996)
DEU 1 Jul 1997 The Federal Institute for Drugs and Medical Devices has amended the authorizations for
medicinal products containing the calcium antagonists amlodipine, fodipine, isradipine,
nicardipine, nifedipine, nilvadipine, nimodipine, nisoldipine and nitrendipine with effect
from 1 July 1997. The indications for nifedipine have been restricted to vasospastic
angina pectoris (variant angina), chronic stable angina pectoris, essential hypertension,
hypertensive crisis, and Raynaud?s syndrome. Contraindications have been extended to
include unstable angina pectoris, and acute myocardial infarction. The adverse reactions
section will include a warning that occasionally patients with existing angina pectoris may
experience an increase in frequency, duration and severity of angina pectoris attacks,
and that myocardial infarction has occasionally been observed. Because of dose related
cardiovascular complications, therapy with immediate-release products containing
nifedipine should be initiated only when other products are contraindicated. The
maximum daily intake has been restricted to 60mg.
(Reference: (DEUCFI) Communication, , , 07 Apr 1994)
(Reference: (DAZ) Deutsche Apotheker Zeitung, 137(15):1172, , 1997)
WHO Comment : Calcium channel blockers were introduced in the sixties. They are
mainly used in coronary heart disease, as antiarrhythmic agents and also in the
treatment of hypertension. The long-acting calcium channel blockers like
verapamil and diltiazem, due to their longer half-life time, have a somewhat
different therapeutic and safety profile from the short-acting agents discussed
above. Nifedipine and verapamil are listed in the WHO Model List of Essential
Drugs.

Product Name Chloramphenicol in combination

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BEL 1980 Preparations containing chloramphenicol in combination with tetracyclines are prohibited
having regard to the cumulative toxicity of the two antibiotics.
(Reference: (BELAR) Arrêté Royal, , , Oct 1980)
ESP Mar 1985 Registration of combination products containing chloramphenicol was disallowed
because of the propensity of this drug to cause aplastic anaemia.
IND Nov 1988 Fixed dose oral and parenteral combination products containing chloramphenicol were
banned.
(Reference: (INDDHS) Directorate of Health Services, , , 11 Mar 1992)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 294

Product Name Chloramphenicol in combination

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Oct 1989 Products containing chloramphenicol in combination with nitrofurantoin, sulfisoxazole and
methylene blue have been withdrawn for reasons of increased risk of toxicity, especially
blood dyscrasias, and lack of therapeutic advantage over products containing
chloramphenicol only.
(Reference: (THAMH) Ministry of Public Health, , , 15 Apr 1991)

Product Name Chlormadinone acetate/mestranol (in oral contraceptives)

Scientific and common names, and synonyms

MESTRANOL/CHLORMADINONE ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1970 Oral contraceptives containing this combination were voluntarily withdrawn from the
market because of the development of breast nodules in beagle dogs administered 10 to
25 times the human dosage of active components. The beagle is especially prone to
breast nodules, regularly developing these in later life. The naturally occurring nodules
are generally accepted to be benign mixed tumours. However, in these studies, the
treated dogs developed more nodules at an earlier age than did the control dogs which
were not given the drug. Species difference in the metabolism of the chemicals and the
large doses used also prevent direct transposition of these data to human beings.
SAU Oral contraceptives with these and other ingredients are available only on a prescription
basis.
VEN Not approved for use and/or sale as ingredients in oral contraceptives.

Product Name Clopamide, reserpine and dihydroergocristine mesilate

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
LTH May 2000 The State Medicines Control Agency has not renewed marketing authorization for
combination products containing clopamide, reserpine and dihydroergocristine mesilate
on the grounds that safer and more effective medicinal products are available.
(Reference: (LTHMCA) Order of State Medicines Control Agency, No. 61, , 17 May 2000)

Product Name Contrast media (ionic and non-ionic)

Scientific and common names, and synonyms

IOXITALAMIC ACID
IOXAGLIC ACID
IOMEPROL
IOVERSOL
IOHEXOL
IOPAMIDOL

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 295

Product Name Contrast media (ionic and non-ionic)

Scientific and common names, and synonyms

IOTROLAN
IOTALAMIC ACID
IODIXANOL
LYSINE AMIDOTRIZOATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU Nov 1995 Pending an evaluation by the Federal Institute for Drugs and Medical Devices and in view
of an increased number of hypersensitivity reactions, sometimes delayed, that have been
observed after the administration of iodixanol or iotrolan, the manufacturer has
temporarily suspended marketing of iotrolan (Isovist®-280).
(Reference: (DEURFI) Rapid Alert - Pharmacovigilance, , , 13 Oct 1995)
(Reference: (DEUCFI) Communication, , , 28 Nov 1995)
JPN Mar 1996 The Pharmaceutical Affairs Bureau issued a warning about adverse reactions to non-
ionic contrast media which, although less frequent than those reported with ionic contrast
media, may be serious and are often delayed in onset. The products involved are
iopamidol, iohexol, ioversol, iomeprol and ioxaglic acid. The reactions concern delayed
allergic reactions including shock and anaphylactoid symptoms. Emergency measures
for the treatment of shock should be available when x-rays are performed using these
preparations.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No. 136, , Mar 1996)
DEU Sep 1997 The Federal Institute of Drugs and Medical Devices has withdrawn the marketing
authorization for an ionic contrast medium containing lysine amidotriazoate (Peritrast®-
180/36%), since new large-scale studies show that low osmolar non-ionic contrast media
have a much lower risk potential than high osmolar ionic contrast media, including
Peritrast®-180/36%, and therefore the use of these products can no longer be justified.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 142(37): 3096, , 1997)
DEU Jul 1998 The Federal Institute of Drugs and Medical Devices has announced its intention to revoke
the marketing authorizations for ionic contrast media containing lysine amidotriazoate,
iotalamic acid or ioxitalamic acid, either alone or in combination, for intravasal
administration, because their use has been associated with severe adverse reactions
including hypotension, arrhythmias, pulmonary oedema and renal disorders. At the same
time, products that are indicated for intra-arterial and intravenous use and for use in the
body cavities may now only be used in the body cavities.
(Reference: (DEUNFI) Notification, , , 06 July 1998)

Product Name Cycloserine/isoniazid

Scientific and common names, and synonyms

ISONIAZID/CYCLOSERINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DOM This combination has been prohibited for use and/or sale since the benefits of treatment
have not been found to outweigh the risks.

Product Name Desensitizing vaccines

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 296

Product Name Desensitizing vaccines

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR May 1994 The Committee on Safety of Medicines has reviewed the efficacy and safety of
desensitizing vaccines and has concluded that these products should be used only for
the following indications: seasonal allergic hay fever not responding to anti-allergy drugs
and hypersensitivity to wasp and bee venoms. Desensitization should be carried out only
where facilities for cardiopulmonary resuscitation are immediately available.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol. 20, , May 1994)

Product Name Dicycloverine(dicyclomine)/doxylamine/pyridoxine)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA 8 Feb 1994 The Ministry of Public Health has decided to withdraw all combination pharmaceutical
products indicated for the prevention of vomiting containing dicycloverine (dicyclomine),
doxylamine and pyridoxine. This action is based on the perceived teratogenic potential of
this combination preparation.
(Reference: (THAFDA) Communication to WHO, , , 08 Feb 1994)
WHO Comment : See also under dicycloverine alone in full edition. Its use was
restricted in several countries for reasons other than suspicions of teratogenicity
associated with the combination preparation.

Product Name Dihydroergotamine/heparin

C.A.S. number 511-12-6
Scientific and common names, and synonyms
HEPARIN/DIHYDROERGOTAMINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 9 Feb 1988 The approved indications of injectable preparations containing dihyroergotamine in
combination with heparin have been amended to limit their use as follows: "post-
operative prophylaxis against deep vein thromboses and lung embolism in pateints at
high risk of thrombotic complications who have undergone elective non-traumatic
surgery". This reflects the risk of vasospastic reations, some of which have necessitated
limb amputation, in particular in treated patients who had undergone surgery for trauma.
(In addition to the reference given, also see Farmaceutiska specialiteter i Sverige.
L,kemedelsinformation AB, 23,635,1988).
(Reference: (SWEFSL) Farmaceutiska specialiteter i Sverige. Läkemedelsinformation
AB, 23, 635-636, 1988)
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, 13(4),
115, 1988)

Product Name Dihydrostreptomycin sulfate/streptomycin sulfate

Scientific and common names, and synonyms

STREPTOMYCIN SULFATE/DIHYDROSTREPTOMYCIN SULFATE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 297

Product Name Dihydrostreptomycin sulfate/streptomycin sulfate

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Combination withdrawn from the market and prohibited for export by the Food and Drug
Administration on the grounds of an unfavourable benefit/risk ratio.

Product Name Dipotassium clorazepate/acepromazine/aceprometazine

Scientific and common names, and synonyms

ACEPROMETAZINE/ACEPROMAZINE/DIPOTASSIUM CLORAZEPATE
ACEPROMAZINE/DIPOTASSIUM CLORAZEPATE/ACEPROMETAZINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Mar 1983 Disapproved for use due to effects of liver toxicity and Parkinsonism. There is a lack of
evidence of greater efficacy in the combination than with the component drugs given
individually. Acepromazine is approved for veterinary use only.

Product Name Estrogen-progestogen preparations for secondary amenorrhea

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DNK Oct 1974 Use of high-dosage products has been cancelled.
DEU 1980 The Federal Health Office has withdrawn from the market relatively high-dosage
combination products containing estrogens and progestogens indicated for the treatment
of secondary amenorrhoea. An expert committee had emphasized the need to exclude
pregnancy before such products are used, having regard to their propensity to induce
abortion.
SAU The Drug Committee has advised using these combination products only after pregnancy
has been ruled out. Relatively high-dosage products are restricted for use.
VEN Combinations for secondary amenorrhoea are not approved for use and/or sale.

Product Name Estrogens

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Sep 1989 Products containing estrogens may no longer be indicated for suppression of lactation
and prevention of breast engorgement in mothers who elect not to breastfeed.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T89-56, , 27 Sep 1989)
DEU Jan 1992 The use of estrogens for substitution therapy was restricted to the treatment of post-
menopausal women who have undergone hysterectomy.
(Reference: (DEUPZ) Pharmazeutische Zeitung, 136(3), 85, 1992)
BEL 7 Jun 1993 The Ministry of Health has subjected preparations containing estrogens for vaginal use to

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 298

Product Name Estrogens

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
prescription control. They will be required to be labelled with the skull and crossbones
symbol and stored in a poisons cupboard.
(Reference: (BELAP) Annales Pharmaceutiques belges, Dec. 8/9: 19, , 07 June 1993)
WHO Comment : Estrogens have been used for the prevention of postpartum
breast pain and engorgement. However, because of an increased risk of puerperal
thromboembolism and a risk of rebound effect, and since only 10% of women
benefit therapeutically from such intervention, the United States Food and Drug
Administration has requested manufacturers to no longer indicate preparations
containing estrogens for this purpose. The World Health Organization is not aware
of similar action having been taken elsewhere.

Product Name Estrogens (in oral contraceptives)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Apr 1988 Oral contraceptives containing more than 50 mcg of estrogen have been voluntarily
withdrawn by the manufacturers, because they are associated with a higher risk of
venous thrombo-embolism than low dose preparations.
(Reference: (HHSNS) HHS News: US Department of Health and Human Services, P88-7,
, 14 Apr 1988)
WHO Comment : Preparations containing both an estrogen and a progestogen in
fixed combination were introduced for oral contraception in 1960. In late 1960's,
use of products containing more than 50 mcg of estrogen was demonstrated to be
associated with an increased risk of thrombo-embolic disease. Such formulations,
which offer no advantage in terms of efficacy have subsequently been largely
abandoned.

Product Name Estrogens/testosterone

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Under the provisions of the Drugs (Control) Ordinance, combinations of ethinyl estradiol
and methyltestosterone have been banned. It has been found to be a highly misused
preparation with carcinogenic properties and side effects include menstrual irregularities,
increased blood pressure, uterine bleeding and others.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)

Product Name Etamivan in combination

Scientific and common names, and synonyms

BENZAMIDE, N,N-DIETHYL-4-HYDROXY-3-METHOXY-
ETHAMIVAN
N,N-DIETHYLVANILLAMIDE

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 299

Product Name Etamivan in combination

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Feb 1994 The Ministry of Public Health has decided to withdraw all combination pharmaceutical
products containing etamivan, including etamivan/etofylline and etamivan/hexobendine
dihydrochloride. Single component injectable and oral solution formulations will remain
available but have been rescheduled as "specially controlled drugs" for use in hospitals
only.
(Reference: (THAFDA) Communication to WHO, , , 08 Feb 1994)
WHO Comment : Etamivan is a central and respiratory stimulant.

Product Name Ethinylestradiol/methyltestosterone

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
BGD 1982 Combinations of ethinyl estradiol and methyltestosterone were banned under the
provisions of the Drugs (Control) Ordinance. They were subject to misuse and had been
associated with carcinogenic properties, menstrual irregularities, increased blood
pressure and uterine bleeding.
(Reference: (BGDCO) The Drugs (Control) Ordinance, , , 1982)

Product Name Etidocaine hydrocloride/epinephrine tartrate

Scientific and common names, and synonyms

EPINEPHRINE TARTRATE/ETIDOCAINE HYDROCHLORIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Mar 1977 This combination, for use as an anesthetic and analgesic, has been disapproved.
Hypertensive crisis may result when used on individuals with high blood pressure.

Product Name Fluphenazine and nortriptyline

C.A.S. number 2003-1-1003

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 2000 This combination was suspended due to the unfavourable risk-benefit ratio; the
combination of the neuroleptic agent and the antidepressant provided no special
advantage while exposing the patients to unjustifiable risk.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)

Product Name Gangliosides

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 300

Product Name Gangliosides

Country Effective Description of action taken

Date Grounds for decision
BRA Jun 2001 Registration has been cancelled due to association with cases of Guillain-Barre
Syndrome. Some cases were fatal.
(Reference: (BRARES) Resolucao n., 527/ANVISA, , 08 June 2001)

Product Name Guaifenesin/camphor/ether

Scientific and common names, and synonyms

CAMPHOR/GUAIFENESIN/ETHER
ETHER/CAMPHOR/GUIFENESIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Nov 1983 Combinations of these ingredients mixed with an alcohol (e.g. phenol, cincol, eucalyptol,
chlorobutanol) are being phased out of use since they are ineffective in cough relief and
may cause lipodystrophy and lipoid pneumonia.

Product Name Herbal dietary supplements

C.A.S. number 2003-1-5001

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CAN Feb 2002 The manufacturer has issued a product recall for herbal medicines PC-SPES and SPES
since these products were found to contain warfarin and alprazolam, respectively.
Consumers have been advised to stop using these products and consult their physicians.
(Reference: (CANWHC) Warnings/Advisories, , , 08 Feb 2002)
IRL Feb 2002 The manufacturer has issued a product recall for herbal medicines PC-SPES and SPES
since these products were found to contain warfarin and alprazolam, respectively.
Consumers have been advised to stop using these products and consult their physicians.
(Reference: (IRLCN) Current News & IMB Statements, , , 15 Feb 2002)
USA Feb 2002 The manufacturer has issued a product recall for herbal medicines PC-SPES and SPES
since these products were found to contain warfarin and alprazolam, respectively.
Consumers have been advised to stop using these products and consult their physicians.
(Reference: (USAOPA) Warning, , , Feb 2002)

Product Name Hormonal pregnancy tests

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR 1970 Withdrawn from the market.
USA Feb 1975 The combination of norethindrone acetate and ethinyl estradiol has been withdrawn from
the market by the Food and Drug Administration as a presumptive test for pregnancy due
to a lack of proof of safety for that use in view of the potential danger in the presence of
pregnancy and the availability of accurate alternatives. Prohibited for export.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 301

Product Name Hormonal pregnancy tests

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1977 Owing to evidence of congenital abnormalities, these products were withdrawn by the
manufacturer.
AUT 1978 Withdrawn in view of their apparent association with birth defects.
BEL 1978 Withdrawn from the market following consideration of the evidence associating their use
with birth defects.
DEU 1978 Withdrawn from the market.
ITA 1978 Withdrawn from the market.
SGP Apr 1978 Banned for importation.
ETH 1979 Estrogen/progestogen preparations should no longer be promoted for pregnancy testing.
This use should be included among the contraindications listed in package inserts.
GRC 1980 All preparations containing estrogens and progestogens intended for pregnancy testing
were withdrawn.
NZL Voluntarily withdrawn from the market.
SAU In view of their association with birth defects, all such estrogen/progestogen preparations
are not recommended for use.
THA Pregnancy tests with a combination of norethisterone and estradiol are prohibited.
VEN Not approved for use and/or sale.
ZAF Preparations for oral use are not indicated and may not be promoted for pregnancy
testing, based on information received from the World Health Organization.

Product Name Hydrochlorothiazide/potassium

Scientific and common names, and synonyms

POTASSIUM/HYDROCHLOROTHIAZIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DOM Products with this combination of ingredients have been prohibited for use and/or sale
since they have been shown to cause small bowl ulceration.

Bibliographical references
IARC MONOGRAPH, 50, 337, 1990

Product Name Hydroxyquinolines in combination

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IND Feb 1996 The Drug Controller of India has banned the manufacture, sale and distribution of fixed-
dose combinations of hydroxyquinolines with other drugs, except for preparations
intended for external use. This action has been taken because the fixed-dose
combination products are considered either as not having the therapeutic value claimed
or they contain ingredients and in quantities for which there is no therapeutic justification.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 302

Product Name Hydroxyquinolines in combination

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
(Reference: (INDEPH) The Eastern Pharmacist, , , Feb 1996)

Product Name Iron preparations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1997 The Food and Drug Administration has required warning statements in the product
information on products taken in solid oral dosage form: " WARNING: Accidental
overdose of iron-containing products is a leading cause of fatal poisoning in children
under 6. Keep this product out of reach of children. In case of accidental overdose, call
a doctor or a poison control centre immediately".
(Reference: (FEREAC) Federal Register, 62(10) , p. 2218, 1997)
WHO Comment : The toxicity of oral iron preparations to children is the result of
their corrosive effect on gastrointestinal mucosa, internal haemorrhage and
cardiovascular collapse. Parenteral iron preparations may cause a variety of
adverse effects of which the anaphylactic reaction is the most dangerous. Ferrous
salts for peroral use are listed in the WHO Model List of Essential Drugs. Iron
dextran is listed as an example of a therapeutic group.

Product Name Kaolin and pectin

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
YEM 1998 The Supreme Board of Drugs and Medical Devices has withdrawn the suspension
formulation of the kaolin and pectin because of a lack of evidence of efficacy in the
management of diarrhoea.
(Reference: (YEMCW) Communications to WHO, , , 10 Oct 1998)

Product Name Kava products

C.A.S. number 2003-1-5002

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CHE Apr 2001 Acetone extract of kava root was withdrawn due to unfavourable benefit-risk profile and
associations with hepatic injury.
CHE Sep 2001 Kava ethanol extract products have been moved from OTC to 'pharmacy only' status as a
precautionary measure.
(Reference: (CHEPR) Press Release, , , June 2002)
DEU Jun 2002 The Federal Institute of Germany has withdrawn all kava-containing pharmaceutical
products and homeopathic products with dilutions up to D4 due to hepatotoxic risks and
insufficient data on efficacy with these products.
(Reference: (DEUCW) Communication to WHO, , , 17 June 2002)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 303

Product Name Kava products

C.A.S. number 2003-1-5002
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

IRL Jul 2002 The Irish Medicines Board has decided to maintain the on-going voluntary withdrawal of
all kava containing products that was initiated in February 2002. This decision follows the
German Regulatory Authority's conclusion that kava products have an unfavourable risk-
benefit profile.
(Reference: (IRLPSI) Kava Statement, , , )
SGP Jul 2002 The Singapore Health Sciences Authority (HAS) is proceeding to gazette kava-kava and
its constituents under the Poisons Act to prohibit importation following German
Regulatory measures for kava.
(Reference: (SGPPR) Press Release, , , 25 July 2002)
AUS Aug 2002 Australia's Therapeutic Goods Administration (TGA) has initiated a voluntary recall of all
complementary medicines containing the herb kava. The action follows the death of a
woman in Australia who used a medicine containing kava. The TGA will undertake
further evaluation to determine additional regulatory measures.
(Reference: (AUSMDR) Media Release, TW20/02, , 15 Aug 2002)
CAN Aug 2002 Health Canada has ordered a stop-sale and recall of all kava-containing products from
the Canadian market following Canadian and worldwide reports of liver failure.
(Reference: (CANWHC) Warnings/Advisories, , , 21 Aug 2002)
GBR Dec 2002 An order prohibiting the supply of medicinal products containing kava has been issued in
the UK following the UK Medicines Control Agency's investigation into cases of liver
toxicity from kava.
(Reference: (GBRKPR) MCA Press Release, 2002/0528, , 20 Dec 2002)

Product Name Lidocaine, salicylic acid and chloral hydrate

C.A.S. number 2003-1-1004

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Aug 2001 Withdrawn due to the mutagenic and carcinogenic potential of chloral hydrate which
make its use unfavourable in the treatment of buccal infections or as an oral rinse in
stomatologic procedures.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)

Product Name Loratadine and pseudoephedrine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL 2000 The Department of Health Bureau of Food and Drugs has banned and withdrawn the
fixed-dose combination, loratadine + pseudoephedrine.
(Reference: (PHADO) Administrative Order, (99) s. 2000, , 09 Aug 2000)

Product Name Medroxyprogesterone acetate/ethinylestradiol

Scientific and common names, and synonyms

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 304

Product Name Medroxyprogesterone acetate/ethinylestradiol

Scientific and common names, and synonyms

ETHINYLESTRADIOL/MEDROXYPROGESTERONE ACETATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Withdrawn from the market and prohibited for export by the Food and Drug
Administration after studies in dogs showed an increased incidence of mammary tumors
from the medroxyprogesterone acetate component.

Product Name Meprobamate/diazepines

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1980 Withdrawn from the market since the combination is considered unacceptable having
regard to the higher incidence of adverse reactions than reported with monocomponent
preparations.

Product Name Mepyramine maleate/pamabrom

Scientific and common names, and synonyms

PYRILAMINE MALEATE/PAMABROM
PAMABROM/PYRILAMINE MALEATE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA 1974 Combinations of pamabrom and mepyramine maleate (pyrilamine maleate) have been
withdrawn from the market.

Product Name Mercuric derivatives (topical)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Jul 1969 Aminomercuric chloride was banned by the Pharmaceutical Affairs Bureau due to skin
disorders associated with long-term use.
BRA 15 Jul 1980 Products containing mercuric derivatives, with the exception of merbromin and
thiomersal, are prohibited.
(Reference: (BRAPT) Portaria do Servico Publico Federal, No.10, , July 1980)
PHL Nov 1983 Mercury-based products for topical use are being phased out due to dubious efficacy and
safety.
FRA 19 Dec 1986 The Ministry of Health has decided to withdraw dermatological preparations containing
ammoniated mercury following a warning that such products may produce allergic
reactions and mercury intoxication.
(Reference: (FRAPC) Press Communiqué, , , Dec 1986)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 305

Product Name Mercuric derivatives (topical)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NGA 1988 All soaps containing mercury compounds have been banned.
(Reference: (NGAPN) Pharmanews, 10(11), 15, 1988)
GHA 1 Sep 1989 All mercury based soaps have been banned.
(Reference: (GHAPDR) Pharmacy and Drugs (Banned Drugs) Regulations, Legislative
Instruments, 1484, , 1989)
CAN Apr 1997 Health Canada has warned consumers not to use DianaR Cream (Diana de Beauté), a
product that is used for skin lightening, mainly by Afro and Caribbean communities. The
product, which is manufactured in the Lebanon, has not been approved for sale in
Canada and is being illegally imported. It contains ammoniated mercury, bismuth
subnitrate and salicylic acid and the mercury content poses a high risk of mercury
poisoning in adults and a serious health hazard to unborn and nursing infants of women
who use the product.
(Reference: (CANPR) Press Release, 1997-28, , 18 Apr 1997)
ITA Withdrawn from the market owing to an unfavourable risk-benefit ratio and the lack of
substantial evidence of efficacy.
WHO Comment : Mercuric derivatives were formerly widely available in topical anti-
infective preparations. The hazards associated with their use, including
hypersensitivity and allergy, outweigh any therapeutic benefit and such
preparations have been withdrawn in many countries. Systemic absorption has
resulted in chronic mercury poisoning and acrodynia (pink disease) in children.

Product Name Metamizole sodium, fenpiverinium bromide and pitofenone hcl

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
LTH May 2000 The State Medicines Control Agency has not renewed marketing authorization for
combination products of metamizole socium, fenpiverinium bromide and pitofenone
hydrochloride for reasons of safety.
(Reference: (LTHMCA) Order of State Medicines Control Agency, No. 8, , 22 Sep 2000)

Product Name Metoclopramide/polidocanol

Scientific and common names, and synonyms

POLIDOCANOL/METOCLOPRAMIDE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Mar 1983 Disapproved for use in gastrointestinal disturbances since marked liver toxicity limits its
therapeutic use.

Product Name Neomycin sulfate/polymyxin bisulfate/nystatin/acetarsol

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 306

Product Name Neomycin sulfate/polymyxin bisulfate/nystatin/acetarsol

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL Sep 1977 This combination, for use in trichomonal vaginitis, has been disapproved due to the
irrational and potentially harmful nature of the combination, which is not shown to be
more effective than its individual ingredients given separately in appropriate doses.

Product Name Nitrates

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MYS 1994 The Drug Control Authority has decided that package inserts for all nitrates for stable
angina pectoris be amended to include the following statement: "Development of
tolerance may occur with all forms of nitrate therapy, particularly with the long active
preparations that maintain continuously high plasma nitrate concentration".
(Reference: (MYSDI) Berita Ubat-Ubatan (Drug Information), 8(2): 4, , 1994)
WHO Comment : Glyceryl trinitrate (nitroglycerin) and isosorbide dinitrate are
listed in the WHO Model List of Essential Drugs.

Product Name Nonsteroidal anti-inflammatory agents

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 16 Oct 1995 In the context of its review of marketed products, the Federal Institute for Drugs and
Medical Devices has announced that the product information for nonsteroidal anti-
inflammatory agents for systemic use (54 agents, including ibuprofen, ketoprofen and
naproxen) has been modified to state in the section on adverse reactions that, in rare
cases, a time correlation has been observed between the systemic administration of
nonsteroidal anti-inflammatory agents and a worsening of the infection-induced
inflammation (e.g. the development of necrotizing fasciitis), probably due to the
mechanism of NSAIDs. If, during treatment with an NSAID, worsening of existing
symptoms occurs or signs of new infection appear, the patient should be advised to
consult his/her physician immediately. An assessment should be made to ascertain
whether anti-infective/antibiotic therapy is appropriate.
(Reference: (DEUNFI) Notification, , , 16 Oct 1995)
WHO Comment : Qualitatively the tolerability of all nonsteroidal anti- inflammatory
agents is similar. Ibuprofen is listed in the WHO Model List of Essential Drugs.

Product Name Oral contraceptives (third generation)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Oct 1995 The Committee on Safety of Medicines has recommended that women who are taking
combined oral contraceptives containing gestodene or desogestrel should complete their
current cycle. The risks associated with unwanted pregnancies are far greater than the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 307

Product Name Oral contraceptives (third generation)

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
risks associated with these pills. Combined oral contraceptives containing gestodene or
desogestrel should not be used by women with risk factors for venous thromboembolism
(e.g. obesity) and should only be used by women who are intolerant of other combined
contraceptives and who are prepared to accept an increased risk of thromboembolism.
(Reference: (GBRCW) Communication, , , 18 Oct 1995)
NOR Dec 1995 The Norwegian Medicines Control Authority has restricted the indications for oral
contraceptives containing desogestrel or gestodene to oral contraception where other
oral contraceptives are not considered suitable.
(Reference: (NORMCA) Norwegian Medicines Control Authority, , , 20 Dec 1995)
CHE 14 Dec 1995 The Intercantonal Office for the Control of Medicines has revised the product information
for combined oral contraceptives containing gestodene or desogestrel to include a
statement concerning risk factors that should be taken into account when prescribing
these products. Contraindications include a history of pulmonary embolism or venous
thromboembolism or a high incidence in the family (cases of venous thromboembolism in
close relatives in their youth). Caution must be exercised in women with pronounced
obesity and in mature women with serious varicose veins.
(Reference: (CHEOCM) Statement on venous thrombosis and “pills”, , , 18 Apr 1996)
NZL Jul 1996 It is recommended that, because of the higher risk of venous thrombo- embolism with the
third generation oral contraceptives compared with earlier combined oral contraceptives,
in women who have no contraindications to the use of a combined low dose oral
contraceptive and have indicated that they wish to take a combined oral contraceptive,
consideration should be given to prescribing a low dose combined oral contraceptive
containing no more than 35 micrograms ethinylestradiol and a progestogen other than
desogestrel or gestodene.
(Reference: (NZLPU) Prescriber Update, No.12, , July 1996)
WHO Comment : Data from three independently conducted epidemiological studies
have raised the problem of thromboembolic risks associated with combination oral
contraceptives containing desogestrel or gestodene (so-called third generation
oral contraceptives) in comparison with the same type of risk associated with the
levonorgestrel-containing oral contraceptives (so-called second generation
contraceptives). There are differences between countries in the evaluation of risks
associated with different combination oral contraceptives. There is no plausible
biological explanation for the differences between the two groups of oral
contraceptives; however, inherent biases cannot be excluded. Thus the matter
remains open.

Product Name Oral sodium phosphate bowel preparations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NZL Apr 1998 Oral sodium phosphate bowel preparations have been reclassified to Prescription
Medicine, because of the risk of potentially life-threatening dehydration and electrolyte
imbalance with incorrect use.
(Reference: (NZLPU) Prescriber Update, No.16, , Apr 1998)
USA 21 May 1998 Following reports of deaths associated with an overdosage of sodium phosphates oral
solution when the product was packaged in a larger-size container and a larger than
intended dose was ingested inadvertently, the Food and Drug Administration has limited
the container size for sodium phosphates oral solution (dibasic sodium phosphate/

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 308

Product Name Oral sodium phosphate bowel preparations

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
monobasic sodium phosphate oral solution) to not greater than 90 ml when used as an
over-the-counter (OTC) laxative drug product. The agency has also required warning and
direction statements to inform consumers that exceeding the recommended dose of oral
and rectal sodium phosphates products in a 24-hour period can be harmful.
(Reference: (FEREAC) Federal Register, 63(98) , p. 27836, 1998)

Product Name Pancreatic enzymes

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA Jul 1994 The Health Authorities have issued a warning and modified the product information of all
pancreatic enzyme preparations alerting prescribers that cases of bowel strictures have
been reported in children from 3 to 13 years old and including a maximum recommended
dosage.
(Reference: (FRAAMN) Notification, , , 01 Aug 1994)
GBR Nov 1995 The Committee on Safety of Medicines issued a warning about reports of fibrosing
colonopathy (bowel strictures) occurring in children aged between 3 and 13 years with
cystic fibrosis who were receiving high-dose pancreatic enzyme preparations. The
Committee recommends that the total dose of pancreatic enzyme supplements used in
children should not usually exceed 10,000 units of lipase per kg body weight per day.
(Reference: (GBRCW) Communication, , , 21 Dec 1993)
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, (20) Nov 1994, & (21),
Nov 1995)
NZL Jul 1996 Pancreatic enzymes were reclassified to Prescription Medicine, and doctors were
advised to warn patients not to use more than 10,000 units of lipase per kg of body
weight per day.
(Reference: (NZLPU) Prescriber Update, No.12, , July 1996)

Product Name Paracetamol/methionine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR Apr 1997 SmithKline Beecham has decided to withdraw its combination paracetamol/methionine
product (Pameton) from sale in pharmacies because evidence exists that links excess
dietary intake of methionine to clinical problems. A review of the data suggested that
methionine offers no additional benefit to regular paracetamol in normal use and
therefore it should be made available only on direct request to the company for use in
cases where there is a risk of self-poisoning.
(Reference: (GBRSKB) Communication, , , 21 Apr 1997)
(Reference: (GBRMCA) Communication to WHO, , , 26 Mar 1997)

Product Name Penicillin/streptomycin

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 309

Product Name Penicillin/streptomycin

Scientific and common names, and synonyms

STREPTOMYCIN/PENICILLIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1978 Withdrawn from the market having regard to an unacceptable benefit-to-risk ratio.
IND May 1995 The Drugs Technical Advisory board has recommended that fixed-dose combinations of
penicillin and streptomycin should be banned from manufacture and sale, since the use
of this combination in enterococcal endocarditis or pre-surgical sterilization cannot be
justified in view of the availability of other broad-spectrum antibiotics.
(Reference: (INDEPH) The Eastern Pharmacist, , , May 1995)
IND Jan 1998 The Ministry of Health and Family Welfare, Department of Health, has prohibited the
manufacture and sale of parenteral preparations containing fixed dose combinations of
streptomycin with penicillins because it has been concluded that fixed dose combinations
of streptomycin with penicillins do not have the therapeutic value claimed or purported to
be claimed for them.
(Reference: (INDEPH) The Eastern Pharmacist, , , Sep 1997)
WHO Comment : Streptomycin and penicillin are listed separately in the WHO
Model List of Essential Drugs.

Product Name Penicillin/tetracycline

Scientific and common names, and synonyms

TETRACYCLINE/PENICILLIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1975 Withdrawn from the market having regard to its low benefit-to-risk ratio.
ITA 1977 These products intended for general use have been withdrawn from the market owing to
suspected liver toxicity.

Product Name Phenformin/chlorpropamide

Scientific and common names, and synonyms

CHLORPROPAMIDE/PHENFORMIN

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1986 Withdrawn from the market having regard to its low benefit-to-risk ratio.

Product Name Phenobarbital, difebarbamate and febarbamate (Tetrabamate)

C.A.S. number 2003-1-1005

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 310

Product Name Phenobarbital, difebarbamate and febarbamate (Tetrabamate)

C.A.S. number 2003-1-1005
FRA Mar 2001 The combination of febarbamate, difebarbamate and phenobarbital has been withdrawn
in France due to reports of serious hepatic effects and cutaneous reactions including
Lyell syndrome.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)
ESP May 2002 The Spanish Committee on the Safety of Medicines has ordered the suspension of
tetrabamate (a complex of phenobarbital, difebarbamate and febarbamate) due to reports
of hepatotoxicity and the unfavourable risk-benefit ratio.
(Reference: (ESPCDR) Communication on Drug Risks, No. 2002/04, , 03 May 2002)

Product Name Phlebotonics

C.A.S. number 2003-1-5003

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
ESP Sep 2002 The Spanish Medicines Agency has withdrawn the marketing authorization for several
oral vascular disorder therapies (phlebotonics) including those containing diosmin, horse
chestnut extract, naftazone and troxerutin because of unfavourable risk-benefit profile.
Calcium dobesilate has been restricted to the treatment of diabetic retinopathy while all
other oral vascular therapies remaining on the market are authorized only for the short-
term relief (2-3 months) of oedema and other symptoms of chronic venous insufficiency.
(Reference: (ESPMAD) Doccument, 2002/09, , 10 Sep 2002)

Product Name Pipradol/hesperidin

Scientific and common names, and synonyms

HESPERIDIN/PIPRADOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DOM Products with this combination of ingredients have been prohibited for use and/or sale
since they have been found to be harmful.

Product Name Prednisolone/phenobarbital

Scientific and common names, and synonyms

PHENOBARBITAL/PREDNISOLONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
THA Not permitted in combination for the treatment of asthma.

Product Name Promethazine in combination

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 311

Product Name Promethazine in combination

Country Effective Description of action taken

Date Grounds for decision
USA Sep 1989 Combination preparations containing promethazine, indicated for the symptomatic relief
of upper respiratory infections, were subjected to prescription control because their use in
children of less than two years of age had been associated with sudden infant death
syndrome. Concern was also raised about their potential to induce extrapyramidal
disorders. In the light of these concerns, two combination preparations were voluntarily
withdrawn by the manufacturer in 1991.
(Reference: (FEREAC) Federal Register, 58(50), 10904, 1991)
WHO Comment : See WHO comment for H1-antihistamines.

Product Name Pseudoephedrine and phenylpropanolamine

Scientific and common names, and synonyms

D-ISOEPHEDRINE.D-?-EPHEDRINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
MAR Aug 1999 The Commission for Pharmacovigilance in Morocco decided to restrict the use of all drug
products containing pseudoephedrine or phenylpropanolamine to adults and has
prohibited their use in children under 12 years. The products have also been subjected to
prescription control. This decision was taken following reports of serious risks to health
associated with the intake of these vasoconstrictors, including 83 neuropsychiatric
effects, 4 cardiovascular problems and 2 deaths. Therefore the French Agency of
Medicines has restricted the use of pseudoephedrine and phenylpropanolamine products
for adults.
(Reference: (MARDMP) Letter to WHO, , , 24 Aug 1999)
OMN 2000 The Directorate General of Pharmaceutical Affairs & Drug Control has restricted the
prescribing of any preparation containing phenylproanolamine hydrochloride or
pseudoephedrine hydrochloride to adults and children over 2 years of age. This action
has been taken following the results of research performed by the French Commission
for Pharmacovigilance which revealed serious risks to health associated with the intake
of these vasoconstrictors in paediatric use.
(Reference: (OMNCR) Circular, No. 3/2000, , 13 May 2000)

Product Name Pyrazolones in combination (see also aminophenazone, metamizole so

Scientific and common names, and synonyms

AMIDOPYRINE
ISOPYRINE
METAMIZOLE SODIUM
NIFENAZONE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
JPN Sep 1977 The Central Pharmaceutical Affairs Council recommended that, because of their
propensity to cause skin eruptions and shock, pyrazolones should no longer be included
in proprietary cold medicines or in antipyretic-analgesic preparations available without a
doctor's prescription.

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 312

Product Name Pyrazolones in combination (see also aminophenazone, metamizole so

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
PHL May 1979 Several combination products containing pyrazolones have been disapproved for use.
GRC Oct 1980 The Ministry of Health and Welfare has severely restricted the use and sale of these
products for domestic use.
(Reference: (GRAGA) Ministry of Health Decision, No.7116, , July 1983)
DEU 1982 Eighty analgesic preparations containing a pyrazolone in combination with another active
compound were withdrawn from sale either: 1) because their indications were not
consonant with those approved by the Federal Health Office, or 2) on suspicion that the
other active constituent might potentiate the accepted known risk of the pyrazolone
component. These actions were largely directed against drugs containing metamizole
sodium, but products containing isopyrine and nifenazone were also implicated. The
situation is complex, however, since preparations containing one or more active
ingredient remain on the market.
DEU 1983 Labelling for certain pyrazolone-containing drugs was recently revised to limit indications
for use. Substances affected include: metamizole, isopropylaminophenazone,
nifenazone, propyphenazone, phenazone and morazone. Indications were limited to the
treatment of acute severe pain, such as post-traumatic and post-operative pain and colic,
and high fever unresponsive to other therapy. Specific contraindications include use in
inflammatory arthroses, conditions predisposing to shock or bone marrow depression,
known allergy to pyrazolones and phenylbutazone, and certain metabolic deficiencies
such as hepatic porphyria. The importance of weighing the need for treatment against the
slight but life-threatening risks of anaphylactic shock and agranulocytosis is stressed.
ISR 1983 The Pharmaceutical Administration of the Ministry of Health has suspended all
combination products containing noramidopyrine methanesulfonate sodium (metamizole
sodium).
ITA 1989 Having regard to the adverse effects associated with their long-term use, products
containing pyrazolones may now be indicated only for the short-term treatment of severe
acute pain or pyrexia.
(Reference: (BIFTI) Bolletino d'Informazione sui Farmaci, 13(2), 5, 1989)
MEX Combinations of pyrazolones with antihistamines, vasoconstrictors, decongestants,
muscle relaxants, antibiotics or vitamins are prohibited due to the toxic properties of
pyrazolones.
SAU All pyrazolones are used only under prescription.
WHO Comment : Pyrazolone derivatives, which include aminophenazone,
metamizole sodium, phenylbutazone and propyphenazone have been associated
with serious adverse effects. Since safer alternatives are widely available some
regulatory authorities have withdrawn or severely restricted all pharmaceutical
preparations containing pyrazolone derivatives. See also WHO comments for
aminophenazone, metamizole sodium, phenylbutazone and propyphenazone.

Product Name Pyrethroids

Scientific and common names, and synonyms

BIOALLETHRIN
CARBARIL
PHENOTHRIN
PERMETHRIN
TETRAMETHRIN

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 313

Product Name Pyrethroids

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
OMN 1997 The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the
registration, import and sale of pyrethroids such as bioallethrin, permethrin, phenothrin,
tetramethrin and carbaril in all parasiticidal preparations because of a potential risk of
carcinogenicity.
(Reference: (OMNPN) Pharmaceutical Newsletter, 5(4): 8, , 1997)
OMN Dec 1997 The Directorate General of Pharmaceutical Affairs & Drug Control has prohibited the
registration, import and sale of pyrethroids such as bioallethrin, permethrin, phenothrin,
tetramethrin and carbaril in all parasiticidal preparations because of a potential risk of
carcinogenicity.
(Reference: (OMNPN) Pharmaceutical Newsletter, 5(4): 8, , 1997)

Product Name Quinidine/verapamil

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DEU 1996 In order to minimize the risks associated with fixed combination products containing the
antiarrhythmics quinidine and verapamil, the Federal Institute for Drugs and Medical
Devices has restricted the indications to: cardioversion in vestibular flutter and fibrillation
when electrocardioversion cannot be carried out, and recurrent chronic vestibular flutter
after successful conversion with this drug in patients in whom restoration of the sinus
rhythm has led to an improvement of severe symptoms.
(Reference: (DAZ) Deutsche Apotheker Zeitung, 136(29):2438, , 1996)
WHO Comment : Quinidine and verapamil are listed separately in theWHO Model
List of Essential Drugs.

Product Name Quinolone antimicrobial agents

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
NOR Jun 1993 The Medicines Control Authority has decided to restrict the indications for parenteral
formulations of the quinolone antibiotics, ciprofloxacin (Ciproxin: Bayer) and ofloxacin
(Tarivid: Hoechst) as follow: (1) Parenteral ciprofloxacin: severe salmonella infections,
complicated urinary tract infections and osteomyelitis due to sensitive gram-negative
staphylococci when oral treatment is not possible. (2) Parenteral ofloxacin: complicated
urinary tract infections due to sensitive gram-negative staphylococci when oral treatment
is not possible. Because of the risk of development of resistance, ciprofloxacin is not
approved for treatment of sepsis. The Medicines Control Authority emphasizes that
parenteral treatment with quinolone antibiotics should only be carried out in a hospital.
(Reference: (NNSLM) Nytt fra Statens Legemiddelkontroll, No.2, p.3, 1993)
JPN Oct 1994 The Pharmaceutical Affairs Bureau has amended the product information for enoxacin,
fleroxacin, norfloxacin, sparfloxacin and tosufloxacin tosilate to state that rhabdomyolysis
may occur.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.128, , Oct 1994)
LKA Nov 1996 The Drug Evaluation Sub-Committee has decided that the product information of
fluoroquinolone antibiotics should include a warning stating: "The onset of tendon pain

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 314

Product Name Quinolone antimicrobial agents

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
calls for immediate withdrawal of fluoroquinolone antibiotics."
(Reference: (LKADES) Drug Evaluation Sub-Committee, 27th Meeting, , 26 Nov 1996)
WHO Comment : Since their introduction on the market in 1988 sporadic cases of
tendinitis and rhabdomyolysis have been reported with quinolone antibacterial
agents which are used in a large variety of infections.

Product Name Repaglinide and gemfibrozil

C.A.S. number 2004-1-1002

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
EME 21 May 2003 The use of repaglinide is contraindicated with gemfibrozil.
(Reference: (EMEAPS) Public statement, EMEA/11700/03, , 21 May 2003)

Product Name Sulfathiazole sodium with sodium lactate or sodium bicarbonate

Scientific and common names, and synonyms

SODIUM LACTATE/SULFATHIAZOLE SODIUM
SODIUM BICARBONATE/SULFATHIAZOLE SODIUM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
DOM Combinations of sulfathiazole sodium with sodium lactate or sodium bicarbonate or other
sulfonamides have been prohibited for use and/or sale since they have been associated
with serious side effects and recent studies have shown them to be of questionable
efficacy. The risks of these combinations have not been found to outweigh the benefits
and other sulfonamides are available that present much lower risk with use.

Product Name Superheporin

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
IDN 1980 Superheporin capsules, a traditional herbal mixture of angelica radix, ligustica rhizoma,
salviae radix, pteropii excrementum and carthamic flos, has been withdrawn from sale
following reports of congenital malformations in babies whose mothers had taken this
compound in early pregnancy.
VEN Not approved for use and/or sale.

Product Name Tetracycline in combination

Scientific and common names, and synonyms

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 315

Product Name Tetracycline in combination

Scientific and common names, and synonyms

CHLORAMPHENICOL/TETRACYCLINE

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1971 This combination, for oral and parenteral use, was withdrawn from the market.
DOM Tetracycline in combination with oleandomycin or with novobiocin is prohibited for use
and/or sale since studies have shown that this combination can be hazardous to health.
VEN Banned for use and/or sale.

Product Name Theophylline/meprobamate/barbiturates

Scientific and common names, and synonyms

BARBITURATES/MEPROBAMATE/THEOPHYLLINE
MEPROBAMATE/THEOPHYLLINE/BARBITURATES

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GRC 1986 Withdrawn from the market having regard to its low benefit-to-risk ratio (respiratory
depression).

Product Name Thiazides/potassium chloride

Scientific and common names, and synonyms

POTASSIUM CHLORIDE/THIAZIDES

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
USA Oct 1971 The combination of these two compounds, alone or with reserpine or rauwolfia
serpentina, has been withdrawn from the market and prohibited for export by the Food
and Drug Administration on the grounds that no adequate data demonstrating safety and
efficacy exist. These combinations were used as diuretics to treat certain edemas due to
cardiac, renal and hepatic failure, and to treat specific cases of hypertension. In its
decision, the FDA cited cases of small-bowel lesions that had developed with the
administration of these drugs, for which a causal relationship had not been excluded by
appropriate tests.
SAU Following reports of small bowel lesions resulting in ulcers, obstruction, haemorrhage and
perforation, this combination was withdrawn.

Product Name Tilbroquinol/tiliquinol

Scientific and common names, and synonyms

7-BROMO-5-METHYL-8-QUINOLINOL / 5-METHYL-8-QUINOLINOL

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 316

Product Name Tilbroquinol/tiliquinol

Country Effective Description of action taken

Date Grounds for decision
FRA Jul 1997 The Agence du Médicament has decided that the therapeutic indications of
tilbroquinol/tiliquinol (Intetrix®) will be restricted to the treatment of intestinal amoebiasis
as an adjuvant to a tissular amoebicide, or as monotherapy in health carriers
contaminated with interluminal amoebae. This decision was reached in the absence of
efficacy data for the treatment of infectious diarrhoeas and because of the risk of liver
toxicity.
(Reference: (FRAAMI) Infofax - Pharmacovigilance, , , 04 July 1997)

Product Name Tiratricol/cyclovalone/retinol

Scientific and common names, and synonyms

CYCLOVALONE/TIRATRICOL/RETINOL
RETINOL/CYCLOVALONE/TIRATRICOL

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
FRA 30 Oct 1988 A preparation containing an association of tiratricol, cyclovalone and retinol has been
withdrawn from the market.
(Reference: (FRARP) La Revue Prescrire, 9(81), 18, 1989)
WHO Comment : This combination product, indicated for the treatment of obesity,
has not been demonstrated to possess anytherapeutic effect and has been
associated with cases of cellular hepatitis, of which at least one was fatal. It is not
yet known which of the constituents is the causative agent.

Product Name Trancylopramine and trifluoperazine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
GBR 1999 The licence for the antidepressant, trancylopramine and trifluorperazine has not been
renewed by the Committee on Safety of Medicines because of concerns over drug
interactions and the risk of severe hypertensive crises. As a result the company have
withdrawn the product from the market.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol. 25, , June 1999)

Product Name Trimethoprim/sulfamethoxazole

C.A.S. number 8064-90-2
Scientific and common names, and synonyms
CO-TRIMOXAZOLE
SULFAMETHOXAZOLE/TRIMETHOPRIM

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
SWE 1987 The approved indications for products containing trimethoprim and sulfamethoxazole
were restricted to exclude the treatment of urinary tract infections, having regard to the

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 317

Product Name Trimethoprim/sulfamethoxazole

C.A.S. number 8064-90-2
Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
association of these combination products with severe and even fatal adverse effects,
including sensitivity reactions, mucocutaneous syndrome, blood dyscrasias and hepatic
disorders. A similar restriction applies to products containing trimethoprim and
sulfadiazine.
(Reference: (SSLMS) Information från Socialstyrelsens Läekemedelsavdelning, 3(12),
48, 1987)
IRL Jun 1987 Products containing trimethoprim and sulfamethoxazole may now be indicated only for
respiratory and urinary tract infections, on the grounds that they are associated with a
greater risk of adverse effects, in particular in the elderly, including potentially fatal cases
of blood dyscrasias and erythema multiforme, than other commonly used anti-infectives.
(Reference: (IRDAB) National Drugs Advisory Board Annual Report, , 26, 1987)
GBR Jul 1995 In view of reports of serious adverse reactions, blood dyscrasias and generalized skin
disorders, the Committee on Safety of Medicines recommends that the use of
trimethoprim/sulfamethoxazole (co-trimoxazole) should be limited to : Pneumocystis
carinii pneumonia; toxoplasmosis and nocardiasis; acute exacerbations of chronic
bronchitis and infections of the urinary tract when there is bacteriological evidence of
sensitivity to trimethoprim/sulfamethoxazole and good reason to prefer this to single
antibiotics.
(Reference: (GBRCPP) Current Problems in Pharmacovigilance, Vol.21, , July 1995)
WHO Comment : The combination of sulfamethoxazole and trimethoprim (5:1) was
introduced in 1971 for the treatment of a wide variety of bacterial infections. Its use
has been associated with severe sensitivity reactions, many of which have been
attributed to the sulphonamide component. Elderly people seem to be more
vulnerable. The World Health Organization has no information further to the above
concerning restrictive action taken on this combination.
Trimethoprim/sulfamethoxazole is listed in the WHO Model List of Essential Drugs.

Product Name Tyrothricin/fomocaine/diphenhydramine

Legislative or regulative action

Country Effective Description of action taken

Date Grounds for decision
CYP 23 Oct 1992 The Drugs Council decided to withdraw the marketing approval for a gel preparation
containing tyrothricin0.1%, fomocaine hydrochloride 2.5% and diphenhydramine 1% used
for the treatment of wounds and burns. The decision also applies to the powder
formulation.
(Reference: (CYPPS) Pharmaceutical Services, Ministry of Health, , , 23 Oct 1992)
WHO Comment : Tyrothricin, fomocaine and diphenhydramine is a combination of
antimicrobial, local anaesthetic and H1 receptor antagonist respectively.
Tyrothricin, which is a mixture containing gramacidin and tyrocidine, is too toxic to
be administered systematically because of liver and kidney toxicity. The product
has been removed on the grounds that absorption of tyrothricin through broken
skin may result in renal myelotoxicity.

Product Name Xibornol and lidocaine

C.A.S. number 2003-1-1006

Legislative or regulative action

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (COMBINATION AND GROUP PRODUCTS) 318

Product Name Xibornol and lidocaine

C.A.S. number 2003-1-1006
Country Effective Description of action taken
Date Grounds for decision
FRA Apr 2001 Suspended due to grave allergic reactions including oedema of Quincke, anaphylaxis and
bullous eruptions associated with xibornol.
(Reference: (FRACW) Communication to WHO, , , 05 Oct 2001)

Legislative or regulation action

Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 319

Product Name Acetanilide

C.A.S. number 103-84-4
Trade and brand names
Acetanil Capsula dr. knapf Digiseb
Phenalgin
For regulatory information, see page 31

Product Name Acetarsol

C.A.S. number 97-44-9
Trade and brand names
190 f Acetarsolum Acetarsone
Acetphenarsine Acetylarsan Amarson
Amoebal Arsabott Arsaphen
Arsonine Auryphan Chrlich 594
Collarsin Devegan Disparicida
Dynarsan Edoiacolo Ehrlich 594
F 190 Fluryl Fourneau 190
Ginarsol Goyl Gynoplix
Kharophen Kharophene Kubarsol
Limarsol Monargan Neo-vagex
Nilacid Oralcid Orarsan
Osarsal Osarsol Osarsole
Osvarsan Pallacid Paroxyl
Rvc Spirozid Stovarsol
Stovarsolan Svc Trichovan
Vagipurin Vagisep Vagival
Vagoflor
For regulatory information, see page 31

Product Name Acetylfuratrizine

C.A.S. number 1789-26-0
Trade and brand names
Panfuran Panfuran-troche
For regulatory information, see page 32

Product Name Acetylsalicylic acid (paediatric)

C.A.S. number 50-78-2
Trade and brand names
Aspirin Compralgyl Melabon
Rumicine Salipran Spalt
Tapal Zorprin
For regulatory information, see page 32

Product Name Acitretin

C.A.S. number 55079-83-9
Trade and brand names
Etretin Neotigason Neotigason (r) 10
Neotigason roche 10 mg Neotigason sauter kapsein 25 mg Soriatane
For regulatory information, see page 35
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 320

Product Name Acridine derivatives

C.A.S. number 260-94-6
Trade and brand names
Euflavin Proflavin
For regulatory information, see page 36

Product Name Alclofenac

C.A.S. number 22131-79-9
Trade and brand names
Allopydin Allopydinac Alopidin
Alopydin Argan Argun
Darkeyfenac Desinflam Epinal
Medifenac Mervan Mevan
Mirvan Mirvan a My 101
Neosten Neoston Prinalgin
Reufenac Vanadian W7320
W-7320 Zubirol Zumaril
For regulatory information, see page 38

Product Name Allergen extracts

C.A.S. number UN-87-0001
Trade and brand names
A.d.l. Alavac Alavac-p
Alavac-s Albay pure venom Allpyral specific
Allpyral-d Allpyral-g Allpyral-mite fortified house dust
Aurafair Auralgicin Bencard skin testin solutions
Bencard-a Conjuvac two grass Glycerinated skin testing solutions
Merck skin testin solutions Migen Norisen
Norisen grass Otipyrin Pharmalgen
Pollinex Rapifen S.d.l.
Sdv specific desentistising caccine Spectralgen Spectralgen pollens
Suspal Tyrivac
For regulatory information, see page 39

Product Name Aloxiprin

C.A.S. number 9014-67-9
Trade and brand names
Aloxipirine tablets Lyman tabs Palaprin forte
Paloxin Palprin Rumatral
Shin-rheufen Superpyrin Tiatral
For regulatory information, see page 40

Product Name Alprostadil

C.A.S. number 745-65-3
Trade and brand names
Coverject Liple Minprog
Minprog pad Postivas Prostadin
Prostalgin Prostandin Prostavasin
Prostin vr pediatric Prostin-vr Prostivas
For regulatory information, see page 40
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 321

Product Name Alprostadil

C.A.S. number 745-65-3
Trade and brand names

Product Name Amfepramone

C.A.S. number 90-84-6
Trade and brand names
Adiposan Adiposon Adipyn
Alipid Amfepromone Anfamon
Anorex Apisate Bonumin
Brenalalit Brendalit Cegramine
Controlgras D.i.p. D.i.p.n
Danylen Delgamer Deramix
Derfon Dietec Dietil retard
Dietil-retard Dobesin Frekentine
Lineal-plus Lineal-rivo Lineal-valeas
Linea-valeas Lipomin Liposlim
Magrene Menutil Moderatan
Moderatan diffucap Neobes Nobensin-75
Nobensine Nobesine Nobesine-25
Nulobes Obesitex Perfamone
Prefamone Propion Redicres
Regenon Regenon retard Regibon
Sinapet Slim-plus Super emegrin
T-712 Tenuate Tenuate dospan
Tenucap Tepanil Tylinal
For regulatory information, see page 42

Product Name Amfetamine

C.A.S. number 300-62-9
Trade and brand names
Actedron Adipan Allodene
Amfetamin Amfetasul Amphamed
Amphedrine Anorexine Benzebar
Benzedrine Benzolone Bifentamin
Centramina Dexamin Dexatrine
Durophet Elastonon Finam
Isoamyn Isomyn Mecodrin
Neoton Norphedrane Novydrine
Novydrinene Obesin Obesine
Obesitab Obetrol Oktadrin
Ortedrine Percomon Perduretas anfetamina
Phenedrine Phenopromin Profamina
Propisamine Raphetamine Rhinalator
Simpamina Simpatedrin Simpatina
Sympamine Sympatedrin Sympatina
Synatan Wekamine Zedrine
For regulatory information, see page 42
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 322

Product Name Aminoglutethimide

C.A.S. number 125-84-8
Trade and brand names
16038 Ba-16038 C-16038-ba
Crytraden Cytadren Doredin
Elipten Mamomit Orimeten
Ormeten
For regulatory information, see page 44

Product Name Aminophenazone

C.A.S. number 58-15-1
Trade and brand names
Adexogan Agevis Algimicin anttitermico
Amidazopen Amidazophen Amidazophene
Amidozen Aminophenazonum Anafebrin
Anafebrina Aneuxol Anoixal
Antigripina Areumal Axiston
Balbion Barsedan Baukal
Baukal suppositories Bayer 1387 p Bronchisan
Brufaneuseol Brufaneuxol Butapyrine
Capsyka dr knapf Capysal Chinopyrin
Cibalgin Ciclazon Clinit
Coffan Compral Cusayth
Demolpas Dentigoa Depiral c
Dereuma Dexa escopyrin Dha 51
Dialpyrin Digisab Dimametten
Dimapyrin Dimopyrin Dipirin
Diprin Dipyrin Dipyrine
Dolo-attirin Dolo-optineural Dolorphen
Dolovosano Donobin Duerin
Dysmensan Escopyrinus Espasnatex
Eufibran Eunalgit Euprogan
Febren Febrinina Febron
Febrosolvin Fenodon Fenodone
Fever Flivalgin Flumil
Fortalidon Framidone Ftalazon
Funapon Galenopyrin Glucopirina
Glucopitina Helvagit-f Hemicraneal
Hisense-p Hyparon Influnal depot
Inst Irgapyrine Isoftal
Itamidone Kalmine Katareuma
Lagaflex Latepyrine Lauroanginol
Mamallet-a Manslu Medispanmin
Melaforte Meloka Metapirazone
Netsusarin Neuro-demoplast Nifedon
Nikartrone Nostress Novamidon
Optalidon Optineural(analgesic) Optipax
Osadrine Osmotipax P.s.b.p.
Paralgin Piracodid Piradenil
Piradol Piramidon Piramidone
Pirasco Piraseptolo Piridol
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 323

Product Name Aminophenazone

C.A.S. number 58-15-1
Trade and brand names
Piro rectal Piromidina Piroreumal
Pneumol Polinalin Premineat
Prontylin Pyradon Pyraelmedal
Pyramidon Pyramidone Pyrodin
Regitol Remlomed Reu-bon
Reumanova Reumasedina Reumo termina
Reumoftal Reumotranc Revulex
Rini c Rinoplex Sanglin
Sapotera Sedafen Selbon-a
Somnopyrin Spasmo-barbanub Spasmo-deterex
Spasmo-dimonil Spasmo-tropax Spasmovalin
Spasmoverlgin Spasmus Suppnon
Tonosan Trogal Tropax
Tsefokon Tympagesic Viadol
Waudobuzon
For regulatory information, see page 44

Product Name Aminophylline

C.A.S. number 317-34-0
Trade and brand names
Afonilum Aminocardol Aminodrox
Aminodur Aminomal Aminophylline
Aminophylline injection Aminophylline mudrane Aminophylline oral
Amino-slow Amnivent Asmafilin
Cardophyllin Cardophylline Carena
Carine Colonofilin Corfilamine
Corophyllin Corophylline Corphyllamin
Diaphylline Duraphyllin Escophylline
Ethophylline Eudiamine Eufilina
Euphyllin Euphyllin 0.48 Euphyllin retard
Euphylllin cr Euphylllina Fadfilina
Godafilin Inophylline Jaa aminophylline
Mini-lix Mudrane Mudrane gg
Mundiphyllin Myocardon Palaran
Palaron Pecram Pecran
Peterphylin Phyllocontin Phyllotemp
Planphylline Somophyllin Somophyllin-12
Syntophyllin Tefamin Teophyllamin
Thodrox Truphylline Variaphylline
For regulatory information, see page 47

Product Name Aminorex

C.A.S. number 2207-50-3
Trade and brand names
Aminoxafen Aminoxaphen Apiquel
Mcn 742 Menocil
For regulatory information, see page 47
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 324

Product Name Amitriptyline

C.A.S. number 50-48-6
Trade and brand names
Adepril Amavil Ami-anelun
Amilent Amilit-ifi Amineurin
Aminiurin Amitimid Amitril
Amitrip Amitriptol Amitrol
Amyline Amyzol Annolytin
Apo-amitriptylline Apo-pram Deprelio
Deprestal Diapatal Domical
Elatrol Elatrolet Elavil
Elavil plus Emitrip Endep
Enovil Entrafon-210 Entrafon-2-10
Entrafon-2-25 Entrafon-a Entrafon-forte
Etarfon Etrafon-a Etrafon-forte
Euplit Laroxal Laroxyl
Larozyl Lentizol Levat
Levate Limbatarail Limbatral
Limbitryl Limitrol Longopax
Loxaryl Mareline Meravil
Muaban d Mutaban a/d/f Mutabase
Nobrital Normaln Novotriptyn
Novotryptin Novo-tryptin Pantrop
Parks-plus Pms levazine Prouvil
Redomex Saratem Saroten
Sarotena Sarotex Sedans
Sk-amitriptyline Sylvemid Tensorelax
Teperin Trepiline Trepulin
Triavil Triptizol Triptonal
Triptpane Trivial Trivial-4-10
Trivial-4-50
For regulatory information, see page 48

Product Name Amobarbital

C.A.S. number 57-43-2
Trade and brand names
Altinal Alupent-sed Amal
Amasust Ambese-la Amital
Amobell Amsal Amsebarb
Amybal Amycal Amydorm
Amylbarb Amylobeta Amytal
Amytal sodium Analgilasa Appenil
Asthmin Barbamyl Beatol
Binoctal Bludex Calavon
Cuaot Dexaspan Dexital
Dorlotyn Dorminal Dormytal
Ergo-lonarid Estimal Etamyl
Eunoctal Ifenin Isoamitil sedante
Isobec Isomyl Isomytal
Isonal Jalonac Lonarid n
Medi-trol Mudeka Mylodorm
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 325

Product Name Amobarbital

C.A.S. number 57-43-2
Trade and brand names
Mylodorm sustrel N8 Neur-amyl
Novambobarb Novogen Obe_slim
Pentymal Placidel Protasma
Robarb Schiwanox Sednotic
Sedo-rythmodan Somnal Somvit
Stadadorm Sumital Sy-dexam
Talamo Tensophoril Transital
Tuinal
For regulatory information, see page 49

Product Name Amodiaquine

C.A.S. number 86-42-0
Trade and brand names
Amodoquin tablets Basoquin Camoquin
Caniquin Flavoquin Flavoquine
For regulatory information, see page 49

Product Name Ampicillin/cloxacillin

C.A.S. number 2002-1-1003
Trade and brand names
Pfizerpen
For regulatory information, see page 286

Product Name Aprobarbital

C.A.S. number 77-02-1
Trade and brand names
Allypropymal Alurate Alurate sodium
Aprozal Isonal Nervisal
Numal Somnipron
For regulatory information, see page 52

Product Name Aristolochic acid

C.A.S. number 313-67-7
Trade and brand names
Acidum aristolchicum Descresepet Fago-paraxin
Fluocinova Predno-facilus haemota Tardolyt
Tr 1736
For regulatory information, see page 52

Product Name Astemizole

C.A.S. number 68844-77-9
Trade and brand names
Alermizol Astezol Astol
Hismanal Histamanal Novo-nastizol
For regulatory information, see page 54
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 326

Product Name Azapropazone

C.A.S. number 13539-59-8
Trade and brand names
Ahr 3018 Apazone Azapren
Cinnamin Cinnopropazone Dolo-prolixan
Pentosol Prodisan Prolix
Prolixan Prolixana Rheumox
Sinnamin Tolyprin Tolyprina
Xani
For regulatory information, see page 56

Product Name Azaribine

C.A.S. number 2169-64-6
Trade and brand names
Cb 304 Ribo-azauracil Triazure
For regulatory information, see page 56

Product Name Azatadine maleate/pseudoephedrine sulfate

C.A.S. number 2002-1-1004
Trade and brand names
Verban
For regulatory information, see page 290

Product Name Barbital

C.A.S. number 57-44-3
Trade and brand names
Deba Diemal Dormileno
Dormon Dormonal Escoderm
Hypnogene Hypnox Lidor
Malonal Megal Plexonal
Sedeval Somnytic tablets Uronal
Verinogen Verodon Veroletten
Verolitten Veronal Veronigen
For regulatory information, see page 57

Product Name Bencyclane

C.A.S. number 2179-37-5
Trade and brand names
Angiociclan Angiodel Bioarterol
Card-fludilat Dantrium Desoblit
Dilangio Dilangio caposium Dilapres
Fludilat Fludilat (r)-dti Fludilat amp 50 mg
Fludilat drag 100 mg Fludilat dragee Fludilat retard
Fludilat tropfen Flussema Fluxema
Halidor Iloramina Ludilat
Ludilat dti Novo card-fludilat Tardilat
Tensilence Vasodarkey
For regulatory information, see page 58
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 327

Product Name Benorilate

C.A.S. number 5003-48-5
Trade and brand names
Benolat Benoral Benorile
Benortan Benorylate Benotamol
Bentum Doline Durium
Duvium Faw 76 Fenasprate
Quinexin Salipran Sinalgin
Spierifex Triadol Vetedol
Win 11450 Winolate Winorlate
Winorylate Winrolate Wiolate
For regulatory information, see page 58

Product Name Benoxaprofen

C.A.S. number 51234-28-7
Trade and brand names
90459 compound Benoxapran Bexopron
Compound 90459 Coxigon Inflamid
Lilly 3794 Lilly 90459 Lrcl 3794
Opren Oprenal Oraflex
Uniprofen
For regulatory information, see page 58

Product Name Benzarone

C.A.S. number 1477-19-6
Trade and brand names
Benzarin Fragivix Fragivix (r) forte
Vasco Vasoc Venagil
For regulatory information, see page 59

Product Name Benzbromarone

C.A.S. number 2004-0-0001
Trade and brand names
Desuric
For regulatory information, see page 59

Product Name Benzoylperoxide

C.A.S. number 94-36-0
Trade and brand names
Altex
For regulatory information, see page 59

Product Name Benzyl alcohol

C.A.S. number 100-51-6
Trade and brand names
Actamin c Benhur Bigram
B-neuron Brophylline D & m tablets
Dermaspray Dex-a-vet Duphaspasmin
Eclipse Fertagyl Hydraplex
Lidazon Lokalin Madinex
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 328

Product Name Benzyl alcohol

C.A.S. number 100-51-6
Trade and brand names
Omnadren Orostat Parkestaf
Procadolor Reflex-spray Solvidont
Sudocrem Topic Triofan
For regulatory information, see page 60

Product Name Benzylpenicillin sodium (topical preparations)

C.A.S. number 69-57-8
Trade and brand names
Abbocillin Bicillin Bicillin all purpose
Ceilipen Cidan Cidan-cilina
Cilipen Coliriocilina Crisocilin-g
Cristapen Crystamycin Crystapen
Crystapen g Demosa casi penicilina Dermosa cusipenicilina
Falaper Gonoper Hormocillin forte
Hyasorb Ilcocillin Juvanesta
Lasacilina Liademycin M-cillin b
Megacillin Monocillin Natricilin
Novopen P.g.a. P-50
Paclia g Patosica Penibiot
Penicilina klari Penilevel Penimiluy
Peniroger Penitasa "450" simple Pentids
Pfizerpen Sancilin Saniciline
Servipan Sk-penicillin g Sodiopen
Sodipen Specilline Specilline g
Sugracillin Tabillin Therapen-na
Triplopen Unicilina Unicilina sodia
For regulatory information, see page 61

Product Name Berberine

C.A.S. number 2086-83-1
Trade and brand names
3 p maid Berberal Berbericine
Berberil Detal Kenmin-s
Kinosin s Phelloverin a Tangenin
Thalsin Umbellatin Umbellatine
For regulatory information, see page 62

Product Name Bithionol

C.A.S. number 97-18-7
Trade and brand names
Actamer Anafogene Bacteriostat cs-1
Bidiphen Bit Bithin
Bitin Cp 3438 Lorothidol
Lorothiodol Neopellis Nobacter
Prevenol Tbp Vancid
Vancide bl Xl 7
For regulatory information, see page 65
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 329

Product Name Boric acid and borates

C.A.S. number 10043-35-3
Trade and brand names
Alpagelle Anojel Anugard
Anojel Anugard Anusol hc
Anusol hc Berlicetin Betadrin
Berlicetin Betadrin Bexon
Bexon Bluboro Boroformal
Bluboro Boroformal Borogal
Borogal Borsyre viskos Cacimag
Borsyre viskos Cacimag Caclcifor
Caclcifor Calcamyl-24 Calcibenzamin
Calcamyl-24 Calcibenzamin Camilca
Camilca Chibro Coneolent
Chibro Coneolent Cutaden
Cutaden Dissol Ear-dry
Dissol Ear-dry Egosol-bs
Egosol-bs Evercil Fermakzem
Evercil Fermakzem Flex-care
Flex-care Glaucadrine Glucocalcium
Glaucadrine Glucocalcium Gynedron
Gynedron Kalopsisi Kerapos
Kalopsisi Kerapos Kodomo smarin
Kodomo smarin Komex Lindemil
Komex Lindemil Macaldex
Macaldex Mentol sedans sulfamidad Neo-smarin dia
Mentol sedans sulfamidad Neo-smarin dia Neo-vagipurin
Neo-vagipurin Normol O-biol
Normol O-biol Oestro-gynedron
Oestro-gynedron Ophtalmin Otocaina
Ophtalmin Otocaina Pedoz
Pedoz Perborate Phoscanol
Perborate Phoscanol Phytex
Phytex Poly-gynedron Preferal
Poly-gynedron Preferal Proculin
Proculin Rhinophenazol Saddle mate
Rhinophenazol Saddle mate Swim-ear
Swim-ear Swim-eye Tensophoril
Swim-eye Tensophoril Timazincum
Timazincum Tipolin Tricho-gynedron
Tipolin Tricho-gynedron Unisol
Unisol Vetacalin-m Alpagelle
Vetacalin-m
For regulatory information, see page 65

Product Name Bromocriptine

C.A.S. number 25614-03-3
Trade and brand names
Bromed Lactismine Parilac
Parlodel Umprel
For regulatory information, see page 68
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 330

Product Name Bromocriptine

C.A.S. number 25614-03-3
Trade and brand names

Product Name Broxyquinoline (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 521-74-4
Trade and brand names
Aprilin Auanosept Brodiar
Bromoxin Colepur Colipar
Dibromoksin Dibromoquin Dibromoxin
Dibromoxine Digesept Diromo
Dirorno Dysentrocym Enosept
Enterokvin Fenilor Intestopan
Intestopan-q Noroquinol Paramiba
Paramibe Paramibrodiar Phenipan
Sandocycline Sandoin Starogyn
Susiform ad is vet
For regulatory information, see page 68

Product Name Bucetin

C.A.S. number 1083-57-4
Trade and brand names
Beelin Bonanza Haitmin
Hoe 15239 New isomidon Ringl-s
For regulatory information, see page 69

Product Name Bufexamac

C.A.S. number 2438-72-4
Trade and brand names
Anderm Bufemac Bufexamac-ratiopharm (r) creme
Bufexine Bufexine ratiopharm(r) f-sable Calmaderm
Droxan Droxarol Droxaryl
Droxaryl zalf 50 mg Duradermal Flogicid
Flogocid Flogocid gel n.n Flogocid sable
Malipuran Mofenar Norfemac
Paraderm Parafenac Parafenac (r) milch
Parafenac 5% creme Parafenac basishad Parafenac sable
Parafenal Parfenac Parfenal
Parfenal creme derm Viafen Viafen u est.crema 40 g
For regulatory information, see page 69

Product Name Buformin

C.A.S. number 692-13-7
Trade and brand names
Adebit Andebit Andelit
Andere Biforon Bigunal
Biquinal Bs-5892 Bufonamin
Bulbonin Diabrin Dibetos
Dutformin Gliporal Glybigid
Insulamin Krebon Panformin
Silubin Silubin retard Sindiatil
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 331

Product Name Buformin

C.A.S. number 692-13-7
Trade and brand names
Tidemol retard Ziavetine
For regulatory information, see page 69

Product Name Bumadizone

C.A.S. number 3583-64-0
Trade and brand names
Bumadizon Bumaflex Eumatol
Rheumatol
For regulatory information, see page 70

Product Name Bunamiodyl

C.A.S. number 1233-53-0
Trade and brand names
Bunaiod Buniodyl Orabilex
Orabilix
For regulatory information, see page 71

Product Name Buprenorphine

C.A.S. number 52485-79-7
Trade and brand names
Buprenex Buprex Buprx
Finibron Prefin Temagesic
Temgesic
For regulatory information, see page 71

Product Name Cadralazine

C.A.S. number 64241-34-5
Trade and brand names
Cadraten Cadraten 21 cpr 20 mg Cadraten 30 cpr 10 mg
Cadraten 30 cpr 15 mg Cadratin Cadrilan
For regulatory information, see page 72

Product Name Calamus

C.A.S. number 8015-79-0
Trade and brand names
Acore vrai Oil of calamus Sweet flag root
For regulatory information, see page 73

Product Name Camelia sinensis

C.A.S. number 2004-0-0003
Trade and brand names
Exolise
For regulatory information, see page 73
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 332

Product Name Camphor

C.A.S. number 76-22-2
Trade and brand names
Anbesol Caladryl Cresophene
Dasin Ddd Endrine
Makatussin Mentol sedans sulfamidad Nasello
Resol Root bark oil Spirit of camphor
Tcp Tetesept Topic
For regulatory information, see page 73

Product Name Canrenone

C.A.S. number 976-71-6
Trade and brand names
Luvion
For regulatory information, see page 74

Product Name Canthaxanthin

C.A.S. number 514-78-3
Trade and brand names
Apotrin Food orange 8 Phenoro
For regulatory information, see page 74

Product Name Cathine

C.A.S. number 492-39-7
Trade and brand names
Adiposetten n Amorphan Amorphan depot
Andiposetten Appetrol Dietene
Exponcit Insacial Miniscap
Minusin depot Mirapront n Neo-soldana
Novese Phyteia schlankheitsdragees Reduform
Redufrom Thinz
For regulatory information, see page 76

Product Name Cefalosporins (topical preparations)

C.A.S. number UN-88-0002
Trade and brand names
Cepalorin Ceporin Faredina
Latorex Lauridin
For regulatory information, see page 76

Product Name Cerivastatin

C.A.S. number 145599-86-6
Trade and brand names
Cholstat Lipobay Rivastatin
For regulatory information, see page 77

Product Name Chenodeoxycholic acid

C.A.S. number 474-25-9
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 333

Product Name Chenodeoxycholic acid

C.A.S. number 474-25-9
Trade and brand names
Chendol
For regulatory information, see page 78

Product Name Chloramphenicol

C.A.S. number 56-75-7
Trade and brand names
Acne-sol Acnoxin Actimac
Actinac Alficetyn Alficetyn susp.
Altabactin Ambofen Ambrasynth
Amphemycin-prednisonum Amphenicol Amphicol
Ampliomicetin Amseclim Amseclor
Anacetin Angimidone Angiters
Antibiopto Aquamycetin Aquapred
Armacol Arrlicetin Austracol
Aviatrin Balkamycin B-cpct
Bemacol Berlicetin Biocetin
Biofeniol Biophenicol Biophtas
Biotocap Bismophenyl Bitencyl
C. o fluo-fenicol C. o hidrocor-clora Caf
Cafenolo Caladryl Calmina
Cam Campiol Caosol
Cap Catilan Cavumycetina
Ccombinado balsamico Ccorticol Cebenicol
Cetina Chemibal Chemicetin
Chemicetina Chemyzin Chlomin
Chlomycol Chloramex Chloramfenicol
Chloramficin Chloramfilin Chloramol
Chloramphenicol cinnamate Chloramphenicol intervetra Chloramphenicol sodium succinate
Chloramphenicol-pos Chloramphycin Chloramplast
Chloramsaar Chloramson Chloranfeni-mck
Chloranfeni-opipno Chloranfeni-otico Chloranfeni-ungena
Chlorasol Chlora-tabs Chloreptic
Chlorical Chloricol Chlornitromycin
Chloro-25 vetag Chloroantibion Chlorocaps
Chlorocid Chlorocide Chlorocidin c
Chlorocidin c tetran Chlorocortal Chlorofair
Chloroject l Chloroject s Chloromex
Chloromik Chloromimyxin Chloromycetin
Chloromycetin kapseals Chloromycetin palmitate Chloromycetin sodium succinate
Chloronitrin Chloroptic Chloroptic p. oint.
Chlorosol Chlorostrep Chlorotin
Chlorotyxin Chlorovules Chlorsig
Chlotaon Ciclepen Cidocetin
Ciplamycetin Clinafenol Clofenal
Clofibrase Clomicin enzym Cloramex
Cloramfen Cloramicol Cloramidina
Cloran Cloranfenicol-mck Cloranfeni-opifno
Cloranfeni-otico Cloranfeni-ungena Cloransul
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 334

Product Name Chloramphenicol

C.A.S. number 56-75-7
Trade and brand names
Clorbiotina Clorbis supp. Clorocyn
Clorofenicina Cloromicetin Cloromisan
Cloromoin Cloromycetin Cloroptic
Cloroptic farmicetina Clorosyntex Colidene
Colimy-c Comycetin Cortican
Cortidermale Cortimisin Cortiphenicol
Cortison-quemicet Cortivert Cortol
Cph Cutispray no. 4 Cyphenicol
Cysticat Davuron sedante D-chloramphenicol
Dectamicina Delta optil Desphen
Detreomycin Devamycetin Dexa-biofinicol
Dextromycetin Doctamicina Dorsec
D-threo-chloramphenicol Duphenicol Econoclor
Ejificol Ejificol strept Ejificol sulfa
Elase chloromycel Embacetin Emetren
Enicol Enteromycetin Enttocetrin
Erbaplast Erittronicol Erteilen
Esterofenil Estevecicina cloranfenico Eubetal
Extracicilina Fago-praxin Farmicetina
Fenicol Fluorobioptal Furacol l
Furamecetil alpha magna Furamecetil magna Furatrimon
Furokatin Gammaphenicol Ginetris
Gino-dectacil Gliscol Globenicol
Globveticol Glorous Goticas
Gotimycetin Ichthoseptal Intramycetin
Iruxol Iruxolum Isicetina
Ismicetina Isopto fenicol Juvamycetin
Kamaver Kavipe Kemicetine
Kloramfex Klorita Klorocid s
Kloromicin Labamicol Labamicol-bismuth
Lennacol Leuchlon Leukamycetin
Leukomyan Leukomycin Levocycline
Levomanilin Levomicetina Levomicin
Levomitsetin Levomycetin Levomycetina
Levoninizol Levopa Levosin
Levovetin Lifabiotico Liquichlor
Lisoprecol Locomycetine Lomecetina
Loromisin Mammphenicol Mastiphen
Mediamycetin Medichol Medicol
Meliplus Mephenicol powder Metisept
Micloretin Micoclorina Micoclorine
Micodry Micofilina Microcetina
Mindaril Minims Minims chloramphenicol
Misetin Muracin Mycetin
Mycetobis Mychel Mychel-s
Mychel-vet Mycinol Myclocin
Mycochlorin Naxogin compositum Neocetin
Neo-dexoclin Niamycetin Nitrocetin
Nitrocol Norbum Normimycin v
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 335

Product Name Chloramphenicol

C.A.S. number 56-75-7
Trade and brand names
Nova-phenicol Novoclorocap Novomycetin
Oftalent Oftan Oleomycetin
Opclor Ophthaphenicol Ophthochlor
Opthalon Optrin Oralmisetin
Otachron Otiprin Otophen
Otopred ear drops Pantofenicol Pantovernil
Paraxin Parcyclin Pedimycetin
Pentamycetin Pentocetina Pertaril
Pimabiciron Pinimentac Plastoderma
Prednomycetine Procusulf Protercicline
Prurivet Pulmo vinco Quemicetina
Quitrase Quitrase antibiotico Ranphenicol
Ranstrepcol Reclor Redidropsol
Renegen Reocetin Reostop
Rheofin Rivomycin Rivomycin sulfa
Rolintrex Romphenil Roncovita
Ronphenil Roscomycin Rovictor
Samaphenicol Scanicol Scanicoline
Scieramycetin Septicol Sergo-amigdalar
Serviclofen Sificetina Sigmicilina
Sintomicetin Sintomicetina Sintomicetine r
Sintomitsin Snophenicol Soludectancil
Sopamycetin Spasmo-paraxin Spersanicol
Stanomycetin Strepticine Streptoglobenicol
Streptophenicol Subital supp. Suismycetin
Sulfaglobenicol Sulfamycetin Synthomycetin
Synthomycetina Synthomycetine Synthophtone
Tardomyocel Tega-cetin Tetrachlorasone
Tetracol Tetranfen Tetraphenicol
Tetra-phenicol oculos Tevcocin Tifomycine
Tiframilk Tiromycetin Toramin
Transicetina Transpulmycin Tribiotic
Trophen Troymycetin Tusolone
Tycloran Unimycetin Uro-gliscal
Uro-gliscal 500 Uroletten-s Uroplex 4
Ut forte Uvomycin Vagisept
Variolan V-crayolan Vetical
Vetophenicol Viceton Viklorin
Virogin Vitaklorin Vsmpozim
Wintetil Zoppib spray blu
For regulatory information, see page 78

Product Name Chlormadinone acetate

C.A.S. number 302-22-7
Trade and brand names
Gestafortin Luteran Ovosiston
For regulatory information, see page 79
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 336

Product Name Chlornaphazine

C.A.S. number 494-03-1
Trade and brand names
Aleukon Chloronaftina Erysan
Nafticlorina Naphthylamine mustard
For regulatory information, see page 81

Product Name Chloroform

C.A.S. number 67-66-3
Trade and brand names
Ametuss Benafed Benatuss
Benyphed Broncho-rivo syrup Chlor-histine
Codacol Codimal dm Co-specto
Cotrol-d Cyprol expectrant Dalet
Dectuss Eludril Expec-c
Fk-tussex Guanor Histalix
Hydril Kentuss Linctuss
Mc 3 Muflin Nagalyn
Notose Orthos kavident Panosoma
Penta-zine Phenacol-dm Phenatuss
Phlogarol P-m-z Promex
R 20 Rexahisine
For regulatory information, see page 81

Product Name Chloroquine

C.A.S. number 54-05-7
Trade and brand names
Aralen Aralen hcl Aralin (diphosphate)
Artrichin Artrochin Avloclor (diphosphate)
Bemaphate Bipiquin Chemochin
Chlorochin Cidanchin Clorochina
Delagil Dichinalex Endamal
Erestol Gontochin Hiliopar
Imagon Instana Lagaquin
Letaquine Malaraquin Malarex (diphosphate)
Malariron (diphosphate) Malquin Mesylith
Miniquine Nivaquine Nivaquine b'
Nivembin Norolon Pfizerquin
Presocyl Quinachlor Quinercyl
Resichin Resochin (diphosphate) Resoquine
Reumachlor Rivoquin Salestol
Sanoquin Scaniquine (diphosphate) Serviquin
Silbesan Siragon Tanakan
Tresochin Trochin
For regulatory information, see page 83

Product Name Chlorphentermine

C.A.S. number 461-78-9
Trade and brand names
Apsedon Avicol Avipron
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 337

Product Name Chlorphentermine

C.A.S. number 461-78-9
Trade and brand names
Chenracol Clorfentermina Desopimon
Effox Lucofen Lucofen retard
Lucofen sa Minilip Phenacon
Pre-sate Reamine Sinfat
Teramine
For regulatory information, see page 84

Product Name Cianidanol

C.A.S. number 154-23-4
Trade and brand names
Ausoliver Catergen Cirramina
Drenoliver Transepar
For regulatory information, see page 84

Product Name Cinchophen

C.A.S. number 132-60-5
Trade and brand names
Aglophenyl Agotan Alcophenyl
Alutyl Artam Artexin
Atigoa Atocin Atofan
Atophan Cefeno Cinchophene
Cinconal Cincosal Fenofan
Iriphan Mylofanol Mylophanol
Phenoquin Rhematan Rheumin
Tervalon Tophol Traubofan
Vantyl Viophan
For regulatory information, see page 85

Product Name Cinnarizine

C.A.S. number 298-57-7
Trade and brand names
Rinomar
For regulatory information, see page 86

Product Name Cisapride

C.A.S. number 810968-60-4
Trade and brand names
Calmax Cisapid Cismotil
Digenol
For regulatory information, see page 86

Product Name Clemastine

C.A.S. number 15686-51-8
Trade and brand names
Agasten Alagyl Aller-ez
Aller-ez plus Alogynan Alphamin
Anhistan Antihist-1 Arrest
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 338

Product Name Clemastine

C.A.S. number 15686-51-8
Trade and brand names
Benaznyl Clemanil Clemastin fumerate syrup
Corto-tavegil Dexa-tavegil Fuluminol
Fumarsutin Inbestan Kinotomin
Lacretin Licasol Maikohist
Mallermin Marsthine Masletine
Piloral Rhinergal Rhinergal tavegil
Tavegil Tavegyl Tavist
Tavist 1 Tavist tablets Tavist-1
Tavist-d Tavist-syrup Telgin-g
Xolamin
For regulatory information, see page 89

Product Name Clioquinol (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 130-26-7
Trade and brand names
Alchloquin Amebio-formo Amoenol
Anterobe Aristoform Aristoform "d"
Aristoform "r" Bactol Barquinol
Barquinol hc Betnorate-c Britaderm
Britadex-vioform Budoform Carboform
Cifoform Cleocin Cliquinol
Cloro-yodo-hidroxi Clorpine Combias
Copover Cortex Corticreme
Corti-glottyl Cremo-quin Dependal
Dermadex Dermo-quinol Dermozolan
Dexalocal Diaban Dioderm
Dioderm c Dioderm c-c Diodotracin
Dioquinol Diproform Dizenterol
Domeform Eczecidin Emaform
Enteral Enteritan Ente-rivo
Enterokin Enterosan Enterosept
Enteroseptol Entero-valodon Entero-vioform
Entero-vioformio Entero-vioformo Enterozol
Enterquinol Entox Entrasorb
Entrokin Entrokinol Fraquinol
Fusalor-yodocloro Fyloxxal Gmd
Guanosept Haelan-c Hi-enterol
Hocacorten-vioform Hydroform Hysone
Iodenterol Iodochlorhydroxyquinol Iodo-cortifair
Iodocortindon Iodoenterol Iodo-max
Isoderm Khlorlinkotsin Klinicin
Lecortin Lederform-d Lekosept
Lemoderm Linola Locacorten-vioform
Locorten Locorten-vioform Metrijet
Metrityl Mexafermento Mexafom
Mexaform Mycoquin Nasello
Nefurox Nioform Obstecrim
Oralcer Oxyquin Pedi-cort
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 339

Product Name Clioquinol (see also halogenated hydroxyquinoline derivatives)

C.A.S. number 130-26-7
Trade and brand names
Percural Phen-ortis Pricort cream
Propaderm-c Quadriderm Quin
Quin iii Quina band Quinambicide
Quiniodochlor Reticus Rheaform
Rometin Sebryl Sedacol
Septo-canulase Silic c Steroderm
Synalar-c Tequinophil Toptic
Torofor Unidiarea Uteroject
Ventribex Viform Vioform
Vioform bolus Vioform hydrocortisan Vioform hydrocortisone
Vioforme Viosept
For regulatory information, see page 89

Product Name Clobenzorex

C.A.S. number 13364-32-4
Trade and brand names
Asenlix Finedal
For regulatory information, see page 91

Product Name Clofibrate

C.A.S. number 637-07-0
Trade and brand names
Aatroayerst Aitiflus Amotril
Angiocapsul Anparton Antilipid
Apolan Arterioflexin Arterioflexion
Artes Artevil Artriosan
Asa/cpib Ateculon Aterioplexin
Ateriosan Ateroayrest Ateroclar
Aterofront Ateronlen Aterosol
Atevil Atheroayerst Atheromide
Atheropront Atroayerst Atrofort
Atrolan Atrolen Atromid
Atromidin Atromid-s Atrom-s
Atrovis Ay 61 Azionyl
Biocleran Bioscleran Cartagyl
Cinnarizin Citiflus Clareden
Claresan Claripex Claripex cpib
Cloberab Cloberat Clobrat
Clobrate Clobren Clobren-5 f
Clof Clofenit Clofibral
Clofibrat Clofibrate ayerst Clofibrate compose
Clofibrato ayerst Clofibrato procaps Clofibrem
Clofimide Clofini Clofin-icn
Clofinit Clofipront Clofipront 5000
Clofirem Clofirin Clofi-t
Clopin Col 180 Contra-lipide
Corafen Cr/085 Dabical
Delipid Deliva Dilectus
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 340

Product Name Clofibrate

C.A.S. number 637-07-0
Trade and brand names
Doctus Duplinal Duraclofibrate
Ellemger Elpi Epib
Eramid Fibramid Fibrolynt
Geri-70 Geromid Gerostop
Healthstyle Hyclorate Ici 28257nt
Ipolipid Klofibrat Klofiran
Kontalipide Levatram Levatrom
Liapten Liparil Lipaten
Lipavil Lipavlon Lipavlon 500
Lipicidon Lipidicon Lipofacton
Lipomid Liponorm Liporan
Liporeduct Liporil Liposid
Liprin Liprinal Liptrinal
Lobetrin Lostat Miscleron
Negalip Neoatromid Neo-atromid
Nibratal Nibratol Nnormet
Nobret Norinolipol Normalip
Normet Normet richter Normolipol
Nosterolin Novofibrate Omelip
Persantinat Provasa Recade
Recolip Regelan Regelan n 500
Sclerovasal Serolipid Serotinex
Sestron Sinteroid Sklero
Sklerocip Sklerolip Skleromex
Skleromexe Sklero-tablinen Sklerovasal
Supraoxid Tepincal Tepingal
Ticlobran Vimedel Vocaline
Xyduril Yoclo
For regulatory information, see page 92

Product Name Cloforex

C.A.S. number 14261-75-7
Trade and brand names
Avicol sl Avicol-la Chloferex
D 237 Frenapyl Lipociden
Oberex Vidipon Zeisin
For regulatory information, see page 94

Product Name Clomethiazole

C.A.S. number 533-45-9
Trade and brand names
Clomiazin Distraneurin Distraneurine
Emineurina Gebriazol Hemineurin
Hemineurine Heminevrin Somnevrin
For regulatory information, see page 95
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 341

Product Name Clozapine

C.A.S. number 5786-21-0
Trade and brand names
Clozaril Iprox Leponex
Leponox
For regulatory information, see page 95

Product Name Cobalt (non-radioactive forms)

C.A.S. number 7440-48-4
Trade and brand names
C.i. 77320 Cobalt-59 Impromin
Inter-con Kometileneamin Levacide-c
Orkomin Panacur Sofracaps
Tasvite Trelenium
For regulatory information, see page 96

Product Name Codeine

C.A.S. number 6095-47-8
Trade and brand names
Algisedal Codicept Codol
Diarrest Methylmorphin Novacetol
Sedarene
For regulatory information, see page 97

Product Name Cyclamates in drugs

C.A.S. number 139-05-9
Trade and brand names
Adocyl Ampenoline balsamoco Assugrin
Azucrona Cyclarin Glusac super
Ilgon Sladicin Sucaryl
Sucaryl calcium Sucaryl sodium Sucrum
Sucrum 7
For regulatory information, see page 98

Product Name Cyproheptadine

C.A.S. number 129-03-3
Trade and brand names
Anarexal Antegan Apeplus
Brantina Brantine Brontin
Carnigol Carpantin Ciplactin
Cipractin Cipro Cipro n
Ciprocort Cypromin Cyrasarl
Eiproheptadine Estialim Histatets
Ifrasarl Kontrast u Naidoretico
Nuran Nurdelin Nuttriben
Oractine Orexigen Periactin
Periactine Periactinol Periactol
Perideca Peritol Pranzo
Reparal carnitina Siglatan Sigloton
Sipraktin Siprodin Vimicon
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 342

Product Name Cyproheptadine

C.A.S. number 129-03-3
Trade and brand names
For regulatory information, see page 99

Product Name Danazol

C.A.S. number 2004-0-0004
Trade and brand names
Danol
For regulatory information, see page 101

Product Name Dantron

C.A.S. number 117-10-2
Trade and brand names
Doss Normax Regulex-d
For regulatory information, see page 101

Product Name Depot medroxyprogesterone acetate (DMPA)

C.A.S. number 71-58-9
Trade and brand names
Amen Clinovie Cliovir
Curretab Dep0-clinover Dep0-map
Depcorlutin Depo-prodasone Depo-progevera
Depo-promone Depo-provera Deporone
Dugen Farlurin Farlutal
Farlutale Gesinal Gestapuran
Gestapuron G-farlutal Hysron
Intex Luteocrin orale Luteodione
Luteos Lutoporal Lutoral
Meprate Metigestene Metigestrona
Nadigest Nidaxin Nogest
Onco-provera Oragest Perlutest
Perlutex Petogen Piermap
Povera Prodasone Progestalfa
Progevera Promone-e Pronone
Provera Proverone Provest
Repromix Sindomens Sirprogen
Sodelut Sodelut "g" Supprestal
Verafen Veramix Veramix plus v
For regulatory information, see page 102

Product Name Dequalinium chloride

C.A.S. number 522-51-0
Trade and brand names
Decabis Dequacaine Dequafungan
Dequin Evazol Faringina
Gargilon Grocreme Labosept
Maltyl Phylletten Soor-gel
Sorot Tetesept
For regulatory information, see page 103
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 343

Product Name Dequalinium chloride

C.A.S. number 522-51-0
Trade and brand names
Product Name Dexamfetamine
C.A.S. number 51-64-9
Trade and brand names
Adiparthrol Afatin Amfe-dyn
Amphaetex Bipheramine Curban
D-amfetasul Dexadrine Dexamed
Dexamin Dexampex Dexedrina
Dexedrine Dexten Dextro-profetamine
Drinamyl Durophet Durophet-m
Ferndex Maxiton Mephadexamine-r
Mephadexamin-r Obetrol Obotan
Proptan Robese Simpamina d
Steladex Stil-2 Synatan
For regulatory information, see page 104

Product Name Dexfenfluramine

C.A.S. number 3239-44-9
Trade and brand names
d-Fenfluramine Diomeride
For regulatory information, see page 104

Product Name Dextromethorphan

C.A.S. number 125-71-3
Trade and brand names
Agrippol Dextophan Dextrophen
For regulatory information, see page 105

Product Name Dibenzepin hydrochloride

C.A.S. number 315-80-0
Trade and brand names
Ansiopax Deprex Ecatrol
Hf 1927 Neodalit Neodit
Noveril Victoril
For regulatory information, see page 105

Product Name Diclofenac sodium

C.A.S. number 15307-79-6
Trade and brand names
Aflamin Alfamin Allvoran
Artren Blesin B-voltaren
Cgp 9194 Chlorgyl Ct-diclo
Delphimix Dichloronic Dichronic
Diclo attritin Diclo spondril Diclo-attritin
Diclo-burg Diclo-phlohont Diclo-puren
Diclo-recip Dicloreum Diclo-spondyril
Diclo-wolf Dolaren Dolobasan
Dolotrem Doragon Duravolten
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 344

Product Name Diclofenac sodium

C.A.S. number 15307-79-6
Trade and brand names
Duvavotten Effekton Feloran
Fenoflam Flogofenac Flogogenac
Forgenac Inflamac Klast
Kriplex Monoflam Myogit
Neriodin Neuro-effekton Neurofenac
Neuro-voltaren Neviodin Novapirina
Olfen Panamor Parsal
Prophenatin Rewodina Rheumalgen
Rheumavincin Rheumavincin-n Seecoren
Shignol Silino Sofarin
Sorelmon Thicataren Toryxil
Tsudohmin Tsudomin Valetan
Voltaren Voltarene Voltarol
For regulatory information, see page 105

Product Name Dicycloverine

C.A.S. number 77-19-0
Trade and brand names
Abacid plus Ametil Atumin
Babypasmil Babyspasm Babyspasmil
Baycyclomine Benacol Bendectin
Bentomine Bentyl Bentylol
Clomin Colix Cyclobex
Cyclocen Debendox Diarrest
Diclophen Dicyclomine Dicycloverin
Diocyl Dyspas Eatongel
Esentil Fomulex Formulex
Gastrosilane Icramin Incramin
Incron Inctacol-c Isospamex
Kolanticon Kolantyl Lagasediv
Lomine Mamiesan Menospasm
Merbantal Merbentyl Mydocalm
Neoquess Nomocramp Notensyl
Or-tyl Ovol Pamin
Panakiron Prinel Procyclomin
Protylol Sawamin Spactil
Spasmoban Spastil Tarestin
Viscerol Wyovin
For regulatory information, see page 106

Product Name Dienestrol

C.A.S. number 84-17-3
Trade and brand names
Agaldog Avc/dienestrol Crinohermal fem
Cycladiene D.v. Dehydrostilboestrol
Dienoestrol Dienol Dienostrol cream
Dienstrogen Dinestrol Dinol
Dinovex Dufemine Dv
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 345

Product Name Dienestrol

C.A.S. number 84-17-3
Trade and brand names
Estraguard Estrodienol Estroral
Farmacyrol Follidiene Follormon
Foragynol Frein Gynefollin
Hormofemin Isodienestrol Klianyi forte
Klianyl Lipamone Neo-oestrogenine
Oestrasid Oestrodien Oestrodiene
Oestrodienol Oestroral Oestrovis
Ortho Ortho (cream) Ortho dienestrol cream
Para-dien Restrol Retalon
Sexadien Sexadieno Synestrol
Synoestrol Teserene Willnestrol
For regulatory information, see page 107

Product Name Diethylaminoethoxyhexestrol

C.A.S. number 2691-45-4
Trade and brand names
Coralgil Coralgina Coralgyl
Trimanyl
For regulatory information, see page 107

Product Name Diethylstilbestrol

C.A.S. number 56-53-1
Trade and brand names
Distilbene Oestro-gynedron Stilphostrol
For regulatory information, see page 107

Product Name Difenoxin

C.A.S. number 28782-42-5
Trade and brand names
Dioctin Lyspafen Lyspofen
Lyspofenac Motofen
For regulatory information, see page 109

Product Name Difurazone

C.A.S. number 804-36-4
Trade and brand names
Panzon Payzone
For regulatory information, see page 109

Product Name Dihydrostreptomycin

C.A.S. number 128-46-1
Trade and brand names
Abiocine Abocillin Biostrep
Complexobiotico Dhsm Diapenin 3
Diapenin balsamico Diarrestival Didromycin
Didrothenate Dihydrocidan sulfato Dihydrostreptofar
Dihydrostreptom Diidro-pantostrept Distreptopab
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 346

Product Name Dihydrostreptomycin

C.A.S. number 128-46-1
Trade and brand names
Dreiciclina balsamica Dst Entera-strept
Estreptoluy Estreptosirup Helle-strep-forte
Hp 48 Mastigun Mixtencillin
Retromyopen Rocopenstrep Sanstrepto
Solmycin Solvo-strept Streptoduocin
Veticar Veycil-as Vibriomycin
For regulatory information, see page 109

Product Name Dihydroxymethylfuratrizine

C.A.S. number 794-93-4
Trade and brand names
Furatone Panfuran s Panfuran-s
For regulatory information, see page 110

Product Name Dimazole

C.A.S. number 95-27-2
Trade and brand names
Asterol Atelor Atelora
Aterola Kesten Mycotol
For regulatory information, see page 111

Product Name Dinoprostone

C.A.S. number 363-24-6
Trade and brand names
Minprostin Prostaglandin E2 Prostarmon e
Prostenon Prostin e2 Prostin vr pediatric
For regulatory information, see page 111

Product Name Diphenoxylate

C.A.S. number 915-30-0
Trade and brand names
Diarphem Diarsed Diarsed-neomycin
Diatro Eldox Logen
Lomanate Lomax Lomotil
Lomotil liquid Lonox Protector
Reasec Saleton Sedistal
For regulatory information, see page 112

Product Name Dithiazanine iodide

C.A.S. number 514-73-8
Trade and brand names
Abminthic Anelmid Anguifugan
D.i.m. Dejo Delvex
Deselmine Dilombrine Dithiazine (dye)
Dizan Dtdc Eastman 7663
Elmizin Nekel Netocyd
Omni-passin Ossiurene Partel
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 347

Product Name Dithiazanine iodide

C.A.S. number 514-73-8
Trade and brand names
Telmicid Telmid Telmide
For regulatory information, see page 113

Product Name Domperidone(injectable)

C.A.S. number 57808-66-9
Trade and brand names
Euciton Evixub Kw 5338
Moperidona Motilium Nauzelin
Neta662 Peridon Peridys
R 33812 Tametil Touristic
For regulatory information, see page 114

Product Name Doxepin

C.A.S. number 1668-19-5
Trade and brand names
Adapin Apo-doxepin Aponal
Co dox Deptran Doksapan
Dolat Doxal Doxedyn
Doxepin hcl Gilex Novo-doxepin
Novoxapin Quitaxon Sinequan
Sinquan Sinquan concentrate Sinquane
Tolllluan Triadapin Zonalon
For regulatory information, see page 114

Product Name Doxycycline hyclate(injectable)

C.A.S. number 24390-14-5
Trade and brand names
Abadox Azudoxat Bassado
Bio-tab Clisemina Cloran
Cyclidox Deoxymykoin Diocimex
Docostyl Doryx Dosil
Dotur Doxatet Doxi sergo
Doxicento Doxifin Doxilen
Doximycin Doxin Doxina
Doxinate Doxiten bio Doxivis
Doxy Doxy-100 Doxy-basan
Doxybiocin Doxychel Doxycyl
Doxy-diolan Doxydyn Doxyfim
Doxygram Doxylag Doxylan
Doxylar Doxylets Doxylin
Doxymycin Doxy-p Doxytem
Doxy-wolff Dumoxin Duradoxal
Esadoxi Farmodoxi Ghimadox
Gram-val Granudoxy Helvedoclyn
Icladox Idocyklin Mespafin
Miraclin Monocline Monodox
Monodoxin Nordox Novelciclina
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 348

Product Name Doxycycline hyclate(injectable)

C.A.S. number 24390-14-5
Trade and brand names
Philcociclina Radox Retens
Roximycin Roxyne Samecin
Semelciclina Sigadoxin Solupen
Spanor Stamicina Supracyclin
Tetradox Tetrasan Unacil
Unidox Vibracina Vibramicina
Vibramycin Vibramycin hyclate Vibramycine
Vibra-tab Vibra-tabs Vibraveineuse
Vibravenos Vibravenosa Ximicina
Zadorin
For regulatory information, see page 115

Product Name Droperidol

C.A.S. number 548-73-2
Trade and brand names
Dehydrobenzperidol Diaperidol Inopsin
For regulatory information, see page 116

Product Name Emetine

C.A.S. number 483-18-1
Trade and brand names
Asmorex Broncho-tetracycline Dicton-retard
Emedrin Emetin Emetina
Emetocamphrol Hemometina Optairosol
Pectinfant
For regulatory information, see page 117

Product Name Ephedra

C.A.S. number 2004-0-0005
Trade and brand names
Magic herb
For regulatory information, see page 118

Product Name Epinephrine

C.A.S. number 51-43-4
Trade and brand names
Adnephrine Adrefil Adrehinal
Adren Adrenal Adrenalin
Adrenalin chloride Adrenalin medihal Adrenalina ace.p.d.
Adrenalina clorhi Adrenalina delta Adrenalina fustery
Adrenalina hormona Adrenalina p davis Adrenalina wiener
Adrenaline Adrenamine Adrin
Bronkaid mistometer Cetanest Chelafrin
D epinefrin Dento-caine D-epifrin
Depinefrin Dysne-inhal E-caprine
Epiboran ofteno Epifrin Epiglaufrin
Epinephrine hcl Epinephrine pediatric Epineramine
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 349

Product Name Epinephrine

C.A.S. number 51-43-4
Trade and brand names
Epipen Epirenan Epitrate
Exadrin Ganda Glaucadrin
Glaucadrine Glaucoaicon Glaucon
Glauconin Glaucosan Glaucotahil
Glycirenan Haemostasin Hektalin
Hemisine Hemostatin Intranefrin
Isopto epinefrina Kidoline L-caine
L-epinephrine Levorenine Levoreninl-adrenaline
Licothionil Lidoacton Lyodrin
Lyophrin Marcaom Medihaler-epi
Metanephrine Methylaminoethanolcatechol Methylarterenol
Mucidrina Neo-rybarex Nephridine
Nieraline Niphridine Octacaine
Orostat P2e1 Paranephrine
Pe Piladren Primatene mist
Renagladin Renaglandin Renaglandulin
Renaleptine Renalina Renoform
Renostypticin Renostyptin Scurenaline
Sedo-asmol Simplene Styptirenal
Supracapsulin Supranephrane Supranephrine
Suprarenaline Suprarenine Suprel
Suprexon Suprexon 5 Surrenine
Susphrine Sus-phrine Sympathin i
Takamina Vaponefrin Vaponephrine
Vasoconstrictine Vasoconstrictor Vasodrine
Vasotonin Xylestesin a Xylotox
For regulatory information, see page 118

Product Name Erythromycin estolate

C.A.S. number 3521-62-8
Trade and brand names
Antibio-aberel Apo-erythro-s Bio-exazol
Biometran Biomicron Bristamycin
Chemthromycin Cimetrin Cusimicina balsamica
Doboiosol Dowmicyn Dreimicina
Duozplin vitaminado Dynabiotal E.e.s
Ees-200 Ees-400 E-mycin
E-mycine Endoeritrina Erimec
Erirobios Eriscel Eritrazol
Eritrobios Eritrobiotic Eritrocin
Eritrodes Eritroger Eritronicol
Eritropan Eritroveinte Eritrovienite
Eritrowolf Eritro-wolf Ermysin
Eromycin Ery derm Eryc
Erymycin Erypar Eryped
Ery-tar Erythrocin Erythromictine
Erythromid Erythro-prat Ery-toxinal
Erytrarco Erytrodol Erytro-prot
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 350

Product Name Erythromycin estolate

C.A.S. number 3521-62-8
Trade and brand names
Eryt-toxinal Espimina Estimina
Estomicina Estomiicina Estomycin
Ethril Fesmicina Iloson
Ilosone Ilosone pulvules Ilosone ready-mix
Ilothycin Ilotycin Kesso-mycin
Laucetin Laurilin Lauritran
Lauromicina Liferitrin Loderm
Lubomycina Lubomycine Makrocyklina
Manilina Marcoeritrex Marocid
Mistral Monomycin Neo-erycinum
Neo-ilolycina Neo-iloticina Niux
Novorythro Pediamycin Pels
Pfizer-e Propiocine enfant Propriocin enfante
Prospiocine Proterytrin Pulmomas
Purmycin Ritromin Robimycin
Roxo chemil Roxochemil Rp-mycin
Rubibacter Selvicin Sk-erythromycin
Spetrasone Stella micina Stellamicina
Taimoxin Togerin Togiren
Togrien Tosinova Tropoxin
Wyamycin Wyamycin e Wyamycin s
For regulatory information, see page 120

Product Name Etanercept

C.A.S. number 185243-69-0
Trade and brand names
Enbrel Tanercept yhu TNFR: Fc
For regulatory information, see page 121

Product Name Ethambutol

C.A.S. number 74-55-5
Trade and brand names
Aethambutolum Embutol Etbutol
For regulatory information, see page 121

Product Name Ethanol

C.A.S. number 64-17-5
Trade and brand names
Absolute alcohol Alcohol aethylicus Alcool
Avitoin Banatol B-tonin
Colfin Desqyam-x Duonale-e
Efatin Equithesin Hizeneck-d
Honkon-n Kapsitrin Keralyt
Levovinizol Mikrozid Neotizol
Panoxy Papette Piadarn
Polislerol Protectaderm Sicol
Sodaphilline Softa man Sotracarix
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 351

Product Name Ethanol

C.A.S. number 64-17-5
Trade and brand names
Verucid Weingeist Xeracin
For regulatory information, see page 121

Product Name Ethylestrenol

C.A.S. number 965-90-2
Trade and brand names
Dexabolin Durabolin-o Duraboral
Ethylnandrol Fertabolin Maxibolin
Neodurabolin Orabolin Orgabolin
Orgaboral Vibolin
For regulatory information, see page 123

Product Name Etomidate

C.A.S. number 33125-97-2
Trade and brand names
Amidate Hypnomidat Hypnomidate
Hypnomidate concentrate Hypnomidate injection Hypromidate
Nalgol Radenarcon Sibul
For regulatory information, see page 124

Product Name Etretinate

C.A.S. number 54350-48-0
Trade and brand names
Ro 10-9359 Tegison Tigasan
Tigason
For regulatory information, see page 124

Product Name Factor IX

C.A.S. number UN-87-0003
Trade and brand names
Bebulin Haimaplex Preconativ
Profilnine Proplex Prothromplex
For regulatory information, see page 125

Product Name Factor VIII

C.A.S. number UN-87-0004
Trade and brand names
Factorate Hemofil Humafac
Humanate Hyate:c Koate
Kryobulin Profilate
For regulatory information, see page 126

Product Name Famotidine

C.A.S. number 76824-35-6
Trade and brand names
Amifatidine Famodil Pepsidac
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 352

Product Name Famotidine

C.A.S. number 76824-35-6
Trade and brand names
For regulatory information, see page 126

Product Name Fenclofenac

C.A.S. number 34645-84-6
Trade and brand names
Feclan Flenac Gidalon
Monosan Rx 67408nac
For regulatory information, see page 126

Product Name Fenetylline

C.A.S. number 3736-08-1
Trade and brand names
Biocapton Captagon Captagon cpr nsfp
For regulatory information, see page 127

Product Name Fenoterol

C.A.S. number 13392-18-2
Trade and brand names
Berotec Dosberotec Duovent
Fensol Partusisten
For regulatory information, see page 128

Product Name Feprazone

C.A.S. number 30748-29-9
Trade and brand names
Analud Bentudor Brotazona
Cocresol Da 2370 Danfenona
Feniprenazone Fepramole Golaman
Grisona Impremial Methrazone
Metrazone Naloven Naoven
Nazona Nessazona Nilatin
Prenakes Prenazon Prenazone
Rangozona Represil Solielin
Tabrien Tbrien Vapesin
Zepelin Zontal Zoontal
For regulatory information, see page 128

Product Name Fipexide

C.A.S. number 34161-24-5
Trade and brand names
Attenil Attenil 30 conf. 20 mg Fipexitum
Fipexium Vigilor Vigilor 200 mg cpr msfp
For regulatory information, see page 129

Product Name Flecainide

C.A.S. number 54143-55-4
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 353

Product Name Flecainide

C.A.S. number 54143-55-4
Trade and brand names
Flecaine
For regulatory information, see page 129

Product Name Floctafenine

C.A.S. number 23779-99-9
Trade and brand names
Tambocor
For regulatory information, see page 131

Product Name Flunitrazepam

C.A.S. number 1622-62-4
Trade and brand names
Darkene Flumipam Flunipam
Hipnosedon Hiposedon Hypnodorm
Hypnosedon Libelins Narcozep
Noviel Primun Riopnol
Rohipnol Rohpinol Rohpnol
Rohypnol Roipnol Valsera
Valseram
For regulatory information, see page 132

Product Name Fluvoxamine

C.A.S. number 54739-18-3
Trade and brand names
Faverin Fevarin
For regulatory information, see page 133

Product Name Furazolidone

C.A.S. number 67-45-8
Trade and brand names
Benilen B-fsudi Carbopuradin
Coryzium Dapecfuran Dectolin
Diafuron Dialidene Diarexin
Diarin Diclofur Doreplston
Dushel Enterar Enteroxon
Foroxon Foroxone Framenterol
Ft 15 Furaberin Furacol l.
Furacort Furalatin p. Furalidan
Furaliqua Furall Furazol
Furazon Furovag Furox
Furoxal Furoxane Furoxon
Furoxona Furoxona-cp Furoxone
Furoxone swine mix Fuvitan Fuxol
Fuzatyl Galacid Gamafur s.
Giardil Giarlam Giarlin
Ginvel Injecur Intefuran
Kalpec-f Lacolysat Mastisept
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 354

Product Name Furazolidone

C.A.S. number 67-45-8
Trade and brand names
Medaron Multi-med 2 Multi-med 3
Multi-med 6 Neforox Neforox alpha cpto
Neftin Neftivit Nf 180
Nicolen Nicolen r Nifulidone
Nifulin Nifuran Optazol
Parkestress forte Puradin Roptazol
Saleton Scantrimon Sclaventerol
Sibren Sirben Syralbuna
Tetrafur Tikofuran Topazone
Tranatogen-ova Trichofuron Tricofuron
Tricoron Trifurox Ufa-cfo-400
Uterojekt Vagifurona Vetoprim
Viofuragyn Vsf-medical g 15
For regulatory information, see page 133

Product Name Gallopamil

C.A.S. number 1662-47-8
Trade and brand names
Benpredil Corapamil Methoxyverapamil
For regulatory information, see page 134

Product Name Gamelonic acid

C.A.S. number 2003-0-1001
Trade and brand names
Efamast Epogam
For regulatory information, see page 135

Product Name Gemfibrozil

C.A.S. number 25812-30-0
Trade and brand names
Gevilon Hipolixan Ipolipid
Lipur Lopid Tenorac
For regulatory information, see page 135

Product Name Ginkgo biloba

C.A.S. number 2002-0-1010
Trade and brand names
Tanakan
For regulatory information, see page 137

Product Name Glafenine

C.A.S. number 3820-67-5
Trade and brand names
Adalgur Disipan Espasmo-giliganan
Exidol Glafezon Glifadex
Glifan Glifanan Glifarelax
Osodent Privadol
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 355

Product Name Glafenine

C.A.S. number 3820-67-5
Trade and brand names
For regulatory information, see page 137

Product Name Glucosamine sulfate

C.A.S. number 3416-24-8
Trade and brand names
Adaxil Anartril Antatril
Arthryl Chitosamine Corti-anartril
Dona 200-s Dona compositum Donna 200
Pona Terramycin Terrastatom
Tetracyn Thiocondramine Viartril
For regulatory information, see page 138

Product Name Glutethimide

C.A.S. number 77-21-4
Trade and brand names
Alfimid C "5" Doriden
Doridene Doriden-sed Doridine
Dorimid Dorimide Elrodorm
Glimid Gludorm Noxyron
Rigenox Sarodormin Somid
Tardyl
For regulatory information, see page 139

Product Name Griseofulvin

C.A.S. number 126-07-8
Trade and brand names
Ansaid B-gf Cebutid
Delmofluvina Delmofulvina Flugolin
Flurofen Froben Fulcin
Fulcine Fulcine-125 Fulcine-s
Fulvicin Fulvicin p/g Fulvicin u/f
Fulvicina Fungivin Gefulvine
Greosin Grfulvin v Gricin
Grifulin Grifulvin Grifulvin v
Grisactin Grisaltin Grisefalin
Grisefulin Grisefulvin Griseo
Griseomed Griseostatin Grisol
Grisovin Grisovina Grisovina fp
Grisovine Grisovin-fp Grisowen
Gris-peg Grysio Lamoryl
Lamoryl-novum Lamoyl Likuden
Likuden m Microcidal Neo fulcin
Neo-filcin Norofluvin Ocufen
Polygris Sulvina
For regulatory information, see page 140
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 356

Product Name Halogenated hydroxyquinoline derivatives

C.A.S. number 148-24-3
Trade and brand names
Aci-jel Benzease Chinosol
Cp-cap Dermacid Dermoplast
Fennosan h 30 Heriat Hydroxybenoxopyridine
Medicone derma-hc Oxin Oxine
Oxykin Oxyquinoline-rhp Pedivol
Phenopyridine Preconsol Quinoderm
Quinoped Quinophenol Recta medicone-hc
Semori Serohinol Serorhinol
Superol Trimo-san Triva douch powder
Triva jel Tumex
For regulatory information, see page 142

Product Name Halogenated salicylanilides

C.A.S. number UN-KG-0034
Trade and brand names
Alamin Annul Bada
Hilomid Salinidol Temasept
For regulatory information, see page 143

Product Name Heptabarb

C.A.S. number 509-86-4
Trade and brand names
Heptadorm Medapan Medomin
Medomina Medomine
For regulatory information, see page 144

Product Name Herpes simplex vaccines

C.A.S. number UN-KG-0035
Trade and brand names
Deptavac hvt Herpevac Herpevax
Herpevax hvt Hexidol Marimune
Taf test Tracherine
For regulatory information, see page 144

Product Name Hexachlorophene

C.A.S. number 70-30-4
Trade and brand names
99 armour formula Acnestrol (broparestrol) Acnestrol 3
Aeroseb-hc Akne pyodron kur Aknefug
Aknelan Anacal Armohex
Asecool Aserbine cream Bilevon
Bilvon vet Bismodyne Cidal
Cinthol Clenisep Coopaphene
Cordocel-h Cotofilm Cresophene
Delta pimafucort Derivative Derl
Derma 10 Derma leaf Dermalex
Dermohex Dermolle Dexolan
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 357

Product Name Hexachlorophene

C.A.S. number 70-30-4
Trade and brand names
Dial toilet soap Distocid Dk 2
Dovaso Ecto pellicur Ectofum
Emlab Exofene E-z scrub
Fisohen Fisohexx Fitty derm
Flenaphthol G-11 Gamophen
Gamophen surgical soap Germibon Gill soap
Haemovin Hcp Heksaden
Hepadist Hexabalm Hexadespon
Hexal Hexaph Hexaphenyl
Hexaphenyl(1&b) Hexascrub Hexocreme
Hexosan Hex-o-san Jabon antiseptico
Kalacid Lf 530 Loftyzon
Mamex Mantacido Med liquide san t
Micogamma Nabac Nestosyl
P 47 Paradentol Permucal
Phaisohex Phasca Phiso scrub
Phisodan Phisohex Phisohex(winthrop)
Phiso-med Phisoscrub Phlebodine
Phorac Phosohex Predekzem
Pre-op Pretulon Proct anex
Prodermopur Sapo-chlor Sapoderm
Sebbafon Sebo-cds Sergi-cen
Skrub kreme Solu-heks Soy-dome
Steraskin Steridermis Steridermis washing cream
Ster-zac Ster-zac antibacterial shaving foam Ster-zac antibacterial soap
Ster-zac dc skin cleanser Ster-zac powder Sumasept
Super sat Surg salve Surge vet
Surgi-cen Surofene Tersaseptic
Toracsol Torbetol lotion Vanseb
Vetalderm Vulnusol spray Wesco hex
Wescohex Westasept Xerac
Zalpon Zalpon antibacterial washing cream
For regulatory information, see page 145

Product Name Hexestrol

C.A.S. number 5635-50-7
Trade and brand names
Dihydrodiethylstilbestrol Synoestrolum
For regulatory information, see page 145

Product Name Hexobarbital

C.A.S. number 56-29-1
Trade and brand names
Citodon Citopan Cyclonal
Cyclonal sodium Cyclopan Dorico
Dorico soluble Eviderm Evipal
Evipal sodium Evipan Evipanl
Hexanal Hexanastab Hexanastab oral
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 358

Product Name Hexobarbital

C.A.S. number 56-29-1
Trade and brand names
Hexatrol Hexenal Methexenyl sodium
Narcosan soluble Noctivane Noctivane sodium
Privenal Sleepwell Sodium narcosate
Sombucaps Sombulex Somnalert
Stodinox Tobinal Toleran
For regulatory information, see page 146

Product Name Hyaluronidase

C.A.S. number 9001-54-1
Trade and brand names
Diffusin Hylase
For regulatory information, see page 147

Product Name Hydroquinone

C.A.S. number 123-31-9A
Trade and brand names
Aida Ambi- skin tone Artra
Black and white Creme des 3 fleur d'orient Eldopaque
Eldopaque forte Eldoquin Eldoquin forte 4% cream
Epocler Esoterica Esoterica facial
Esoterica regular Esoterica sensitive skin Esoterica sunscreen
Melanex Melanex topical sollution Melpaque hp
Melqui hp Neostrata aha gel Neostrata hq
Nuquin hp Phiaquin Pigmanorm
Porcelana Sinquin Solaquin
Solaquin forte Solaquin forte sun bleaching Superfade age spot
Ultraquin Ultraquin plaine
For regulatory information, see page 147

Product Name Hyoscine methonitrate

C.A.S. number 6106-46-3
Trade and brand names
Mescomine Mesconit Skopolate
Skopyl Skopyle Viscope
For regulatory information, see page 148

Product Name Ibuprofen

C.A.S. number 15687-27-1
Trade and brand names
Abbifen Abuprohm Abu-tab
Aches-n-pain Acril Actifen
Actiprofen Actren Addaprin
Advil Advil 200 mg Advil cold & sinus
Agisan Aktren Aldospray
Algiasdin Algifor Algisan
Algofen Algofer Altior
Amersol Anadin ibuprofen Analgesico
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 359

Product Name Ibuprofen

C.A.S. number 15687-27-1
Trade and brand names
Analgil Analgyl Anco
Andran Anflagen Antalgil
Antiflam Antiruggen Apo-ibuprofen
Apsifen Arfen Artofen
Artren Artril Artrofen
Bayer select Bayer select ibuprofen pain reliever Benflogin
Betagesic Betaprofen Brofen 200 mg
Brofen 400 mg Brufanic Brufen
Brufert Brufort Buborone
Bufedon Bufigen Burana
Butylenin Cesra Children's advil
Children's motrin Coadvil Codafen
Codafen continus Contraneural Contrneural
Cope Cuisialigil Cunil
Cuprofen Danilon Dansida
Dentigoa Dentigoa forte Dignoflex
Dimetap sinus Dimidon Dismenodl n
Dolgirit Dolgit Dolocyl
Dolo-dolgit Dologesic Dolo-neos
Dolo-puren Doltibil Dolven
Donjust-b Dorival Dristan sinus
Duradyne Dura-ibu Duralbuprofen
Dysdolen Ebufac Ecoprofen
Ediluna Emodin Epobron
Esprenit Evasprin Excedrin ib
Exidol Exneural Femafen
Femapirin Femidol Fenalgic
Fenbid Fenlong Flubenil
Focus Genpril Guildprofen
Halprin Haltran Ibenon
Ibol Ibosure Ibruthalal
Ibu-attritin Ibucasen Ibu-cream
Ibufac Ibufen tablets Ibufen-l
Ibufug Ibugel Ibugesic
Ibuhexal Ibular Ibulav
Ibuleve Ibulgan Ibumetin
Ibuphlogont Ibupirac Ibuprin
Ibuprocin Ibuprofen 200 Ibuprohm
Ibu-slo Ibu-slow Ibusure
Ibu-tab Ibutad Ibutid
Ibutop Ibuvivimed Ibux
Imben Imbun Inabrin
Incefal Inflam Inoven
Inza Ipren Iproben
Irfen Isdol Isisfen
Junifen Kalma Kos
Lacondan Lamidon Leonal
Librofem Librofen Lidifen
Liptan Lisi-budol Medipren
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 360

Product Name Ibuprofen

C.A.S. number 15687-27-1
Trade and brand names
Mediprofen Melfen Menado ibuprofen usp
Midol Midol 200 advanced pain formula Midol ib
Migrafen Minadol Mobilat
Moment Motrin Motrin ib
Myprodol Narfen Neobrofen
Neobrufen Nerofen Niapren
Nobfelon Nobfen Novaprin
Novogent Novoprofen Nu-ibuprofen
Nuprin Nurofen Optalidon
Optifen Opturem Pacifene
Padudent Pamprin Pantrop
Parsal Paxofen Pediaprofen
Pfeil Phor pain Posodolor
Proflex Prontalgin Rafen
Rebugen Recudik Relcofen
Rheufen Rimafen Rofen
Roidenin Rufen Saleto
Saleto-600 Seclodin Sedaspray
Serviprofen Sine-aid ib Solufen
Spedifen Stadasan Superior pain medicine
Supreme pain medicine Supren Suspren
Tabalon Tempil Tendar
Todalgil Trauma-dolgit Ultraprin
Urem Valprin
For regulatory information, see page 148

Product Name Indalpine

C.A.S. number 63758-79-2
Trade and brand names
Lm 5008 Upstene
For regulatory information, see page 149

Product Name Indometacin and indometacin farnesil

C.A.S. number 53-86-1
Trade and brand names
Argan
For regulatory information, see page 149

Product Name Indoprofen

C.A.S. number 31842-01-0
Trade and brand names
Bor-ind Endyne Fenint
Flogosan Flosin Flosine
Flosint Flosyn Isindone
K 4277 Miantor Praxis
Reumofene
For regulatory information, see page 150
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 361

Product Name Iodinated casein strophanthin (neo-barine)

C.A.S. number UN-KG-0038
Trade and brand names
Coratose
For regulatory information, see page 150

Product Name Iproniazid

C.A.S. number 54-92-2
Trade and brand names
Euphozid Ipropran Isotamine
Laniazid Marsilid Nydrazid
P-1-n forte Pms isoniazid Rifamate
Rimactane Rimifon Ro 7-1554
Teebaconin Triniad Uniad
For regulatory information, see page 151

Product Name Isaxonine phosphate

C.A.S. number 4214-72-6
Trade and brand names
Nerfactor Verfactor
For regulatory information, see page 151

Product Name Isocarboxazid

C.A.S. number 59-63-2
Trade and brand names
Enerzer Marplan Marplon
Ro 5-0831/1
For regulatory information, see page 151

Product Name Isoprenaline

C.A.S. number 7683-59-2
Trade and brand names
Aerolone Aerotrol Afdosa
Aldo asma Aleudrin Aleudrina
Aludrin Anthastmin Asmadren
Asmalar Asmastop Atom-asma
Bellasthman Dey-dose Dispos-a-med
Duo-autohaler Duo-medihaler Dyspnoesan
Erydin Euspiran Frenal composium
Imuprel Ingelan Intal compositum
Iprenol Iso-autohaler Isomenyl
Isonorin Isoprel Isoprel-neomistometer
Isoprop Isorenin Isovon
Isuprel Katwilon n Lenoprel
Luf-iso Medihaler-duo Medihaler-iso
Meterdos-iso Neo epinine Nephenalin
Norisodrin aerotol Norisodrin with calcium idodide Norosodrine
Novodrin Older Orotenol
Prenomiser Propynalin Protenol
Saventrine Sedantosol Sooner
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 362

Product Name Isoprenaline

C.A.S. number 7683-59-2
Trade and brand names
Suscardia Vapo-iso Vapo-n-iso
For regulatory information, see page 152

Product Name Isotretinoin

C.A.S. number 4759-48-2
Trade and brand names
Accutane Accutane roche Apsor
Isotretinoin Neovamin a acid Neovitamin a acid
Ro 4-3780 Roaccutan Roaccutane
Roacutan
For regulatory information, see page 152

Product Name Isoxicam

C.A.S. number 34552-84-6
Trade and brand names
Floxicam Maxicam Pacy
Pacyl Vectren
For regulatory information, see page 154

Product Name Kaolin

C.A.S. number 1332-58-7
Trade and brand names
Biskapect Chloropect Collodyne
Diaguard forte Diastat Donnagel
Donnagel pg liquid Donnagel-mb Donnagel-pg
Enterosan Fissan Kaodinnon-narcotic
Kaolin w/pectin Kaomagma with pectin Kaomycin
Kaoneo Kaopectate Kaopectate n
Kaoprompt-h Kao-spen Kapetolin
Kc Kln Medipect
Noventerol Parepectolin Pectolin
Pectrolyte Peterpect Streptomagma
For regulatory information, see page 154

Product Name Kebuzone

C.A.S. number 853-34-9
Trade and brand names
Benjor Chebutan Chepirol
Chetazol Chetazolidin Chetil
Chetopir Chetosol Copirene
Ejor Gammachetone Hichillos
Kentan Kentan-s Kenta-s
Kenzon r Ketanol Ketazon
Ketazone Ketobutane-jade Ketofen
Neo-panalgyl Neufenil Neuphenyl
Pecnon Phloguron Recheton
Reuchetal Reumo Tkb
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 363

Product Name Kebuzone

C.A.S. number 853-34-9
Trade and brand names
Vintab Vintop
For regulatory information, see page 155

Product Name Ketoconazole

C.A.S. number 65277-42-1
Trade and brand names
Cerozalol Cetonax Fetonal
Fungarest Fungarol Fungo-hubber
Ketocidin Ketoderm Ketoisdin
Ketonan Ketoral Micoral
Micotek Micoticum Nizcrem
Nizoral Nizoral 2% shampoo Nizoral 20% cream
Nizovules Nizshampoo Oromycosal
Oronazol Panfungol Rofenid
Spike Unidox
For regulatory information, see page 156

Product Name Latamoxef

C.A.S. number 64952-97-2
Trade and brand names
Baxal Betalactam Festamoxin
Latoxacet Mactam Moxacef
Moxalactam Moxam Moxatres
Oxacef Priollat Sectam
Shiomalin Shiomarin
For regulatory information, see page 158

Product Name Lead oxide and lead salts

C.A.S. number UN-KG-0040
Trade and brand names
Hiroval Wndomethasone
For regulatory information, see page 159

Product Name Levacetylmethadol

C.A.S. number 34433-66-4
Trade and brand names
Levomethadylacetate Orlaam
For regulatory information, see page 159

Product Name Levamfetamine

C.A.S. number 156-34-3
Trade and brand names
Amphedrine-m Cydril
For regulatory information, see page 159
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 364

Product Name Levamisole hydrochloride

C.A.S. number 16595-80-5
Trade and brand names
Vermisol
For regulatory information, see page 160

Product Name Levarterenol

C.A.S. number 51-41-2
Trade and brand names
Adrenor Levophed Noradrec
Xylotox
For regulatory information, see page 160

Product Name Lindane

C.A.S. number 58-89-9A
Trade and brand names
Benhexachlor Gamex Gamma benzene
Hexachloride
For regulatory information, see page 161

Product Name Lipoic acid

C.A.S. number 1077-28-7
Trade and brand names
Liposan Thioactacid
For regulatory information, see page 162

Product Name Loperamide

C.A.S. number 53179-11-6
Trade and brand names
Amerol Ami-29 Arret
Blox Brek Colifelin
Colifilm Diareze Dissenten
Dissenter Duplibiot Elcoman
Firtasec Fortasec Imodium
Imosec Lopemid Lopemin
Loperam Loperan Loperin
Lopermid Loperyl Motilix
Orulop Pf 185 Pricilone
R-18553 Regulan Regulane
Seldiar Suprasec Taguinol
Tebloc Telboc Totrtasec
For regulatory information, see page 162

Product Name L-Tryptophan

C.A.S. number 73-22-3
Trade and brand names
Ardeytropin Kalma Optimax
Sedanoct Tryptan
For regulatory information, see page 164
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 365

Product Name Lynestrenol

C.A.S. number 52-76-6
Trade and brand names
Anacyclin Anacycline 101 Anacylin
Anacylin 101 Anacylin 28 Ancylin
Athilyn Endometril Exlutena
Exlution Exluton Exluton (a)
Exlutona Fisioquens Fysiognens
Fysionorm Fysioquens Gestrol
Lindiol 2.5 Lyn_ratiopharm Lyn_ratiophram_sequenz
Lyndeol Lyndile tt Lyndiol
Lyndiol e Lyndiol e. Lyndiolett
Lynoenstrenol Lyn-ratiopharm Minette
Mini pregnon Minifol Minilyn
Ministat Neo lyndiol Neo-lindiol
Neo-lynobol Nonovulet Noracyclin
Noracyclin 22 Noracycline Normophasic
Novostat Org 485-50 Orgaluton
Orgametil Orgametril Orgametrol
Ovamezzo Ovanon Ovanone
Ovanon-e Ovariostat Ovoresta
Ovoresta m Ovoresta micro Ovosta
Ovostat Ovostat-28 Ovostat-micro
Phasicon Physiostat Physistat
Pregnon Pregnon-28 Restovar
Yermonil
For regulatory information, see page 166

Product Name Mazindol

C.A.S. number 22232-71-9
Trade and brand names
Dasten Degonon Fagolipo
Lipese Magrilan Mazanor
Mazanor tablets Mazeldene Mazinil
Maznor Sanorex Tenorac
Terenac Teronac
For regulatory information, see page 166

Product Name Meclozine

C.A.S. number 569-65-3
Trade and brand names
Ancolan Ancoloxin Ancoloxine
Antivert Bonamina Bonamine
Bonine Calmonal Chiclida
Cobinamide Diadril Dradril
Duremesan Itinerol Mecazine
Navicalm Neo-istafenc Neo-istafene
Peremesin Postafen Postafene
Premesin Ravelon Rovert-m
Ru-vert-m Sabari Sea-leg
Supermesin Superminal Suprimal
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 366

Product Name Meclozine

C.A.S. number 569-65-3
Trade and brand names
Taizerl Ucb 5062 V-cline
Veritab Vertizine Vomaxine
Vomisseis
For regulatory information, see page 167

Product Name Megestrol acetate

C.A.S. number 3562-63-8
Trade and brand names
Citestrol Co-ervonum Combiquens
Femagest Kombiquens Megace
Megecat Megeron Megestat
Menoquens Neo-delpregnin Nia
Niaestine Niagestin Niagestine
Novaquin Novokvens Novolina
Novoquens Oracolnal Ovaban
Ovarid Pallace Serial 28
Volidan Volplan
For regulatory information, see page 168

Product Name Mephenesin

C.A.S. number 59-47-2
Trade and brand names
Atensin Avosyl Bioglan m/q
Cresoxydiol Curythan Daserd
Daserol Decontractyl Decontracyl
Decontracyl-baum Diloxol Dioloxol
Forte Geno-sal Glykresinum
Glyotol Glyptol Kencaps
Kinavosyl Lissephen Mefentil
Memphenesin Mepha-gesic Mepherol
Mephesin Mephesol Mephson
Midisalb-m Myanesin Myocalm
Myocuran Myolisysin Myoxane
Neo-xoline-m Nochyrol Noctynol
Oranixon Prolax Relaxar
Relaxil Relaxil-g Renarcol
Rhex Rhex "hobein" Rp 3602
Salimed compound Sansdolor Sinan
Spartoloxyn Spasmolyn Stilalgin
Thioxidil Tolansin Tolax
Tolcil Tolhart Tolosate
Toloxyn Tolseram Tolserol
Tolseron Tolsin Tolulexin
Tolulox Tolyspaz Walconesin
For regulatory information, see page 170
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 367

Product Name Meprobamate

C.A.S. number 57-53-4
Trade and brand names
3p bamte Amepromat Amosene
Anastress Anatimon Andaxin
Aneural Ansietan Ansiowas
Anzil Apascil Apo-meprobamate
Arcoban Artolon Atraxin
Ayeramate Bamo 400 Biobamat
Biobamate Calmax Calmiren
Canquil-400 Cap-o-tran Carb-a-med
Carbaxin Cirpon Cirponyl
Clindoorm Coprobate Crestanil
Cusitan Cyrpon Dapaz
Daritran Detensitral Dicandiol
Diron Dolovisano Dormabrol
Dormilfo n Dystoid Ecuanil
Edental Epikur Equanil
Equiner Equinil Equqtrqte
Fas-cile 200 Gadexyl Gene-bamate
Harmonin Hartol Holbamate
Idemin Indemin Irs 109 a
Iterco Juvamidon Kaologeais
Kesso-bamate Klort Lan-dol
Larten Lenicor Lepetown
Libiolan M.a.s. M.p. trantabs
Mar-bate Margaris Meditran
Mepantin Mepavlon Mep-e
Meposed Meprate Mepriam
Meprin Meprindon Mepro
Meprobadal Meprobamat Meproban
Meprobil Meprocompren Meprocon cmc
Meprodil Meprogesic q Meprol
Meprolin Mepron Mepronel
Mepronil Meprosa Mepro-secergan 400
Meproserpina Meprospan Meprospan 400
Meprotabs Meproten Meprotil
Meproyrin Meprozine Meptran
Meriprobate Mesmar Metranquil
Micrainin Microbamat Midixin
Milspan Miltaun Miltown
Miltown s-r Misedant Morbam
My-trans Neo-nervostal Neo-tran
Nervonus Neuramate Neuro
Neurocalm Novomato Novomepro
Nyktogen Oasil Oasil procalmadiol
Odsil 10 Panquil Paxin
Pensive Pentaneural Perequil
Pertranquil Placitate Pm 2
Pmb 4000 Prequil Probal
Probasan Probromato Procalmidol
Promate Protran Psico-retard
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 368

Product Name Meprobamate

C.A.S. number 57-53-4
Trade and brand names
Quaname Quanil Quietidon
Rastenil Regium Relaxin
Reostral Restenil Rilax
Robamate Seda baxacor Sedanyl
Sedavier Sedazil Selene
Selodorm Serenade Seril
Setran Shalvaton Sintown
Sk-bamate Sopanil Sowell
Spantran Spasmobamat Stensolo
Stopayne Tamate Tcm 200
Tcm 400 Trankilin Trankvilan
Tranlisant Tranmep Tranquil
Tranquilan Tranquilax Tranquiline
Trelmar Tri-reumo-campil Urbil
Urbilat Vasocalm Vio-bamate
Visano cor Vistabamate Wescomep
For regulatory information, see page 170

Product Name Mercuric derivatives (topical)

C.A.S. number UN-KG-0046
Trade and brand names
Mercuro clinico Mercurocol Neko
For regulatory information, see page 304

Product Name Mesna

C.A.S. number 19767-45-4
Trade and brand names
Ausobrone Mexnex Mistabron
Mistabron co Mistabronco Mistalon
Mucofluid Mucolene Uromitexan
Uronexitan
For regulatory information, see page 170

Product Name Metamfetamine

C.A.S. number 537-46-2
Trade and brand names
Amone Desoxyn Dexophrine
Dexoval Doxyfed Doxyn
Drinalfa Efroxine Euphrodinal
Gardstat Gerobit Geronyl
Lemobese Madrine Mediatric
Meloda Metamsustac Methampex
Methedrinal Methedrine Neodrine
Neodrine-triple Norodin Obedrin-la
Obelones Obe-slim Pervitin
Phedrisox Phelantin Philopon
Soxympamine Syndrox Tonedron
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 369

Product Name Metamfetamine

C.A.S. number 537-46-2
Trade and brand names
Uno
For regulatory information, see page 171

Product Name Metamizole sodium

C.A.S. number 68-89-3
Trade and brand names
Abalgine Acabel compositum Acefalgin
Acrobal Acrogesico Adolkin
Algia-nil Alginodia Alginodia compose.
Algisedal Algobuscopan Algocalmin
Algopriv Algopyrin Algopyriv
Alkozin Amiglan Aminocid
Amitralil Ampi tumisan Anadex
Analcedor Analgin Analginum
Analject Anarinyl Anchrina
Andolor Anespas cpto Angiter
Ankaljin An-t Apasmo
Arantil Arpf Arquidon
Artritex Ascorbalgine Ascortin
Aseptobron Atecilina Atn-020/2
Aureomicina Avafortan Ayoral
Baralgin Baralgine Bayer 1387
Bebealjin Bebigut Belatropin
Belflex/2 Beneurin Beserol
Bexopirona Biogamma2 Biotangin
Bipasmin compuesto Bonpyrin Bort
Bristacilia Britercina Bromalgin
Bromalgon Broncofenil Broncolysin
Bucarboxal Buscapina comp. Buscapina compuesto
Buscapina compuestum Buscol compositum Buscopan composto
Buscopan compostum Buscopina compostum Butalgine
Butylpan Byladoce Calgayan-c
Calmetron Camizol Causalon
Cessantyl Chini-med Cintaverin compuesto
Citalgan Clizim Clofexan
Codalgin Codasal injetavel Cofen
Colgenol Comaril 5000 Conmel
Corilin pediatric Cortempirol Cortitracin
Cronopen balsamico Deltricin Devalgin
Dexa butarin Di-bal-rone Dimethedon
Dinopirina Dioxadol Dipiron
Dipirona Dipirone Diprofarm
Dipyrivo Dipyrone Dispalgine
Divarin Divarmin Do-ba-rone
Dobetin Dolaren Dolatets
Dolazon Dolemicin Dolispan
Dolispasmo Dolo adamon Dolo baralgine
Dolo buscopan Dolo nerv Dolo neurobion
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 370

Product Name Metamizole sodium

C.A.S. number 68-89-3
Trade and brand names
Dolo neurobion forte Dolo pangavit Dolo raptalgin
Dolo spasuret Dolojudolor Dolo-neurobion
Dolopirina Doloscopin Dopiral
Dorflex merrell Dorlisin Doron
Dorscopena Dorsedin D-pron
Dumalgin Duralnordin Dya-tran
Edgartet Eespanal Enzipan combinado
Espasfher Espasmir Espasmo-cibalgina
Espasmoqual Espasmotex Espasmoviral
Espyre Farbinol Farmolisina
Feverall Fevonil Flogolisin
Formatrix G.r. ulix compuesto Genservet
Gentil Geralgine Gifaril
Glutisal Greplicina belsa H 116
H 117 H 118 Hagalgin
Hasain Indextron Influbene
Kb-502 Kefren Kesan
Keypyrone Killgrip Kipyrone
Kitax alpha Kitax n Konitan
Labymetacincpo Lactmicina Lagalgin
Lagalgine Lamprcsnum Lapalgine
Larq 731 Lasain Lavaciclina
Levapa Levismon Lisador
Lisalgil Magdor Magnalsa
Magnemidon Magnol Magnopyrol
Mapir Mecoten Megal
Melpen Menalgine Metapyrin
Methampyrone Metilon Mialgan
Minalgin Minalgine Minoval
Miocitalgan Nadalgine Naftalgin
Naltrium Napasone Naron
Nartate Natralgin Natric
Neo-melubrim Neo-melubrin Neo-melubrina
Neo-melubrine Neo-oxipen Neosal-n
Neosoldina Neuro-fortamin Nevralgin
Nevralgina Nisidina Nlo conicilina balsamica
Nobelgin Nolotil Nolotil composirum
Notermin Novacid Novalcina
Novaldin Novalgetol Novalgin
Novalgin quinine Novalgina Novalgine
Nova-lyseen Novamidazofen Novamidazophen
Novamideazophene Novamina Novaminophenazone
Novaminsulfon Novaminsulfon ratiopharm Novaminsulfone sodium
Novaminsulfonium Novaminsulfonum Novaminsulton
Novazolon dexametasona Noveltex Novemida
Novemina Novil Oftlamin
Optalgin Orphalginen Ortopirona
Oxiquiunazine Pabron gold Panalvon
Panax Patalgin Pentrodin
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 371

Product Name Metamizole sodium

C.A.S. number 68-89-3
Trade and brand names
Phanalgin Pharmalgine Porbiot
Pplan 2500 Probaphen Prodol
Prydonnal Pydirone Pyralgin
Pyralgine Pyretin Pyril
Pyrilgin Pyriligin Pyrisan
Pyrojec Quarelin Reflex rectal
Relexal compuesto Repriman Resquim
Rheuma-spalt Ridol Rumalisine
Rupalgin Santeprednisan a Sebon
Sedabel Sedarel Sedarene
Sedazepane Selpiran Sertalanalgesico
Severen Severin Sinalgex
Sintaverin Sinvirol Sistalgin
Spasdolsom Spaslar Spasmalgon
Spasmin Spasmium-comp. Spasmizol
Spasmodor Spasmopyralgin Spasmothil
Sufonovin Sulfonovin Sulpin
Sulpyrin Sulpyrine Supadol
Supergine Surpyrine Syntaverin
Tanper Tapal Tega-pyrone
Temp Tempil Tepal
Termonil Tetrabal-hosbon Tetraspasmil
Tiadexol Tiartan Toloxin andromaco
Trenteron Triartan Trinalgen
Tumisan globulina Ultragim Ultragin
Unagen Unalgen hc Vetalgin
Viperone Visceralgine forte
For regulatory information, see page 171

Product Name Methapyrilene

C.A.S. number 91-80-5
Trade and brand names
3p pane Brexin Conac
Dexapirilene Dormin Duohist
Duo-tussin Dylhista Histadyl
Histadyl ec Hitalones Isopap
Lallamin Lullamin M.p.
Methistaline Methril spansul M-p
Myci-spray Norane Paradormalene
Peral Placitabs Pyrathyn
Pyrinistab Pyrinistol Rejam
Rest-on Restryl Semikon
Tenalin Thenylene Thionylan
W83
For regulatory information, see page 175
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 372

Product Name Methaqualone

C.A.S. number 72-44-6
Trade and brand names
Aqual Babix-rectal Bon-sonnilal
Cateudyl Citexal Diudorm
Divinoctal Dormigoa Dormigoa-schlafmittel
Dormir Dormisedilal Dormogen
Dormutil Duromine m 40 Eatan
Fadormir Holodorm Hyminal
Hypocol Hyptor Hyptor base
Ipnofil Isonox Jurmun
Mandrax Maoa Melsed
Melsedin Melsedine base Melsomin
Mepalgic Mequal Mequelon
Mequin Metadorm Metakualon
Metakvalon Metaqualon Methadorm
Methaquaion Methaqualoneinone Methased
Methasedil Metodril Metodril 2
Metodril napa Metolquizolone Mollinox
Motolon Mozambin Mtq
Neuro a2 Nitro-tromacardin Nobadorm
Nobadorm compostium Nobedorm Noctilene
Noctulon Normi-nox Normorest
Noxybel Oblioser Omnyl
Optimil Optinoxan Orthonal
Ortonal Paldona Pallidan
Papatral Parest Parmilene
Paxidorm Pexaqualone Portaderm
Pro dorm Quaalude Qz 2
Rebuso Rectulon Revonal
Ric 272 Riporest Rm 526
Rorer 148 Rorer 714 Roulone
Rouqualone Rovonal Savedorm
Sedalone Sedanoct Sedatyl
Silternum Sindesvel Sleepinal
Somberol Somnafac Somnex
Somnibel Somnium Somnofac
Somnomed Somnosan Somnotropon
Sonal Sopor Soval
Sovelin Soverin Sovinal
Spasmopront Tiqualone Toquilone
Toraflon Toriador Torinal
Tr 495 Tualone Tuazole
Tuazolona Tuazolone Vitalone
For regulatory information, see page 176

Product Name Methiodal sodium

C.A.S. number 126-31-8
Trade and brand names
Abrodan Abrodil Conturex
Diagnorenol Kontrast Myelotrast
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 373

Product Name Methiodal sodium

C.A.S. number 126-31-8
Trade and brand names
Neo-sombraven Radiographol Segosin
Sergozin Skiodan sodium Urombal
For regulatory information, see page 177

Product Name Methylphenidate

C.A.S. number 113-45-1
Trade and brand names
4311 ciba Calocain Centedrin
Cetedrin Meridil Methidate
Ritalin Ritalin sr Ritaline
Rubifen
For regulatory information, see page 177

Product Name Methyprylon

C.A.S. number 125-64-4
Trade and brand names
Noludar Nolurate
For regulatory information, see page 178

Product Name Metofoline

C.A.S. number 2154-02-1
Trade and brand names
R 4-1778/1 Versidyne
For regulatory information, see page 179

Product Name Mianserin

C.A.S. number 24219-97-4
Trade and brand names
Athimil Athymil Bolvidon
Lantanon Lerivon Miansan
Norval Org gb 94 Tolvin
Tolvon
For regulatory information, see page 180

Product Name Mifepristone

C.A.S. number 84371-65-3
Trade and brand names
Mifegyne Ru-486
For regulatory information, see page 181

Product Name Miglustat

C.A.S. number 72599-27-0
Trade and brand names
Vevesca
For regulatory information, see page 181
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 374

Product Name Minocycline

C.A.S. number 10118-90-8
Trade and brand names
Klinomycin Lederderm Mino-50
Minocin Minomycin Mynocine
For regulatory information, see page 182

Product Name Misoprostol

C.A.S. number 59122-46-2
Trade and brand names
Cyprostol Oxaprost Prostalgin
For regulatory information, see page 182

Product Name Mofebutazone

C.A.S. number 2210-63-1
Trade and brand names
Arcobutine Arcomonol Buta lyseen
Butazone Chemiartrol Clinit
Diadin Fenartril Jovapyrin
Mobutazone Mobuzon Mofasal
Mofesal Monazan Monazone
Monbutina Monobutina Monobutyl
Monofen Monomil Monoprine
Monorheumetten Monozon Mozol
Reumatox Rheuma Rheuma-cur
Rheumaorctat Rivodol Sodepyrine b 1
For regulatory information, see page 182

Product Name Nabilone

C.A.S. number 51022-71-0
Trade and brand names
Cesamet
For regulatory information, see page 185

Product Name Nandrolone decanoate (injectable)

C.A.S. number 360-70-3
Trade and brand names
Abolon Activin Anabolin la 100
Anador Anadur Analone-50
Androlone d Androlone d 100 Androlone d 50
Decabolin Deca-durabol Deca-durabolin
Deca-durabolin decanoate Deca-hybolin Deca-noralone
Docabolin Durabol Durabolin
Fherbolico Fortabolin Hybolin-decanoate
Iebolan Kabolin Keratyl
Methybol Methybol-depot Nandrolone decanoate
Nordecon Retabolil Stenabolin
Sterobolin Turinabol-depot
For regulatory information, see page 186
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 375

Product Name Nandrolone phenylpropionate (injectable)

C.A.S. number 62-90-8
Trade and brand names
Activin Anabolicas Anabolicus
Anabolin depot Anabolin la-100 Anador
Anadur Androline Androlone
Androlone-d Anticatabolin Bexobolic
Deca-durabol Decadurabolin Deca-durabolin
Docabolin Durabolin Durabolin phenpropionate
Dynabalon Energital Fenobolin
Fherbolico Fts Hepa-obaton
Hybolin decabiate Hybolin improved Kabolin
Keratyl Kompleteron Menidrabol
Methybol-depot Nandrobolic Nandrolin
Neo-durabolic Nerobil Nerobolil
Nerobolin Neutrosteron Norabol
Noralone Norandrol Norandros
Noromon Norstenol Nortesto
Npp Ntpp Orgabolin
Phenobolin Sintabolin Stenabolin
Strabolene Superanabolon Superbolin
Suprabolin Turinabol
For regulatory information, see page 186

Product Name Nefazodone

C.A.S. number 2004-0-0008
Trade and brand names
Serzone
For regulatory information, see page 187

Product Name Neomycin sulfate

C.A.S. number 1405-10-3
Trade and brand names
Abilene Akentect Amcort
Amphocort Antibitulle Apokalin
Aurex Auriod Baneopol
Barriere-mycin Bastu-angin Bedermin 100
Benestermycin Bio hubber Biodry
Biofradin Biofur Biosol
Biosol-m Bio-vitastrept Bivacyn
Blastoestimulina Bykanula Bykomycin
Canaural Canoral Cebemyxine
Cefrocyn Cg 3224 Cicatrex
Cleniderm Conderm Conjuctilone
Cornemin Cortinen Damapo
Davimycin Degramycin Derbitan antibiotico
Dermicema Dermo sonerge Dermoface
Dermosan Dermovate-nn Derobion
Dexaamisolone-n Dexabiotan Dexacidin
Dexamist Dexavetaderm Diacin
Dia-ject Diarest Dicortineff
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 376

Product Name Neomycin sulfate

C.A.S. number 1405-10-3
Trade and brand names
Dienterol Dimicina Doreplaston/doser/f
Dorithicin Dulcicortine Duphacerate
Dv 201 Emcortina Emorex k berna
Enbacin Endomixin Enteromac
Enteropast Enterosintex Eustoporin
Extracort Febrizene Fissan
Fl 6321 n Flogocid Fluonid
Fml-neo-liquifilm Foille Forbesotic
Formula 888 Forte Forticillin
Fradyl Frakidex Frakitacine
Gastromycin Gregoderm Gustibon
H plus n Hagrosept Halicomb
Halog Heliomycort Hydrocortiderm
Hydro-neo oculos I-caps Idepa
Ido-op Intradermo caf Iodentero0neomicina
Itro Jenomycin Kaomycin
Kaopectate n Kortikiod mepha Lanbiotic
Larmicin Latodurin Linitut
Locorten Mammanopen Mastrinal
Medisec neo Medisec-cloxa Medri-biotic
Meimyd Menaderm antiacne Myacyne
Mycerin Mycidex Mycifradin
Myciguent Mycimist Mycipo
Mytrex Nasomixin Naso-neomicin
Nasydrin Nefluan Neimicina roger
Neo decaderm Neo-analsona Neoaristovet
Neobacimyx-h Neobicin Neobiotic
Neobrettin Neobristan Neo-cantil
Neocidin Neocillin Neoclox
Neocones Neodecasone Neo-delta-cortef
Neofluid Neo-hydro Neointestin
Neolate Neo-m Neomac
Neo-mantle Neo-mastitar Neomin
Neomix Neomycane Neo-myx
Neo-otosol-hc Neopec Neopenol
Neopt Neo-remusin Neostrep
Neosule Neosulf Nifuramicin
Nisocla Nisoclyn Nisodyn
Nivemycin Nodryl Nokamycin
Noperil Normoc Npa
Ophthlmycin Optiprime opthcoat Optison
Optisone Oribiotic Oterna
Oticair Oto vitna Otocortison
Oto-flunal Otomycin Oto-sinerbe
Panotile Paralen Parkeole
Parkesteron Pentalmicina Pervet
Phytacorcin Pivalone Polemycin
Polybactrin-g Polydexa Polygynax
Poly-pred Polyspecrin Porcijec
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 377

Product Name Neomycin sulfate

C.A.S. number 1405-10-3
Trade and brand names
Prednicidin Prevotec Propaderm-n
Pulveodil Pyocidin hc Quadrex
Renokab Rino Rino vitna
Rinofilax Rinojet Rovicine
Saleton Salvacolina nn Sanibiovit
Sanimix Sanistress Secantol
Septa Septomixine forte Silderm
Siquent neomycin Sofan Sorbitoxin
Spersapolymyxin dispersa Steros-anal S-thalmic
Stiedex Sulfix-6 Super masticort
Super mastitare Synalar polyvalent Syralbina
Tampovagan Tariston Telestyl
Tiframild Tobispray Topicon
Topitasico Tresaderm Tribiotic
Tri-bow Tricilone Tri-optics
Troc Trofodermin Tweenal
Ubrocelan Ucb 630 Uniriod
Uro-beniktol Uro-nebctin Varicella-rit
V-cortanmycetine Vetroyl Vetsovate
Vista-methasone n V-softa
For regulatory information, see page 187

Product Name Nevirapine

C.A.S. number 129618-40-2
Trade and brand names
Nevimune Viramune
For regulatory information, see page 188

Product Name Nialamide

C.A.S. number 51-12-7
Trade and brand names
Espril Nialamid Niamid
Niamidal Niamide Niaquital
Niaquitil Niazin Novazid
Nuredal Nyazin Psyco-retard
Surgexl
For regulatory information, see page 188

Product Name Nimesulide

C.A.S. number 51803-78-2
Trade and brand names
Nimulid
For regulatory information, see page 189

Product Name Nitrefazole

C.A.S. number 21721-92-6
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 378

Product Name Nitrefazole

C.A.S. number 21721-92-6
Trade and brand names
Altimol Emd 15700
For regulatory information, see page 190

Product Name Nitrofural

C.A.S. number 59-87-0
Trade and brand names
Acmor Acmor-s Acutol
Akutol Aldomycin Alfucin
Amifur Anginofur Auroid
Babrocid Beca furazona Bifuran
Burnazone Chemofuran Coxistat
Dermobion Dymazone Ectofural
Escofuran Escofuron Fluorobioptal
Fultrexin Fura Furacilinum
Furacin Furacinas Furacine
Furacinethin Furacinetten Furacin-sol
Furacin-streusol Furacoccid Furacocid
Furacol Furaderm Furaldon
Furalone Furan Furan-ofteno
Furaplast Furaseptin Fura-septin
Furaskin Fura-vet Furazin
Furazina Furazol w Furea
Furesan Furesol Furosem
Furotalgin Furovol Germax
Germex Ginejuvent I fomula
Ii formula Kamfomen Kindrog
Lifuzol Macmiror Mammex
Mammiject Mastidol Mastofuran
Muldacin Nefco Neovagon
Nfs Nfz 1 Nfz mix
Nifucin Nifuzon Nitocetin
Nitrocol plus Nitro-rea Nitrozone
Notaba Rivafurazon Sanifur
Scandantin Shield Sulfamyton-n
Taristop Tranoxa Tuocurine
Urafadyn Uroletten Vabrocid
Viropulver Yalrocin Yatrocin
Zoppin spray blu
For regulatory information, see page 190

Product Name Nitrofurantoin

C.A.S. number 67-20-9
Trade and brand names
Furan Nitrofan
For regulatory information, see page 191
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 379

Product Name Nitroxoline

C.A.S. number 4008-48-4
Trade and brand names
5-nitrok Dovenix Entercol
Enterocol Isinok Nibiol
Nicene Nikinol Nikopet
Noxibiol Noxine Trodax
Uritrol Urocoli Uro-coli
For regulatory information, see page 191

Product Name Nomifensine

C.A.S. number 24526-64-5
Trade and brand names
Alival Anametrin Caribium
Hoe 984 Hostalival Merital
Merival Musettamycin Neurolene
Nomival Psicronizer Psyton
For regulatory information, see page 192

Product Name Norethisterone enantate (injectable)

C.A.S. number 3836-23-5
Trade and brand names
Binovum Brevicon Brevinor
Conceplan Doryxas Gesta plan
Lg 335 Medicon Menonorm
Menophase Miconor Modicon
Neocon Nor 50 Noriday
Norigest Norimin Noristerat
Norlutate acetate Nor-q-d Norquentiel
Norquest fe Novulon Nur-isterate
Orlestrin Ortho-novum Ovcon-50
Ovismen Ovosiston Ovysmen
Primolut Tri-norinyl Utovlar
For regulatory information, see page 192

Product Name Noscapine

C.A.S. number 128-62-1
Trade and brand names
Bequitussin Bisolvon compositum Broncha-tulisan eucalyptol
Broncho-tulisan eucalyptol Brosolin-rectocap Capval
Codipect Codyl Codyl cum expectoras
Coscopin Coscotab Degoran
Dettuso Difimetus Difimetus compositum
Finipect Hederix Lyabex retard
Lyobex Narcotussin Nipaxan
Nipaxon Nitepax Nosaclin
Noscalin Noscapal Noscapect
Noscarex Noscatuss Reatos
Rectolmin bronquial Ribelfan Spasmofen
Stilco Teletux Tucotin
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 380

Product Name Noscapine

C.A.S. number 128-62-1
Trade and brand names
Tuscapin Tussamine plus Tussanil n
Tusscalman Tussicure Tussisedal
Tussoretard
For regulatory information, see page 193

Product Name Novobiocin

C.A.S. number 303-81-1
Trade and brand names
Albamycin
For regulatory information, see page 194

Product Name Opium in antitussive preparations

C.A.S. number 8008-60-4
Trade and brand names
Dia-quel Escopon Ka-thal-pec
Pantopon Pat
For regulatory information, see page 195

Product Name Oxyphenbutazone

C.A.S. number 129-20-4
Trade and brand names
Algi-tandril Anarreumol-b Artroflog
Artzone Butaflogin Butapirone
Butazonic Buteril Butilene
Californit Campozim Crovaril
Defolgin Difmedol Dolo-phlogase
Dolo-tandril Fibutrox Flanaril
Floghene Flogistin Flogitolo
Flogodin Flogoril Gp 40705
Iltazon Iltoxon Imbun
Inflamil Iridil Isobutil
Kymalzone Metabolite i Mindaril
Miyadril Mysite Neo-farmadol
Offitril Oflamin Optimal
Otone Oxalid Oxybutazone
Oxybutol Oxybuton Oxyperol
Oxyphenbutone Oxyphentamin Phlogase
Phlogistol Phlogont Phloguran
Pilabutina Piraflogin Rapostan
Realin Rheumapax Rumapax
Segudol Suganril Tanal
Tandacot Tandalgesic Tandearil
Tanderil Telidal Tendearil
Teneral Vefren Visubutina
For regulatory information, see page 197
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 381

Product Name Oxyphenisatine acetate

C.A.S. number 115-33-3
Trade and brand names
Acelax Acetalax Alophen pills
Ameiax Api-slender Artroflog
Artzone Belloform Biivectan
Bisflatan Boxogetten Brocatine
Buta pirone Butaflogin Buteril
Butilene Butofen Butolfen
Bydolax Californit Chlofel
Chur-lax Ciracen Cirotex
Cirotyl Contax Critex
Curolax Darmoletten Deililax
Dialose plus Diasatin Ditinil
Ditmedol Espotabs Eulaxin
Evac-u-gen Evac-u-lax Ex-lax
Ex-lax pills Febutolo Fenisan
Fibutrox Fim-a-mint Fin-a-mint gum
Fisiolax Flib 518 Flogistin
Flogitolo Flogodin Imbun
Inlax Ipebutona Iridil
Isaaxan Isacen Isaphen
Isaphenyn Isobutil Isocrin
Izaman La 96 Lavema
Laveman Laxan-vomoxin Laxaseptol
Laxem Laxnormal Laxocol
Laxocoleva Laxo-isatin Laxon
Laxos Laxyl Lisagal
Med-laxan Menabil complex Muxol
Naleran Neocervulax Neo-favmadol
Neo-soldana Nourilax Nurilaksi
Obstilax Otone Oxalid
Oxibutol Oxybutazone Phenlaxine
Phenolax Phlogase Phlogistol
Phlogont Piraflogin Poliflogil
Potsilo Promassolax Promassoletten
Prulet Prulet liquitab Prusol
Puragaceen Purgaceen Purgophen
Rapostan Regal Rheumapax
Rivolax Rumapax Sanapert
Schokilax Syndian Tandacote
Tandalgesic Tandearil Tanderil
Tanderil-alka Tete-lax Validil
Veripaque
For regulatory information, see page 199

Product Name Oxytocin

C.A.S. number 50-56-6
Trade and brand names
Oxytocin Pituitrin
For regulatory information, see page 201
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 382

Product Name Oxytocin

C.A.S. number 50-56-6
Trade and brand names

Product Name Paracetamol

C.A.S. number 103-90-2
Trade and brand names
Anacin Crocin Tylenol
For regulatory information, see page 201

Product Name Paromomycin

C.A.S. number 7542-37-2
Trade and brand names
Gabbroral Humagel Humatin
Sinosid
For regulatory information, see page 202

Product Name Pectin

C.A.S. number 9000-69-5
Trade and brand names
Adm Arhemapectin Astriharina s
Betaine digestive aid Bio hubber Bio hubber fuerte
Biskapect Chloropect Collodyne
Dexinca Diacalm Diaguard
Diaguard forte Diareze Diarrhosan d
Diastat Diban Diban diet complex 1500
Diet-trim Donnage Donnagel
Donnagel pg capsule Donnagel-mb Donnagel-pg
Enterolyte Estreptokectil Estreptonetrol
Estreptoral Estreptosirup Fiblet
H.e.c Humagel Kantrexil
Kaomagma Kaomagma with pectin Kaomycin
Kaoneo Kaopectate Kaopectate n
Kaopectin Kaoprompt-h Kao-spen
Kaostaten Kln Medipect
Neopec Norquinol Noventerol
Orahesive Parepectolin Pectigels
Pectolin Pectrolyte Peterpect
Pomana a Salvacolina nn Sorbitoxin
Streptomagma Varihesive
For regulatory information, see page 203

Product Name Pentazocine

C.A.S. number 359-83-1
Trade and brand names
Fortagesic Fortal Fortalgesic
Fortral Fortralin Fortwin
Liticon Pentafen Pentalgina
Sosegon Talacen Talwin
Talwin nx
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 383

Product Name Pentazocine

C.A.S. number 359-83-1
Trade and brand names
For regulatory information, see page 204

Product Name Pentobarbital

C.A.S. number 76-74-4
Trade and brand names
Aethaminalum Barbityral Barbopent
Burtylonel Butylone Cafergot p.b.
Calpental Carbrital Chloropent
Continal Di-barbs Dipental
Distonocalm Embutal Ergobel plus
Ethaminal Hypnol Hypnotal
Hyptonal Insom rapido Isoamytal
Isobarb Isom rapido Iturate
Mebubarbital Mintal Napental
Narcoren Nembudeine Nembutal
Neodorm Nicaphlogyl Novarectal
Nova-rectal Novopentobarb Novo-pentobarb
Or-trin Pacifan Palpent
Pembul Penbar Penbon
Pental Pentalgin Pentanca
Pentobarb Pentodorm Pentodormol
Pentogen Pentolos Penton
Pentone Petab Petonel
Praecicalm Prodormol Repocal
Rivadorm Schlafen Sedanox
Sombutol Somnopentyl Somnophyt
Somnotol Sonistan Sopental
S-spac Stopp-15 Wans
Wigraine-pb Yastyl
For regulatory information, see page 204

Product Name Phenacetin

C.A.S. number 62-44-2
Trade and brand names
292-comprimes 369, pulvules 3p bugesic
Acetylosal Achrocidin Acifein
Acromas Acropac Algocratine
Alumidyne Amypron Amypylo-n
Anapac Angifebrine Anodin
Antiflu des Anti-opt Apadine
Apc Apidin Apracur
Arcin Asa compound Asceine
Ascophen Ascthimindon Asfeen
Ban-o-pain Bexophene Bromo quinina
Bromo seltzer Buff-a-comp Butal compound
Butorinal Calmante muri Capacetyl
Capramin Caps dr knapp Capsula dr. knapp
Ceachin Cefinal Cequinyl fort
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 384

Product Name Phenacetin

C.A.S. number 62-44-2
Trade and brand names
Chloracet Citra-fort Citramol
Clistanol Codempiral Codopyrin
Codral Compralgyl Conta-schmerz
Contradouleur Coricidin Coricidin f
Coriforte Coryban-d Cotradol
Daprisal Darvocomp-n Darvon compound
Darvon compuesto 65 Darvon n compuesto Dasikon
Dasin Dasin ch Dbnf
Dentocaps Dolafort Dolene
Dolomo Dolostop Doloxene comp forte, capsules
Dolviron Doregrippin Doscafis
Doviron Drinacet Edrisal
Empiral Empirin compound Emprazil
Emprazil-c Epragen Estrifen
Femcaps Fenacetina Fenascor
Fenbutal Fenidina Fenina
Fiorinal Flexalgit Florital
Fonal Fortacyl Fridol
Friocellin Funapann Gelonida
Gesic Gewodin Gripanidan
Harbureta Helvagit Hemagene taylor
Hjorton's powder Hocophen Icn 65
Influenza tabs Isollyl Isomidon
Kafa Kalmin Kapron
Katagrip Lekasin Linarol
Malex Manasul Mardon
Melabon Migesic Mironal
Monacet Myolate Neopyrine
Nevral vit b1 b6 Norgesic Novacetol
Novosephalgin Olfano Omniadol
Pamprin Papnin Para-grip
Paramette Parametten Paratodol
Pargesic compound Pasadex Pedigel
Percobarb Percodan Pertonal
Phenacet Phenacetine powder Phenacetinum
Phenacitin Phenacon Phenaphen
Phenaphen plus Phenazetin Phenazetina
Phenedina Phenidin Phenin
Phenodyne Phenorial Polypyrine
Poxy Procomp-65 Prodigestan
Prodolor Progesic Protension
Pyraphen Pyrroxate Quadrochin
Quadronal Rectoral Refagan
Reformin Repro Respritin
Rhinazol Rilan Rinurel
Rinutan Robaxisal-ph Robaxisan-pm
Ron-drive Rumicine S antineuralgic
S fc Sacadol Sadaspir
Salgydal Sanalgin Sanalgine
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 385

Product Name Phenacetin

C.A.S. number 62-44-2
Trade and brand names
Saridon Sedalmerck Seranex
Sinedal Sinutab Sinutab ii
Sk 65 compound Sk 65 compound caps. Soma
Soma compound Soma compuesto Sonalgin
Spacin Spasmindon Spasmo-compralgyl
Stellacyl Super anahist Supralgin
Synalgos Synalogos-dc Th
Tacol Terracydin Tetrex-apc
Tetrracydin Thephorin a-c Tiiomapirina
Tomapiena Treupel Tripin
Triplex Uga-no Valcophen
Vandar-65 Vasogesic Veganine
Vicks action 500 Viden Wigraine
Xaril Zactirin compound-100
For regulatory information, see page 205

Product Name Phenazone

C.A.S. number 60-80-0
Trade and brand names
Aerol Analgesine Anodynin
Anodynine Antigestin Antipyrin
Apirelina Asthma dellipsoids Aurafair
Auralgan Auralgicin Auraltone
Azophen Azophene Bajumol
Breezeazy Calmasmin Cetussan
Codalgin Crema antisolar evanescente Doleron novum
Dolo-med-much Dol-stop Felsol
Fenazone Iap Kalopsis
Lanceotic Lavylgan Methozin
Mig-antos Migranin Natt-lunedon
Neo-felsol Orecil Otipyrin
Otosan-sulfan Otothricinol Palacaine
Parodyne Pasta antisola Phenazon
Phenicarbazide Phenylon Pomada heridas
Prednefrin Prefrin Prefrin liquifilm
Prefrin z Priatan Prophyllen
Pyrazophyl Remolmed Salicopil
Sanasthmyl Sedatin Sedatine
Sedaural Sedonan Shhe 21
Spalt Spalt n Tympagesic
Visublefarite
For regulatory information, see page 207

Product Name Phenazopyridine

C.A.S. number 94-78-0
Trade and brand names
Azo gantrisin Azodine Phenazo
Pyridiate Pyridium Pyronium
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 386

Product Name Phenazopyridine

C.A.S. number 94-78-0
Trade and brand names
Sedural
For regulatory information, see page 208

Product Name Phendimetrazine

C.A.S. number 634-03-7
Trade and brand names
Adipo ii Adipost Adphen
Amphasub Anorex Anoxine-t
Antapentan Arcotrol Bacarate
Bontril Di-ap-trol Dietrol
Dital Dyrexan-od Elphemet
Forte Fringanor Hourbese
Hyrex Hyrex-105 Limit
Melfiat Minus Neo-nilorex
Obe-del Obepar Obesan
Obesan-x Obex la Obex-la
Obezine Panrexin-m Phenazine
Plegine Plegline Prelu-2
Pt-1-5 Reducto Reton
S7 Sedafamen Sly-ll
Slyn-ll Sprx 105 Statobex
Statobex-d Stodex Symetra
Trimcaps Trimstat Trimtabs
Wehless Weighttrol X-trozine
For regulatory information, see page 208

Product Name Phenformin

C.A.S. number 114-86-3
Trade and brand names
Adibetin Antipond Azucaps
Beta-pebg Bi-uglucon ud87 Cronoformin
D bretard Daopar Db comb.
Db retard Dbi Db-retard
De be Debej Debeon
Debinyl Diabis Diaformin
Dibein Dibein retard Dibenide
Dibinyl Dibiraf Dibolin
Dibophen Dibotin Dibun
Diebin Diebin retard Diguabet
Dipar Dobeom Feguanide
Fenfoduron Fenformin Fenguanide
Fenormin Gluciferne Glucifrene
Glucopostin Glucopstin Glukopostin
Glyphen Insoral Kataglicina
Lentobetic Ls 6030 Meltrol
Nci-c01741 Normoglucina Oraleo
Pbi Pedg Phenformine
Phenformix Prontoformin Retard
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 387

Product Name Phenformin

C.A.S. number 114-86-3
Trade and brand names
Retardo Tolbrtaphen W 32
For regulatory information, see page 209

Product Name Phenicarbazide

C.A.S. number 103-03-7
Trade and brand names
Antipyretic dellepsoids d26
For regulatory information, see page 211

Product Name Phenmetrazine

C.A.S. number 134-49-6
Trade and brand names
A 66 Anorex Bromadryl
Emagrin Filon Gratsidin
Marsin Neo-zine Oxazimedrine
Phenmetrazine Prelazine Preludin
Probese-p Psychamine a 66
For regulatory information, see page 211

Product Name Phenobarbital

C.A.S. number 50-06-6
Trade and brand names
3p spas Aaciasthma Adocor
Adonal Agrypnal Allergasthmin
Alnagon Amylofene Anaspaz
Anti-spas Apb Aphenylbarbit
Asmo fedrilum Asthmatussin Austrominal
Bakersed Barbellen Barbenyl
Barberine Barbilletae Barbiphenyl
Barbipil Barbita Barbivis
Barcole Barophen Bay-ase
Bebtoyl Bediphen Belergamin
Bellademal s Belladenal Bellasectal
Bellastal Bellergal Bellergal s
Belllumal Bergofen Blu-phen
Bock-ase Bonexyl Broncosmin
C 147 Calminal Ce 10010
Ceepa Cemealonal Clemodril
Coffecodin Cor-asthmolyticum Cortasmyl
Corverum Dafodil Damoral
Digi-pulsnorma Dithene-r Dolo-eupaco
Donibin Donna-lix Donnaplex
Donnatal Dormiral Doscalun
Duneryl Duovent Eeskabarb span
Elibese Elmigrin Ensobarb
Ephedrobarbital-t Ephestmin Epidormb
Epilantin Epsylone Ergojuvan
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 388

Product Name Phenobarbital

C.A.S. number 50-06-6
Trade and brand names
Eskabarb Espafren Extrovent
Fasconal Fedrilum Fedrinal
Fenalgin Fenemal Fenilcal
Fenosed Fenosed bitabs Gardenal
Gardenale Gardepanyl Gastrop
Gentarol Giolate Glyanphen
Glyuferal Gourmase Gratusminal
Hasp Hyonol Hypnaletten
Hypnolone Hysteps Ila-med
Irs 109a Kenedes Koronar
Lagaspasm Lardet Legatin
Lepinal Lepinaletten Liquital
Lircapil Lixophen Lubergal
Lumcalcio Luminal Lunadon
Lysadestal Mazur-a Md 1020
Mediphen Meprobit Mepropon
Metrojen Mialgone Migrane-dolviran
Modirit Myocardon Neo-nervostat
Neurobarb Nilspasm Noptil
Nova-pheno Novodon Novospasmin
Nunol Oasil Oxabar
Oxoids Pavadel Peba
Pencardin Pen-nitate Pentran
Perphyllon Phen bar Phenaemal
Phen-bel Phenemal Phenobar
Phenobarbyl Phenogen Pheno-gesic
Phenonyl Phental Phentral cratecil
Phob Piraminal Plivalgin
Preminal Prenoxan Pribetal
Purphen Quad-sed Rau-fridetten
Resirol Respisane S 611-3
Salviton Sanepil Sapos
Scotatal Secophen-c Sedacoral
Seda-intestain Seda-ko Sedalgin
Sedapar Seda-tablinen Sedo corodil
Sedonal Sedophen Sedopsic
Sedragesic Sevenal Solofoton
Somonal Soniphen Spascol
Spasdel Spasmalones Spasmo-compragyl
Spasmogentarol Spasmotal Spasmo-van
Spasmoveragin Spastyl Spondyneuron
Stental extentabs Stollerine Supamidal
Susano Syntospon Tedralan
Teofedrin Teolaxin Thefedral
Theodrine Theotabs Tridezibarbitur
Triphenatol Tropax Valpin
Vanital Vantal Versomnal
Zirkonorm
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 389

Product Name Phenobarbital

C.A.S. number 50-06-6
Trade and brand names
For regulatory information, see page 211

Product Name Phenol

C.A.S. number 108-95-2
Trade and brand names
3p maid Agre-gola Anbesol
Apralan Benamine Benzenol
Carbolic acid Cepastat Chloraseptic
Chloraseptic dm Derma cas Ego psoryl
Egomycol Epivetol Fenicado
Hydroxybenzene Izal Izal germicide
Merastat Monophenol Pao sole
Paoscle Pernomol Phenylic acid
Poscle Pregine Protaphane hm insulin
Sarna Sedaural Ura
Vaopin
For regulatory information, see page 212

Product Name Phenolphthalein

C.A.S. number 77-09-8
Trade and brand names
Agaffin Agarol Agoral
Alophen Alophen pills Anodyne dellipsoids 4
Ap-la-day Bold laxine Bom-bon
Bon-bon Canisan Certolax
Chocolax D & m tablets Darmol
Dormol Doxidan Espotabs
Euchessina Euchessinia Evac-q-tabs
Evac-qwik tablets Evactil Evac-u-gen
Ex-lax Feen-a-mint Formosa camphor
Fractines vichy Fractine-vichy Fructines-vichy
Gum camphor Japan camphor Kalimalterin
Kest Kondremul with phenolphtalein Koprol
Laurel camphor Laxante yer Laxatabs
Laxatone Laxen busto Laxin
Laxogen Lilo Minilax
Modane Modane plus Mucinum
Musilaks Neoprunex Neopurghes
Novopuren Paradeines Peplax
Petrolaglar emulsion Petro-mul-phen Phenolax
Phillips laxcaps Prifunal Prulet
Prunetta Pugrante el aleman Purex
Purga Purganol Purganos-daguin
Purgant aleman Purgante Purgante orravan
Purgen Purgenum Purgestol
Purgoids Purgyl Purjen sahap
Sarolax Spulmako-lax Thalinol
Thalinol mrt Trilax Unisvelt
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 390

Product Name Phenolphthalein

C.A.S. number 77-09-8
Trade and brand names
Veracolate
For regulatory information, see page 213

Product Name Phenoxybenzamine

C.A.S. number 59-96-1
Trade and brand names
Dibenyline Dibenzyline Dibenzyran
For regulatory information, see page 214

Product Name Phentermine

C.A.S. number 122-09-8
Trade and brand names
Adipex Adipex nouveau Adipex-p
Aneroxina Bellapront Dapex
Duromin Ex-adipos Fastin
Inonamin Ionakraft Ionamin
Ionamine Levum Linyl
Lipopill Minobese Minobese forte
Mirapront Netto-longcaps Obestin 30
Oby-trim Omnibex Ona-mast
Panbesy Panshape Parmine
Phentermyl Pronidin Raucherstop 5 ht
Reducyl Regulin Span r/d
Teramine
For regulatory information, see page 214

Product Name Phenylbutazone

C.A.S. number 50-33-9
Trade and brand names
Algesin Algirreudin Algoverine
Alindor Alka butazolidin Alkabutazona
Alkabutazone Alka-phenylbutazone Alka-sterazolidin
Ambene Anarthral Antadol
Anuspiramin Apophenylbutazone Apo-phenylbutazone
Arteopan Arthirikin Artibrin
Artrisin Artrizin Artrodesmol extra
Artropan Azolid Benzone
Betazed Bizolin 20 Bizolin 700
Butacal Butacol Butacompren
Butacote Butadilat Butadin
Butadion Butadiona Butadyne
Butafenil Butagesic Butagros
Butakvertin Butalan Butalgin
Butalgina Butaluy Butaparin
Butaphen Buta-phen Butapirazol
Butarex Butartiril Butatril
Butazina Butazolidin Butazolidin alka
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 391

Product Name Phenylbutazone

C.A.S. number 50-33-9
Trade and brand names
Butazolidina Butazone Butial
Butidiona Butinol Butiwas
Buto beta Butone Butoroid
Butoroid cream Butoz Butrex
Buvetzone Buzon Carudol
Celestalgon Celestazone Chembutazone
Colfezone Corbuvit Dartranol
Debutazon Delta-butazolidin Delta-demoplas
Delta-myogit Delta-tomanol Deltawaukobuzon
Demoplas Dephimixn Dexa tomanol
Dexa-attritin Dexa-escopyrin Dexamed
Dexatrzona Dibuzon Digibutina
Diossidone Direstop Ditrone
Doctofril Dolosin dexa Dolpirina
Ecobutazone Ectobutazone Elmedal
Equi bute Equipalazone Eributazone
Escopyrin Ethibute Exraheudon
Exrheudon F 650 Fenibutasan
Fenibutina Fenibutol Fenotone
Flebosil Flexazone Glycyl
Hepabuzon Ia-but Inflazone
Intalbut Intrabutazone Intrabuzone
Intrazone Kadol Malgesic
Mammyl Megazone Mephabutazon
Mepha-butazone Mepropyrin Merizone
Mi 540 Nadozone Naupax
Neo-zoline Neuro-demoplas Neuro-elmedal
Neuzoline m Novobutazone Novophenyl
Oluprin Oppazoen Osadrinim
Panazone Parazolidin Parzolidon
Pasirheuman Pbz Penetradol
Phebuzin Phenbuff Phenbutazol
Phenbutazone Phenylarthrite Phenylbetazone
Phenylon plus Phenylone Phenyzone
Phlebolan Pirabutil Pirarreumol-b
Pirarreumol-p Praecirheumin Prebutex
Precirhemin Prednirheumin Proxyfezone
Proydynam Pyrbutal Ranocor
Rectofasa Reopin Reumasyl
Reumazin Reumilene Reumuzol
Reupolar Rheopyrin Rheosolon
Rheumanoln Rheumaphen Rheumycalm
Rhumalgan Robizone-v Salzone
Schemergen Servizolidin Shigrodin
Sigma-elmedal Sintobutina Spondyril
Stabilat Tetnor Tevocodyn
Therazone Tibutazone Ticinil
Ticinil calcio Ticinil calico Todalgil
Trabar Trabit Uzone
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 392

Product Name Phenylbutazone

C.A.S. number 50-33-9
Trade and brand names
Waukobuzon Wescozone Wofapyrin
Zolapelin Zolidinium
For regulatory information, see page 215

Product Name Phenylephrine

C.A.S. number 59-42-7
Trade and brand names
Fenox Forte Isopto frin
Minims Mydfrin Neo-synephrine
Nostril Prefrin Visadron
For regulatory information, see page 218

Product Name Phenylpropanolamine

C.A.S. number 14838-15-4
Trade and brand names
A.g.multix Acutrim Adistop-f
Amertuss Amplisiex Am-tuss liq
Anorexin Antiadipositum Apoephedrine
Aridose Arm Bifed-20
Biphetane Biphetap Blu-hist
Brocon cr Bromanate Bromepaph
Brometapp Bromophen Bronco-quintoxil
Cenadex Chlor-rest Cinturex
Cletanol Codimal Cofpac
Cold cap Coldecon Col-decon
Conex-grippe Contop Control
Coricidin f Corsym Coryztime
Cremacoat Dalca Day nurse
Decidex Decomine Demazine
Deprecstop Dexatrim Dimetane
Dimotane D-sinus Efed ii
Eficol Endal Endecon
Endex E-son Espornade spansule
E-tapp 3 Exyphen Factus
Fornagest Fugoa n Gardax
Ginsopan Headway Histabid
Histade Histatapp Hsp 540
Ilvin Ipercron Kol-tac
Kontexin Koryza Leder
Lipo-sinahist Lunerin Mardram
Minus-x Monatuss Monydrin
Mucolyt-expecto Mucorama Nd-hist
Nectatussin Neosoldana Nexaam
Nobese Norephedrine Nornatane
Obestat Ornacol Ornatos
Ornex Pabron nose Panacorn
Panadyl Parhist Partapp
Partuss Permatrim Phenapap
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 393

Product Name Phenylpropanolamine

C.A.S. number 14838-15-4
Trade and brand names
Pholcolix Pholcolix spansule Pneumidex
Polcimut Probocon Profenade
Propadrin Propadrine Propagest
Reduzin Rhindecon Rhinergal
Rhinervert Rhinicept Rhinidrin
Rhinocap Rinexin Rinomar
Rinotussal Rinurel Rinurel lictus
Rinurel tablets Rinutan Rotabromophen
Rupton Ru-tuss Rynatapp
Rynex Ryza-gesic Sacietyl
Scotuss Secron Sinac
Sinacin Sinubid Sinudan
Sinu-lets Sinus Sinutab cough l
Spandecon Srda Sto-caps
Sulfa-probocon Symptrol Syrtussar
Taviset Tepanil Tinaroc
Totolin Tricon Tri-congestic
Triogesic elixir Triominic Triotussic
Tritane Turbispan Tussilene-dm
V cold Veltane Veltap
Vernate Vistaminic Voxin-pg
W 58 W 66 X 112 antiadipo
Zerinol
For regulatory information, see page 218

Product Name Phthalylsulfathiazole

C.A.S. number 85-73-4
Trade and brand names
Afi-ftalyl Canidis-anti-diarr Carbidiar
Carbotalin Colicitina Coliclase
Crematalil Cremothalidine Diacolin
Direver Disenterol Ef-micin
Enteramida Enterocalme Entero-hermes
Entero-red Enterosteril Entero-sulfina
Entero-toxan Entexidina Esteraplidin mag
Eugeniteed Fitazil Ftalil-esteve
Ftalil-septol Ftalil-tiazol Ftalysept
Ilentazol Inrestibla strepto Intestiazol
Iodentero-neomicina Logical Massotalil
Neo-sulfazon Novosulfina Phtalazol
Phtazol Septiftalil Sulfacetil
Sulfathalidine Sulftalyl Syptan
Taleudron Talidine Talisulfazol
Taloudron Tamil Thalazole
Thalinil Thalistanin Thalistatyl
Thiazole Ultratiazol Vetoryl
For regulatory information, see page 220
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 394

Product Name Pipamazine

C.A.S. number 84-04-8
Trade and brand names
Mornidine Nausidol Normetine
For regulatory information, see page 221

Product Name Pipenzolate

C.A.S. number 13473-38-6
Trade and brand names
Dropenzil Pedroacal Pipenzolate mb san
Piper Piptal Piptal pediatrico
Piptal pediatrique Piptalin
For regulatory information, see page 221

Product Name Piperazine

C.A.S. number 110-85-0
Trade and brand names
Adelmintex Adipalis Adipalit
Adiprazine Adiver Ancaris thenium
Ancazine Antelmina Antepar
Antepar (b-w) Anterobius Anthalazine
Anthelmina Anticucs Antiren
Antivermine Antoban Arduvermin
Arpezine Ascalix Ascarinex
Ascarivet Asca-trol no.3 Asepar
Askaripar Averamexan Bel-zine
Bioxurin B-piperazine Brirel
Bryrel Candizine Carudol
Ciperazin Citrazine Coopane
Dak Demovermil Diatesurico
Dicevermin Dietelmin Digesan
Dilaurazine Dispermin Diurazina
Divermex Dowzene Dyrex
Ecosan Endorid Entacyl
Entazin Equizole-a Eraverm
Escovermin Esteropipate Etaphylline (acetyllinate)
Exelmin Exopin Gentiazina
Glycopiparsol Heksapar Helmacid
Helmezin Helmicide Helmifren
Helmipar Helmirazine (adipate) Helmirazine (citrate)
Helmitin Helmizin Herb royal round worm treatment
Hexanthelin Ismiverm Janes liquid permifu
Jarabe neox Jetsan supp. (adipate) Justalmin
Kennel-maid Kihomato Kontipar
Lamboxil Lom Lombricida tropico
Lombrifher Lombrikal Lombrimade
Lumbrical Mapiprin Maskito
Multifuge Multifuj Mydriaticum
Nea-vermiol Nemadital Nemafugan
Nemasin Nematocton Nematorazine
Neo-ifusa Neox Nometan
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 395

Product Name Piperazine

C.A.S. number 110-85-0
Trade and brand names
Noxiurotan Ogen Okuside
Optiverm Oxiril syrup (hydrate) Oxiuran (hydrate)
Oxiurasin Oxiustip Oxiustip elix
Oxivermin Oxizin Oxucid
Oxurasin Oxuril Oxypaat
Oxypip Oxyzin P.c. (citrate)
Padrax Paravermin Parazine
Pariamate Parid Par-tega
Perin Piaverm Piavermit
Pincet Pincide Pinozan
Pinrou Pinsirup Pin-tega
Pipadox Pipan Pip-a-ray
Pipenin Piperacid Piperamicin
Piperascat Piperaskat Piperasol
Piperate Piperaverm Piperazate
Piperazinal Piperazine (adipate) Pipercrean
Piperex Piperiod Piperital od
Piperitol Piper-jodina Piperol fort
Piperone Piperoverm Pipertox
Piperver Piperzinal Pipeverm
Pipezol Pipizan Pipizan citrate
Pipracid Piprazid Piprazyl
Pipricide Piptelate Piverma
Polo-verm Polyquil Pripsen
Provtovermil Pulvex Razinol
Rhomex Rondelim Rondoxyl
Safersan Santoban Siropar
Supraverm Taenifigin Tasnon
Ta-verm Teniver Thelmin
Thenatol Tivazine Toxocan
Uricida Uridina Uroclear (hexamine)
Urodan (phosphate) Urosolvina Uvilon syrup (hydrate)
Vanpar (hydrate) Veripar Vermago
Vermazine Vermenter Vermicompren
Vermidol Vermifug Vermilass
Vermipan Vermiphsarmette Vermiquimpe
Vermiquimyc Vermisit Vermisol
Vermitox Vermofrik Verocid
Veroxil Wairmex Worm-away
Wurmex Wurmirazin Wurmsirup siegfried
For regulatory information, see page 221

Product Name Pipradrol

C.A.S. number 467-80-7
Trade and brand names
Alertonic Detaril Gerodryl
Leptidrol Meratonic Meratran
Metadin Peratran Piridrol
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 396

Product Name Pipradrol

C.A.S. number 467-80-7
Trade and brand names
Stimolag fortis
For regulatory information, see page 222

Product Name Pituitary-chorionic gonadotropin (injectable)

C.A.S. number UN-KG-0058
Trade and brand names
A.p.l. Antuitrin Choragon
Choriantin Choritropin Chorulon
Dap-test Ekluton Endocorion
Entromone Ferti-cept Follutein
Fractolon Gonabion Gonadex
Gonadoplex Gonafollin Gonagestrol
Gonault Gravimun Grom hgh
Hcg Hcg standard tablets Lh 5000
Luteovet Neogonadil Nymfalon
Praelutin forate Pregnesin Profasi hp
Puberogen Riogon Sensi-t
Suigonan
For regulatory information, see page 223

Product Name Podophyllum resin

C.A.S. number UN-KG-0059
Trade and brand names
Biliboldo Bon korets Condilomin
Condyline Dermacytostat Podofilm
Salicylin-p Vericap Wartec
Warticon Wartkil Wart-off
For regulatory information, see page 224

Product Name Polyoxyethylated castor oil

C.A.S. number UN-87-0006
Trade and brand names
Cremophor rh40 Cremophor rh60
For regulatory information, see page 225

Product Name Polyvidone

C.A.S. number 9003-39-8
Trade and brand names
Acu-dyne Adapettes Adsorbobase
Adsovbotear Agent at 717 Albigen a
Aldacol q Amiorel eritro Amyderm s
Anbesol Andrestrac 2-10 Anexa
At 717 B 7509 Betadine
Betaisod Bolinan Bridine
Clinidine Crospovidone Disphex
Efo-dine Final step Frepp
Frepp/sepp Ganex p 804 Ga-pvp-101
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 397

Product Name Polyvidone

C.A.S. number 9003-39-8
Trade and brand names
Gyno-bidex Hemodesis Hemodez
Iodopiron Isodine Isoline
Isoplasma Jodoplex K 115
K 15 K 25 K 30
K 60 K 90 Kollidon
Kollidon 12pf Kollidon 17 Kollidon 25
Kollidon 30 Kollidon 90 Kollidon ce 50/50
Kollidon k 25 Kollidon k 30 Luviskol
Luviskol k 17 Luviskol k 25 Luviskol k 30
Luviskol k 90 Luvisteol Medicort
Molycu Mundidon Neojodin
Oftan flurekain Peragal st Periston
Periston-n Periston-n-toxobin Pevidine
Peviston Plasdone Plasmadone
Plasmoid Plasmosan Plassint
Podiodine Polyclar at Polyclar h
Polyclar l Poly-karaya Polyplasdone xl
Polyvidone-escupient Polyvidonum Polyvinyl pyrrolidone
Povadyne Povidone k 29-32 Protagent
Proviodine Pvp 40 Pvp 50
Pvp0 Pvp-k 15 Pvp-k 25
Pvp-k 3 Pvp-k 30 Pvp-k 60
Pvp-k 90 Pvp-macrose Pvp-macrox
Pvpp Rocmuth Sd 13
Sepp Soft-care Subtosan
Tears plus Traumasept Ultradine
Venostasin retard Vetedine Vini
Vinisil Yodiplexin
For regulatory information, see page 225

Product Name Potassium canrenoate

C.A.S. number 2181-04-6
Trade and brand names
Aldactone Aldactone-diurapid Aldadiene potassium
Kadiur Kanrenol Lasiren
Luvion Osiren Osirenol
Osyrol Osyrol-lasix Phanurane
Sincomen Sincomen pro injectione Soldactone
Soludactone Speroctan-m Spiroctan
Venactone
For regulatory information, see page 226

Product Name Potassium chloride

C.A.S. number 7447-40-7
Trade and brand names
Apo-k Celeka Chlorvescent
Diffu-k Durules-k Kadalex
Kalinorm Kalipor Kalitabs
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 398

Product Name Potassium chloride

C.A.S. number 7447-40-7
Trade and brand names
Kalium durules Kaon-cl Kato
Kay-cee-l K-contin K-dur
K-lease K-long K-lor
Klor-con Klorvess Klotrix
K-lyte/cl K-norm K-tab
Lento-kalium Leo k Miopotasio
Nu-k Plenish-k Potasion
Rekawan Roychlor Rum-k
Slow-k Span-k Swiss-kal sr
Ten-k Ultra-k-chlor
For regulatory information, see page 226

Product Name Potassium nitrate

C.A.S. number 7757-79-1
Trade and brand names
Cholal modifico Cholal simple Collo-bo
Dewitt's pills for backache and joint pain Viridite Viridite k
For regulatory information, see page 227

Product Name Practolol

C.A.S. number 6673-35-4
Trade and brand names
A 25 Cardiol Cordialina
Dalzic Eraldin Eraldina
Praktol Pralon Teranol
For regulatory information, see page 227

Product Name Prasterone

C.A.S. number 53-43-0
Trade and brand names
17-chetovis 17-hormoforin Astenile
Cetavister Climatost Dastonil
Deandros Dha-s (prasterone) Diandron
Diandrone Gynodian Longevital 5000
Maxepa Mentalormon Mylis
Neurocotex Psicosterone Ro 66827
Sh 833 Ultrapla
For regulatory information, see page 228

Product Name Progabide

C.A.S. number 62666-20-0
Trade and brand names
Gabaphore Gabren Gabrene
Halogabide Sl 76 002
For regulatory information, see page 229
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 399

Product Name Propafenone

C.A.S. number 54063-53-5
Trade and brand names
Arythmol Nofenan Nofenon
Nomorytmin Normotrytmin Normotrytmin (r) 10 mg
Prolekofen Retmonorm Ryhmonorma
Rythmole Rytmonorm
For regulatory information, see page 230

Product Name Propofol

C.A.S. number 2078-54-8
Trade and brand names
Diprivan Disoprivan Disprofol
Rapinovet
For regulatory information, see page 231

Product Name Propylhexedrine

C.A.S. number 3595-11-7
Trade and brand names
Benzedrex Chp-depot Cyclexedrine
Dristan Eggobesin Eventin
For regulatory information, see page 231

Product Name Propyphenazone

C.A.S. number 479-92-5
Trade and brand names
539 grippe-dragees Amipylo-n Azur
Balpiren Baukal Budirol
Caffalgina Camoplex Cantacin
Causyth Cerebrol Cibalgina
Commotional Daturmed Degripol
Dentocaps a Dim-antos Dolibral
Dolibrax Dolo-mineuron Dysmalgin
Ejcopyrin Epizon Escomen
Estesina Eufibron Europan
Fd 8 Febral Finigripp
Grippocaps Heaven Infantex
Influvit Isopronazon Kavapyret
Kuronde Larodon Lysadestat
Mamaslu Milneuron Myo-europan
Neuramin Neuridal Neuro-spondryl
Nodiras Noric Otobacid
Pfeil Reomin Retamex
Rheumanol Rhinivict Sanalgin-p
Saridon neu Saridone Sedospin
Servalgin Sonotryl Spalt
Spongamed Stona Synpyrin
Vivcet Wauco-sin Wecontrin
For regulatory information, see page 232
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 400

Product Name Pyritinol

C.A.S. number 1098-97-1
Trade and brand names
Biocefalin Biontabol Bonifen
Bonifwn Bonol Cefalogen
Cerebrotrofina Cervitalin Danaden
Divalvon-d Enbol Encefabol
Encefort Encephabol Encerbrovit
Encerebron Enerbol Epocan
Fulneurina Geribolina Gerontabol comp.
Juniormen Leonar Life
Logos Maind Musa
Neuroxin Piriditol Piririomin
Piritinol Piritiomin Plenumil
Sawaxin Scintidin Tibased
Tomevit Tonobrein Tonomentis
For regulatory information, see page 234

Product Name Retinol

C.A.S. number 68-26-8
Trade and brand names
Avibon
For regulatory information, see page 236

Product Name Santonin

C.A.S. number 481-06-1
Trade and brand names
Semenen
For regulatory information, see page 237

Product Name Scopolamine

C.A.S. number 51-34-3
Trade and brand names
Diban Donnagel Donnagel-pg
Donnatal Phenacon Ru-tuss
Scopoderm tts Spasmofen Susano
Transcop Tropax
For regulatory information, see page 238

Product Name Secobabital

C.A.S. number 76-73-3
Trade and brand names
Immenoctal Seconal Seconal sodium
Tuinal
For regulatory information, see page 238

Product Name Sildenafil

C.A.S. number 139755-83-2
Trade and brand names
Segurex Viagra
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 401

Product Name Sildenafil

C.A.S. number 139755-83-2
Trade and brand names
For regulatory information, see page 240

Product Name Silver acetate

C.A.S. number 563-63-3
Trade and brand names
Smokerette Tabmint
For regulatory information, see page 240

Product Name Sodium dibunate

C.A.S. number 14992-59-2
Trade and brand names
Antussan Balmini Becantal
Becantex Bechisan Bexedyl dibunaat
Bexedyl dibunaat expectasans Cito-guakalin Expect-blacken-pastillen n
Makatussin Pastillas koki Sedobex
Super koki
For regulatory information, see page 241

Product Name Somatropin (pituitary-derived)

C.A.S. number 12629-01-5
Trade and brand names
22krl Antuitrin growth Antuitrin-t
Asellacrin Cb 311 Corpormon
Crescormon Grorm Hgh
Human groth hormone Human growth hormon Humatrope
Leutrophin Nanormin Nanormon
Phynatol Phyol Phyoneon
Protopin Protropin Rx 099916
Somacton Somatonorm Somatormone
Somatotrope choay Somatrofin Somatropin
Sth
For regulatory information, see page 241

Product Name Spironolactone

C.A.S. number 52-01-7
Trade and brand names
Acelat Airolactone Aldace
Aldactazide Aldactide Aldactide 25
Aldactone Aldactone-a Aldazida
Aldonorm Aldopur Aldospirone
Aldozone Alexan Almatol
Alpamed Altex Altexide
Aporasnon Aquareduct Carditan
Crk 635 Ct-spiro Deverol
Diatensec Digi-aldopur Dilakton
Dira Duraspiron Euteberol
Hexalacton Hokulaton Hokuraton
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 402

Product Name Spironolactone

C.A.S. number 52-01-7
Trade and brand names
Hydrospiron Idrolatton Idrolattone
Lacalmin Lacdene Lacilactone
Laractone Laralmin Lasilacton
Lasitone Loractone Mf 218d
Nefurofan Noidouble Novospiroton
Novospirozine Novosprioton Novospriozine
Osiren Osyrol Penantin
Pirolacton Pirolcaton Plarenil
Practon Practon 50 Raudazida
Risicordin Rolactone Rolactone microfine
Sagisal Sali-spiroctan Saluretin
Sas 1060 Sc 9420 Servilactone
Sincomen Spiractin Spiresis
Spiretic Spiridazide Spiridon
Spirix Spiro Spiro comp
Spiro50-d Spiroctan Spirodigital
Spiro-f Spirolang Spiron
Spironazide Spironomocompren Spironone
Spironothiazide Spiropal Spiroprop
Spirostada Spiro-tablinen Spirotone
Suprapuren Supra-puren Suracton
Synureticum Tensin Tensoflex
Uractone Urosonine Urusonin
Verospiron Verospirone Xenalone
Xeualon
For regulatory information, see page 243

Product Name Streptomycin

C.A.S. number 57-92-1
Trade and brand names
Antidiarrhoicum Bio hubber Bio hubber fuerte
Bio hubbersimple Cidan est Darostrep
Derbitan antibiotico Diastat Direver
Estrepromade Estrepromicina Estrepto e
Estrepto level Estrepto ph Estrepto wolner
Estreptomicina normon Gamafin Injectin
Neodistreptotab Neodualtrepto Novostrep
Novo-strep Servistrep Solustrep
Solvo-strep-s Solvo-strept-s Strep-diva
Strepolin Streptan Streptaquaine
Streptocal Strepto-fatal Streptomycin
Streptosol 25 Streptothenat Stretobretin
Strycin Sul-mycin ii
For regulatory information, see page 244

Product Name Sulfadicramide

C.A.S. number 115-68-4
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 403

Product Name Sulfadicramide

C.A.S. number 115-68-4
Trade and brand names
Ingamid Ingamid ophtal Irgamid
For regulatory information, see page 245

Product Name Sulfadimidine

C.A.S. number 57-68-1
Trade and brand names
Crermomethazine Deladine Dimezathine
Dimidin Hava-span Intradin
Neotrizine Rigesol Rivodin
S-dimidine Spanbolet Sulka-s
Sulphamezathine Sulphfmezatine Superseptyl
Sustain iii Tersulpha Trisulfaminic
Trisulfaminie
For regulatory information, see page 246

Product Name Sulfaguanidine

C.A.S. number 57-67-0
Trade and brand names
Aseptil-guanidina Aterian Coliseptale
Devaguanil Diacta Dirkan
Emerin Ente-rivo simplex Ganidan
Granidan Guamide Guanicil
Guanidan Guanimycin Guanowept
Guasept Inorgan Intestovet
Ordenol Orgaguanidon Resulfon
Ruocil Sgd S-guanidan
S-guanidine Shigatox Suganyl
Sulfacarbon Sulfentidine Sulfogua
Sulgin Tetrawest Trisulvet
For regulatory information, see page 246

Product Name Sulfamerazine sodium

C.A.S. number 127-58-2
Trade and brand names
Bio hubber simple Cremo-merazine Debnal m
Mebacid Neotrizine Peccocode
Septosil Spanbolet ii Tersulpha
Trisulfaminic Trisulpha
For regulatory information, see page 248

Product Name Sulfamethizole

C.A.S. number 144-82-1
Trade and brand names
3p methazol Amer-azo Ayerlucil
Azocline Azotrex Dorsec
Famet Lu Lucatyl
Lucosil Methazol Methisul
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 404

Product Name Sulfamethizole

C.A.S. number 144-82-1
Trade and brand names
Microsul Micturol ampicilina seda Nicene
Orozl Procijec Proklar-m
Renasul Rp 2145 Rufol
Salimol S-methizole Spasmo-harnosal
Starisil Suladyne Sulfa gram
Sulfametin Sulfapyelon Sulfstat
Sulfurine Tetracid Thidicur
Thiosulfil Thiosulfil a Tiosulfan
Ultrasul Uratrac Urobiotic
Urocydal Urodiaton Urolex
Urolucosil Uroluxcosil Uro-nebactin
Uropeutic Urotrex Uroz
Utrasul Vk 53
For regulatory information, see page 248

Product Name Sulfamethoxypyridazine

C.A.S. number 80-35-3
Trade and brand names
Amidin Aseptilex Asey-sulfa
Bimalong Biocorn Bio-cron
Bio-pectodil Davosin Davosin suspension
Deltavagin Depovernil Desulfon
Durasul Durasul jarabe Durox
Elix Ensulfa Eusulfa
Exazol Exazole Farinffnicol
Fercasulf Hesse-sulfon Ketiak
Kiron Kynex Kynex acetyl
Lederkyn Lentac Lentosulfa
Linder Logisul jarabe Longamid
Longisul Metamit Metazina
Metuzina Microcid Midicel
Midikel Minikel Myasul
Mylosul Novosulfin Opinsul
Paramid supra Petrisul Pirasulfon
Quinoseptyl Ralenta Retasulfin
Rotardon S.d.m. Septotryl
Smop Spofadazine Sulamin
Sulfa spirig Sulfabon Sulfadazina
Sulfadepot Sulfadin Sulfadurazin
Sulfaintensa Sulfakeyn Sulfalex
Sulfametopyridazin Sulfamizina Sulfamyd
Sulfapyrazin Sulfatar Sulfdurazin
Sulfocidan Sulfonamid Sulforetent
Sulfo-rit Sultirene Unisulfa
Unisulfa dulcis Uroplex Valetan
Velaten Vinces Volocid
Vtg 44
For regulatory information, see page 248
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 405

Product Name Sulfamethoxypyridazine

C.A.S. number 80-35-3
Trade and brand names

Product Name Sulfanilamide

C.A.S. number 63-74-1
Trade and brand names
Acetonal vaginal Amidrin Astreptine
Avc Avc cream suppositoty Avc/dienestrol
Avril Azol Azol polvo
Azol pomada Buco pental Buco regis
Chemiovis Daromid Defonamid
Dorsec Exoseptoplix Expseptoplix
Faderma Fricton Gagaril sulfamida
Gynaedron Instilin Jacosulfon
Medeyol Mentol sedans sulfamidad Nasopomada
Odamida Oestro-gyneadron Otocaina
Otonasal Otorrilan Ovuthricinol
Oxidermiol Paraseptol Pental
Pental forte Pentalmicina Polvo sulfamida leti
Polvo sulfamida orrvan Polvos wilfe Pomada heridas
Pomada wilfe Prontablin Pulvi bacteramide
Pyodental Pyodron Quimpeamida
Rhinamide Rino glucol sulf Septoplix
Streptamin Sulfacromo Sulfonamid spuman
Sulfonamide-spuman-style Sulfonanilamid Sulfosellan-salbe
Ung. vemleigh Vagitrol
For regulatory information, see page 249

Product Name Sulfathiazole

C.A.S. number 72-14-0
Trade and brand names
Argazol Azoseptale Bucosol
Chemiovis Chemosept Cibazol
Coryza Crionil Csp 500
Csp-250 Edifeno Eleudron
Femakzem Flumamine Formotablin antidiarreico
Gyne-sulf Gyn-sulf Ingalipt
Neosutrin Polvos wilfe Pomada wilfe
Prothiazol Septex cream no. 2 Septozol
Streptacillin Streptotriad Sulfamul
Sulfa-orzon Sulfavitina Sulfazol
Sulfex Sulfhatose Sulfintestin
Sulfopyrol Sulfour Sulfzol
Sulnac Sulphatriad Sultrin
Sulzol Tampovagan pss Thiadyl
Thiazamid Thiazamide Thiuramide
Tiadyl Trimeto Trisulpha
Trysul Tylasul Ufa 902-duo
Vetoprim mi Wintrazol
For regulatory information, see page 250
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 406

Product Name Sulfathiazole

C.A.S. number 72-14-0
Trade and brand names
Product Name Sulfisomidine
C.A.S. number 515-64-0
Trade and brand names
Aristamid Elkosin Gynedron
Isosulf Oestro-gynedron Poly-gynedron
Sulfamethine Tricho-gynedron
For regulatory information, see page 250

Product Name Suloctidil

C.A.S. number 54767-75-8
Trade and brand names
Bemperil Cerebro Circleton
Cp 556s Dulasi Duloctil
Euvasal Farectil Fluversin
Fluvisco Hemoantin Iangene
Ibisul Loctidon Locton
Metactiv Octamet Polivasal
Sudil Sulc Sulocton
Sulodene Suloktil Sutidil
Tamid Vascudil
For regulatory information, see page 251

Product Name Sulprostone

C.A.S. number 60325-46-4
Trade and brand names
CP-34089 Nalador
For regulatory information, see page 252

Product Name Sultopride

C.A.S. number 53583-79-2
Trade and brand names
Banotil Barnetil Barnotil
Topral
For regulatory information, see page 252

Product Name Suprofen

C.A.S. number 40828-46-4
Trade and brand names
Algiamida Algiasdi Bordol
Erdol Maldocil Masterfen
Sufenid Supranol Suprol
Surfex
For regulatory information, see page 254
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 407

Product Name Suxibuzone

C.A.S. number 27470-51-5
Trade and brand names
Calibene Danalon om Danilon
Flamilon Flofos Flogos
Solurol
For regulatory information, see page 255

Product Name Tartrazine

C.A.S. number 1934-21-0
Trade and brand names
1 yellow 1409 yellow A.f. yellow no.4
Acid leather yellow t Acid yellow 23 Acid yellow t
Acilan yellow Acilan yellow gg Airedale yellow t
Aizen tartrazine Amacid yellow t Amacid yellow t-ex
Atul tatrazine Ayellow t B 3014
Biovital C.i. 19140 C.i. acid yellow 23
C.i. food yellow 4 Calcocid yellow mcg Calcocid yellow xx
Cancert tartrazine Certecol tartrazol yellow s Cilefa yellow t
Curon D and c yellow no. 5 Dolkwal tartrazine
Dye yellow lake E 102 E 102 (dye)
Edicol supra tartrazine n Egg yellow a Erio tartrazine
Erio yellow t supra Eurocert tartrazine Fast yellow 5g
Fd and c yellow no. 5 Fenazo yellow t 4 Food dye yellow 4
Food yellow 4 Food yellow no. 4 Galinid
Hd tartrazine Hd tartrazine supra Hexacert yellow no 5
Hexacol tartrazine Hispacid fast yellow t Hydrazine yellow
Hydroxine yellow l Japan yellow no. 4 Jaun tartrique
Kako tartrazine Kayaku food colour yellow no. 4 Kayaku tartrazine
Kca foodcol tartrazine pf Kca tartrazine pf Kiton yellow t
L yellow z 1020 Lake yellow Lemon yellow a
Lemon yellow a geigy Maple tartrazol yellow Mitsui tartrazine
Naphtocard yelow o Neklacid yellow t Oxanal yellow t
San ei tartrazine Sugai tartrazine Tartar yellow fs
Tartar yellow n Tartar yellow pf Tartar yellow s
Tartran yellow Tartraphenine Tartrayellow
Tartrazin Tartrazine a export Tartrazine b
Tartrazine b.p.c. Tartrazine c Tartrazine extra pure a
Tartrazine fq Tartrazine g Tartrazine lake
Tartrazine lake yellow n Tartrazine m Tartrazine mcgl
Tartrazine n Tartrazine ns Tartrazine o
Tartrazine o specially pure Tartrazine t Tartrazine xx
Tartrazine xx especially pure Tartrazine xxx Tartrazine yellow
Tartrazol bpc Tartrazol yellow Tartrine yellow o
Unitertracid yellow te Usacert yellow no 5 Vondacid tartrazine
Wood yellow Xylene fast yellow gt Yellow lake 69
For regulatory information, see page 256

Product Name Temafloxacin

C.A.S. number 108319-06-8
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 408

Product Name Temafloxacin

C.A.S. number 108319-06-8
Trade and brand names
8Omniflox 8Teflox 8Temac
For regulatory information, see page 257

Product Name Terconazole

C.A.S. number 67915-31-5
Trade and brand names
Fungistat Gyno-terazol Terazol
Terazol 3 Tercospor
For regulatory information, see page 258

Product Name Terfenadine

C.A.S. number 50679-08-8
Trade and brand names
Antifen Fenadin
For regulatory information, see page 258

Product Name Terodiline

C.A.S. number 15793-40-5
Trade and brand names
Bicor Mictrol Micturin
Mitrol Miucurin Terolin
For regulatory information, see page 260

Product Name Testosterone propionate (injectable)

C.A.S. number 57-85-2
Trade and brand names
Agovirin Andro heart injecta Androfort
Androlan in oils Androtest Androteston
Anertan Aquaviron Bio-testiculina
Cortrifosal Durateston v Enarmon
Enarmon-oil Encilcort Galanrent
Gondrone Gyno-terazol Hermo m
Homandren Homosterone Hormoteston
Jeifer-old Malogen Malogen in oil
Malotrone Masenate Mertestate
Micro-sterandryl Napionate Nasdol
Neo-hombreol Okasa-mascul Orchiol
Orchisterone-p Orchistin Oreton
Oreton-f Pantesin Perandern
Percutacrine androgenique Pertesis Primotest
Primotestone Propiokan Recthormone
Recthormone testosterone Solvotest Sterotest
Sutanone Synandrol Syneron
Synovex-h Telipex Terazol
Teslen Tesrina Testaform
Testanderogen Testenat Testex
Testigrmon Testilen Testirene
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 409

Product Name Testosterone propionate (injectable)

C.A.S. number 57-85-2
Trade and brand names
Testobase Testodet Testodrin
Testogen Testoici Testoidral
Testolets Testonate Testonique
Testopin Testopinate Testopropon
Testoral Testo-retard Testormol
Testosid Testoviron Testoviron (ampule)
Testoviron-10/-25/-50 Testoviron-depot-50/-100 Testovis
Testoxyl Testrex Testron
Tostrina Triomone Uniteston
Vantostol-p Viromon Virormone
Virosterone
For regulatory information, see page 260

Product Name Tetracycline (paediatric)

C.A.S. number 60-54-8
Trade and brand names
Achrocidin Achromycin Achromycin v
Achromycin y Apo-tetra Cyclopar
Decycline Double-t Gt-250
Hosta-500 Medicycline Muracine
Mysteclin-f Nasopomada Neo-tetrine
Nor-tet Novotetra Panmycin
Retet Robitet Sk-tetracycline
Steclin Sumycin Tepcycline
Teropicycline Tetrabotic Tetra-c
Tetracap Tetracaps Tetracyn
Tetralan Tetram Tetrex
Tetrpsol Wintracin
For regulatory information, see page 261

Product Name Thalidomide

C.A.S. number 50-35-1
Trade and brand names
Algosediv Asidon Bonbrain
Contergan Distaval E-217
Funed Glupan Glutanon
Hippuzon Imidan Isomin
Kevadon Kevadone Nerufatin
Neurosedyn Pangul Pantosedive
Pro-ban Quetimid Sanodormin
Sedalis Sedoval Shinaito
Shinnibrol Sleepan Slipro
Softenil Softenon Talimol
Tlargan Yodomin
For regulatory information, see page 262
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 410

Product Name Thenalidine

C.A.S. number 86-12-4
Trade and brand names
Sanbosten Sandosten Sandostene
For regulatory information, see page 263

Product Name Thiomersal

C.A.S. number 56-64-8
Trade and brand names
Thiobactal
For regulatory information, see page 264

Product Name Tianeptine sodium

C.A.S. number 30123-17-2
Trade and brand names
Coaxil Stablon
For regulatory information, see page 264

Product Name Ticlopidine

C.A.S. number 55142-85-3
Trade and brand names
4-c-32 53-32-c Anagregal
Aplaquette Caudaline Derivatives
Klodin Opteron Panaldine
Pcr 5332 Tcp Ticlid
Ticlidan Ticlodix Ticlodone
Ticlopedine Ticlosan Tiklid
Tiklyd Tilcid
For regulatory information, see page 265

Product Name Tienilic acid

C.A.S. number 40180-04-9
Trade and brand names
Anp 3624 Diflarex Diflurex
Fr 3068 Selacryn Selcryn
Skf-62698 Ticrex Ticrynafen
Ticrynapen
For regulatory information, see page 266

Product Name Tocainide

C.A.S. number 41708-72-9
Trade and brand names
Apx Citocard Taquidil
Tonocard Toquidil Xylotocan
For regulatory information, see page 267

Product Name Tramadol

C.A.S. number 27203-92-5
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 411

Product Name Tramadol

C.A.S. number 27203-92-5
Trade and brand names
Trabar Tramal
For regulatory information, see page 269

Product Name Tranylcypromine

C.A.S. number 155-09-9
Trade and brand names
Cuait Estelapar Jatrosom
Oculocidon Parnate Parnate tylciprine
Parnetene Parstelazin Parstelin
Stelapar Transamin Transaminase
Transaminase sgo Transaminase sgp Transamine
Tylciprine
For regulatory information, see page 269

Product Name Trazodone

C.A.S. number 19794-93-5
Trade and brand names
Beneficat Bimaran Deprax
Desyrel Devidone Manegan
Molipaxin Pragmarel Pragmazone
Taxagon Thittico Thombran
Thromban Tombran Tramensan
Tritico Trittico
For regulatory information, see page 270

Product Name Tretinoin

C.A.S. number 302-79-4
Trade and brand names
A-acido Aberel Aberela
Acid a vit Acnavit Acnavyse
Acretin Airoderm Airol
Aknebon Aknefug Aknoten
Anition Antibio-aberel Apsor
A-vitamisyre Avitoin Cordes vas
Dermairol Dermoclar Dermojuventas
Derugin Effederm Epi-aberel
Eudyna Locacid Pigmanorm
R0 22-6595 Reiderma Retin a
Retin-a Ro 1-5488 Roaccutane
Sebo-psor Stie vaa Stievaa
Tretin m Vas dexa Verra-med
Vitacid a Vitamin a acid
For regulatory information, see page 270

Product Name Triacetyldiphenolisatin

C.A.S. number 18869-73-3
Trade and brand names
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 412

Product Name Triacetyldiphenolisatin

C.A.S. number 18869-73-3
Trade and brand names
Schlakforte
For regulatory information, see page 271

Product Name Triazolam

C.A.S. number 28911-01-5
Trade and brand names
Halcion Novidorm Novoderm
Novodorm Nuctane Songar
Songarn
For regulatory information, see page 271

Product Name Trimipramine

C.A.S. number 739-71-9
Trade and brand names
Apo-trimip Herphonal No-tripramine
Novo-tripramine Rhotrimine Rhotromine
Sapilant Stangyl Surmantil
Surmontil Tydamine
For regulatory information, see page 274

Product Name Troglitazone

C.A.S. number 97322-87-7
Trade and brand names
Rezulin Ronglitazone
For regulatory information, see page 274

Product Name Trolamine

C.A.S. number 102-71-6
Trade and brand names
Sabril Sabrilex
For regulatory information, see page 275

Product Name Trypsin

C.A.S. number 9002-07-7
Trade and brand names
Parenzyme Trypsillin
For regulatory information, see page 276

Product Name Valproic acid

C.A.S. number 99-66-1
Trade and brand names
Valproine Vederon
For regulatory information, see page 278
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 413

Product Name Vigabatrin

C.A.S. number 60643-86-9
Trade and brand names
Sabril Sobril Sobril tab 25 mg
For regulatory information, see page 278

Product Name Vinbarbital

C.A.S. number 125-42-8
Trade and brand names
Butenemal Delvinal Delvinal sodium
Diminal Suppoptanox Vinbarbiton
For regulatory information, see page 279

Product Name Vincamine

C.A.S. number 1617-90-9
Trade and brand names
Angiopac Cerebroxine Cetal
Equipur Ocu-vinc Oxygeron
Pervincamine Vadicate Vinca
Vinca minor Vincacen Vincapront
Vincavix Vincimax
For regulatory information, see page 279

Product Name Warfarin

C.A.S. number 81-81-2
Trade and brand names
Athrombin Coumadin Coumadine
Marevan Mervan Sofarin
Waran Warfilone
For regulatory information, see page 280

Product Name Xenazoic acid

C.A.S. number 1174-11-4
Trade and brand names
Cv 58903 Xenalmine Xenovis
For regulatory information, see page 281

Product Name Zimeldine

C.A.S. number 56775-88-3
Trade and brand names
Normid Normud Zelmid
Zelmidine
For regulatory information, see page 281

Product Name Zipeprol

C.A.S. number 34758-83-3
Trade and brand names
Antitaxil-z Antituxil-z Balutox
Broncozina Bronx Cerm-3024
Twelfth Issue PHARMACEUTICALS (TRADE NAMES) 414

Product Name Zipeprol

C.A.S. number 34758-83-3
Trade and brand names
Citizeta Mirsol Ogyline
Respilene Respirase Respirex
Santus Talasa Zitoxil
For regulatory information, see page 281

Product Name Zomepirac

C.A.S. number 33369-31-2
Trade and brand names
Calinador Calmador Dolgenal
Dolwas Mcn 2783 Mcn 2783-21-98
Miranil Zomax Zomaxin
Zopirac
For regulatory information, see page 282

Product Name Zopiclone

C.A.S. number 43200-80-2
Trade and brand names
Zimovane
For regulatory information, see page 282
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

10043-35-3 Boric acid and borates.................................................................................. 65, 292, 329
................................................................................................
100-51-6 Benzyl alcohol............................................................................................... 60, 327, 328
...........................................................................................
100981-43-9 Ebrotidine...................................................................................................... 117
........................................................................................
10118-90-8 Minocycline................................................................................................... 182, 374
..........................................................................................
102-71-6 Trolamine...................................................................................................... 275, 412
.........................................................................................
103-03-7 Phenicarbazide............................................................................................. 211, 387
.............................................................................................
103628-48-4 Sumatriptan................................................................................................... 252
..........................................................................................
103-84-4 Acetanilide.................................................................................................... 31, 319
.........................................................................................
103-90-2 Paracetamol.................................................................................................. 201
...........................................................................................
10540-29-1 Tamoxifen..................................................................................................... 255
..........................................................................................
106515-24-9 Sertindole...................................................................................................... 239
........................................................................................
106650-56-0 Sibutramine................................................................................................... 240
..........................................................................................
107-06-2 Ethylene dichloride........................................................................................ 123
.............................................................................................
1077-28-7 Lipoic acid..................................................................................................... 162, 364
........................................................................................
108319-06-8 Temafloxacin................................................................................................. 257, 407, 408
...........................................................................................
1083-57-4 Bucetin.......................................................................................................... 69, 330
.......................................................................................
108-95-2 Phenol........................................................................................................... 212, 389
.......................................................................................
1098-97-1 Pyritinol......................................................................................................... 234, 400
......................................................................................
109-95-5 Ethyl nitrite (spirit)......................................................................................... 122
.........................................................................................
110-85-0 Piperazine..................................................................................................... 221, 394, 395
.........................................................................................
110871-86-8 Sparfloxacin.................................................................................................. 243
..........................................................................................
113427-24-0 Epoetin alfa................................................................................................... 119
.........................................................................................
113-45-1 Methylphenidate............................................................................................ 177, 373
.............................................................................................
114-86-3 Phenformin.................................................................................................... 209, 386, 387
..........................................................................................
115-33-3 Oxyphenisatine acetate................................................................................ 199
..................................................................................................
115-68-4 Sulfadicramide.............................................................................................. 245, 402, 403
............................................................................................
116001-96-8 Pentosan polysulfate sodium........................................................................ 204
.....................................................................................................
116644-53-2 Mibefradil....................................................................................................... 180
.......................................................................................
117-10-2 Dantron......................................................................................................... 101
........................................................................................
1174-11-4 Xenazoic acid................................................................................................ 281, 413
...........................................................................................
117591-79-4 Remoxipride.................................................................................................. 236
...........................................................................................
122-09-8 Phentermine.................................................................................................. 214, 390
...........................................................................................

415
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

122312-54-3 Epoetin beta.................................................................................................. 119
..........................................................................................
123-31-9A Hydroquinone................................................................................................ 147
............................................................................................
1233-53-0 Bunamiodyl................................................................................................... 71, 331
...........................................................................................
125-42-8 Vinbarbital..................................................................................................... 279, 413
........................................................................................
125-64-4 Methyprylon................................................................................................... 178, 373
..........................................................................................
125-71-3 Dextromethorphan........................................................................................ 105, 343
................................................................................................
125-84-8 Aminoglutethimide........................................................................................ 44, 322
...............................................................................................
126-07-8 Griseofulvin................................................................................................... 140
.........................................................................................
12629-01-5 Somatropin (pituitary-derived)...................................................................... 241, 401
....................................................................................................
126-31-8 Methiodal sodium.......................................................................................... 177, 372, 373
..............................................................................................
127-58-2 Sulfamerazine sodium.................................................................................. 248, 403
..................................................................................................
128-46-1 Dihydrostreptomycin..................................................................................... 109, 345, 346
................................................................................................
128-62-1 Noscapine..................................................................................................... 193
..........................................................................................
129-03-3 Cyproheptadine............................................................................................. 99
.............................................................................................
129-20-4 Oxyphenbutazone......................................................................................... 197
................................................................................................
129618-40-2 Nevirapine..................................................................................................... 188, 377
.........................................................................................
130-26-7 Clioquinol (see also halogenated hydroxyquinoline derivatives).................. 89
......................................................................................................................
13149-68-3 Pangamic acid.............................................................................................. 201
.............................................................................................
132-60-5 Cinchophen................................................................................................... 85
...........................................................................................
132875-61-7 Remifentanil.................................................................................................. 235
..........................................................................................
1332-58-7 Kaolin............................................................................................................ 154, 362
......................................................................................
13364-32-4 Clobenzorex.................................................................................................. 91
...........................................................................................
13392-18-2 Fenoterol....................................................................................................... 128, 352
........................................................................................
134308-13-7 Tolcapone..................................................................................................... 268
..........................................................................................
134-49-6 Phenmetrazine.............................................................................................. 211, 387
.............................................................................................
13463-41-7 Pyrithione zinc............................................................................................... 233
..........................................................................................
134678-17-4 Lamivudine.................................................................................................... 157
..........................................................................................
13473-38-6 Pipenzolate................................................................................................... 221, 394
..........................................................................................
134-80-5 Amfepramone hydrochloride........................................................................ 42
.......................................................................................................
13539-59-8 Azapropazone............................................................................................... 56, 326
.............................................................................................
13838-14-7 Diphenazine.................................................................................................. 112
...........................................................................................
139-05-9 Cyclamates in drugs..................................................................................... 98
................................................................................................

416
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

139133-26-9 Lexipafant...................................................................................................... 161
........................................................................................
139755-83-2 Sildenafil....................................................................................................... 240, 400, 401
.......................................................................................
1403-66-3 Gentamicin (topical preparations)................................................................. 136
......................................................................................................
1405-10-3 Neomycin sulfate.......................................................................................... 187, 375, 376, 377
..............................................................................................
14261-75-7 Cloforex......................................................................................................... 94
.......................................................................................
144-82-1 Sulfamethizole.............................................................................................. 248, 403, 404
............................................................................................
145599-86-6 Cerivastatin................................................................................................... 77, 332
.........................................................................................
14611-51-9 Selegiline...................................................................................................... 239
........................................................................................
147059-72-1 Trovafloxacin mesilate.................................................................................. 276
................................................................................................
1477-19-6 Benzarone..................................................................................................... 59, 327
..........................................................................................
148-24-3 Halogenated hydroxyquinoline derivatives................................................... 142
.............................................................................................................
14838-15-4 Phenylpropanolamine................................................................................... 218, 392, 393
..................................................................................................
14882-27-4 Bismuth subsalicylate................................................................................... 64
................................................................................................
149-80-6 Acetylleucine................................................................................................. 32
..........................................................................................
14992-59-2 Sodium dibunate........................................................................................... 241, 401
..............................................................................................
15307-79-6 Diclofenac sodium........................................................................................ 105, 343, 344
...............................................................................................
154-23-4 Cianidanol..................................................................................................... 84
.........................................................................................
155-09-9 Tranylcypromine........................................................................................... 269, 411
..............................................................................................
156-34-3 Levamfetamine............................................................................................. 159, 363
..............................................................................................
15686-51-8 Clemastine.................................................................................................... 89
..........................................................................................
15687-27-1 Ibuprofen....................................................................................................... 148
........................................................................................
157605-25-9 Alatrofloxacin mesilate.................................................................................. 37
...............................................................................................
15793-40-5 Terodiline...................................................................................................... 260, 408
........................................................................................
1617-90-9 Vincamine..................................................................................................... 279, 413
..........................................................................................
161967-81-3 Grepafloxacin hydrochloride......................................................................... 139
....................................................................................................
1622-62-4 Flunitrazepam............................................................................................... 132, 353
............................................................................................
16595-80-5 Levamisole hydrochloride............................................................................. 160, 364
...................................................................................................
1662-47-8 Gallopamil..................................................................................................... 134, 354
.........................................................................................
1668-19-5 Doxepin......................................................................................................... 114, 347
........................................................................................
174722-31-7 Rituximab...................................................................................................... 237
.........................................................................................
1789-26-0 Acetylfuratrizine............................................................................................ 32, 319
...........................................................................................
185243-69-0 Etanercept..................................................................................................... 121, 350
.........................................................................................

417
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

1867-66-9 Ketamine hydrochloride................................................................................ 155
..................................................................................................
18869-73-3 Triacetyldiphenolisatin.................................................................................. 271, 411, 412
...............................................................................................
1934-21-0 Tartrazine...................................................................................................... 256, 407
........................................................................................
1972-08-3 Dronabinol..................................................................................................... 116
.........................................................................................
19767-45-4 Mesna........................................................................................................... 170, 368
........................................................................................
19794-93-5 Trazodone..................................................................................................... 270, 411
..........................................................................................
2002-0-1001 Albumin......................................................................................................... 37
........................................................................................
2002-0-1002 Amyl nitrite.................................................................................................... 50
........................................................................................
2002-0-1003 Human dura mater........................................................................................ 146
................................................................................................
2002-0-1004 Hydroquinidine.............................................................................................. 147
............................................................................................
2002-0-1005 Sodium hydrogen bicarbonate (paediatric).................................................. 241
..............................................................................................................
2002-0-1006 Aldesleukin................................................................................................... 39
..........................................................................................
2002-0-1007 Aristolochia................................................................................................... 52
.........................................................................................
2002-0-1008 Pexiganan..................................................................................................... 205
..........................................................................................
2002-0-1009 Pumactant..................................................................................................... 233
..........................................................................................
2002-0-1010 Ginkgo biloba................................................................................................ 137, 354
...........................................................................................
2002-1-1001 Acetylsalicylic acid/antacid........................................................................... 285
.................................................................................................
2002-1-1002 Amoxicillin/clavulanic acid............................................................................ 286
.................................................................................................
2002-1-1003 Ampicillin/cloxacillin...................................................................................... 286, 325
............................................................................................
2002-1-1004 Azatadine maleate/pseudoephedrine sulfate............................................... 290, 326
................................................................................................................
2002-1-1005 Dicycloverine(dicyclomine)/doxylamine/pyridoxine)..................................... 296
..................................................................................................................
2002-1-1006 Etamivan in combination.............................................................................. 298
...................................................................................................
2002-1-1007 Hydroxyquinolines in combination................................................................ 301
........................................................................................................
2002-1-1008 Paracetamol/methionine............................................................................... 308
...................................................................................................
2002-1-1009 Quinidine/verapamil...................................................................................... 313
...............................................................................................
2002-1-1010 Tilbroquinol/tiliquinol..................................................................................... 315
............................................................................................
2002-1-1012 Barbiturates in asthma preparations............................................................ 290
.........................................................................................................
2002-1-1013 Clopamide, reserpine and dihydroergocristine mesilate.............................. 294
.....................................................................................................................
2002-1-1014 Kaolin and pectin.......................................................................................... 302
.............................................................................................
2002-1-1015 Loratadine and pseudoephedrine................................................................. 303
.........................................................................................................
2002-1-1016 Metamizole sodium, fenpiverinium bromide and pitofenone hcl.................. 305
......................................................................................................................
2002-1-1017 Pseudoephedrine and phenylpropanolamine............................................... 311
..................................................................................................................

418
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

2002-1-1018 Trancylopramine and trifluoperazine............................................................ 316
.........................................................................................................
2002-1-5001 Anorectic drugs............................................................................................. 287
............................................................................................
2002-1-5003 Calcium channel blockers............................................................................. 293
...................................................................................................
2002-1-5004 Contrast media (ionic and non-ionic)............................................................ 294
........................................................................................................
2002-1-5005 Desensitizing vaccines................................................................................. 295
.................................................................................................
2002-1-5007 Iron preparations........................................................................................... 302
............................................................................................
2002-1-5008 Nitrates.......................................................................................................... 306
......................................................................................
2002-1-5009 Nonsteroidal anti-inflammatory agents......................................................... 306
..........................................................................................................
2002-1-5010 Oral contraceptives (third generation).......................................................... 306
........................................................................................................
2002-1-5011 Oral sodium phosphate bowel preparations................................................. 307
...............................................................................................................
2002-1-5012 Pancreatic enzymes..................................................................................... 308
.................................................................................................
2002-1-5013 Pyrethroids.................................................................................................... 312
.........................................................................................
2002-1-5014 Quinolone antimicrobial agents.................................................................... 313
......................................................................................................
2003-0-1001 Gamelonic acid............................................................................................. 135, 354
.............................................................................................
2003-0-1002 Glutoxim........................................................................................................ 139
........................................................................................
2003-1-1001 Allopurinol and benzbromarone.................................................................... 286
.......................................................................................................
2003-1-1002 Calcium bromidum and chloral hydrate........................................................ 292
............................................................................................................
2003-1-1003 Fluphenazine and nortriptyline...................................................................... 299
....................................................................................................
2003-1-1004 Lidocaine, salicylic acid and chloral hydrate................................................. 303
..........................................................................................................
2003-1-1005 Phenobarbital, difebarbamate and febarbamate (Tetrabamate).................. 309
......................................................................................................................
2003-1-1006 Xibornol and lidocaine.................................................................................. 317
................................................................................................
2003-1-5001 Herbal dietary supplements.......................................................................... 300
....................................................................................................
2003-1-5002 Kava products............................................................................................... 302
............................................................................................
2003-1-5003 Phlebotonics................................................................................................. 310
...........................................................................................
2004-0-0001 Benzbromarone............................................................................................ 59, 327
...............................................................................................
2004-0-0002 Bicalutamide................................................................................................. 63
...........................................................................................
2004-0-0003 Camelia sinensis........................................................................................... 73, 331
.............................................................................................
2004-0-0004 Danazol......................................................................................................... 101
........................................................................................
2004-0-0005 Ephedra........................................................................................................ 118, 348
.........................................................................................
2004-0-0007 Metrodin HP.................................................................................................. 179
...........................................................................................
2004-0-0008 Nefazodone................................................................................................... 187, 375
...........................................................................................
2004-0-0010 Paroxetine..................................................................................................... 202
.........................................................................................

419
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

2004-0-0011 Vinarol and viga (dietary supplements)........................................................ 279
..........................................................................................................
2004-1-1001 Benzbromarone and Benziodarone.............................................................. 292
............................................................................................................
2004-1-1002 Repaglinide and gemfibrozil......................................................................... 314
....................................................................................................
2078-54-8 Propofol......................................................................................................... 231, 399
.......................................................................................
2086-83-1 Berberine...................................................................................................... 62, 328
.........................................................................................
2098-66-0 Cyproterone acetate..................................................................................... 100
................................................................................................
2152-34-3 Pemoline....................................................................................................... 203
.........................................................................................
2154-02-1 Metofoline...................................................................................................... 179, 373
........................................................................................
2169-64-6 Azaribine....................................................................................................... 56, 326
........................................................................................
21721-92-6 Nitrefazole..................................................................................................... 190, 377, 378
........................................................................................
2179-37-5 Bencyclane................................................................................................... 58, 326
...........................................................................................
2181-04-6 Potassium canrenoate.................................................................................. 226, 397
..................................................................................................
21829-25-4 Nifedipine...................................................................................................... 189
........................................................................................
2207-50-3 Aminorex....................................................................................................... 47, 323
.........................................................................................
2210-63-1 Mofebutazone............................................................................................... 182, 374
.............................................................................................
22131-79-9 Alclofenac..................................................................................................... 38, 320
.........................................................................................
22232-71-9 Mazindol........................................................................................................ 166, 365
........................................................................................
23779-99-9 Floctafenine.................................................................................................. 131, 353
..........................................................................................
23887-46-9 Cinepazide.................................................................................................... 85
..........................................................................................
24219-97-4 Mianserin....................................................................................................... 180, 373
........................................................................................
2438-72-4 Bufexamac.................................................................................................... 69, 330
...........................................................................................
24390-14-5 Doxycycline hyclate(injectable)..................................................................... 115, 347, 348
....................................................................................................
24526-64-5 Nomifensine.................................................................................................. 192
...........................................................................................
2537-29-3 Proxibarbal.................................................................................................... 232
.........................................................................................
25614-03-3 Bromocriptine................................................................................................ 68, 329, 330
...........................................................................................
25803-14-9 Clometacin.................................................................................................... 94
..........................................................................................
25812-30-0 Gemfibrozil.................................................................................................... 135, 354
.........................................................................................
260-94-6 Acridine derivatives....................................................................................... 36, 320
.............................................................................................
2691-45-4 Diethylaminoethoxyhexestrol........................................................................ 107, 345
.....................................................................................................
27203-92-5 Tramadol....................................................................................................... 269, 410, 411
.........................................................................................
27469-53-0 Almitrine........................................................................................................ 39
.......................................................................................
27470-51-5 Suxibuzone................................................................................................... 255, 407
...........................................................................................

420
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

28782-42-5 Difenoxin....................................................................................................... 109, 345
........................................................................................
28911-01-5 Triazolam...................................................................................................... 271, 412
.........................................................................................
298-57-7 Cinnarizine.................................................................................................... 86
.........................................................................................
29883-15-6 Laetrile.......................................................................................................... 157
......................................................................................
300-25-4 Guanofuracin................................................................................................ 141
............................................................................................
300-62-9 Amfetamine................................................................................................... 42, 321
...........................................................................................
30123-17-2 Tianeptine sodium........................................................................................ 264, 410
...............................................................................................
302-22-7 Chlormadinone acetate................................................................................. 79, 335
..................................................................................................
302-79-4 Tretinoin........................................................................................................ 270, 411
.......................................................................................
303-81-1 Novobiocin.................................................................................................... 194
..........................................................................................
30748-29-9 Feprazone..................................................................................................... 128, 352
..........................................................................................
31329-57-4 Naftidrofuryl (parenteral formulations).......................................................... 185
.......................................................................................................
313-67-7 Aristolochic acid............................................................................................ 52, 325
...........................................................................................
3137-73-3 Anagestone acetate...................................................................................... 50
................................................................................................
315-80-0 Dibenzepin hydrochloride............................................................................. 105, 343
...................................................................................................
317-34-0 Aminophylline................................................................................................ 47, 323
...........................................................................................
31793-07-4 Pirprofen....................................................................................................... 223
........................................................................................
31842-01-0 Indoprofen..................................................................................................... 150
.........................................................................................
32359-34-5 Medifoxamine................................................................................................ 167
............................................................................................
3239-44-9 Dexfenfluramine............................................................................................ 104, 343
.............................................................................................
3239-45-0 Dexfenfluramine hydrochloride..................................................................... 104
......................................................................................................
33005-95-7 Tiaprofenic acid............................................................................................ 265
............................................................................................
33125-97-2 Etomidate...................................................................................................... 124, 351
.........................................................................................
33369-31-2 Zomepirac..................................................................................................... 282, 414
..........................................................................................
33386-08-2 Buspirone hydrochloride............................................................................... 72
..................................................................................................
34161-24-5 Fipexide......................................................................................................... 129, 352
.......................................................................................
3416-24-8 Glucosamine sulfate..................................................................................... 138
................................................................................................
34433-66-4 Levacetylmethadol........................................................................................ 159, 363
...............................................................................................
34552-84-6 Isoxicam........................................................................................................ 154, 362
........................................................................................
34645-84-6 Fenclofenac.................................................................................................. 126, 352
...........................................................................................
34758-83-3 Zipeprol......................................................................................................... 281, 413, 414
.......................................................................................
3521-62-8 Erythromycin estolate................................................................................... 120, 349, 350
................................................................................................

421
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

3562-63-8 Megestrol acetate......................................................................................... 168, 366
..............................................................................................
3583-64-0 Bumadizone.................................................................................................. 70, 331
............................................................................................
3595-11-7 Propylhexedrine............................................................................................ 231, 399
.............................................................................................
359-83-1 Pentazocine.................................................................................................. 204
...........................................................................................
360-70-3 Nandrolone decanoate (injectable)............................................................... 186, 374
........................................................................................................
363-24-6 Dinoprostone................................................................................................. 111, 346
...........................................................................................
364-62-5 Metoclopramide (paediatric)......................................................................... 179
....................................................................................................
3736-08-1 Fenetylline..................................................................................................... 127, 352
........................................................................................
37612-13-8 Encainide...................................................................................................... 117
.........................................................................................
3820-67-5 Glafenine....................................................................................................... 137, 354
........................................................................................
3836-23-5 Norethisterone enantate (injectable)............................................................ 192
........................................................................................................
390-64-7 Prenylamine.................................................................................................. 229
...........................................................................................
3930-20-9 Sotalol........................................................................................................... 242
......................................................................................
39562-70-4 Nitrendipine................................................................................................... 190
.........................................................................................
4008-48-4 Nitroxoline..................................................................................................... 191
........................................................................................
40180-04-9 Tienilic acid................................................................................................... 266, 410
........................................................................................
40828-46-4 Suprofen....................................................................................................... 254, 406
.........................................................................................
41708-72-9 Tocainide...................................................................................................... 267, 410
.........................................................................................
4214-72-6 Isaxonine phosphate..................................................................................... 151, 361
................................................................................................
43200-80-2 Zopiclone...................................................................................................... 282, 414
.........................................................................................
456-59-7 Cyclandelate................................................................................................. 98
...........................................................................................
458-24-2 Fenfluramine................................................................................................. 127
...........................................................................................
461-78-9 Chlorphentermine......................................................................................... 84, 336
...............................................................................................
467-80-7 Pipradrol........................................................................................................ 222, 395, 396
.......................................................................................
468-68-1 Oxeladin........................................................................................................ 196
........................................................................................
474-25-9 Chenodeoxycholic acid................................................................................. 78, 332, 333
..................................................................................................
4759-48-2 Isotretinoin..................................................................................................... 152, 362
.......................................................................................
479-92-5 Propyphenazone........................................................................................... 232, 399
...............................................................................................
481-06-1 Santonin........................................................................................................ 237, 400
........................................................................................
483-18-1 Emetine......................................................................................................... 117, 348
........................................................................................
492-39-7 Cathine.......................................................................................................... 76, 332
.......................................................................................
494-03-1 Chlornaphazine............................................................................................. 81, 336
.............................................................................................

422
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

496-67-3 Bromisoval.................................................................................................... 67
..........................................................................................
5003-48-5 Benorilate...................................................................................................... 58, 327
........................................................................................
50-06-6 Phenobarbital................................................................................................ 211, 387, 388, 389
...........................................................................................
50-29-3A Clofenotane................................................................................................... 91
..........................................................................................
50-33-9 Phenylbutazone............................................................................................ 215, 390, 391, 392
..............................................................................................
50-35-1 Thalidomide.................................................................................................. 262, 409
...........................................................................................
50-48-6 Amitriptyline.................................................................................................. 48, 324
.........................................................................................
50-56-6 Oxytocin........................................................................................................ 201
........................................................................................
50-59-9 Cefaloridine................................................................................................... 76
.........................................................................................
50679-08-8 Terfenadine................................................................................................... 258, 408
..........................................................................................
50-78-2 Acetylsalicylic acid (paediatric)..................................................................... 32, 319
..................................................................................................
509-86-4 Heptabarb..................................................................................................... 144
..........................................................................................
51022-71-0 Nabilone........................................................................................................ 185, 374
........................................................................................
511-12-6 Dihydroergotamine/heparin.......................................................................... 296
.....................................................................................................
51-12-7 Nialamide...................................................................................................... 188, 377
.........................................................................................
51234-28-7 Benoxaprofen................................................................................................ 58, 327
............................................................................................
51-34-3 Scopolamine................................................................................................. 238, 400
............................................................................................
51-41-2 Levarterenol.................................................................................................. 160, 364
..........................................................................................
51-43-4 Epinephrine................................................................................................... 118, 348, 349
..........................................................................................
514-73-8 Dithiazanine iodide........................................................................................ 113, 346, 347
.............................................................................................
514-78-3 Canthaxanthin............................................................................................... 74, 332
............................................................................................
51-55-8 Atropine in combination................................................................................ 290
.................................................................................................
515-64-0 Sulfisomidine................................................................................................ 250, 406
...........................................................................................
51-64-9 Dexamfetamine............................................................................................. 104, 343
..............................................................................................
51-79-6 Urethane....................................................................................................... 277
.........................................................................................
51803-78-2 Nimesulide.................................................................................................... 189, 377
..........................................................................................
52-01-7 Spironolactone.............................................................................................. 243, 401, 402
............................................................................................
521-74-4 Broxyquinoline (see also halogenated hydroxyquinoline derivatives).......... 68, 330
......................................................................................................................
52214-84-3 Ciprofibrate................................................................................................... 86
.........................................................................................
522-51-0 Dequalinium chloride.................................................................................... 103, 343
................................................................................................
52432-72-1 Oxeladin citrate............................................................................................. 196
...........................................................................................
52468-60-7 Flunarizine..................................................................................................... 131
........................................................................................

423
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

52485-79-7 Buprenorphine.............................................................................................. 71, 331
.............................................................................................
52-76-6 Lynestrenol.................................................................................................... 166, 365
.........................................................................................
53179-11-6 Loperamide................................................................................................... 162, 364
...........................................................................................
53230-10-7 Mefloquine..................................................................................................... 167
.........................................................................................
533-45-9 Clomethiazole............................................................................................... 95
............................................................................................
53-43-0 Prasterone.................................................................................................... 228, 398
..........................................................................................
53583-79-2 Sultopride...................................................................................................... 252, 406
........................................................................................
537-46-2 Metamfetamine............................................................................................. 171, 368, 369
..............................................................................................
53-86-1 Indometacin and indometacin farnesil.......................................................... 149
..........................................................................................................
539-08-2 Beta ethoxylacetanilide................................................................................. 62
................................................................................................
54-05-7 Chloroquine................................................................................................... 83, 336
..........................................................................................
54063-53-5 Propafenone................................................................................................. 230, 399
............................................................................................
54143-55-4 Flecainide...................................................................................................... 129, 352, 353
........................................................................................
54-32-0 Moxisylyte...................................................................................................... 183
........................................................................................
54350-48-0 Etretinate....................................................................................................... 124, 351
.......................................................................................
54739-18-3 Fluvoxamine.................................................................................................. 133, 353
...........................................................................................
547-44-4 Sulfacarbamide............................................................................................. 245
.............................................................................................
54767-75-8 Suloctidil........................................................................................................ 251, 406
......................................................................................
548-62-9 Methylrosanilinium chloride.......................................................................... 178
...................................................................................................
548-73-2 Droperidol..................................................................................................... 116, 348
.........................................................................................
54910-89-3 Fluoxetine...................................................................................................... 133
........................................................................................
54-92-2 Iproniazid....................................................................................................... 151, 361
.......................................................................................
55079-83-9 Acitretin......................................................................................................... 35, 319
......................................................................................
55142-85-3 Ticlopidine..................................................................................................... 265, 410
........................................................................................
55294-15-0 Muzolimine.................................................................................................... 184
..........................................................................................
55937-99-0 Beclobrate..................................................................................................... 57
.........................................................................................
56180-94-0 Acarbose....................................................................................................... 31
.........................................................................................
56227-39-5 Polidexide sulfate.......................................................................................... 224
............................................................................................
56-29-1 Hexobarbital.................................................................................................. 146
..........................................................................................
5635-50-7 Hexestrol....................................................................................................... 145
........................................................................................
563-63-3 Silver acetate................................................................................................ 240, 401
..........................................................................................
56-53-1 Diethylstilbestrol............................................................................................ 107, 345
..........................................................................................

424
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

56-64-8 Thiomersal.................................................................................................... 264, 410
..........................................................................................
56-75-7 Chloramphenicol........................................................................................... 78, 333, 334, 335
..............................................................................................
56775-88-3 Zimeldine...................................................................................................... 281, 413
.........................................................................................
56824-20-5 Amiprilose..................................................................................................... 48
.........................................................................................
569-65-3 Meclozine...................................................................................................... 167, 365, 366
.........................................................................................
57-24-9 Strychnine and salts...................................................................................... 244
..............................................................................................
57-43-2 Amobarbital................................................................................................... 49, 324, 325
..........................................................................................
57-44-3 Barbital.......................................................................................................... 57, 326
......................................................................................
57-53-4 Meprobamate................................................................................................ 170, 367, 368
.............................................................................................
57574-09-1 Amineptine.................................................................................................... 43
..........................................................................................
57-67-0 Sulfaguanidine.............................................................................................. 246, 403
............................................................................................
57-68-1 Sulfadimidine................................................................................................ 246, 403
...........................................................................................
57808-66-9 Domperidone(injectable).............................................................................. 114, 347
...................................................................................................
57-85-2 Testosterone propionate (injectable)............................................................ 260, 408, 409
........................................................................................................
5786-21-0 Clozapine...................................................................................................... 95
.........................................................................................
57-92-1 Streptomycin................................................................................................. 244, 402
...........................................................................................
58-15-1 Aminophenazone.......................................................................................... 44, 322, 323
................................................................................................
58-89-9A Lindane......................................................................................................... 161, 364
........................................................................................
59122-46-2 Misoprostol.................................................................................................... 182, 374
.........................................................................................
59-42-7 Phenylephrine............................................................................................... 218, 392
............................................................................................
59-47-2 Mephenesin.................................................................................................. 170, 366
............................................................................................
59-63-2 Isocarboxazid................................................................................................ 151, 361
...........................................................................................
59-87-0 Nitrofural....................................................................................................... 190, 378
.......................................................................................
59-96-1 Phenoxybenzamine...................................................................................... 214, 390
..................................................................................................
60325-46-4 Sulprostone................................................................................................... 252, 406
..........................................................................................
60-54-8 Tetracycline (paediatric)............................................................................... 261, 409
................................................................................................
60643-86-9 Vigabatrin...................................................................................................... 278, 413
........................................................................................
60-80-0 Phenazone.................................................................................................... 207, 385
...........................................................................................
60-87-7 Promethazine................................................................................................ 229
............................................................................................
6095-47-8 Codeine......................................................................................................... 97
........................................................................................
6106-46-3 Hyoscine methonitrate.................................................................................. 148
.................................................................................................
62-44-2 Phenacetin.................................................................................................... 205, 385
..........................................................................................

425
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

62666-20-0 Progabide...................................................................................................... 229, 398
.........................................................................................
62-90-8 Nandrolone phenylpropionate (injectable).................................................... 186, 375
............................................................................................................
634-03-7 Phendimetrazine........................................................................................... 208, 386
..............................................................................................
637-07-0 Clofibrate....................................................................................................... 92
.......................................................................................
63-74-1 Sulfanilamide................................................................................................ 249, 405
...........................................................................................
63758-79-2 Indalpine........................................................................................................ 149
.......................................................................................
64-17-5 Ethanol.......................................................................................................... 121, 350, 351
.......................................................................................
64241-34-5 Cadralazine................................................................................................... 72, 331
..........................................................................................
64952-97-2 Latamoxef..................................................................................................... 158, 363
..........................................................................................
65-23-6 Pyridoxine (Vitamin B6)................................................................................ 233
.................................................................................................
65277-42-1 Ketoconazole................................................................................................ 156, 363
............................................................................................
65-28-1 Phentolamine mesilate................................................................................. 215
..................................................................................................
657-24-9 Metformin...................................................................................................... 175
.........................................................................................
66195-31-1 Ibopamine..................................................................................................... 148
..........................................................................................
6673-35-4 Practolol........................................................................................................ 227, 398
.......................................................................................
6707-58-0 Dequalinium.................................................................................................. 103
...........................................................................................
67-20-9 Nitrofurantoin................................................................................................ 191, 378
..........................................................................................
67-45-8 Furazolidone................................................................................................. 133, 353, 354
...........................................................................................
67-56-1 Methanol....................................................................................................... 175
.........................................................................................
67-66-3 Chloroform.................................................................................................... 81, 336
..........................................................................................
67915-31-5 Terconazole.................................................................................................. 258, 408
...........................................................................................
68-26-8 Retinol........................................................................................................... 236, 400
......................................................................................
68767-14-6 Loxoprofen sodium....................................................................................... 164
................................................................................................
68844-77-9 Astemizole.................................................................................................... 54, 325
..........................................................................................
68-89-3 Metamizole sodium....................................................................................... 171, 369, 370, 371
................................................................................................
692-13-7 Buformin........................................................................................................ 69, 330, 331
........................................................................................
69-57-8 Benzylpenicillin sodium (topical preparations)............................................. 61, 328
.............................................................................................................
69756-53-2 Halofantrine................................................................................................... 142
.........................................................................................
70-30-4 Hexachlorophene.......................................................................................... 145
...............................................................................................
71-27-2 Suxamethonium chloride.............................................................................. 254
....................................................................................................
71-58-9 Depot medroxyprogesterone acetate (DMPA)............................................. 102
...................................................................................................................
7175-09-9 Tilbroquinol................................................................................................... 267
.........................................................................................

426
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

72-14-0 Sulfathiazole................................................................................................. 250, 405, 406
..........................................................................................
72-44-6 Methaqualone............................................................................................... 176, 372
.............................................................................................
72599-27-0 Miglustat........................................................................................................ 181, 373
.......................................................................................
7297-25-8 Erythrityl tetranitrate...................................................................................... 119
...........................................................................................
73-22-3 L-Tryptophan................................................................................................. 164, 364
...........................................................................................
73-31-4 Melatonin....................................................................................................... 169
........................................................................................
73590-58-6 Omeprazole.................................................................................................. 194
............................................................................................
739-71-9 Trimipramine................................................................................................. 274, 412
...........................................................................................
74103-06-3 Ketorolac....................................................................................................... 156
........................................................................................
742-20-1 Cyclopenthiazide........................................................................................... 99
.............................................................................................
7440-48-4 Cobalt (non-radioactive forms)..................................................................... 96
.....................................................................................................
7447-40-7 Potassium chloride....................................................................................... 226, 397, 398
...............................................................................................
74-55-5 Ethambutol.................................................................................................... 121, 350
..........................................................................................
745-65-3 Alprostadil..................................................................................................... 40, 320, 321
........................................................................................
7542-37-2 Paromomycin................................................................................................ 202
.............................................................................................
75659-07-3 Dilevalol........................................................................................................ 110
.......................................................................................
76-22-2 Camphor....................................................................................................... 73, 332
..........................................................................................
76568-02-0 Flosequinan.................................................................................................. 131
...........................................................................................
76-73-3 Secobabital................................................................................................... 238, 400
..........................................................................................
76-74-4 Pentobarbital................................................................................................. 204
..........................................................................................
76824-35-6 Famotidine.................................................................................................... 126, 351, 352
..........................................................................................
7683-59-2 Isoprenaline.................................................................................................. 152, 361, 362
..........................................................................................
77-02-1 Aprobarbital................................................................................................... 52, 325
.........................................................................................
77-09-8 Phenolphthalein............................................................................................ 213, 389, 390
.............................................................................................
77-19-0 Dicycloverine................................................................................................. 106, 344
..........................................................................................
77-21-4 Glutethimide.................................................................................................. 139
..........................................................................................
7757-79-1 Potassium nitrate.......................................................................................... 227, 398
.............................................................................................
79-09-4 Propionic acid............................................................................................... 230
...........................................................................................
794-93-4 Dihydroxymethylfuratrizine............................................................................ 110, 346
..................................................................................................
8008-60-4 Opium in antitussive preparations................................................................ 195
.......................................................................................................
8015-79-0 Calamus........................................................................................................ 73, 331
.........................................................................................
80-35-3 Sulfamethoxypyridazine................................................................................ 248, 404, 405
..................................................................................................

427
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

80387-96-8 Difemerine..................................................................................................... 108
.........................................................................................
804-36-4 Difurazone..................................................................................................... 109, 345
.........................................................................................
804-63-7 Quinine sulfate.............................................................................................. 235
...........................................................................................
8064-90-2 Trimethoprim/sulfamethoxazole................................................................... 316
........................................................................................................
80-77-3 Chlormezanone............................................................................................. 80
..............................................................................................
810968-60-4 Cisapride....................................................................................................... 86
........................................................................................
81-81-2 Warfarin........................................................................................................ 280, 413
........................................................................................
82626-01-5 Alpidem......................................................................................................... 40
........................................................................................
82964-04-3 Tolrestat........................................................................................................ 269
.......................................................................................
83480-39-9 Voglibose...................................................................................................... 280
.........................................................................................
83-89-6 Mepacrine..................................................................................................... 169
..........................................................................................
84-04-8 Pipamazine................................................................................................... 221, 394
...........................................................................................
84057-84-1 Lamotrigine................................................................................................... 158
..........................................................................................
84-17-3 Dienestrol...................................................................................................... 107, 344, 345
........................................................................................
84371-65-3 Mifepristone.................................................................................................. 181, 373
..........................................................................................
853-34-9 Kebuzone...................................................................................................... 155, 362, 363
..........................................................................................
85-73-4 Phthalylsulfathiazole..................................................................................... 220, 393
..............................................................................................
86-12-4 Thenalidine................................................................................................... 263, 410
..........................................................................................
86-42-0 Amodiaquine................................................................................................. 49, 325
............................................................................................
864-50-4 Temazepam.................................................................................................. 257
.............................................................................................
9000-69-5 Pectin............................................................................................................ 203
......................................................................................
9001-54-1 Hyaluronidase............................................................................................... 147
............................................................................................
9002-07-7 Trypsin.......................................................................................................... 276, 412
.......................................................................................
9003-39-8 Polyvidone.................................................................................................... 225, 396, 397
..........................................................................................
90101-16-9 Droxicam....................................................................................................... 116
.........................................................................................
9014-67-9 Aloxiprin........................................................................................................ 40, 320
.......................................................................................
9016-01-7 Orgotein........................................................................................................ 195
........................................................................................
90-84-6 Amfepramone............................................................................................... 42, 321
..............................................................................................
91161-71-6 Terbinafine.................................................................................................... 257
.........................................................................................
915-30-0 Diphenoxylate............................................................................................... 112, 346
............................................................................................
915-67-3 Amaranth...................................................................................................... 41
..........................................................................................
91-64-5 Coumarin (synthetic)..................................................................................... 97
...............................................................................................

428
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

91714-94-2 Bromfenac..................................................................................................... 67
..........................................................................................
91-80-5 Methapyrilene................................................................................................ 175, 371
...........................................................................................
94-36-0 Benzoylperoxide............................................................................................ 59, 327
.............................................................................................
94-78-0 Phenazopyridine........................................................................................... 208, 385, 386
..............................................................................................
95-27-2 Dimazole....................................................................................................... 111, 346
.........................................................................................
965-90-2 Ethylestrenol................................................................................................. 123, 351
..........................................................................................
97-18-7 Bithionol........................................................................................................ 65, 328
.......................................................................................
97322-87-7 Troglitazone.................................................................................................. 274, 412
..........................................................................................
97-44-9 Acetarsol....................................................................................................... 31, 319
........................................................................................
976-71-6 Canrenone.................................................................................................... 74, 332
...........................................................................................
99-66-1 Valproic acid................................................................................................. 278, 412
..........................................................................................
UN-87-0001 Allergen extracts........................................................................................... 39, 320
............................................................................................
UN-87-0003 Factor IX........................................................................................................ 125, 351
.......................................................................................
UN-87-0004 Factor VIII...................................................................................................... 126, 351
.......................................................................................
UN-87-0006 Polyoxyethylated castor oil........................................................................... 225, 396
..................................................................................................
UN-87-0008 Oral rehydration salts.................................................................................... 195
..............................................................................................
UN-88-0001 Antirheumatic combinations with glucocorticosteroids................................. 289
...................................................................................................................
UN-88-0002 Cefalosporins (topical preparations)............................................................. 76, 332
.......................................................................................................
UN-88-0004 Sulfonamides (topical preparations)............................................................. 251
........................................................................................................
UN-88-0007 Meprobamate/diazepines............................................................................. 304
.....................................................................................................
UN-88-0008 Penicillin/streptomycin.................................................................................. 308
...............................................................................................
UN-88-0009 Phenformin/chlorpropamide......................................................................... 309
......................................................................................................
UN-88-0010 Theophylline/meprobamate/barbiturates...................................................... 315
.............................................................................................................
UN-90-0001 Mucopolysaccharide polysulfuric acid ester................................................. 183
.............................................................................................................
UN-92-0001 Anabolic steroids.......................................................................................... 50
.............................................................................................
UN-92-0002 Androgens..................................................................................................... 51
..........................................................................................
UN-92-0003 H1-Antihistamines......................................................................................... 141
..............................................................................................
UN-92-0004 Aphrodisiac drugs......................................................................................... 52
..............................................................................................
UN-92-0005 Cell preparations........................................................................................... 77
............................................................................................
UN-92-0006 Estrogens...................................................................................................... 297
.........................................................................................
UN-92-1001 Acetylsalicylic acid/codeine.......................................................................... 285
..................................................................................................
UN-92-1002 Anorectic dugs in combinations.................................................................... 288
......................................................................................................

429
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

UN-92-1003 Estrogens (in oral contraceptives)................................................................ 298
......................................................................................................
UN-92-1004 Tiratricol/cyclovalone/retinol......................................................................... 316
.................................................................................................
UN-95-0001 ACE-Inhibitors............................................................................................... 284
...........................................................................................
UN-95-0002 Antihistamine (topical).................................................................................. 51
...............................................................................................
UN-95-0003 Bovine tissue derived medicines.................................................................. 66
.......................................................................................................
UN-95-0004 Cartilage extract............................................................................................ 75
...........................................................................................
UN-95-0005 Gangliosides................................................................................................. 135, 299
...........................................................................................
UN-95-0006 Germander.................................................................................................... 136
...........................................................................................
UN-95-0007 Nebacumab................................................................................................... 187
............................................................................................
UN-95-0008 Placental tissue derived medicine................................................................ 223
.......................................................................................................
UN-95-0009 Pyrrolizidine................................................................................................... 234
........................................................................................
UN-95-0011 Rubiae tinctorum radix.................................................................................. 237
................................................................................................
UN-95-0012 Vaccines for mumps, measles, and rubella................................................. 277
...............................................................................................................
UN-95-0013 Ziperol........................................................................................................... 282
......................................................................................
UN-95-1001 Analgesics in combination............................................................................ 286
...................................................................................................
UN-95-1002 Antidiarrhoeal combinations......................................................................... 289
....................................................................................................
UN-95-1003 Ethinylestradiol/methyltestosterone.............................................................. 299
.......................................................................................................
UN-95-1004 Promethazine in combination....................................................................... 310
......................................................................................................
UN-95-1005 Tyrothricin/fomocaine/diphenhydramine....................................................... 317
............................................................................................................
UN-CJ-0001 Pyrazolones in combination (see also aminophenazone, metamizole sodi 311
um)................................................................................................................
UN-KG-0001 Acetylsalicylic acid/phenacetin/caffeine (APC)............................................. 285
.............................................................................................................
UN-KG-0012 Arsenic-based compounds........................................................................... 53
......................................................................................................
UN-KG-0014 Barbiturates in combination.......................................................................... 291
...................................................................................................
UN-KG-0015 Bismuth salts................................................................................................ 63
...........................................................................................
UN-KG-0017 Chloramphenicol in combination.................................................................. 293
........................................................................................................
UN-KG-0018 Chlormadinone acetate/mestranol (in oral contraceptives).......................... 294
......................................................................................................................
UN-KG-0019 Cycloserine/isoniazid.................................................................................... 295
...............................................................................................
UN-KG-0020 Dalkon shield................................................................................................ 100
...........................................................................................
UN-KG-0022 Dihydrostreptomycin sulfate/streptomycin sulfate........................................ 296
................................................................................................................
UN-KG-0024 Dipotassium clorazepate/acepromazine/aceprometazine........................... 297
......................................................................................................................
UN-KG-0028 Estrogen-progestogen preparations for secondary amenorrhea................. 297
......................................................................................................................
UN-KG-0030 Estrogens/testosterone................................................................................. 298
.................................................................................................

430
 A. INDEX BY CHEMICAL ABTRACT SERVICE REGISTRY NUMBERS

CAS Product name Page

UN-KG-0031 Etidocaine hydrocloride/epinephrine tartrate................................................ 299
............................................................................................................
UN-KG-0033 Guaifenesin/camphor/ether.......................................................................... 300
.....................................................................................................
UN-KG-0034 Halogenated salicylanilides.......................................................................... 143
...................................................................................................
UN-KG-0035 Herpes simplex vaccines.............................................................................. 144
...................................................................................................
UN-KG-0036 Hormonal pregnancy tests............................................................................ 300
....................................................................................................
UN-KG-0037 Hydrochlorothiazide/potassium.................................................................... 301
.......................................................................................................
UN-KG-0038 Iodinated casein strophanthin (neo-barine).................................................. 150, 361
............................................................................................................
UN-KG-0040 Lead oxide and lead salts............................................................................. 159, 363
..................................................................................................
UN-KG-0041 Lobelia........................................................................................................... 162
......................................................................................
UN-KG-0044 Medroxyprogesterone acetate/ethinylestradiol............................................. 303
...............................................................................................................
UN-KG-0045 Mepyramine maleate/pamabrom.................................................................. 304
...........................................................................................................
UN-KG-0046 Mercuric derivatives (topical)........................................................................ 304, 368
..................................................................................................
UN-KG-0047 Metoclopramide/polidocanol......................................................................... 305
.....................................................................................................
UN-KG-0049 Neomycin sulfate/polymyxin bisulfate/nystatin/acetarsol............................. 305
....................................................................................................................
UN-KG-0050 Dionaea muscipula (extract)......................................................................... 112
....................................................................................................
UN-KG-0055 Penicillin/tetracycline.................................................................................... 309
.............................................................................................
UN-KG-0057 Pipradol/hesperidin....................................................................................... 310
..............................................................................................
UN-KG-0058 Pituitary-chorionic gonadotropin (injectable)................................................ 223, 396
...........................................................................................................
UN-KG-0059 Podophyllum resin........................................................................................ 224, 396
...............................................................................................
UN-KG-0060 Prednisolone/phenobarbital.......................................................................... 310
....................................................................................................
UN-KG-0065 Sulfathiazole sodium with sodium lactate or sodium bicarbonate............... 314
......................................................................................................................
UN-KG-0066 Superheporin................................................................................................ 314
............................................................................................
UN-KG-0068 Tetracycline in combination.......................................................................... 314
...................................................................................................
UN-KG-0069 Thiazides/potassium chloride....................................................................... 315
.....................................................................................................

431
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

A,A-DIMETHYLPHENETHYLAMIN......................................................................................................................................................................
214

A-[4-(1,1-DIMETHYLETHYL)PHENYL]-4-(HYDROXYDIPHENYLMETHYL)-1-PIPERIDINEBUTANOL...........................................................
258

ACEPROMAZINE/DIPOTASSIUM CLORAZEPATE/ACEPROMETAZINE........................................................................................................
297

ACEPROMETAZINE/ACEPROMAZINE/DIPOTASSIUM CLORAZEPATE........................................................................................................
297

ACETAMIDE, 2,2-DICHLORO-N-(2-HYDROXY-1-(HYDROXYMETHYL)-2-(4- NITROPHENYL)ETHYL)-, (R-(R*,R*))................................... 78

ACETAMIDE, N-(4-(2-HYDROXY-3-((1-METHYLETHYL)AMINO)PROPOXY)PHENYL)-.................................................................................
227

ACETAMIDE, N-(4-ETHOXYPHENOL)-..............................................................................................................................................................
205

ACETAMIDE, N-(4-HYDROXYPHENYL)-...........................................................................................................................................................
201

ACETAMINOPHEN..............................................................................................................................................................................................
201

ACETARSONE.....................................................................................................................................................................................................
31

ACETIC ACID, (2,3-DICHLORO-4-(2-THIENYLCARBONYL)PHENOXY)-........................................................................................................

266

ACETIC ACID, O-(2,6-DICHLOROANILINO)PHENYL)-, MONOSODIUM SALT...............................................................................................

106

ACETOPHENETHIDINE......................................................................................................................................................................................
205

ACETOPHENETIDIN...........................................................................................................................................................................................
205

ACETPHENOLISATIN.........................................................................................................................................................................................
199

ACRIFLAVINE......................................................................................................................................................................................................
36

ADRENALINE.......................................................................................................................................................................................................
118

AHR-10282........................................................................................................................................................................................................
67

AHR-3070-C........................................................................................................................................................................................................
179

ALBA........................................................................................................................................................................................................
154

ALCANFOR........................................................................................................................................................................................................
73

ALCOHOL........................................................................................................................................................................................................
121

ALDADIENE........................................................................................................................................................................................................
74

ALDADIENE POTASSIUM...................................................................................................................................................................................
226

ALL-TRANS-RETINOIC ACID..............................................................................................................................................................................
270

ALPHA-(ALPHA-METHOXYBENZYL)-4-(BETA-METHOXYPHENETHYL)-1- PIPERAZINEETHANOL........................................................... 281

ALPHA-(N-PHTHALIMIDO)GLUTARIMIDE.........................................................................................................................................................
263

ALPHA,ALPHA-BIS(P-CHLOROPHENYL)-BETA,BETA,BETA-TRICHLORETHANE......................................................................................91

ALPHA,ALPHA'-DIETHYL-(E)-4,4'-STILBENEDIOL...........................................................................................................................................
108
ALPHA,ALPHA-DIMETHYLPHENETHYLAMINE................................................................................................................................................
214

ALPHA,ALPHA-DIPHENYL-2-PIPERIDINEMETHANOL....................................................................................................................................
222

432
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

ALPHA[3-[[2-(3,4-DIMETHOXYPHENYL)ETHYL]METHYLAMINO]PROPYL]-3,4,5-TRIMETHOXY-ALPHA-(1-METHYL-ETHYL) BENZEN 134

ALPHA-HYDROXYTOLUENE..............................................................................................................................................................................
60

ALPHA-TOLUENOL.............................................................................................................................................................................................
60

AMFEPRAMONE,BENZFETAMINE,BENFLUOREX,FENFLURAMINE,PHENDIMETRAZINE,PHENTERMINE/TIRATRICOL/THYROID H 288

AMFETAMINE-LIKE COMPOUNDS....................................................................................................................................................................
287

AMFETYLINE.......................................................................................................................................................................................................
127

AMIDAZOFEN......................................................................................................................................................................................................
45

AMIDOPYRINE.....................................................................................................................................................................................................
45

AMIDOPYRINE.....................................................................................................................................................................................................
311

AMIDOPYRINE-PYRAMIDON.............................................................................................................................................................................
45

AMINACRINE.......................................................................................................................................................................................................
36

AMINOPHYLLINUM..............................................................................................................................................................................................
47

AMINOPYRINE.....................................................................................................................................................................................................
44

AMINOXAPHEN...................................................................................................................................................................................................
48

AMPHETAMINE...................................................................................................................................................................................................
43

AMYCAZOL........................................................................................................................................................................................................
111

AMYGDALIN........................................................................................................................................................................................................
157

AMYLBARBITONE...............................................................................................................................................................................................
49

ANALESICS/MEPROBAMATE............................................................................................................................................................................
286

ANALGESICS/BARBITURATES.........................................................................................................................................................................
291

ANALGESICS/BENZODIAZEPINES...................................................................................................................................................................
286

ANALGIN........................................................................................................................................................................................................
171

ANDROST-4-EN-3-ONE, 17-(1-OXOPROPOXY)-, (17BETA)-...........................................................................................................................

261

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS.....................................................................................................................................

284

ANTACIDS/BARBITURATES..............................................................................................................................................................................
291

ANTIASTHMATICS/BARBITURATES.................................................................................................................................................................
291

ANTIFEBRIN........................................................................................................................................................................................................
31

ANTIMALARINAE CHLORHYDRAS....................................................................................................................................................................
169

ANTIPYRINE........................................................................................................................................................................................................
44
ANTRAPUROL.....................................................................................................................................................................................................
101

APAZONE........................................................................................................................................................................................................
56

433
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

APC........................................................................................................................................................................................................
285

APROBARBITONE...............................................................................................................................................................................................
52

AQUEOUS CALF CARTILAGE & BONE MARROW EXTRACT........................................................................................................................

75

ARGENTI ACETATE............................................................................................................................................................................................
240

ARISTOLOCHINE................................................................................................................................................................................................
53

ARRITHINUM.......................................................................................................................................................................................................
169

ARTIFICIAL LUNG EXPANDING COMPOUND..................................................................................................................................................

233

ASPIRIN........................................................................................................................................................................................................
32

AS-TRIAZINE-3,5-(2H,4H)-DIONE, 2-(2',3',5'-TRIACETYL-BETA-D- RIBOFURANOSYL)-..............................................................................

56

ATRIUM........................................................................................................................................................................................................
291

AXEROPHTHOCUM............................................................................................................................................................................................
236

AZOPHENUM.......................................................................................................................................................................................................
208

BARBITONE........................................................................................................................................................................................................
57

BARBITURATES/ANALGESICS.........................................................................................................................................................................
291

BARBITURATES/ANTACIDS..............................................................................................................................................................................
291

BARBITURATES/ANTIASTHMATICS.................................................................................................................................................................
291

BARBITURATES/MEPROBAMATE/THEOPHYLLINE.......................................................................................................................................
315

BENEZENEMETHANOL, ALPHA-(1-AMINOETHYL)-,(R*,S*)-, (+/-)..................................................................................................................

218

BENORYLATE.....................................................................................................................................................................................................
58

BENZAMIDE, 3-BROMO-N-[(1-ETHYL-2-PYRROLIDINYL)METHYL]-2,6-DIMETHOXY-, (S)..........................................................................

236

BENZAMIDE, N-(2-PIPERIDINYLMETHYL)-2,5-BIS(2,2,2-TRIFLUOROETHOXY)-..........................................................................................
129

BENZAMIDE, N,N-DIETHYL-4-HYDROXY-3-METHOXY-..................................................................................................................................
298

BENZAMIDE,2-HYDROXY-5-[1-HYDROXY-2-[(1-METHYL-3-PHENYLPROPYL)AMINO]ETHYL]-,[R-(R*,R*]-...............................................111

BENZAMIDE,4-METHOXY-N-[2-[2-(1-METHYL-2-PIPERIDINYL)ETHYL]-PHENY]-,(Ñ)-.................................................................................
117

BENZAMIDE,N-(7-((3-O-(AMINOCARBONYL)-6-DEOXY-5-C-METHYL-4-O-METHYL-BETA-L-LYXO-HEXOPYRANOSYL)OXY)-4-HYDR 194

BENZENACETIC ACID, ALPHA-METHYL-4-(2-THIENYLCARBONYL)-...........................................................................................................

254

BENZENE HEXACHLORIDE, GAMMA...............................................................................................................................................................

161

BENZENEACETIC ACID, 2-((2,6-DICHLOROPHENYL)AMINO)-, MONOSODIUM SALT................................................................................

106

BENZENEACETIC ACID, 2-(2,4-DICHLOROPHENOXY)-.................................................................................................................................

126
BENZENEACETIC ACID, 3-CHLRO-4-(2-PROPENYLOXY)-.............................................................................................................................
38

BENZENEACETIC ACID, 4-(1,3-DIHYDRO-1-OXO-2H-ISOINDOL-2-YL)-ALPHA-METHYL............................................................................

150

434
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

BENZENEACETIC ACID, ALPHA-(HYDROXYMETHYL)-,9-METHYL-3-OXA-9-AZATRICYCLO[3.3.1.0.???]NON-7-YL ESTER,[7(S)-(1AL 238

BENZENEACETIC ACID, ALPHA-(HYDROXYMETHYL)-8-METHYL-8-AZABICYLO[3.2.1]OCT-3-YL ESTER, ENDO(+/-)-.......................... 290

BENZENEACETIC ACID,3-CHLORO-4-(2,5-DIHYDRO-1H-PYRROL-1-YL)-ALPHA-METHYL-......................................................................
223

BENZENECARBINOL..........................................................................................................................................................................................
60

BENZENEETHANAMINE, ALPHA,ALPHA-DIMETHYL......................................................................................................................................
214

BENZENEETHANAMINE, ALPHA-METHYL-, (+/-).............................................................................................................................................

43

BENZENEETHANAMINE, ALPHA-METHYL-,(S)-..............................................................................................................................................
104

BENZENEETHANAMINE, N,?-DIMETHYL-N-2-PROPYNYL-, HYDROCHLORIDE, (R)-.................................................................................

239

BENZENEETHANAMINE, N-ETHYL- -METHYL-3-(TRIFLUOROMETHYL)-, HYDROCHLORIDE...................................................................

127

BENZENEETHANAMINE, N-ETHYL-?-METHYL-3-(TRIFLUOROMETHYL)-, HYDROCHLORIDE.................................................................

127

BENZENEMETHANAMINE, N-(2-CHLOROETHYL)-N-(1-METHYL-2-PHENOXYETHYL)...............................................................................
214

BENZENEMETHANOL........................................................................................................................................................................................
60

BENZENEMETHANOL, 3-HYDROXY-ALPHA-((METHYLAMINO)METHYL)....................................................................................................
218

BENZENEMETHANOL, 4-((1-METHYLETHYL)THIO)-ALPHA-(1-(OCTYLAMINO)ETHYL-, ( R*,S*)-..............................................................251

BENZENEPROPANAMINE, N-(1,1-DIMETHYLETHYL)-ALPHA-METHYL-GAMMA-PHENYL-........................................................................
260

BENZENEPROPANAMINE, N-(1-METHYL-2-PHENYLETHYL)-GAMMA-PHENYL-........................................................................................
229

BENZENEPROPANAMINE, N-METHYL-G-[4-(TRIFLUOROMETHYL)- PHENOXYL]-, (±)-.............................................................................

133

BENZENESULFONAMIDE, 4-AMINO-N-(5-METHYL-1,3,4-THIADIAZOL-2-YL)-..............................................................................................
248

BENZENESULFONAMIDE, 4-AMINO-N-(DIAMINOMETHYLENE)-...................................................................................................................
246

BENZENESULFONAMIDE, 4-AMINO-N-2-THIAZOLYL.....................................................................................................................................
250

BENZOIC ACID, 2-(((4-((2-THIAZOLYLAMINO)SULFONYL)PHENYL)AMINO)-CARBONYL)-........................................................................

220

BENZOIC ACID, 2-(ACETYLOXY)-.....................................................................................................................................................................

32

BENZOIC ACID, 2-[[8-(TRIFLUOROMETHYL)-4-QUINOLINYL]AMINO]-,2,3-DIHYDROXYPROPYL ESTER.................................................

131

BENZOIC ACID, PEROXIDE...............................................................................................................................................................................

60

BENZOTHIAZOL,6-(2-DIETHYLAMINOETHOXY)-2-DIMETHYLAMINO-..........................................................................................................
111

BENZOYL PEROXIDE.........................................................................................................................................................................................
59

BENZYLPENICILLIN............................................................................................................................................................................................
61

BERBERICINE.....................................................................................................................................................................................................
62

BERBERIN........................................................................................................................................................................................................
62
BETA,BETA-CAROTENE-4,4'-DIONE................................................................................................................................................................
74

BETA-NAPHTHYLBIS(BETA-CHLOROETHYL)AMINE.....................................................................................................................................
81

435
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

BIOALLETHRIN....................................................................................................................................................................................................
312

BIS(2-HYDROXY-3,5-DICHLOROPHENYL)SULFIDE........................................................................................................................................
65

BIS(HYDROXYMETHYL)FURATRIZINE.............................................................................................................................................................
110

BISATIN........................................................................................................................................................................................................
199

BOLUS........................................................................................................................................................................................................
154

BORDEAUX-S......................................................................................................................................................................................................
41

BORIC ACID (H3BO3).........................................................................................................................................................................................

65

BORIC ACID (H3BO3).........................................................................................................................................................................................

292

BOVINE SUPEROXIDE DISMUTASE.................................................................................................................................................................

195

BROCIDE........................................................................................................................................................................................................
123

BROMISOVALERYLUREA..................................................................................................................................................................................
68

BROMVALERYLUREA........................................................................................................................................................................................
68

BROMVALETONE................................................................................................................................................................................................
68

BROMYLUM........................................................................................................................................................................................................
68

BTS-54524 (SIBUTAMINE HYDROCHLORIDE).................................................................................................................................................

240

BUFORMINE........................................................................................................................................................................................................
70

BUTADIONE........................................................................................................................................................................................................
216

BUTANAMIDE, 4-(((4-CHLOROPHENYL)(5-FLUORO-2-HYDROXYPHENYL)METHYLENE) AMINO)-..........................................................229

BUTANOVA........................................................................................................................................................................................................
197

BUTFORMIN........................................................................................................................................................................................................
70

BUTYLBIGUANIDE..............................................................................................................................................................................................
70

BUTYLDIGUANIDE..............................................................................................................................................................................................
69

BUTYLFORMIN....................................................................................................................................................................................................
69

BUTYLMALONIC ACID MONO(1,2-DIPHENYLHYDRAZIDE)............................................................................................................................

70

CAFFEINE/PHENACETIN/ACETYLSALICYLIC ACID........................................................................................................................................
285

CAMPHOR/GUAIFENESIN/ETHER....................................................................................................................................................................
300

CAMPHORA........................................................................................................................................................................................................
73

CANTHARIDES....................................................................................................................................................................................................
52

CARBAMIC ACID, ETHYL ESTER......................................................................................................................................................................

277
CARBARIL........................................................................................................................................................................................................
312

CEPHALORIDINE................................................................................................................................................................................................
76

436
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

CG-315........................................................................................................................................................................................................
269

CHENODIOL........................................................................................................................................................................................................
78

CHINACRINA MEPACRINI HYDROCHLORIDIUM.............................................................................................................................................

169

CHININI SULFAS.................................................................................................................................................................................................
235

CHINOFORM........................................................................................................................................................................................................
89

CHITOSAMINE SULFATE...................................................................................................................................................................................
138

CHLORAMPHENICOL/TETRACYCLINE............................................................................................................................................................
315

CHLORETHIAZOL...............................................................................................................................................................................................
95

CHLORETHIAZOLE.............................................................................................................................................................................................
95

CHLORMETHAZANONE.....................................................................................................................................................................................
80

CHLOROIODOQUIN............................................................................................................................................................................................
89

CHLOROPHENOTHANE.....................................................................................................................................................................................
91

CHLORPROPAMIDE/PHENFORMIN..................................................................................................................................................................
309

CHOLAN-24-OIC ACID, 3,7-DIHYDROXY-, (3ALPHA,5BETA,7ALPHA)-..........................................................................................................

78

CHRYSAZIN........................................................................................................................................................................................................
101

CI ACID RED 27...................................................................................................................................................................................................

41

CI FOOD ORANGE 8...........................................................................................................................................................................................

74

CI FOOD RED 9...................................................................................................................................................................................................

41

CI FOOD YELLOW 4............................................................................................................................................................................................

256

CIANIDOL........................................................................................................................................................................................................
84

CINCHONAN-9-OL, 6'-METHOXY-, (8?, 9R)-, SULFATE (2:1) (SALT).............................................................................................................

235

CINCHONINIC ACID, 2-PHENYL-.......................................................................................................................................................................

85

CINNAMIC ACID, 3-BUTYRAMIDO-ALPHA-ETHYL-2,4,6-TRIIODO-,...............................................................................................................

71

CIS-1-[P-((2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL]-4-ISOPROPYL 258

CIS-4-AMINO-5-CHLORO-N-[1-[3-(P-FLUOROPHENOXY)PROPYL]-3-METHOXY-4-PIPERIDYL]-O-ANISAMIDE;...................................... 87

CISAPRIDUM.......................................................................................................................................................................................................
87

CL BASIC VIOLET...............................................................................................................................................................................................
178

CL-581........................................................................................................................................................................................................
155

CLOPHOREX.......................................................................................................................................................................................................
94
CLORAZOLAM.....................................................................................................................................................................................................
272

CN-52372-2........................................................................................................................................................................................................
155

437
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

CODEINE/ACETYLSALICYLIC ACID..................................................................................................................................................................
285

COLOUR INDEX NO. 19140................................................................................................................................................................................

256

COLOUR INDEX NO.16185.................................................................................................................................................................................

41

COLOUR INDEX NO.40850.................................................................................................................................................................................

74

CO-TRIMOXAZOLE.............................................................................................................................................................................................
316

CP-99219-27........................................................................................................................................................................................................
276

CRYSTAL VIOLET...............................................................................................................................................................................................
178

CRYSTALLINE PENICILLIN G SODIUM.............................................................................................................................................................

61

CYCLOHEXANE, 1,2,3,4,5,6-HEXACHLORO-,(1ALPHA,2ALPHA,3BETA,4ALPHA,5ALPHA,6BETA)-.......................................................... 161

CYCLOHEXANEETHANAMINE, N,ALPHA-DIMETHYL-(+/-).............................................................................................................................
231

CYCLOHEXANESULFAMIC ACID......................................................................................................................................................................
98

CYCLOHEXANOL,2-((DIMETHYLAMINO)METHYL))-1-(3-METHOXYPHENYL)-, TRANS-( +/-).....................................................................269

CYCLOPROPANAMINE, 2-PHENYL-, TRANS-(+/-)-..........................................................................................................................................

270

CYCLOVALONE/TIRATRICOL/RETINOL...........................................................................................................................................................
316

DANTHRON........................................................................................................................................................................................................
101

DDT........................................................................................................................................................................................................
91

DEAE-SEPHADEX...............................................................................................................................................................................................
224

DECALINIUM CHLORIDE....................................................................................................................................................................................
103

DECAMINIUM.......................................................................................................................................................................................................
103

DEHYDROANDROSTERONE.............................................................................................................................................................................
228

DEHYDROEPIANDROSTERONE.......................................................................................................................................................................
228

DEPRENYL........................................................................................................................................................................................................
239

DETHYLPROPION HYDROCHLORIDE..............................................................................................................................................................
42

DEXAMPHETAMINE............................................................................................................................................................................................
104

DEXFENFLURAMINE..........................................................................................................................................................................................
287

DEXTRAN 2-(DIETHYLAMINO)ETHYL 2-((2-(DIETHYLAMINO)ETHYL)DIETHYLAMMONIO) ETHYL ETHER SULFATE, EPICHLOROH 224

DEXTROAMPHETAMINE....................................................................................................................................................................................
104

D-GLUCOSE, 2-AMINO-2-DEOXY-, SULFATE..................................................................................................................................................

138

D-GLUCOSE, O-4,6-DIDEOXY-4-[[[1S-(1?,4?, 5?, 6?)]-4,5,6-TRIHYDROXY-3-(HYDROXYMETHYL)-2-CYCLOHEXEN-1-YL]-AMINO]-?- 31

DHEA........................................................................................................................................................................................................
228

DHSM........................................................................................................................................................................................................
110

438
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

DIACETOXYDIPHENYLISATIN...........................................................................................................................................................................
199

DIACETYLDIPHENOLISATIN..............................................................................................................................................................................
199

DIAMTHAZOLE DIHYDROCHLORIDE...............................................................................................................................................................
111

DIANTHON........................................................................................................................................................................................................
101

DIASATIN........................................................................................................................................................................................................
199

DIBENZO(C,F)-PYRAZINO(1,2-A)AZEPINE, 1,2,3,4,10,14B-HEXAHYDRO-2- METHYL.................................................................................

180

DIBENZOYL PEROXIDE......................................................................................................................................................................................
60

DIBROMSALAN....................................................................................................................................................................................................
143

DICHLORODIPHENYLTRICHLOROETHANE (USA).........................................................................................................................................
91

DICYCLOMINE.....................................................................................................................................................................................................
106

DIEMALUM........................................................................................................................................................................................................
57

DIENOL........................................................................................................................................................................................................
107

DIETHYLMALONYLUREA...................................................................................................................................................................................
57

DIETHYLPROPION..............................................................................................................................................................................................
42

DIETHYLSTILBOESTROL...................................................................................................................................................................................
108

DIFENOXYLIC ACID............................................................................................................................................................................................
109

DIHYDROQUINIDINE...........................................................................................................................................................................................
147

DIHYDROSTILBOESTROL..................................................................................................................................................................................
146

DIMETHYL-{3-(3-(10,11-DIHYDRO-5H-DIHENZ[B,F]AZEPIN-5-YL-2-METHYL)PROPYL}AMINE...................................................................
274

DIMETHYLAMINOANTIPYRINE..........................................................................................................................................................................
45

DIMETHYLAMINOPHENAZONE.........................................................................................................................................................................
45

DINOVEX........................................................................................................................................................................................................
107

DIPHENOXYLATI HYDROCHLORIDIUM............................................................................................................................................................
113

DIPHESATIN........................................................................................................................................................................................................
199

DIPYRON........................................................................................................................................................................................................
171

DIPYRONE........................................................................................................................................................................................................
171

D-ISOEPHEDRINE.D-?-EPHEDRINE.................................................................................................................................................................
311

DISOPROFOL......................................................................................................................................................................................................
231

DL-ERYTHRO-2-AMINO-1-PHENYL-1-PROPANOL..........................................................................................................................................
218
DMPA........................................................................................................................................................................................................
102

DST........................................................................................................................................................................................................
110

439
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

D-STREPTAMINE, O-2-DEOXY-2-(METHYLAMINO)-ALPHA-L-GLUCOPYRANOSYL-(1->2)-O-5-DEOXY-3-C-FORMYL-ALPHA-L-LYXO 244

D-STREPTAMINE,O-2-AMINO-2-DEOXY-ALPHA-D-GLUCOPYRANOSYL-1(1-->4)-O-[O-2,6-DIAMINO-2,6-DIDEOXY-BETA-L-IDOPYR 202

D-THREO-(-)-2,2-DICHLORO-N-(BETA-HYDROXY-ALPHA-(HYDROXYMETHYL)-P-NITROPHENETHYL)ACETAMIDE............................ 78

DUTCH LIQUID....................................................................................................................................................................................................
123

E 102........................................................................................................................................................................................................
256

E.161.G........................................................................................................................................................................................................
74

E123........................................................................................................................................................................................................
41

EMETAN, 6',7',10,11-TETRAMETHOXY.............................................................................................................................................................
117

EPIDERMAL THYMOCYTE ACTIVATING FACTOR..........................................................................................................................................

39

EPINEPHRINE TARTRATE/ETIDOCAINE HYDROCHLORIDE........................................................................................................................

299

ERGOTAMAN-3',6',18-TRIONE,2-BROMO-12'-HYDROXY-2'-(1-METHYLETHYL)-5-(2-METHYLPROPYL)-,(5'ALPHA)-.............................. 68

ERYTHROL NITRATE..........................................................................................................................................................................................
120

ERYTHROMYCIN 2'-PROPANOATE DODECYL SULPHATE...........................................................................................................................

120

ERYTHROMYCIN PROPIONATE LAURYL SULPHATE....................................................................................................................................

120

ERYTHROMYCIN, 2'PROPIONATE, DODECYL SULPHATE............................................................................................................................

120

ERYTHRO-P-(ISOPROPYLTHIO)-ALPHA-(1-(OCTYLAMINO)ETHYL)BENZYL ALCOHOL............................................................................
251

ERYTHROPOEITIN..............................................................................................................................................................................................
119

ESTR-4-EN-3-ONE, 17-((1-OXODECYL)OXY)-, (17BETA)................................................................................................................................

186

ESTR-4-EN-3-ONE, 17-(1-OXO-3-PHENYLPROPOXY)-, (17BETA)-................................................................................................................

186

ESTROGENS.......................................................................................................................................................................................................
52

ETHACRIDINE.....................................................................................................................................................................................................
36

ETHAMIVAN........................................................................................................................................................................................................
298

ETHANAMINE, 2-[4-(1,2-DIPHENYL-1-BUTENYL)PHENOXY]-N,N-DIMETHYL, (Z)-, 2-HYDROXY-1,2,3-PROPANETRICARBOXYLATE ( 255

ETHANAMINIUM, 2,2'-[(1,4-DIOXO-1,4,-BUTANEDIYL)BIS(OXY)]BIS[N,N,N,-TRIMETHYL-], DICHLORIDE.................................................

254

ETHANE, 1,1,1-TRICHLORO-2,2-BIS(P-CHLOROPHENYL).............................................................................................................................
91

ETHANE, 1,2-DICHLORO-..................................................................................................................................................................................
123

ETHANESULFONIC ACID, 2-MERCAPTO-, MONOSODIUM SALT..................................................................................................................

170

ETHANOL, 2,2',2'-NITRILOTRIS-........................................................................................................................................................................
275

ETHER/CAMPHOR/GUIFENESIN.......................................................................................................................................................................
300
ETHINYLESTRADIOL/MEDROXYPROGESTERONE ACETATE.....................................................................................................................
304

ETHYL (ALL-E)-9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-3,7-DIMETHYL-2,4,6.8- NONATETRAENOATE............................................. 124

440
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

ETHYL 1-(3-CYANO-3,3-DIPHENYLPROPY-4-PHENYLISONIPECOTATE.....................................................................................................
113

ETHYL 2-(PARA-CHLOROPHENOXY)-2-METHYLPROPIONATE....................................................................................................................
92

ETHYL 2-(P-CHLOROPHENOXY)ISOBUTYRATE.............................................................................................................................................
92

ETHYL 6-[(2-HYDROXYPROPYL)AMINO]-3-PYRIDAZINYL]HYDRAZINECARBOXYLIC ACID ETHYL ESTER............................................ 72

ETHYL ALCOHOL................................................................................................................................................................................................
121

ETHYL ALPHA-(4-CHLOROPHENOXY)-ALPHA-METHYLPROPIONATE.......................................................................................................
92

ETHYL CARBAMATE..........................................................................................................................................................................................
277

ETHYL CLOFIBRATE..........................................................................................................................................................................................
92

ETHYL(+)-2-[[ALPHA-(P-CHLOROPHENYL)-P-TOLYL]OXY]-2-METHYLBUTYRATE.....................................................................................
57

ETHYL(2-MERCAPTOBENZOATO-S)MERCURY..............................................................................................................................................
264

ETHYL(P-CHLORO-ALPHA,ALPHA-DIMETHYLPHENETHYL)-CARBAMATE................................................................................................
94

ETHYLENEDIAMINE............................................................................................................................................................................................
47

ETHYL-N-METHYL-N-[A-(2-METHYLIMIDAZOLE[4,5-C]PYRIDIN-1-YL)TOSYL]-L-LEUCINATE....................................................................
161

ETHYLOESTRENOL............................................................................................................................................................................................
123

ETHYLURETHANE..............................................................................................................................................................................................
277

EUFLAVINE........................................................................................................................................................................................................
36

EUPHYLLINUM....................................................................................................................................................................................................
47

FD&C RED NO.2..................................................................................................................................................................................................

41

FD&C YELLOW NO.5..........................................................................................................................................................................................

256

FENETHYLLINE...................................................................................................................................................................................................
127

FENFLURAMINE..................................................................................................................................................................................................
287

FOSSIL TREE......................................................................................................................................................................................................
137

GAMMA VINYL-GABA..........................................................................................................................................................................................
278

GAMMA-1,2,3,4,5,6-HEXACHLOROCYCLOHEXANE........................................................................................................................................
161

GAMMA-VINYL AMINOBUTYRIC ACID..............................................................................................................................................................

278

GBE-761........................................................................................................................................................................................................
137

GENTIAN VIOLET................................................................................................................................................................................................
178

GLAPHENINE.......................................................................................................................................................................................................
137

GLUCONIC ACID 6-BIS(N-DI-ISOPROPYLAMINO)ACETATE..........................................................................................................................

201
GLUTEMIDE........................................................................................................................................................................................................
139

GLYBIGIDUM.......................................................................................................................................................................................................
70

441
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

GLYCINE, N-[[6-METHOXY-5-(TRIFLUOROMETHYL)-1-NAPHTHALENYL]THIOXOMETHYL]-N-METHYL.................................................. 269

GROWTH HORMONE, HUMAN..........................................................................................................................................................................

241

HEPARIN/DIHYDROERGOTAMINE...................................................................................................................................................................
296

HEPTABARBITONE.............................................................................................................................................................................................
144

HEPTAMALUM.....................................................................................................................................................................................................
144

HESPERIDIN/PIPRADOL....................................................................................................................................................................................
310

HEXACHLOROPHANE........................................................................................................................................................................................
145

HEXOBARBITONE...............................................................................................................................................................................................
146

HEXOESTROL.....................................................................................................................................................................................................
146

HGH........................................................................................................................................................................................................
241

HISTAMINE H1 RECEPTOR ANTAGONISTS....................................................................................................................................................

141

H-PYRROLIZINE-1-CARBOXYLIC ACID, 5-BENZOYL-2,3-DIHYDRO, (+/-)-, COMPOUND WITH 2-AMINO-2-(HYDROXYMETHYL)-1,3-P 156

HYDRAZINECARBOXAMIDE, 2-((5-NITRO-2-FURANYL)METHYLENE)-........................................................................................................
190

HYDROCHINONUM, BENZENE-1,4-DIOL..........................................................................................................................................................
147

HYDROXYBENZENE...........................................................................................................................................................................................
212

HYDROXYPHENBUTAZONE..............................................................................................................................................................................
197

HYDROXYPHENYLBUTAZONE..........................................................................................................................................................................
197

HYOSCINE METHYLNITRATE............................................................................................................................................................................
148

HYSOCINE........................................................................................................................................................................................................
238

IDEC-102........................................................................................................................................................................................................
237

IMIDAZOL[1,2-?]PYRIDINE-3-ACETAMIDE, 6-CHLORO-2-(4-CHLOROPHENYL)-N,N-DIPROPYL...............................................................40

IMIDODICARBONIMIDIC DIAMIDE, N-(2-PHENYLETHYL)-..............................................................................................................................

209

IMIDODICARBONIMIDIC DIAMIDE-, N,N-DIMETHYL-.......................................................................................................................................

175

INTERLEUKIN-2...................................................................................................................................................................................................
39

IODIXANOL........................................................................................................................................................................................................
295

IODOCHLORHYDROXYQUIN.............................................................................................................................................................................
89

IODOCHLORHYDROXYQUINOLINE..................................................................................................................................................................
89

IOHEXOL........................................................................................................................................................................................................
294

IOMEPROL........................................................................................................................................................................................................
294
IOPAMIDOL........................................................................................................................................................................................................
294

IOTALAMIC ACID.................................................................................................................................................................................................
295

442
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

IOTROLAN........................................................................................................................................................................................................
294

IOVERSOL........................................................................................................................................................................................................
294

IOXAGLIC ACID...................................................................................................................................................................................................
294

IOXITALAMIC ACID..............................................................................................................................................................................................
294

ISAPHENIN........................................................................................................................................................................................................
199

ISONIAZID/CYCLOSERINE.................................................................................................................................................................................
295

ISONICOTINIC ACID 2-((2-BENZYLCARBAMOYL)ETHYL)HYDRAZIDE.........................................................................................................

188

ISONICOTINIC ACID 2-ISOPROPYLHYDRAZIDE.............................................................................................................................................

151

ISOPROPYLANTIPYRINE...................................................................................................................................................................................
232

ISOPROPYLARTERENOL...................................................................................................................................................................................
152

ISOPROPYLNORADRENALINE.........................................................................................................................................................................
152

ISOPROTERENOL...............................................................................................................................................................................................
152

ISOPYRINE........................................................................................................................................................................................................
311

ISOQUINOLINE,1-(2-(4-CHLOROPHENYL)ETHYL)-1,2,3,4-TETRAHYDRO-6,7-DIMETHOXY-2-METHYL-.................................................. 179

KETAMINI HYDROCHLORIDUM.........................................................................................................................................................................
155

KETOROLAC TROMETAMOL.............................................................................................................................................................................
156

KETOROLAC TROMETHAMINE.........................................................................................................................................................................
156

KEW TREE........................................................................................................................................................................................................
137

L-2-AMINO-3-(INDOL-3-YL) PROPIONIC ACID..................................................................................................................................................

164

LACTIC ACID-P-PHENETIDINE..........................................................................................................................................................................
63

LACTYLPHENETIDINE........................................................................................................................................................................................
63

LAEVOMYCETINUM............................................................................................................................................................................................
78

LAMOXACTAM.....................................................................................................................................................................................................
158

L-CYSTEINYL-L-TYROSYL-L-ISOLEUCYL-L-GLUTAMINYL-L-ASPARGINYL-L-CYSTEINYL-L-PROLYL-LEUCYLGLYCINAMIDE CYCLI 201

LEVAMISOLI HYDROCHLORIDUM....................................................................................................................................................................
160

LEVAMPHETAMINE............................................................................................................................................................................................
159

L-TETRAMISOLE HYDROCHLORIDE................................................................................................................................................................
160

LU-23-174........................................................................................................................................................................................................
239

LYNENOL........................................................................................................................................................................................................
166
LYNOESTRENOL................................................................................................................................................................................................
166

LYSINE AMIDOTRIZOATE..................................................................................................................................................................................
295

443
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

MAIDENHAIR TREE............................................................................................................................................................................................
137

MALONAL........................................................................................................................................................................................................
57

MECLIZINE........................................................................................................................................................................................................
167

MEPROBAMATE/THEOPHYLLINE/BARBITURATES.......................................................................................................................................
315

MERCURY, ETHYL(4-MERCAPTOBENZOATO-S)-, SODIUM SALT................................................................................................................

264

MESTRANOL/CHLORMADINONE ACETATE....................................................................................................................................................
294

METABROMSALAN.............................................................................................................................................................................................
143

METAMIZOLE SODIUM.......................................................................................................................................................................................
311

METAMPHETAMINE............................................................................................................................................................................................
171

METAPHYLLIN.....................................................................................................................................................................................................
47

METHAMPYRONE...............................................................................................................................................................................................
171

METHANE, TRICHLORO-...................................................................................................................................................................................
81

METHANESULFONAMIDE, N-[4-[1-HYDROXY-2-[(1-METHYLETHYL)AMINO]ETHYL]-PHENYL]-,MONOHYDROCHLORIDE.................... 242

METHANESULFONIC ACID................................................................................................................................................................................
171

METHANESULFONIC ACID, ((2,3-DIHYDRO-1,5-DIMETHYL-3-OXO-2-PHENYL-1H-PYRAZOL-4-YL)METHYLAMINO)-,SODIUM SALT.. 171

METHANESULFONIC ACID, IODO-, SODIUM SALT.........................................................................................................................................

177

METHANOL........................................................................................................................................................................................................
175

METHOPHOLINE.................................................................................................................................................................................................
179

METHYL ALCOHOL.............................................................................................................................................................................................
175

METHYL ALPHA-PHENYL-2-PIPERIDINEACETATE........................................................................................................................................
178

METHYL(3ALPHA,16ALPHA)-14,15-DIHYDRO-14BETA-HYDROXYEBURNAMENINE-14- CARBOXYLATE............................................... 279

METHYLAMPHETAMINE.....................................................................................................................................................................................
171

METHYLROSANILINE CHLORIDE.....................................................................................................................................................................
178

METHYLSCOPOLAMINE NITRATE....................................................................................................................................................................
148

METHYLTESTOSTERONE.................................................................................................................................................................................
52

METOCLOPRAMIDI HYDROCHLORIDIUM........................................................................................................................................................
179

MIXTURE OF NITROUS ACID, 2-METHYLBUTYL ESTER AND NITROUS ACID, 3-METHYLBUTYL ESTER.............................................. 50

MONOSODIUM (2S,5R,6R)-3,3-DIMETHYL-7-OXO-6-(2-PHENYLACETAMIDO)-4-THIA- 1-AZABICYCLO(3.2.0)HEPTANE-2-CARBOXY 61

MORPHINAN-6-OL, 7,8-DIDEHYDRO-4,5-EPOXY-3-METHOXY-17-METHYL-,MONOHYDRATE,(5ALPHA,6ALPHA)................................. 97
MORPHOLINE, 3,4-DIMETHYL-2-PHENYL-, (2S-TRANS)-...............................................................................................................................
208

MORPHOLINE, 3-METHYL-2-PHENYL...............................................................................................................................................................
211

444
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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

MOXALACTAM.....................................................................................................................................................................................................
158

N-(2,6-DIMETHYLPYRIMIDIN-4-YL)SULPHANILAMIDE....................................................................................................................................
250

N-(2,6-DIOXO-3-PIPERIDYL)PHTHALIMIDE......................................................................................................................................................
263

N-(2-CHLOROETHYL)-N-(1-METHYL-2-PHENOXYETHYL)BENZYLAMINE....................................................................................................
214

N-(2-PIPERIDYLMETHYL)-2,5-BIS(2,2,2-TRIFLUOROETHOXY)BENZAMIDE................................................................................................
129

N-(3,3-DIPHENYLPROPYL)-ALPHA-METHYLPHENETHYLAMINE..................................................................................................................
229

N-(4-ETHOXYPHENYL) ACETAMIDE.................................................................................................................................................................
205

N-(4-ETHOXYPHENYL)-2-HYDROXYPROPANAMIDE......................................................................................................................................
63

N-(4-NITRO-2-PHENOXYPHENYL)METHANESULFONAMIDE........................................................................................................................
189

N-(6-(2-(5-NITRO-2-FURYL)VINYL)-1,2,4-TRIAZIN-3-YL) ACETAMIDE...........................................................................................................
32

N-(PARA-ETHOXYPHENYL) LACTAMIDE.........................................................................................................................................................
63

N,N-BIS(2-CHLOROETHYL)- 2-NAPHTHYLAMINE...........................................................................................................................................
81

N,N-DIETHYLVANILLAMIDE...............................................................................................................................................................................
298

N-[(1-ETHYL-2-PYRROLIDINYL)METHYL]-5-(ETHYLSULFONYL)-O-ANISAMIDE..........................................................................................
252

N1-(5-METHYL-1,3,4-THIADIAZOL-2-YL)-SULFANILAMIDE.............................................................................................................................
248

N1-(5-METHYL-1,3,4-THIADIAZOL-2-YL)SULPHANILAMIDE...........................................................................................................................
248

N1-(6-METHOXY-3-PYRIDAZINYL)SULFANILAMIDE.......................................................................................................................................
249

N1-(6-METHOXYPYRIDAZIN-3-YL)SULPHANILAMIDE.....................................................................................................................................
248

N1-(DIAMINOMETHYLENE)SULFANILAMIDE...................................................................................................................................................
247

N1-(THIAZOL-2-YL)SULPHANILAMIDE..............................................................................................................................................................
250

N1-2-THIAZOLYLSULFANILAMIDE....................................................................................................................................................................
250

N-ACETYL-4-HYDROXY-M-ARSANILIC ACID...................................................................................................................................................
31

N-ACETYL-DL-LEUCINE.....................................................................................................................................................................................
32

NAFRONYL OXALATE........................................................................................................................................................................................
185

N-AMIDINOSULPHANILAMIDE MONOHYDRATE.............................................................................................................................................
246

NANDROLONE PHENPROPIONATE.................................................................................................................................................................
186

NAPHTHYLAMINE MUSTARD............................................................................................................................................................................
81

NARCOTINE........................................................................................................................................................................................................
193

N-BUTYLDIGUANIDE..........................................................................................................................................................................................
70
N-BUTYL-IMIDODICARBONIMIDIC DIAMIDE....................................................................................................................................................
70

NIFENAZONE.......................................................................................................................................................................................................
311

445
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

NIFURAZOLIDONUM...........................................................................................................................................................................................
133

NITRE........................................................................................................................................................................................................
227

NITROERYTHRITE..............................................................................................................................................................................................
120

NITROERYTHROL...............................................................................................................................................................................................
120

NITROFURAZOLIDONUM...................................................................................................................................................................................
133

NITROFURAZONE...............................................................................................................................................................................................
191

NITROUS ETHER SPIRIT...................................................................................................................................................................................

122

NN-DIMETHYL-2,2-DIPHENOXYETHYLAMINE.................................................................................................................................................
167

NORADRENALINE...............................................................................................................................................................................................
160

NORAMIDOPYRINE METHANESULFONATE SODIUM....................................................................................................................................

171

NOREPINEPHRINE.............................................................................................................................................................................................
160

NORETHINDRONE..............................................................................................................................................................................................
192

NORSULFAZOLUM..............................................................................................................................................................................................
250

NORTESTERONE DECYCLATE........................................................................................................................................................................
186

NORTESTOSTERONE DECYLATE...................................................................................................................................................................
186

NORTESTOSTERONE PHENYLPROPIONATE................................................................................................................................................
186

N-PHENYLACETAMIDE......................................................................................................................................................................................
31

NSC-134454........................................................................................................................................................................................................
116

N-TERT-BUTYL-1-METHYL-3,3-DIPHEYLPROPYLAMINE...............................................................................................................................
260

NUX VOMICA.......................................................................................................................................................................................................
52

O-3-DEOXY-4-C-METHYL-3-(METHYLAMINO- -L-ARABINO-PYRANOSYL-(1 6)-O-[2,6,DIAMINO-2,3,4,6-TETRADEOXY- -D-ERYTHRO 136

O-3-DEOXY-4-C-METHYL-3-(METHYLAMINO-?-L-ARABINO-PYRANOSYL-(1?6)-O-[2,6,DIAMINO-2,3,4,6-TETRADEOXY-?-D-ERYTH 136

OIL OF CALAMUS................................................................................................................................................................................................
73

OPC-17116........................................................................................................................................................................................................
140

OXAZOLIDIN........................................................................................................................................................................................................
197

OXINE........................................................................................................................................................................................................
143

OXYPHENISATIN DIACETATE...........................................................................................................................................................................
199

OXYQUINOL........................................................................................................................................................................................................
143

OXYQUINOLINE...................................................................................................................................................................................................
143
P-((ALPHA-ETHOXY-P-PHENYLPHENACYL)AMINO)BENZOIC ACID............................................................................................................
281

P-(1-OXO-2-ISOINDOLINYL)HYDRATROPIC ACID...........................................................................................................................................
150

446
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

P-(ACETYLAMINO)PHENOL...............................................................................................................................................................................
201

P,P'-DICHLORODIPHENYLTRICHLOROETHANE............................................................................................................................................
91

P-[(2-OXOCYCLOPENTYL)METHYL]HYDRATROPATE DIHYDRATE.............................................................................................................
164

P-ACETOPHENETIDIDE.....................................................................................................................................................................................
205

PAMABROM/PYRILAMINE MALEATE................................................................................................................................................................
304

PARA-2-THENOYLHYDRATROPIC ACID..........................................................................................................................................................
254

P-BROMO-N-[(E)-({2-[{(2-[DIAMINOMETHYLENE)AMINO]-4-THIAZOYL}METHYL)THIO]ETHYL}AMINO)METHYLENE]BENZENESULF 117

P-CHLORO-ALPHA,ALPHA-DIMETHYLPHENETHYLAMINE...........................................................................................................................
84

PDX-CHLORIDE...................................................................................................................................................................................................
224

PENICILLIN........................................................................................................................................................................................................
61

PENICILLIN G.......................................................................................................................................................................................................
61

PENTANOIC ACID, 5-(2,5-DIMETHYLPHENOXY)-2,2-DIMETHYL...................................................................................................................

135

PENTOBARBITONE............................................................................................................................................................................................
204

PERMETHRIN......................................................................................................................................................................................................
312

PGE1, PROSTAGLANDIN E1.............................................................................................................................................................................

40

PHENACETIN/ACETYLSALICYLIC ACID/CAFFEINE........................................................................................................................................
285

PHENDIMETRAZINE...........................................................................................................................................................................................
287

PHENEMALUM....................................................................................................................................................................................................
211

PHENFORMIN HYDROCHLORIDE.....................................................................................................................................................................
209

PHENIMETHOXAZINE.........................................................................................................................................................................................
208

PHENISATINE......................................................................................................................................................................................................
271

PHENLAXINE.......................................................................................................................................................................................................
199

PHENOBARBITAL/PREDNISOLONE.................................................................................................................................................................
310

PHENOBARBITONE............................................................................................................................................................................................
211

PHENOL, 2,2'-METHYLENEBIS[3,4,6-TRICHLORO-.........................................................................................................................................
145

PHENOL, 4-((7-CHLORO-4-QUINOLINYL)AMINO)-2-((DIETHYLAMINO)METHYL)-.......................................................................................
49

PHENOL, 4,4-'(1,2-DIETHYL-1,2-ETHENEDIYL)BIS-,(E)-.................................................................................................................................
108

PHENOL, 4,4'-(DIETHYLIDENEETHYLENE)DI-.................................................................................................................................................
107

PHENOTHRIN......................................................................................................................................................................................................
312
PHENTERMINE....................................................................................................................................................................................................
287

PHENTOLAMINE METHANESULPHONATE.....................................................................................................................................................
215

447
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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

PHENTOLAMINI MESILAS. 3-[N-(2-IMIDAZOLIN-2-YLMETHYL)-P-TOLUIDINO]PHENOL METHANESULPHONATE................................. 215

PHENYLCARBINOL.............................................................................................................................................................................................
60

PHENYLMETHANOL...........................................................................................................................................................................................
60

PHENYLMETHYL ALCOHOL..............................................................................................................................................................................
60

PHENYLPRENAZONE.........................................................................................................................................................................................
128

PIPERAZINE, 1-((4-CHLOROPHENYL)PHENYLMETHYL)-4-((3-METHYLPHENYL)METHYL)-.....................................................................
167

PIPERAZINE,1-(DIPHENYLMETHYL)-4-(3-PHENYL-2-PROPENYL)...............................................................................................................
86

PIPERAZINE,1-[BIS(4-FLUOROPHENYL)METHYL]-4-(3-PHENYL-2-PROPENYL)-,(E)-................................................................................
131

PIPERIDINE, 4-(5H-DIBENZO[A,D]-CYCLOHEPTEN-5-YLIDENE)-1-METHYL-, HYDROCHLORIDE, SESQUIHYDRATE........................... 99

PIPERIDINE,4-(5H-DIBENZO(A,D)CYCLOHEPTEN-5-YLIDENE)-1-METHYL-................................................................................................
99

PIPERIDINEDIONE..............................................................................................................................................................................................
178

P-LACTOPHENETIDINE......................................................................................................................................................................................
63

PODOPHYLLIN....................................................................................................................................................................................................
224

POLIDOCANOL/METOCLOPRAMIDE................................................................................................................................................................
305

POLY(2-(DIETHYLAMINO)ETHYL)POLYGLYCERYLENE)DEXTRAN..............................................................................................................
224

POLYMERIC CONDENSATION PRODUCT OF ALUMINIUM OXIDE AND 0- ACETYLSALICYLIC ACID.......................................................40

POLYVINYLPYRROLIDONE...............................................................................................................................................................................
225

POTASSIUM 17-HYDROXY-3-OXO-17ALPHA-PREGNA-4,6-DIENE-21-CARBOXYLATE..............................................................................
226

POTASSIUM CHLORIDE/THIAZIDES.................................................................................................................................................................
315

POTASSIUM/HYDROCHLOROTHIAZIDE..........................................................................................................................................................
301

POVIDONE........................................................................................................................................................................................................
225

PREGN-4-EN-20-ONE, 17-(ACETYLOXY)-6-METHYL-, (6ALPHA)...................................................................................................................

50

PREGN-4-ENE,3,20-DIONE, 17-(ACETYLOXY)-6-METHYL-,(6ALPHA)...........................................................................................................
102

PREGN-4-ENE-21-CARBOXYLIC ACID, 7-(ACETYLTHIO)-17-HYDROXY-3-OXO,GAMMA- LACTONE, (7ALPHA,17ALPHA)-................... 243

PREGNA-4,6-DIENE-21-CARBOXYLIC ACID, 17-HYDROXY-3-OXO-, GAMMA-LACTONE ( 17ALPHA)-..................................................... 74

PREGNA-4,6-DIENE-21-CARBOXYLIC ACID, 17-HYDROXY-3-OXO, POTASSIUM SALT ( 17ALPHA)-.......................................................226

PREGNA-4,6-DIENE-3,20-DIONE, 17-(ACETYLOXY)-6-CHLORO...................................................................................................................
80

PREGNA-4,6-DIENE-3,20-DIONE, 17-(ACETYLOXY)-6-METHYL....................................................................................................................
168

PRENAZONE.......................................................................................................................................................................................................
128
PRIMROSE OIL DERIVATIVE.............................................................................................................................................................................
135

PROFLAVINE.......................................................................................................................................................................................................
36

448
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SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

PROPANAMIDE, 2-AMINO-N-(2,6-DIMETHYLPHENYL)-..................................................................................................................................
267

PROPANOIC ACID..............................................................................................................................................................................................
230

PROPANOIC ACID, 2-(4-CHLOROPHENOXY)-2-METHYL, ETHYL ESTER....................................................................................................

92

PROPANOIC ACID, 2-(P-CHLOROPHENOXY)-2-METHYL, ETHYL ESTER...................................................................................................

92

PROPANOIC ACID, 2-[4-(2,2-DICHLOROCYCLOPROPYL)PHENOXYL]-2-METHYL.....................................................................................

86

PROPANOIC ACID, 2-METHYL-, 4-[2-(METHYLAMINO)ETHYL]-1,2-PHENYLENE ESTER...........................................................................

148

PROST-13-EN-1-OIC ACID, 11,15,-DIGYDROXY-9-OXO, (11ALPHA, 13E, 15S)-...........................................................................................

40

PROSTA-5,13-DIEN-1-OIC ACID,11,15-DIHYDROXY-9-OXO-,(5Z,11ALPHA,13E,15S)-.................................................................................
111

PROSTAGLANDIN E2.........................................................................................................................................................................................
111

PROXIBARBITAL.................................................................................................................................................................................................
232

PVP........................................................................................................................................................................................................
225

PYRIDIUM,1-[[2-CARBOXY-8-OXO-7-[(2-THIENYLACETYL)AMINO]-5-THIA-1-AZABICYCLO[4.2.0]-OCT-2-EN-3-YL]METHYL]-,HYDRO 76

PYRILAMINE MALEATE/PAMABROM................................................................................................................................................................
304

PYRITHIOXINE.....................................................................................................................................................................................................
234

PYRROLIDINE, 2-[[1-(4-CHLOROPHENYL)-1-PHENYLETHOXY]ETHYL]-1-METHYL-,[R-(R*,R*)]-...............................................................
89

QUINACRINE HYDROCHLORIDE......................................................................................................................................................................
169

QUINALBARBITONE...........................................................................................................................................................................................
238

R-1132........................................................................................................................................................................................................
113

R-51619........................................................................................................................................................................................................
87

RETINOIC ACID...................................................................................................................................................................................................
270

RETINOIC ACID, 13-CIS......................................................................................................................................................................................

152

RETINOL/CYCLOVALONE/TIRATRICOL...........................................................................................................................................................
316

ROOT BARK OIL..................................................................................................................................................................................................

73

SALICYLIC ACID ACETATE................................................................................................................................................................................

33

SALTPETRE........................................................................................................................................................................................................
227

SC-29333. METHYL 7-{1R,2R,3R)-3-HYDROXY-2-[(E)-(4RS)-4-HYDROXY-4-METHYLOCT-1-ENYL]-5-OXOCYCLOPENTYL}HEPTANO 182

SODIUM (O-(2,6-DICHLOROANILINO)PHENYL) ACETATE.............................................................................................................................

106

SODIUM 2,6-DI-TERT-BUTYL-1(OR 3)-NAPHTHALENESULFONATE............................................................................................................

241

SODIUM 2-MERCAPTOETHANESULFONATE..................................................................................................................................................
170
SODIUM BICARBONATE/SULFATHIAZOLE SODIUM......................................................................................................................................
314

SODIUM IODOMETHANE SULPHONATE.........................................................................................................................................................

177

449
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SODIUM IODOMETHANESULFONATE.............................................................................................................................................................
177

SODIUM LACTATE/SULFATHIAZOLE SODIUM................................................................................................................................................

314

SODIUM PENTOSAN POLYSULPHATE............................................................................................................................................................

205

SODIUM XYLANPOLYSULPHATE......................................................................................................................................................................
205

SODIUM[2-AMINO-3-(P-BROMOBENZOYL)PHELYL]ACETATE SESQUIHYDRATE......................................................................................
67

SOLFAGUANIDINA..............................................................................................................................................................................................
247

SOLFAMMIDE......................................................................................................................................................................................................
249

SOLUBLE SULPHERAMERAZINE.....................................................................................................................................................................
248

SOMATOTROPHIN..............................................................................................................................................................................................
241

SOMATOTROPIN.................................................................................................................................................................................................
241

SPIRO(BENZOFURAN-2(3H), 1'-(2)CYCLOHEXENE)-3,4'-DIONE, 7-CHLORO-2',4,6- TRIMETHOXY-6'-METHYL-,(1'S-TRANS)-............. 140

STH........................................................................................................................................................................................................
241

STILBOESTROL..................................................................................................................................................................................................
108

STREPTOCIDIN...................................................................................................................................................................................................
249

STREPTOMYCIN SULFATE/DIHYDROSTREPTOMYCIN SULFATE...............................................................................................................

296

STREPTOMYCIN/PENICILLIN............................................................................................................................................................................
309

STRETONOVICIN................................................................................................................................................................................................
194

STRICNINA (ITA).................................................................................................................................................................................................
244

STRYCHNIDIN-10-ONE.......................................................................................................................................................................................
244

STRYCHNIN (DEU)..............................................................................................................................................................................................
244

STRYCHNINE......................................................................................................................................................................................................
52

SUCCINYLCHOLINE CHLORIDE........................................................................................................................................................................
254

SULFADIMERAZINE............................................................................................................................................................................................
246

SULFADIMETHYLPYRIMIDINE...........................................................................................................................................................................
246

SULFADIMEZINIUM.............................................................................................................................................................................................
246

SULFADIMIDINUM...............................................................................................................................................................................................
246

SULFAISODIMIDINE............................................................................................................................................................................................
250

SULFAMERAZINUM NATRICUM........................................................................................................................................................................
248

SULFAMETHAZINE.............................................................................................................................................................................................
246
SULFAMETHOXAZOLE/TRIMETHOPRIM..........................................................................................................................................................
316

SULFAMIC ACID, CYCLOHEXYL-......................................................................................................................................................................

98

450
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
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SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

SULFAMIDINUM...................................................................................................................................................................................................
247

SULFAMINUM......................................................................................................................................................................................................
249

SULFANILAMIDOTHIAZOLUM............................................................................................................................................................................
250

SULFANILAMIDUM..............................................................................................................................................................................................
249

SULFANILYLUREA..............................................................................................................................................................................................
245

SULFASOMIDINE................................................................................................................................................................................................
250

SULFONAZOLUM................................................................................................................................................................................................
250

SULGIN........................................................................................................................................................................................................
247

SULGINUM........................................................................................................................................................................................................
247

SULPHAMETHIZOLE...........................................................................................................................................................................................
248

SULPHAMETHOXYPYRIDAZINE........................................................................................................................................................................
249

SULPYRIN........................................................................................................................................................................................................
172

SULPYRINE........................................................................................................................................................................................................
171

SWEET NITRE SPIRIT........................................................................................................................................................................................

122

SYNESTROL........................................................................................................................................................................................................
146

TARTRAZOL YELLOW........................................................................................................................................................................................
256

T-CELL GROWTH FACTOR................................................................................................................................................................................

39

TESTOSTERONE................................................................................................................................................................................................
52

TESTOSTERONE PROPIONATE.......................................................................................................................................................................
261

TETRACHLOROSALICYLANILIDE.....................................................................................................................................................................
143

TETRACYCLINE/PENICILLIN.............................................................................................................................................................................
309

TETRAMETHRIN.................................................................................................................................................................................................
312

TEUCRIUM CHAMAEDRYS................................................................................................................................................................................
136

THENOPHENOPIPERIDINE................................................................................................................................................................................
263

THEOPHYLLAMINUM..........................................................................................................................................................................................
47

THEOPHYLLINE..................................................................................................................................................................................................
47

THIENO(3,2-C)PYRIDINE, 5-((2-CHLOROPHENYL)METHYL)-4,5,6,7-TETRAHYDRO-.................................................................................
265

THIMEROSAL......................................................................................................................................................................................................
264

THYMOXAMINE...................................................................................................................................................................................................
183
TIANEPTINE. 7-[(3-CHLORO-6,11?DIHYDRO-6-METHYLDIBENZO[C,F][1,2] THIAZEPIN-11-YL)AMINO]HEPTANOIC ACID S,S DIOXI 265

TICRYNAFEN.......................................................................................................................................................................................................
266

451
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SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

TRANSAMINE SULPHATE..................................................................................................................................................................................
270

TRIACETYL AZAURIDINE...................................................................................................................................................................................
56

TRIBROMSALAN.................................................................................................................................................................................................
143

TRICHLOROBIS(4-CHLOROPHENYL)ETHANE................................................................................................................................................
92

TRICHLOROFORM..............................................................................................................................................................................................
81

TRICHLOROMETHANE.......................................................................................................................................................................................
81

TRIETHANOLAMINE...........................................................................................................................................................................................
275

TRIMEPRIMINE....................................................................................................................................................................................................
274

TRISODIUM 5-HYDROXY-1-(4-SULPHONATOPHENYL)-4-(4-SULPHONATOPHENYLAZO) PYRAZOLE-3-CARBOXYLATE.................... 256

TROVAFLOXACIN MESYLATE...........................................................................................................................................................................
276

UMBELLATIN.......................................................................................................................................................................................................
62

VENUS FLY TRAP...............................................................................................................................................................................................

112

VINBARBITONE...................................................................................................................................................................................................
279

VITAMIN A........................................................................................................................................................................................................
236

VITAMIN B15........................................................................................................................................................................................................
201

VITAMIN B17........................................................................................................................................................................................................
157

XENALAMINE.......................................................................................................................................................................................................
281

XENALMINE........................................................................................................................................................................................................
281

YOHIMBINE........................................................................................................................................................................................................
52

ZINC 2-PYRIDINETHIOL 1-OXIDE......................................................................................................................................................................

233

ZINC PYRIDINETHIONE, SKIN-CA.....................................................................................................................................................................

233

ZOPICLONUM......................................................................................................................................................................................................
282

[1R-[1ALPHA(Z),2BETA(1E,3R*),3ALPHA]]-7-[3-HYDROXY-2-(3-HYDROXY-4-PHENOXY-1-BUTENYL)-5-OXOCYCLOPENTYL]-N-(ME 252

[S-(R*, R*)]-2,2 1-(1,2-ETHANEDIYLDIIMINO)BIS(1-BUTANOL);......................................................................................................................

121

(((6-2(5-NITRO-2-FURYL)VINYL)-AS-TRIAZIN-3-YL)IMIDO)DI-METHANOL....................................................................................................
110

(-)-2?DEOXY-3?-THIACYTIDINE.......................................................................................................................................................................
158

(-)-3,4-DIHYDROXY-ALPHA-((METHYLAMINO)METHYL)BENZYL ALCOHOL................................................................................................
118

(-)-5-[(1R)-1-HYDROXY-2-[[(1R)-1-METHYL-3-PHENYLPROPYL]AMINO]ETHYL] SALICYLAMIDE...............................................................
111

(-)-6(DIMETHYLAMINO)-4,4-DIPHENYL-3-HEPTANOL ACETATE (ESTER)...................................................................................................

159
(-)-ALPHA-METHYLBENZENEETHANAMINE....................................................................................................................................................
159

(-)-ALPHA-METHYLPHENETHYLAMINE............................................................................................................................................................
159

452
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(-)-M-HYDROXY-ALPHA-((METHYLAMINO)METHYL)BENZYL ALCOHOL......................................................................................................
218

(+)-(2R)-2-[-[[(R)-P-CHLORO-ALPHA-METHYL-ALPHA-PHENYLBENZYL]OXY]ETHYL]-1-METHYLPYRROL.............................................. 89

(+)-2-METHYLAMINO-1-PHENYLPROPANE.....................................................................................................................................................
171

(+)-3,4-DIMETHYL-2-PHENYLMORPHOLINE....................................................................................................................................................
208

(+)-ALPHA-METHYLPHENETHYLAMINE...........................................................................................................................................................
104

(+)-CATECHOL....................................................................................................................................................................................................
84

(+)-ETHYL 1-(ALPHA-METHYLBENZYL)IMIDAZOLE-5-CARBOXYLATE.........................................................................................................
124

(+)-N-(O-CHLOROBENZYL)-ALPHA-METHYLPHENETHYLAMINE.................................................................................................................
91

(+)-NORPSEUDOEPHEDRINE...........................................................................................................................................................................
76

(+)-THREO-2-AMINO-1-HYDROXY-1-PHENYLPROPYLPROPANE.................................................................................................................
76

(+/-)-(2,4-DIFLUOROPHENYL)-6-FLUORO-1,4-DIHYDRO-7-(3-METHYL-1-PIPERAZINYL)-4-OXO-3-QUINOLINECARBOXYLIC ACID..... 257

(+/-)-2-(P-CHLOROPHENYL)-ALPHA-METHYL-5-BENZOXAZOLEACETIC ACID...........................................................................................
59

(+/-)-3-(1,1-DIMETHYLHEPTYL-6,6A BETA,7,8,10,10A ALPHA-HEXAHYDRO-1- HYDROXY-6,6-DIMETHYL-9H-DIBENZO(B,D)PYRAN- 185

(+/-)-ALPHA-METHYLPHENETHYLAMINE.........................................................................................................................................................
43

(+/-)-CIS-1-ACETYL-4-[P-[[2-(2,4-DICHLORPHENYL)-2-(IMIDAZOL-1-YLMETHYL)-1,3-DIOX-OLAN-4-YL]METHOXYLPHENYL]PIPERA 156

(+/-)-ETHYLMETHYL-1,4-DIHYDRO-2,6-DIMETHYL-4-(M-NITROPHENYL)-3,5- PYRIDINEDICARBOXYLATE,........................................... 190

(+/-)-N,ALPHA-DIMETHYLCYCLOHEXANEETHYLAMINE................................................................................................................................
231

(+/-)-NOREPHEDRINE.........................................................................................................................................................................................
218

(+/-)-TRANS 2-((DIMETHYLAMINO)METHYL)-1-(M-METHOXYPHENYL)CYCLOHEXANOL..........................................................................
269

(+/-)-TRANS-2-PHENYLCYCLOPROPYLAMINE................................................................................................................................................
270

(±)-ALL-RAC-5-[P-[(6-HYDROXY-2,5,7,8-TETRA-METHYL-2-CHROMANYL)METHOXY]BENZYL]-2,4-THIAZOLIDINEDIONE.................... 274

(1 ALPHA,2 ALPHA,3 BETA,4 ALPHA,5 ALPHA,6 BETA)-HEXACHLOROCYCLOHEXANE..........................................................................

161

(11 ALPHA, 13E)-11, 16-DIHYDROXY-16-METHYL-9-OXOPROST-13-EN-1-OIC ACID METHYL ESTER.................................................... 182

(1R,2R,3R)-3-HYDROXY-2-[(E)-(3S)-HYDROXY-1-OCTENYL]-5-OXOCYCLOPENTANEHEPTANOIC ACID............................................... 40

(1S,2S)-(2-{[3-(2-BENZINIDAZOYLYL)PROPYL]METHYLAMINE}-ETHYL-6-FLUORO-1,2,3,4-TETRAHYDRO-1-ISOPROPYL-2-NAPHT 180

(2-(4-CHLOROPHENYL)-1,1-DIMETHYLETHYL)-CARBAMIC ACID.................................................................................................................
94

(2,3-DICHLORO-4-(2-THENOYL)-PHENOXY)ACETIC ACID.............................................................................................................................
266

(2,3-DICHLORO-4-(2-THIENYLCARBONYL)PHENOXY)-ACETIC ACID..........................................................................................................
266

(2-HYDROXY-BENZOATO-O)-OXOBISMUTH...................................................................................................................................................
64
(2R*,6R*,11R*)-1,2,3,4,5,6-HEXAHYDRO-6,11-DIMETHYL-3-(3-METHYL-2- BUTENYL)-2,6-METHANO-3-BENZAZOCIN-8-OL................ 204

(2S,3S)-3,4-DIMETHYL-2-PHENYLMORPHOLINE............................................................................................................................................
208

453
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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

(3R,5S,6E)-7-[4-(4-FLUOROPHENYL)-2,6-DIISOPROPYL-5-(METHOXYMETHYL)-3-PYRIDYL]-3,5-DIHYDROXY-6-HEPTENOIC ACID.. 77

(4-ALLYLOXY-3-CHLOROPHENYL) ACETIC ACID...........................................................................................................................................

38

(5Z, 11ALPHA, 13E, 15S)-11, 15-DIHYROXY-9-OXOPROSTA-5, 13-DIEN-1-OIC ACID.................................................................................

111

(9ALPHA,13ALPHA,14ALPHA)-3-METHOXY-17-METHYLMORPHINAN.........................................................................................................
105

(BICYCLOHEXYL)-1-CARBOXYLIC ACID, 2-(DIETHYLAMINO)ETHYL ESTER..............................................................................................

106

(E)-1-[BIS-(P-FLUOROPHENYL)METHYL]-4-CINNAMYLPIPERAZINE............................................................................................................
131

(E,Z)-(1R,2R,3R)-7-[3-HYDROXY-2-[(3S)-(3-HYDROXY-1-OCTENYL)]-5-OXOCYCLOPENTYL]-5-HEPTENOIC ACID................................ 111

(ETHYL-5 QUINUCLIDINYL-2(2)) (METHOXY-6' QUINOLYL-(4))......................................................................................................................

147

(HYDROXYMETHYL)BENZENE..........................................................................................................................................................................
60

(Ñ)-2'-[2-(1-METHYL-2-PIPERIDYL)ETHYL]-P-ANISANILIDE...........................................................................................................................
117

(O-(2,4-DICHLOROPHENOXY)PHENYL)ACETIC ACID....................................................................................................................................
126

(O-(6-O-BETA-D-GLUCOPYRANOSYL-BETA-D-GLUCOPYRANOSIDE)-D-MANDELONITRILE...................................................................157

(P-CHLORO-ALPHA,ALPHA-DIMETHYLPHENETHYL)-CARBAMIC ACID......................................................................................................
94

(S)-N-ETHYL-ALPHA-METHYL-3-(TRIFLUOROMETHYL)BENZENEETHANAMINE.......................................................................................
104

(S)-N-ETHYL-A-METHYL-3-TRIFLUROROMETHYLPHENETHYLAMINE HYDROCHLORIDE.......................................................................
105

(Z)-3-(1-P-BROMOPHENYL)-3-(DIMETHYLAMINO)PROPENYL)-PYRIDINE...................................................................................................
281

1-(2-{4-[5-CHLORO-1-(P-FLUOROPHENYL)INDOL-3-YL]PIPERIDINE}ETHYL)2-IMIDAZOLIDINONE..........................................................
239

1-(3,4-DIHYDROXYPHENYL)-2-ISOPROPYLAMINOETHANOL.......................................................................................................................
152

1-(3-BUTOXY-2-HYDROXYPROPYL)-5-ETHYL-5-PHENYLBARBITURIC ACID CARBAMATE ESTER/1,3-BIS-(3-BUTOXY-2-HYDROXY 291

1-(3-CYANO-3,3-DIPHENYLPROPYL)-4-PHENYL-ISONIPECOTIC ACID.......................................................................................................
109

1(3H)-ISOBENZOFURANONE, 3,3-BIS(4-HYDROXYPHENYL)........................................................................................................................
213

1(3H)-ISOBENZOFURANONE, 6,7-DIMETHOXY-3-(5,6,7,8-TETRAHYDRO-4-METHOXY-6-METHYL-1,3-DIOXOLO[4,5-G]-ISOQUINOLI 193

1-(4-ISOPROPYLTHIOPHENYL)-2-OCTYLAMINOPROPAN-1-OL...................................................................................................................
251

1-(P-CHLORO-ALPHA-PHENYLBENZYL)-4-(M-METHYLBENZYL)PIPERAZINE............................................................................................
167

1-(P-CHLOROPHENETHYL)-1,2,3,4-TETRAHYDRO-6,7-DIMETHOXY-2- METHYLISOQUINOLINE.............................................................179

1-(P-CHLOROPHENYL)-2-METHYL-2-AMINOPROPANE.................................................................................................................................
84

1-(P-FLUOROBENZYL)-2-[[1-(P-METHOXYPHENETHYL)-4-PIPERIDYL]AMINO]BENZIMIDAZOLE............................................................. 54

1,1,1-TRICHLOOR-2,2-BIS(4-CHLOOR FENYL)-ETHAAN (NLD).....................................................................................................................

92

1,1,1-TRICHLOR-2,2-BIS(4-CHLOR-PHENYL)-AETHAN (DEU).......................................................................................................................
92
1,1,1-TRICHLORO-2,2-BIS(4-CHLOROPHENYL)ETHANE...............................................................................................................................
92

1,1,1-TRICHLORO-2,2-BIS(P-CHLOROPHENYL)ETHANE...............................................................................................................................
92

454
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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

1,1,1-TRICHLORO-2,2-DI(4-CHLOROPHENYL)-ETHANE................................................................................................................................
92

1,1,1-TRICLORO-2,2-BIS(4-CLORO-FENIL)-ETANO (ITA)...............................................................................................................................
92

1,1'-DECAMETHYLENEBIS (4-AMINOQUINALDINIUM CHLORIDE)................................................................................................................

104

1,1-DIPHENYL-1-(2-PIPERIDYL)-METHANOL...................................................................................................................................................
222

1,2,3,4,10,14B-HEXAHYDRO-2-METHYLDIBENZO(C,F)-PYRAZINO(1,2-A)AZEPINE....................................................................................
180

1,2,4-TRIAZINE-3,5(2H,4H)-DIONE, 2-(2,3,5-TRI-O-ACETYL-BETA- RIBOFURANOSYL)-............................................................................

56

1,2,4-TRIAZINE-3,5-DIAMINE, 6-(2,3-DICHLOROPHENYL)-.............................................................................................................................
158

1,2,4-TRIAZOLO(4,3-A)PYRIDIN-3(2H)-ONE, 2-(3-(4-(3-CHLOROPHENYL)-1- PIPERAZINYL)PROPYL)-...................................................270

1,2-DICHLOROETHANE......................................................................................................................................................................................
123

1,2-DIHYDRO-1,5-DIMETHYL-2-PHENYL-3H-PYRAZOLE-3-ONE...................................................................................................................
208

1,2-DITHIOLANE-3-PENTANOIC ACID..............................................................................................................................................................
162

1,2-ETHANEDIAMINE, N,N-DIMETHYL-N'-2-PYRIDINYL-N'-(2-THIENYLMETHYL)........................................................................................
175

1,3-BENZENEDIOL,5-[1-HYDROXY-2-[[2-(4-HYDROXYPHENYL-1-METHYLETHYL]AMINO]ETHYL]-..........................................................
128

1,3-BIS(5-NITROFURFURYLIDEN)ACETONEGUANYLHYDRAZONE.............................................................................................................
109

1,3-PROPANEDIOL, 2-METHYL-2-PROPYL-, DICARBAMATE........................................................................................................................

170

1,4-BIS(1-PHENYLISOPROPYL)PIPERAZINE...................................................................................................................................................
112

1,4-BIS(ALPHA-METHYLPHENETHYL)PIPERAZINE........................................................................................................................................
112

1,4-PENTANEDIAMINE, N4-(7-CHLORO-4-QUINOLINYL)-N1,N1-DIETHYL-..................................................................................................
83

1,5-(BUTYLIMINO)-1,5-DIDEOXY-D-GLUCITOL................................................................................................................................................
181

1,7,7-TRIMETHYLBICYCLO(2,2,1)HEPTANE-2-ONE........................................................................................................................................
73

1,8-DIHYDROXYANTHRAQUINONE..................................................................................................................................................................
101

1-[(1-PYRROLIDINYLCARBONYL)METHYL]-4-(3,4,5-TRIMETHOXYCINNAMOYL) PIPERAZINE.................................................................85

1[(4-FLUOROPHENYL)METHYL]-N-[1-[2-(4-METHOXYPHENYL)ETHYL]- 4-PIPERIDINYL]-1H-BENZIMIDAZOL-2-AMINE........................ 54

1-[(P-CHLOROPHENOXY)ACETYL]-4-PIPERONYLPIPERAZINE....................................................................................................................
129

1-[[3-(4,7-DIHYDRO-1-METHYL-7-OXO-3-PROPYL-1-H-PYRAZOLO[4,3-D]PYRIMIDIN-5-YL)-4-ETHOXYPHENYL]SULFONYL]-4-METH 240

1-[1-[4-(FLUOROPHENYL)-4-OXOBUTYL]-1,2,3,6-TETRAHYDRO-4-PYRIDINYL]-1,3-DIHYDRO-2H-BENZIMIDAZOL-2-ONE................... 116

10-(2-DIMETHYLAMINO)ETHYL)-5,10-DIHYDRO-5-METHYL-11H-DIBENZO(B,E),(1,4)-DIAZEPIN-11-ONE MONOHYDROCHLORIDE... 105

10-(3-(4-CARBAMOYLPIPERIDINO)PROPYL)-2-CHLOROPHENOTHIAZINE.................................................................................................
221

10-[2-(DIMETHYLAMINO)PROPYL]-PHENOTHIAZINE.....................................................................................................................................
230
10H-PHENOTHIAZINE-10-ETHANAMINE, N,N,ALPHA-TRIMETHYL-..............................................................................................................
230

10H-PHENOTHIAZINE-10-ETHANAMINE, N,N,?-TRIMETHYL-, MONOHYDROCHLORIDE..........................................................................

230

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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

11BETA-[P-(DIMETHYLAMINO)PHENYL]-17BETA-HYDROXY-17-(1-PROPYNYL)ESTRA-4,9-DIEN-3-ONE............................................... 181

11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO[3,2-B:2 1,3 1-E][1,4]DIAZEPIN-6-ONE........................................................

188

11H-DIBENZO(B,E)(1,4)-DIAZEPIN-11-ONE, 10-(2-DIMETHYLAMINO)-ETHYL)-5, 10-DIHYDRO-5-METHYL-, MONOHYDROCHLORID 105

1-235-TUMOR NECROSIS FACTOR RECEPTOR (HUMAN) FUSION PROTEIN WITH 236-467-IMMUNOGLOBULIN G1 (HUMAN GAM 121

17ALPHA-(2-CARBOXYETHYL)-17BETA-HYDROXYANDROSTA-4,6-DIEN-3-ONE LACTONE.................................................................... 74

17BETA-HYDROXYESTR-4-EN-3-ONE DECANOATE.....................................................................................................................................
186

17BETA-HYDROXYESTR-4-EN-3-ONE HYDROCINNAMATE..........................................................................................................................
186

17-HYDROXY-19-NOR-17ALPHA-PREGN-4-EN-20-YN-3-ONE.......................................................................................................................
192

17-HYDROXY-3-OXO-17ALPHA-PREGNA-4,6-DIENE-21-CARBOXYLIC ACID GAMMA- LACTONE............................................................ 74

17-HYDROXY-6ALPHA-METHYL-PREGN-4EN-20-ONE-ACETATE................................................................................................................
50

17-HYDROXY-6ALPHA-METHYLPREGN-4-ENE-3,20-DIONE ACETATE.......................................................................................................
102

17-HYDROXY-6-METHYLPREGNA-4,6-DIENE-3,20-DIONE ACETATE..........................................................................................................
168

17-HYDROXY-7ALPHA-MERCAPTO-3-OXO-17ALPHA-PREGN-4-ENE-21-CARBOXYLIC ACID, GAMMA-LACTONE ACETATE............. 243

19 NORPREGN-4-EN-20-YN-17-OL, (17ALPHA)-..............................................................................................................................................
166

19-NOR-17-ALPHA-PREGN-4-EN-17-BETA-OL................................................................................................................................................
123

19-NOR-17-ALPHA-PREGN-4-EN-20-YN-17-OL...............................................................................................................................................
166

19-NORPREGN-4-EN-17-OL,(17-ALPHA)..........................................................................................................................................................
123

19-NORPREGN-4-EN-20-YN-3-ONE, 17-HYDROXY-, (17ALPHA)-..................................................................................................................

192

1ALPHA H, 5ALPHA H-TROPAN-3ALPHA-OL (+/-)-TROPATE (ESTER)........................................................................................................

290

1-BUTYLBIGUANIDE...........................................................................................................................................................................................
70

1-CINNAMYL-4-(DIPHENYLMETHYL) PIPERAZINE.........................................................................................................................................
86

1-ETHYL-3-HYDROXY-1-METHYLPIPERIDINIUM BENZILATE........................................................................................................................
221

1H-BENZIMIDAZOL-2-AMINE, 1[(4-FLUOROPHENYL)METHYL]-N-[1-[2-(4-METHOXYPHENYL)ETHYL]-4-PIPERIDINYL]-....................... 54

1H-BENZIMIDAZOLE, 5-METHOXY-2-[[(4-METHOXY-3,5-DIMETHYL-2-PYRIDINYL)METHYL]SULFINYL]-.................................................194

1H-IMIDAZOLE-5-CARBOXYLIC ACID, 1-(1-PHENYLETHYL)-, ETHYL ESTER(+).........................................................................................

124

1H-INDOLE-3-ACETIC ACID, 1-(4-CHLOROBENZOYL)-5-METHOXY-2-METHYL-.........................................................................................

149

1H-INDOLE-5-METHANESULFONAMIDE, 3-[2-(DIMETHYLAMINO)ETHYL]-N-METHYL-, BUTANEDIOATE (1:1)....................................... 252

1H-ISOINDOLE-1,3(2H)-DIONE, 2-(2,6-DIOXO-3-PIPERIDINYL)-....................................................................................................................
263

1H-PURINE-2,6-DIONE,3,7-DIHYDRO-1,3-DIMETHYL-7-[2-[(1-METHYL-2-PHENYLETHYL)AMINO]ETHYL]-.............................................127

1H-PYRAZOLO(1,2-A)(1,2,4)BENZOTRIAZINE-1,3(2H)-DIONE, 5-(DIMETHYLAMINO) -9-METHYL-2-PROPYL-......................................... 56

1H-PYRROLE-2-ACETIC ACID, 5-(4-CHLOROBENZOYL)-1,4-DIMETHYL-....................................................................................................

282

456
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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

1H-PYRROLIZINE-1-CARBOXYLIC ACID, 5-BENZOYL-2,3-DIHYDRO, (±)-, COMPOUND WITH2-AMINO-2-(HYDROXYMETHYL)-1,3-P 156

1-METHOXY 3-(4-(BETA-METHOXYPHENETHYL)-PIPERAZIN-1-YL)-1-PHENYLPROPAN- 2-OL............................................................... 281

1-METHYL-4-N-2-THENYLANILINOPIPERIDINE...............................................................................................................................................
263

1-NAPHTHALENEMETHANAMINE, N-(6,6-DIMETHYL-2-HEPTEN-4-YNYL)-N-METHYL-, (E)-.....................................................................

257

1-PHENETHYLBIGUANIDE.................................................................................................................................................................................
209

1-PHENETHYLBIGUANIDE HCL........................................................................................................................................................................
209

1-PHENYLSEMICARBAZIDE..............................................................................................................................................................................
211

1-PIPERIDINEBUTANAMIDE, 4-(4-CHLOROPHENYL)-4-HYDROXY-N,N-DIMETHYL-ALPHA, ALPHA-DIPHENYL..................................... 162

1-PIPERIDINEBUTANOL.....................................................................................................................................................................................
258

1-PIPERIDINEBUTANOL, ?-[4-(1,1-DIMETHYLETHYL)PHENYL]-4-(HYDROXYDIPHENYLMETHYL)-.........................................................
258

1-PIPERIDINEPROPANOIC ACID, 4-(METHOXYCARBONYL)-4-[(1-OXOPROPYL)PHENYLAMINO]-, METHYL ESTER,MONOHYDROC 235

1-PROPANONE, 1-[2-[2-HYDROXY-3-(PROPYLAMINO)PROPOXY]PHENYL]-3-PHENYL-...........................................................................
230

1-PROPANONE, 2-(DIETHYLAMINO)-1-PHENYL-,...........................................................................................................................................
42

1-VINYL-2-PYRROLIDINONE POLYMER...........................................................................................................................................................
225

2((2-(DIMETHYLAMINO)ETHYL)-2-THENYLAMINO)PYRIDINE........................................................................................................................
175

2-(2-DIETHYLAMINOETHOXY)ETHYL 2 ETHYL-2-PHENYLBUTARATE DIHYDROGEN CITRATE..............................................................196

2-(2-DIETHYLAMINOETHOXY)ETHYL 2-ETHYL-2-PHENYLBUTYRATE........................................................................................................
196

2-(3-(4-(M-CHLOROPHENYL)-1-PIPERAZINYL)PROPYL)-S-TRIAZOLO(4,3-A) PYRIDIN-3(2H)-ONE..........................................................270

2-(3-(4-PIPERIDYL)ETHYL)INDOLE...................................................................................................................................................................
149

2-(3-BUTYRAMIDO-3,4,6-TRIIODOPHENYL-METHYLENE)-BUTYRIC ACID..................................................................................................
71

2-(3-CHLORO-4-(3-PYOLIN-1-YL)PHENYL) PROPIONIC ACID.......................................................................................................................

223

2(3H)-ISOBENZOFURANONE, 3,3-BIS(4-HYDROXYPHENYL)-.......................................................................................................................
213

2-(4-AMINOPHENYL)-2-ETHYLGLUTARIMIDE..................................................................................................................................................
44

2-(4-ISOBUTYLPHENYL)PROPIONIC ACID......................................................................................................................................................
149

2-(DIETHYLAMINO)ETHYL (BICYCLOHEXYL)-1-CARBOXYLATE...................................................................................................................
106

2-(DIETHYLAMINO)PROPIOPHENONE.............................................................................................................................................................
42

2-(DIMETHYLAMINO)-1,1-DIMETHYLETHYL BENZILATE................................................................................................................................
108

2-(ISOPROPYLAMINO)PYRIMIDINE..................................................................................................................................................................
151

2-(P-BUTOXYPHEYL)ACETOHYDROXAMIC ACID...........................................................................................................................................
69
2-(P-CHLOROPHENYL)-TETRAHYDRO-3-METHYL-4H-1,3-THIAZIN-4-ONE 1,1-DIOXIDE...........................................................................
80

2,2',2'-NITRILOTRIETHANOL..............................................................................................................................................................................
275

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SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

2,2-BIS(P-CHLOROPHENYL)-1,1,1-TRICHLOROETHANE...............................................................................................................................
92

2,2-DIMETHY-5-(2,5-XYLYLOXY)VALERIC ACID..............................................................................................................................................
135

2,2'-METHYLENEBIS(3,4,6-TRICHLOROPHENOL)...........................................................................................................................................
145

2,2'-THIOBIS(4,6-DICHLOROPHENOL)..............................................................................................................................................................
65

2,3-DIHYDROXYPROPYL-N-(7-CHLORO-4-QUINOLYL) ANTHRANILATE.....................................................................................................
137

2,3-DIHYDROXYPROPYL-N-(8-TRIFLUOROMETHYL-4-)QUINOLYL)ANTHRANILATE.................................................................................
131

2,3-DIMETHYL-1-PHENYL-3-PYRAZOLIN-5-ONE.............................................................................................................................................
208

2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-(1-CYCLOHEXEN-1-YL)-1,5-DIMETHYL-.......................................................................................
146

2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-(1-METHYLBUTYL)-5-(2-PROPENYL)-...........................................................................................
238

2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-ETHYL-5-(1-METHYLBUTYL)-.........................................................................................................
204

2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-ETHYL-5-(3-METHYL-BUTYL)-.......................................................................................................
49

2,4,6(1H,3H,5H)-PYRIMIDINETRIONE, 5-ETHYL-5-PHENYL-..........................................................................................................................
211

2,4,6,8-NONATETRAENOIC ACID, 9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-, ETHYL ESTER, (ALL-E)-............................................... 124

2,4,6,8-NONATRAENOIC ACID, 9-(4-METHOXY-2,3,6-TRIMETHYLPHENYL)-3,7-DIMETHYL-2,4,6,8-NONATETRAENOIC ACID, (ALL- 36

2,4-BIS(ALLYLAMINO)-6-(4-(BIS-(P-FLUOROPHENYL)METHYL)-1-PIPERAZINYL)-S- TRIAZINE................................................................39

2,4-IMIDAZOLIDENEDIONE, 1-[[5-NITRO-2-FURANYL)METHYLENE]AMINO]-..............................................................................................
191

2,4-PIPERIDINEDIONE, 3,3-DIETHYL-5-METHYL-............................................................................................................................................
178

2,4-THIAZOLIDINEDIONE, 5-[[4-[3,4-DIHYDRO-6-HYDROXY-2,5,7,8-TETRAMETHYL-2H-BENZOPYRAN-2-YL)METHOXY]-PHENYL]M 274

2,6-BIS(1-METHYLETHYL)PHENOL...................................................................................................................................................................
231

2,6-DIAMINO-3-(PHENYLAZO)PYRIDINE..........................................................................................................................................................
208

2,6-DI-ISOPROPYLPHENOL...............................................................................................................................................................................
231

2,6-METHANO-3-BENZAZOCIN-8-OL, 1,2,3,4,5,6-HEXAHYDRO-6,11-DIMETHYL-3-( 3-METHYL-2-BUTENYL)-, (2ALPHA,6ALPHA-11R 204

2,6-PIPERIDINEDIONE, 3-(4-AMINOPHENYL)-3-ETHYL-.................................................................................................................................
44

2,6-PIPERIDINEDIONE, 3-ETHYL-3-PHENYL-..................................................................................................................................................
139

2,6-PYRIDINEDIAMINE, 3-(PHENYLAZO)..........................................................................................................................................................
208

2'-[HYDROXY-3-(PROPYLAMINO)PROPOXY]-3-PHENYLPROPIOPHENONE...............................................................................................
230

21-CYCLOPROPYL-7ALPHA-((S)-1-HYDROXY-1,2,2-TRIMETHYLPROPYL))-6,14-ENDO-ETHANO-6,7,8,14-TETRAHYDRO-ORIPAVIN 71

27267-RP........................................................................................................................................................................................................
282

2-AMINO-2',6'-PROPIONOXYLIDIDE..................................................................................................................................................................
267
2-AMINO-2-DEOXY-BETA-D-GLUCOPYRANOSE SULFATE...........................................................................................................................
138

2-AMINO-5-PHENYL-2-OXAZOLINE...................................................................................................................................................................
48

458
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AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

2-BENZENEDIOL, 4-(1-HYDROXY-2-(METHYLAMINO)ETHYL)-,(R)-..............................................................................................................
118

2-BETA-D-RIBOFURANOSYL-AS-TRIAZINE-3, -5(2H,4H)-DIONE 2',3',5',- TRIACETATE..............................................................................

56

2-BORNANONE...................................................................................................................................................................................................
73

2-BROMO-3-METHYLBUTYRYLUREA...............................................................................................................................................................
68

2-BROMO-ALPHA-ERGOCRYPTINE.................................................................................................................................................................
68

2-CAMPHANONE.................................................................................................................................................................................................
73

2-ETHYL-2-PHENYLGLUTARIMIDE...................................................................................................................................................................
139

2-ETHYLBENZOFURAN-3-YL 4-HYDROXYPHENYL KETONE........................................................................................................................

59

2-FURANPROPANOIC ACID, TETRAHYDRO-?-(1-NAPHTHALENYLMETHYL)-, 2-(DIETHYLAMINO)ETHYL ESTER,ETHANEDIOATE 185

2H-1,2,4-BENZOTHIADIAZINE-7-SULFONAMIDE, 6-CHLORO-3-(CYCLOPENTYLMETHYL)-3,4-DIHYDRO-,1,1-DIOXIDE........................ 99

2H-1,2-BENZOTHIAZINE-3-CARBOXIMIDE, 4-HYDROXY-2-METHYL-N-(5-METHYL-3- ISOXAZOLYL)-, 1,1-DIOXIDE............................... 154

2H-1,4-BENZODIAZEPIN-2-ONE, 5-(2-FLUOROPHENYL)-1,3-DIHYDRO-1-METHYL-7- NITRO-..................................................................

132

2H-1-BENZOPYRAN-2-ONE...............................................................................................................................................................................
97

2H-1-BENZOPYRAN-2-ONE,4-HYDROXY-3-(3-OXO-1-PHENYLBUTYL)-.......................................................................................................
280

2H-BENZIMIDAZOL-2-ONE, 5-CHLORO-1-(1-(3-(2,3-DIHYDRO-2-OXO-1H- BENZIMIDAZOL-1-YL)PROPYL)-4-PIPERIDINYL)1,3-DIHY 114

2H-INDOL-2-ONE,3,3-BIS(4-ACETYLOXY)PHENYL)-1,3-DIHYDRO-...............................................................................................................
199

2-HYDROXYBENZOIC ACID BISMUTH (3+) SALT1..........................................................................................................................................

64

2-METHYL-2-PROPYL-1,3-PROPANEDIOL DICARBAMATE...........................................................................................................................
170

2-METHYL-3-O-TOLYL-4(3H)-QUINAZOLINONE..............................................................................................................................................
177

2-METHYL-4-NITRO-1-(4-NITROPHENYL)IMIDAZOLE.....................................................................................................................................
190

2-NAPHTACENECABOXAMIDE,4,7-BIS(DIMETHYLAMINO)-1,-4,4A,5,5A,6,11,12A-OCTAHYDRO-3,10,12,12A-TETRAHYDROXY-1,-11 182

2-NAPHTACENECARBOXAMIDE,4-(DIMETHYLAMINO)-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-3,5,10,12,12A-PENTAHYDROXY-6-MET 115

2-NAPHTHACENECARBOXAMIDE, 4-(DIMETHYLAMINO)-1,4,4A,5,5A,6,11,12A- OCTAHYDRO-3,6,10,12,12A-PENTAHYDROXY-6-M 261

2-NAPHTHALENAMINE, N,N-BIS(2-CHLOROETHYL)-.....................................................................................................................................
81

2-OXAZOLAMINE, 4,5-DIHYDRO-5-PHENYL-...................................................................................................................................................
48

2-OXAZOLIDINONE, 3-(((5-NITRO-2-FURANYL)METHYLENE)AMINO)-.........................................................................................................
134

2-PHENYL-2-(2-PIPERIDYL)ACETIC ACID, METHYL ESTER..........................................................................................................................

178

2-PHENYLCINCHONINIC ACID..........................................................................................................................................................................
85

2-PHENYLQUINOLINE-4-CARBOXYLIC ACID...................................................................................................................................................
85
2-PIPERIDINEACETIC ACID, ALPHA-PHENYL-, METHYL ESTER, (R*,R*)-(+/-)............................................................................................
178

2-PROPEN-1-AMINE, 3-(4-BROMOPHENYL)-N,N-DIMETHYL-3-(3-PYRIDINYL-, (Z)-....................................................................................

281

459
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

2-PROPYLPENTANOIC ACID.............................................................................................................................................................................
278

2-PYRROLIDINONE, 1-ETHENYL-, HOMOPOLYMER......................................................................................................................................

225

3-((5-NITROFURFURYLIDENE)AMINO)-2-OXAZOLIDINONE...........................................................................................................................
134

3-((5-NITROFURFURYLIDENE)AMINO)-2-OXAZOLIDONE..............................................................................................................................
134

3-(10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTEN-5-YLIDENE)PROPYLDIMETHYLAMINE.................................................................48

3-(ALPHA-ACETONYLBENZYL)-4-HYDROXYCOUMARIN...............................................................................................................................
280

3-(DIBENZ[B,E]OXEPIN-11-YLIDENE)PROPYL-DIMETHYLAMINE.................................................................................................................
115

3-(O-METHYLPHENOXY)-1,2-PROPANEDIOL..................................................................................................................................................
170

3-(P-CHLOROBENZOYL)-6-METHOXY-2-METHYLINDOLE-1-ACETIC ACID.................................................................................................
94

3,3'-(DITHIODIMETHYLENE)BIS(5-HYDROXY-6-METHYL-4-PYRIDINEMETHANOL)....................................................................................
234

3,3,5-TRIMETHYLCYCLOHEXANOL ?-PHENYL-?-HYDROXYACETATE.......................................................................................................
99

3,3,5-TRIMETHYLCYCLOHEXYL MANDELATE................................................................................................................................................
99

3,3-BIS(4-HYDROPHENYL)-PHTHALIDE...........................................................................................................................................................
213

3,3-BIS(4-HYDROXYPHENYL)-1(3H)-ISOBENZOFURANONE.........................................................................................................................
213

3,3-BIS(P-HYDROXYPHENYL)-2-INDOLINONE DIACETATE..........................................................................................................................
199

3,3-BIS-(P-HYDROXYPHENYL)PHTHALIDE.....................................................................................................................................................
213

3,3-DIETHYL-5-METHYL-2,4-PIPERIDINEDIONE..............................................................................................................................................
178

3,4-DIDEOXY-4-[[2-HYDROXY-1-(HYDROXYMETHYL)ETHYL]AMINO]-2-C-(HYDROXYMETHYL)-D-EPI-INOSITOL.................................. 280

3,4-DIHYDROXY-4?-METHYL-5 NITROBENZOPHENONE..............................................................................................................................
268

3,4-DIHYDROXY-5-NITROPHENYL (4-METHYLPHENYL)METAHANONE......................................................................................................
268

3,4-DIHYDROXY-ALPHA-((METHYLAMINO)METHYL)-BENZYL ALCOHOL....................................................................................................
118

3,4-PYRIDINEDIMETHANOL, 5-HYDROXY-6-METHYL-, HYDROCHLORIDE.................................................................................................

233

3,5-DIHYDROXY-ALPHA-[[P-HYDROXY-ALPHA-METHYLPHENYLETHYL)AMINO]METHYL]BENZYL ALCOHOL...................................... 128

3,5-PYRAZOLIDINEDIONE, 4-BUTYL-1-(4-HYDROXYPHENYL)-2-PHENYL-.................................................................................................
197

3,5-PYRAZOLIDINEDIONE, 4-BUTYL-1,2-DIPHENYL-......................................................................................................................................
216

3,5-PYRAZOLIDINEDIONE, 4-BUTYL-1,2-DIPHENYL-4-BUTYL-1,2-DIPHENYYL-3,5,PYRAZOLIDINEDIONE.............................................
221

3,5-PYRIDINEDICARBOXYLIC ACID, 1,4-DIHYDRO-2,6-DIMETHYL-4-(2-NITROPHENYL)-, DIMETHYL ESTER........................................189

3,5-PYRIDINEDICARBOXYLIC ACID, 1,4-DIHYDRO-2,6-DIMETHYL-4-(3- NITROPHENYL)-, ETHYL METHYL ESTER, (+/-)..................... 190

3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2,4,6,8-NONATETRAEN-1-OL........................................................................
236
3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)2-CIS-4-TRANS-6- TRANS-8-TRANS-NONATETRAENOIC ACID............... 152

3-[(1/BENZYLCYCLOHEPTYL)OXY]-N,N-DIMETHYLPROPYLAMINE.............................................................................................................
58

460
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

3-[[[2-[(AMINOIMINOMETHYL)AMINO]-4-THIAZOLYL]METHYL]THIO-N-(AMINOSULFONYL)PROPANIMIDAMIDE.................................... 126

3ALPHA,7ALPHA-DIHYDROXY-5BETA-CHOLAN-24-OIC ACID......................................................................................................................
78

3-AMINO-1-(3,4-DICHLORO-ALPHA-METHYLBENZYL)-2-PYRAZOLIN-5-ONE..............................................................................................
184

3BETA-HYDROXYANDROST-5-EN-17-ONE.....................................................................................................................................................
228

3-CHLORO-4-(3-PYRROLIN-1-YL) HYDRATROPIC ACID................................................................................................................................

223

3-ETHYL-2-(5-(3-ETHYL-2(3H)-BENZOTHIAZOLYLIDENE)-1,3-PENTADIENYL)- BENZOTHIAZOLIUM IODIDE......................................... 114

3-ETHYL-2-(5-(3-ETHYL-2-BENZOTHIAZOLINYLIDENE)-1,3-PENTADIENYL) BENZOTHIAZOLIUM IODIDE..............................................113

3'H-CYCLOPROPA[1,2]PREGNA-1,4,6-TRIENE-3,20-DIONE, 17-(ACETYLOXY)-6-CHLORO-1,2-DIHYDRO-, (1?,2?)-.............................. 100

3H-PYRAZOL-3-ONE, 5-AMINO-2-(1-(3,4-DICHLOROPHENYL)ETHYL)-2,4-DIHYDRO-................................................................................
184

3-HYDROXYDIAZEPAM......................................................................................................................................................................................
257

3-HYDROXY-P-BUTYROPHENETIDIDE............................................................................................................................................................
69

3-ISOXAZOLECARBOXYLIC ACID, 5-METHYL-, 2-(PHENYLMETHYL)HYDRAZIDE......................................................................................

151

3-METHYL-2-PHENYLMORPHOLINE.................................................................................................................................................................
211

3-METHYL-N-SULPHANILYLCROTONAMIDE...................................................................................................................................................
245

3TC........................................................................................................................................................................................................
158

4-((7-CHLORO-4-QUINOLYL)AMINO)-ALPHA-(DIETHYLAMINO)-O-CRESOL................................................................................................
49

4-((ALPHA-(P-CHLOROPHENYL)-5-FLUOROSALICYLIDENE)AMINO)BUTYRAMIDE...................................................................................
229

4(1H)-QUINOLINONE, 7-FLUORO-1-METHYL-3-(METHYLSULFINYL)-..........................................................................................................
131

4-(1-HYDROXY-2-(METHYLAMINO)-ETHYL)-1,2-BENZENEDIOL...................................................................................................................
118

4-(2-(BIPHENYL-4-YL)-1-ETHOXY-2-OXOETHYLAMINO)BENZOIC ACID......................................................................................................
281

4-(2-DIMETHYLAMINOETHOXY)5-ISOPROPYL-2-METHYLPHENYL ACETATE............................................................................................
183

4'-(2-HYDROXY-3-(ISOPROPYLAMINO)-PROPOXY)ACETANILIDE................................................................................................................
227

4-(2-THENOYL)-2,3-DICHLOROPHENOXYACETIC ACID................................................................................................................................
266

4'-(2-THIAZOLYLSULFAMOYL)PHTHALANILIC ACID.......................................................................................................................................
220

4(3H)-QUINAZOLINONE, 2-METHYL-3-(2-METHYLPHENYL)-.........................................................................................................................
177

4-(3-METHYL-2-BUTENYL)-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE..........................................................................................................
128

4-(3-METHYLBUT-2-ENYL)-1,2-DIPHENYLPYRAZOLIDONE-3,5-DIONE........................................................................................................
128

4-(3-OXOBUTYL)-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE..........................................................................................................................
155

4-(4,6-DIMETHYLPRIMIDINE-2-YL)SULPHANILIMIDE......................................................................................................................................
246
4(5H-)-OXAZOLONE, 2-AMINO-5-PHENYL-......................................................................................................................................................
203

4-(DIMETHYLAMINO)-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-3,6,10,12,12A- PENTAHYDROXY-6-METHYL-1,11-DIOXO-2-NAPHTHACE 261

461
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

4-(P-CHLOROPHENYL)-4-HYDROXY-N,N-DIMETHYL-ALPHA,ALPHA-DIPHENYL-1- PIPERIDINEBUTYRAMIDE..................................... 162

4,4'-(1,2-DIETHYLETHYLENE)DIPHENOL.........................................................................................................................................................
146

4,4'-(1,2-DIETHYLIDENE-1,2-ETHANEDIYL)BIS-PHENOL,(E,E)-.....................................................................................................................
107

4,4'-DICHLORODIPHENYLTRICHLOROETHANE.............................................................................................................................................
92

4-4 1-(1,2-DIETHYL-1,2-ETHANEDIYL)BIS[PHENOL].......................................................................................................................................
146

4-ACETAMIDOPHENYL SALICYLATE ACETATE.............................................................................................................................................

58

4-AMINOBENZENESULPHONAMIDE................................................................................................................................................................
249

4-AMINOHEX-5-ENOIC ACID..............................................................................................................................................................................
278

4-BUTYL-(4-HYDROXYMETHYL)-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE HYDROGEN SUCCINATE....................................................

255

4-BUTYL-1-(P-HYDROXYPHENYL)-2-PHENYL-3,5-PYRAZOLIDINEDIONE...................................................................................................
197

4-BUTYL-1,2-DIPHENYL-3,5-PYRAZOLIDINEDIONE........................................................................................................................................
216

4-BUTYL-1-PHENYL-3,5-PYRAZOLIDINEDIONE..............................................................................................................................................
182

4-CHLORO-ALPHA,ALPHA-DIMETHYL-BENZENEETHANAMINE...................................................................................................................
84

4-DIMETHYLAMINO-2,3-DIMETHYL-1-PHENYL-3-PYRAZOLIN-5-ONE..........................................................................................................
45

4H-(1,2,4)TRIAZOLO(4,3-A)(1,4)BENZODIAZEPINE, 8-CHLORO-6-(2- CHLOROPHENYL)-1-METHYL-......................................................272

4-HYDROXY-2-METHYL-N-(5-METHYL-3-ISOXAZOLYL)-2H-1,2-BENZOTHIAZINE-3- CARBOXAMIDE 1,1-DIOXIDE................................ 154

4-ISOPROPYL-2,3-DIMETHYL-1-PHENYL-3-PYRAZOLIN-5-ONE...................................................................................................................
232

4-METHYL-1-PIPERAZINECARBOXYLIC ACID ESTER WITH 6-(5-CHLORO-2-PYRIDYL)- 6,7-DIHYDRO-7-HYDROXY-5H-PYRROLO( 282

4-PIPERIDINECARBOXYLIC ACID, 1-(3-CYANO-3,3-DIPHENYLPROPYL)-4-PHENLY,-ETHYL...................................................................

113

4-PIPERIDINECARBOXYLIC ACID, 1-(3-CYANO-3,3-DIPHENYLPROPYL)-4-PHENYL-................................................................................

109

4-QUINOLINEMETHANOL, ?-2-PIPERIDINYL-2,8-BIS(TRIFLUOROMETHYL)-, (R*, S*)-(±)-.........................................................................

168

5-(1-CYCLOHEXEN-1-YL)-1,5-DIMETHYLBARBITURIC ACID.........................................................................................................................
146

5-(2-CHLOROETHYL)-4-METHYLTHIAZOLE.....................................................................................................................................................
95

5-(CYCLOHEPT-1-ENYL)-5-ETHYLBARBITURIC ACID....................................................................................................................................
144

5-(CYCLOHEX-1-ENYL)-1,5-DIMETHYLBARBITURIC ACID.............................................................................................................................
146

5-(O-CHLOROBENZYL)-4,5,6,7-TETRAHYDROTHIENO-(3,2-C)PYRIDINE....................................................................................................
265

5-(O-FLUOROPHENYL)-1,3-DIHYDRO-1-METHYL-7-NITRO-2H-1,4-BENZODIAZEPIN-2- ONE...................................................................
132

5-(P-CHLOROBENZOYL)-1,4-DIMETHYLPYRROLE-2-ACETATE...................................................................................................................
282

5-(P-CHLOROBENZOYL)-1,4-DIMETHYLPYRROLE-2-ACETIC ACID.............................................................................................................
282
5-(P-CHLOROPHENYL)-2,5-DIHYDRO-3H-IMIDAZOL[2,1-A]ISOINDOL-5-OL.................................................................................................
167

5,5-DIETHYLBARBITURIC ACID.........................................................................................................................................................................
57

462
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

5,6-DIHYDRO-9,10-DIMETHOXY-BENZO(G)-1,3-BENZODIOXOLO(5,6-A) QUINOLIZINIUM.........................................................................
62

5,7-DIBROMO-8-QUINOLINOL............................................................................................................................................................................
68

5-ALLYL-5-(1-METHYLBUTYL) BARBITURIC ACID..........................................................................................................................................

238

5-ALLYL-5-(2-HYDROXYPROPYL)BARBITURIC ACID.....................................................................................................................................
232

5-ALLYL-5-ISOPROPYLBARBITURIC ACID.......................................................................................................................................................
52

5-AMINO-1-CYCLOPROPYL-7-(CIS-3,5-DIMETHYLPIPERAZIN-1-YL)-6,8-DIFLUORO-4-OXOQUINOLINE-3-CARBOXYLIC ACID............ 243

5-BENZOXAZOLEACETIC ACID, 2-(4-CHLOROPHENYL)-ALPHA-METHYL, (+/-).........................................................................................

59

5-BENZOYL-?-METHYL-2-THIOPHENEACETIC ACID.....................................................................................................................................
265

5-CHLORO-1-(1-(3-(2-OXO-1-BENZIMIDAZOLINYL)PROPYL)-4-PIPERIDYL)-2- BENZIMIDAZOLINONE....................................................114

5-CHLORO-7-IODO-8-QUINOLINOL...................................................................................................................................................................
89

5-CHLORO-7-IODOQUINOLINOL.......................................................................................................................................................................
89

5-DIMETHYLAMINO-9-METHYL-2-PROPYL-1H-PYRAZOLO(1,2-A)(1,2,4)BENZOTRIAZINE-1, 3(2H)-DIONE............................................. 56

5-ETHYL-5-(1-METHYLBUT-1-ENYL)BARBITURIC ACID.................................................................................................................................
279

5-ETHYL-5-(1-METHYLBUTYL)BARBITURIC ACID...........................................................................................................................................
204

5-ETHYL-5-ISOPENTYLBARBITURIC ACID......................................................................................................................................................
49

5-ETHYL-5-PHENYLBARBITURIC ACID............................................................................................................................................................
211

5H-DIBENZO(B,E),(1,4)DIAZEPINE, 8-CHLORO-11-(4-METHYL-1-PIPERAZINYL)-.......................................................................................
95

5-METHOXY-4'-(TRIFLUOROMETHYL)VALEROPHENONE (E)-0-(2-AMINOETHYL)OXIME.........................................................................133

5-METHOXY-N-ACETYL TRYPTAMINE.............................................................................................................................................................
169

5-METHYL-3-(2-PYRIDYL)-2H,5H-1,3-OXAZINO[5,6-C]-[1,2]BENZOTHIAZINE-2,4(3H)-DIONE 6,6-DIOXIDE..............................................116

5-METHYL-3-ISOXAZOLECARBOXYLIC ACID 2-BENZYLHYDRAZIDE..........................................................................................................

151

5-NITRO-2-FURALDEHYDE SEMICARBAZONE...............................................................................................................................................
190

5-NITRO-8-QUINOLINOL.....................................................................................................................................................................................
191

5-NITROFURFURYLIDENAMINOGUANIDINE...................................................................................................................................................
141

5-OXA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID,7-((CARBOXY(4-HYDROXYPHENYL)ACETYL)AMINO)-7-METHOXY- 158

6'-(THIAZOLYLAMINOSULFAMOYL)PHTHALANILIC ACID..............................................................................................................................
220

6,14-ETHENOMORPHINAN-7-METHANOL, 17-(CYCLOPROPYLMETHYL)-ALPHA-(1,1- DIMETHYLETHYL)-4,5-EPOXY-18,19-DIHYDR 71

6BETA,7BETA-EPOXY-1ALPHAH,5ALPHAH-TROPAN-3ALPHA-OL(-)-TROPATE (ESTER)........................................................................ 238

6-CHLORO-17-HYDROXYPREGNA-4,6-DIENE-3,20-DIONE ACETATE.........................................................................................................
80
6-DEOXY-5BETA-HYDROXYTETRACYCLINE HYDROCHLORIDE.................................................................................................................
115

6-HYDROXY-3-METHOXY-N-METHYL-4,5 EPOXYMORHIN-7-ENE................................................................................................................
97

463
 B. INDEX TO PHARMACEUTICALS BY SCIENTIFIC
AND COMMON NAMES, AND SYNONYMS
SCIENTIFIC AND COMMON NAMES, AND SYNONYMS PAGE

7,8,13,13A-TETRAHYDRO-9,10-DIMETHOXY-2,3-METHYLENEDIOXY-BERBINIUM....................................................................................
62

7,8-DIDEHYDRO-4,5-ALPHA-EPOXY-3-METHOXY-17-METHYLMORPHINAN-6-ALPHA-OL MONOHYDRATE.......................................... 97

7-[(10,11-DIHYDRO-5H-DIBENZO{A,D}CYCLOHEPTEN-5-YL)AMINO]HEPATANOIC ACID HYDROCHLORIDE........................................ 43

7-[2-[ALPHA-METHYLPHENETHYL)AMINO]ETHYL]THEOPHYLLINE.............................................................................................................
127

7-{(1R,5S,6S)-6-[(S)-2-AMINOPROPIONAMIDO)PROPIONAMIDO]-3-AZABICYCLO[3.1.0]HEX-3-YL}-1-(2,4-DIFLUOROPHENYL)-6-FLU 37

7-BROMO-5-METHYL-8-QUINOLINOL...............................................................................................................................................................
267

7-BROMO-5-METHYL-8-QUINOLINOL / 5-METHYL-8-QUINOLINOL...............................................................................................................
315

7-CHLORO-2',4,6-TRIMETHOXY-6'BETA-METHYLSPIRO(BENZOFURAN-2(3H),1'-(2) CYCLOHEXENE)-3,4'-DIONE............................... 140

7-CHLORO-3-HYDROXY-1-METHYL-5-PHENYL-1,4-BENZODIAZEPIN-2-ONE.............................................................................................
257

7-CHLORO-4-((4-(DIETHYLAMINO)-1-METHYLBUTYL)AMINO)-QUINOLINE.................................................................................................
83

8-[4-(4-PYRIMIDIN-2-YLPIPERAZIN-L-YL)BUTYL]-8-AZASPIRO[4,5]DECANE-7,9-DIONE HYDROCHLORIDE........................................... 72

8-AMINO-1,2,3,4-TETRAHYDRO-2-METHYL-4-PHENYLISOQUINOLINE........................................................................................................
192

8-CHLORO-11-(4-METHYL-1-PIPERAZINYL)-5H-DIBENZO(B,E)(1,4)DIAZEPINE..........................................................................................
95

8-CHLORO-6-(O-CHLOROPHENYL)-1-METHYL-4H-S-TRIAZOLO(4,3-A)(1,4) BENZODIAZEPINE..............................................................271

8-ISOQUINOLINAMINE, 1,2,3,4,-TETRAHYDRO-2-METHYL-4-PHENYL,........................................................................................................
192

8-METHOXY-6-NITROPHENANTHRO(3,4-D)-1,3-DIOXOLE-5-CARBOXYLIC ACID.......................................................................................
53

8-QUINOLINOL.....................................................................................................................................................................................................
142

9,10-ANTHRACENEDIONE,1,8-DIHYDROXY-...................................................................................................................................................
101

9,10-ANTHRACENEDIONE,1,8-DIHYDROXY,1,8-DIHYDROXYANTHRAQUINONE.......................................................................................
101

9H-DIBENZO(B,D)PYRAN-9-ONE, 3-(1,1-DIMETHYLHEPTYL)-6,6A,7,8,10,10A- HEXAHYDRO-1-HYDROXY-6,6-DIMETHYL, TRANS-, ( 185

9-PHENANTHRENEMETHANOL, 1,3-DICHLORO-?-[2-(DIBUTYLAMINO)ETHYL]-6-(TRIFLUOROMETHYL)-,HYDROCHLORIDE............ 142

?-(N-PHTHALIMIDO)GLUTARIMIDE..................................................................................................................................................................
263

?-D-GLUCOFURANOSE, 3-0-[3-(DIMETHYLAMINO)PROPYL]-1,2-0-(1-METHYLETHYLIDENE)-, HYDROCHLORIDE.............................. 48

464
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
A 25 398 A 66 387
A.d.l. 320 A.f. yellow no.4 407
A.g.multix 392 A.p.l. 396
Aaciasthma 387 A-acido 411
Aatroayerst 339 Abacid plus 344
Abadox 347 Abalgine 369
Abbifen 358 Abbocillin 328
Aberel 411 Aberela 411
Abilene 375 Abiocine 345
Abminthic 346 Abocillin 345
Abolon 374 Abrodan 372
Abrodil 372 Absolute alcohol 350
Abuprohm 358 Abu-tab 358
Acabel compositum 369 Accutane 362
Accutane roche 362 Acefalgin 369
Acelat 401 Acelax 381
Acetalax 381 Acetanil 319
Acetarsolum 319 Acetarsone 319
Acetonal vaginal 405 Acetphenarsine 319
Acetylarsan 319 Acetylosal 383
Aches-n-pain 358 Achrocidin 409
Achrocidin 383 Achromycin 409
Achromycin v 409 Achromycin y 409
Acid a vit 411 Acid leather yellow t 407
Acid yellow 23 407 Acid yellow t 407
Acidum aristolchicum 325 Acifein 383
Aci-jel 356 Acilan yellow 407
Acilan yellow gg 407 Acmor 378
Acmor-s 378 Acnavit 411
Acnavyse 411 Acne-sol 333
Acnestrol (broparestrol) 356 Acnestrol 3 356
Acnoxin 333 Acore vrai 331
Acretin 411 Acril 358
Acrobal 369 Acrogesico 369
Acromas 383 Acropac 383
Actamer 328 Actamin c 327
Actedron 321 Actifen 358
Actimac 333 Actinac 333
Actiprofen 358 Activin 374
Activin 375 Actren 358
Acu-dyne 396 Acutol 378
Acutrim 392 Adalgur 354
Adapettes 396 Adapin 347
Adaxil 355 Addaprin 358
Adebit 330 Adelmintex 394
Adepril 324 Adexogan 322
Adibetin 386 Adipalis 394

465
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Adipalit 394 Adipan 321
Adiparthrol 343 Adipex 390
Adipex nouveau 390 Adipex-p 390
Adipo ii 386 Adiposan 321
Adiposetten n 332 Adiposon 321
Adipost 386 Adiprazine 394
Adipyn 321 Adistop-f 392
Adiver 394 Adm 382
Adnephrine 348 Adocor 387
Adocyl 341 Adolkin 369
Adonal 387 Adphen 386
Adrefil 348 Adrehinal 348
Adren 348 Adrenal 348
Adrenalin 348 Adrenalin chloride 348
Adrenalin medihal 348 Adrenalina ace.p.d. 348
Adrenalina clorhi 348 Adrenalina delta 348
Adrenalina fustery 348 Adrenalina hormona 348
Adrenalina p davis 348 Adrenalina wiener 348
Adrenaline 348 Adrenamine 348
Adrenor 364 Adrin 348
Adsorbobase 396 Adsovbotear 396
Advil 358 Advil 200 mg 358
Advil cold & sinus 358 Aerol 385
Aerolone 361 Aeroseb-hc 356
Aerotrol 361 Aethambutolum 350
Aethaminalum 383 Afatin 343
Afdosa 361 Afi-ftalyl 393
Aflamin 343 Afonilum 323
Agaffin 389 Agaldog 344
Agarol 389 Agasten 337
Agent at 717 396 Agevis 322
Agisan 358 Aglophenyl 337
Agoral 389 Agotan 337
Agovirin 408 Agre-gola 389
Agrippol 343 Agrypnal 387
Ahr 3018 326 Aida 358
Airedale yellow t 407 Airoderm 411
Airol 411 Airolactone 401
Aitiflus 339 Aizen tartrazine 407
Akentect 375 Akne pyodron kur 356
Aknebon 411 Aknefug 411
Aknefug 356 Aknelan 356
Aknoten 411 Aktren 358
Akutol 378 Alagyl 337
Alamin 356 Alavac 320
Alavac-p 320 Alavac-s 320
Albamycin 380 Albay pure venom 320

466
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Albigen a 396 Alchloquin 338
Alcohol aethylicus 350 Alcool 350
Alcophenyl 337 Aldace 401
Aldacol q 396 Aldactazide 401
Aldactide 401 Aldactide 25 401
Aldactone 397 Aldactone 401
Aldactone-a 401 Aldactone-diurapid 397
Aldadiene potassium 397 Aldazida 401
Aldo asma 361 Aldomycin 378
Aldonorm 401 Aldopur 401
Aldospirone 401 Aldospray 358
Aldozone 401 Alermizol 325
Alertonic 395 Aleudrin 361
Aleudrina 361 Aleukon 336
Alexan 401 Alfamin 343
Alficetyn 333 Alficetyn susp. 333
Alfimid 355 Alfucin 378
Algesin 390 Algiamida 406
Algia-nil 369 Algiasdi 406
Algiasdin 358 Algifor 358
Algimicin anttitermico 322 Alginodia 369
Alginodia compose. 369 Algirreudin 390
Algisan 358 Algisedal 369
Algisedal 341 Algi-tandril 380
Algobuscopan 369 Algocalmin 369
Algocratine 383 Algofen 358
Algofer 358 Algopriv 369
Algopyrin 369 Algopyriv 369
Algosediv 409 Algoverine 390
Alindor 390 Alipid 321
Alival 379 Alka butazolidin 390
Alkabutazona 390 Alkabutazone 390
Alka-phenylbutazone 390 Alka-sterazolidin 390
Alkozin 369 Aller-ez 337
Aller-ez plus 337 Allergasthmin 387
Allodene 321 Allopydin 320
Allopydinac 320 Allpyral specific 320
Allpyral-d 320 Allpyral-g 320
Allpyral-mite fortified house dust 320 Allvoran 343
Allypropymal 325 Almatol 401
Alnagon 387 Alogynan 337
Alophen 389 Alophen pills 389
Alophen pills 381 Alopidin 320
Alopydin 320 Aloxipirine tablets 320
Alpagelle 329 Alpamed 401
Alphamin 337 Altabactin 333
Altex 327 Altex 401

467
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Altexide 401 Altimol 377
Altinal 324 Altior 358
Aludrin 361 Alumidyne 383
Alupent-sed 324 Alurate 325
Alurate sodium 325 Alutyl 337
Amacid yellow t 407 Amacid yellow t-ex 407
Amal 324 Amarson 319
Amasust 324 Amavil 324
Ambene 390 Ambese-la 324
Ambi- skin tone 358 Ambofen 333
Ambrasynth 333 Amcort 375
Amebio-formo 338 Ameiax 381
Amen 342 Amepromat 367
Amer-azo 403 Amerol 364
Amersol 358 Amertuss 392
Ametil 344 Ametuss 336
Amfe-dyn 343 Amfepromone 321
Amfetamin 321 Amfetasul 321
Ami-29 364 Ami-anelun 324
Amidate 351 Amidazopen 322
Amidazophen 322 Amidazophene 322
Amidin 404 Amidozen 322
Amidrin 405 Amifatidine 351
Amifur 378 Amiglan 369
Amilent 324 Amilit-ifi 324
Amineurin 324 Aminiurin 324
Aminocardol 323 Aminocid 369
Aminodrox 323 Aminodur 323
Aminomal 323 Aminophenazonum 322
Aminophylline 323 Aminophylline injection 323
Aminophylline mudrane 323 Aminophylline oral 323
Amino-slow 323 Aminoxafen 323
Aminoxaphen 323 Amiorel eritro 396
Amipylo-n 399 Amital 324
Amitimid 324 Amitralil 369
Amitril 324 Amitrip 324
Amitriptol 324 Amitrol 324
Amnivent 323 Amobell 324
Amodoquin tablets 325 Amoebal 319
Amoenol 338 Amone 368
Amorphan 332 Amorphan depot 332
Amosene 367 Amotril 339
Ampenoline balsamoco 341 Amphaetex 343
Amphamed 321 Amphasub 386
Amphedrine 321 Amphedrine-m 363
Amphemycin-prednisonum 333 Amphenicol 333
Amphicol 333 Amphocort 375

468
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Ampi tumisan 369 Ampliomicetin 333
Amplisiex 392 Amsal 324
Amsebarb 324 Amseclim 333
Amseclor 333 Am-tuss liq 392
Amybal 324 Amycal 324
Amyderm s 396 Amydorm 324
Amylbarb 324 Amyline 324
Amylobeta 324 Amylofene 387
Amypron 383 Amypylo-n 383
Amytal 324 Amytal sodium 324
Amyzol 324 Anabolicas 375
Anabolicus 375 Anabolin depot 375
Anabolin la 100 374 Anabolin la-100 375
Anacal 356 Anacetin 333
Anacin 382 Anacyclin 365
Anacycline 101 365 Anacylin 365
Anacylin 101 365 Anacylin 28 365
Anadex 369 Anadin ibuprofen 358
Anador 374 Anador 375
Anadur 374 Anadur 375
Anafebrin 322 Anafebrina 322
Anafogene 328 Anagregal 410
Analcedor 369 Analgesico 358
Analgesine 385 Analgil 358
Analgilasa 324 Analgin 369
Analginum 369 Analgyl 358
Analject 369 Analone-50 374
Analud 352 Anametrin 379
Anapac 383 Anarexal 341
Anarinyl 369 Anarreumol-b 380
Anarthral 390 Anartril 355
Anaspaz 387 Anastress 367
Anatimon 367 Anbesol 332
Anbesol 396 Anbesol 389
Ancaris thenium 394 Ancazine 394
Anchrina 369 Anco 358
Ancolan 365 Ancoloxin 365
Ancoloxine 365 Ancylin 365
Andaxin 367 Andebit 330
Andelit 330 Andere 330
Anderm 330 Andiposetten 332
Andolor 369 Andran 359
Andrestrac 2-10 396 Andro heart injecta 408
Androfort 408 Androlan in oils 408
Androline 375 Androlone 375
Androlone d 374 Androlone d 100 374
Androlone d 50 374 Androlone-d 375

469
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Androtest 408 Androteston 408
Anelmid 346 Aneroxina 390
Anertan 408 Anespas cpto 369
Aneural 367 Aneuxol 322
Anexa 396 Anfamon 321
Anflagen 359 Angifebrine 383
Angimidone 333 Anginofur 378
Angiocapsul 339 Angiociclan 326
Angiodel 326 Angiopac 413
Angiter 369 Angiters 333
Anguifugan 346 Anhistan 337
Anition 411 Ankaljin 369
Annolytin 324 Annul 356
Anodin 383 Anodyne dellipsoids 4 389
Anodynin 385 Anodynine 385
Anoixal 322 Anojel 329
Anorex 387 Anorex 321
Anorex 386 Anorexin 392
Anorexine 321 Anoxine-t 386
Anp 3624 410 Anparton 339
Ansaid 355 Ansietan 367
Ansiopax 343 Ansiowas 367
An-t 369 Antadol 390
Antalgil 359 Antapentan 386
Antatril 355 Antegan 341
Antelmina 394 Antepar 394
Antepar (b-w) 394 Anterobe 338
Anterobius 394 Anthalazine 394
Anthastmin 361 Anthelmina 394
Antiadipositum 392 Antibio-aberel 411
Antibio-aberel 349 Antibiopto 333
Antibitulle 375 Anticatabolin 375
Anticucs 394 Antidiarrhoicum 402
Antifen 408 Antiflam 359
Antiflu des 383 Antigestin 385
Antigripina 322 Antihist-1 337
Antilipid 339 Anti-opt 383
Antipond 386 Antipyretic dellepsoids d26 387
Antipyrin 385 Antiren 394
Antiruggen 359 Anti-spas 387
Antitaxil-z 413 Antituxil-z 413
Antivermine 394 Antivert 365
Antoban 394 Antuitrin 396
Antuitrin growth 401 Antuitrin-t 401
Antussan 401 Anugard 329
Anusol hc 329 Anuspiramin 390
Anzil 367 Apadine 383

470
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Apascil 367 Apasmo 369
Apazone 326 Apb 387
Apc 383 Apeplus 341
Aphenylbarbit 387 Apidin 383
Apiquel 323 Apirelina 385
Apisate 321 Api-slender 381
Ap-la-day 389 Aplaquette 410
Apo-amitriptylline 324 Apo-doxepin 347
Apoephedrine 392 Apo-erythro-s 349
Apo-ibuprofen 359 Apo-k 397
Apokalin 375 Apolan 339
Apo-meprobamate 367 Aponal 347
Apophenylbutazone 390 Apo-phenylbutazone 390
Apo-pram 324 Aporasnon 401
Apo-tetra 409 Apo-trimip 412
Apotrin 332 Appenil 324
Appetrol 332 Apracur 383
Apralan 389 Aprilin 330
Aprozal 325 Apsedon 336
Apsifen 359 Apsor 362
Apsor 411 Apx 410
Aqual 372 Aquamycetin 333
Aquapred 333 Aquareduct 401
Aquaviron 408 Aralen 336
Aralen hcl 336 Aralin (diphosphate) 336
Arantil 369 Arcin 383
Arcoban 367 Arcobutine 374
Arcomonol 374 Arcotrol 386
Ardeytropin 364 Arduvermin 394
Areumal 322 Arfen 359
Argan 360 Argan 320
Argazol 405 Argun 320
Arhemapectin 382 Aridose 392
Aristamid 406 Aristoform 338
Aristoform "d" 338 Aristoform "r" 338
Arm 392 Armacol 333
Armohex 356 Arpezine 394
Arpf 369 Arquidon 369
Arrest 337 Arret 364
Arrlicetin 333 Arsabott 319
Arsaphen 319 Arsonine 319
Artam 337 Arteopan 390
Arterioflexin 339 Arterioflexion 339
Artes 339 Artevil 339
Artexin 337 Arthirikin 390
Arthryl 355 Artibrin 390
Artofen 359 Artolon 367

471
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Artra 358 Artren 359
Artren 343 Artrichin 336
Artril 359 Artriosan 339
Artrisin 390 Artritex 369
Artrizin 390 Artrochin 336
Artrodesmol extra 390 Artrofen 359
Artroflog 380 Artroflog 381
Artropan 390 Artzone 380
Artzone 381 Arythmol 399
Asa compound 383 Asa/cpib 339
Ascalix 394 Ascarinex 394
Ascarivet 394 Asca-trol no.3 394
Asceine 383 Ascophen 383
Ascorbalgine 369 Ascortin 369
Ascthimindon 383 Asecool 356
Asellacrin 401 Asenlix 339
Asepar 394 Aseptilex 404
Aseptil-guanidina 403 Aseptobron 369
Aserbine cream 356 Asey-sulfa 404
Asfeen 383 Asidon 409
Askaripar 394 Asmadren 361
Asmafilin 323 Asmalar 361
Asmastop 361 Asmo fedrilum 387
Asmorex 348 Aspirin 319
Assugrin 341 Astenile 398
Asterol 346 Astezol 325
Asthma dellipsoids 385 Asthmatussin 387
Asthmin 324 Astol 325
Astreptine 405 Astriharina s 382
At 717 396 Atecilina 369
Ateculon 339 Atelor 346
Atelora 346 Atensin 366
Aterian 403 Aterioplexin 339
Ateriosan 339 Ateroayrest 339
Ateroclar 339 Aterofront 339
Aterola 346 Ateronlen 339
Aterosol 339 Atevil 339
Atheroayerst 339 Atheromide 339
Atheropront 339 Athilyn 365
Athimil 373 Athrombin 413
Athymil 373 Atigoa 337
Atn-020/2 369 Atocin 337
Atofan 337 Atom-asma 361
Atophan 337 Atraxin 367
Atroayerst 339 Atrofort 339
Atrolan 339 Atrolen 339
Atromid 339 Atromidin 339

472
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Atromid-s 339 Atrom-s 339
Atrovis 339 Attenil 352
Attenil 30 conf. 20 mg 352 Atul tatrazine 407
Atumin 344 Auanosept 330
Aurafair 385 Aurafair 320
Auralgan 385 Auralgicin 320
Auralgicin 385 Auraltone 385
Aureomicina 369 Aurex 375
Auriod 375 Auroid 378
Auryphan 319 Ausobrone 368
Ausoliver 337 Austracol 333
Austrominal 387 Avafortan 369
Avc 405 Avc cream suppositoty 405
Avc/dienestrol 405 Avc/dienestrol 344
Averamexan 394 Aviatrin 333
Avibon 400 Avicol 336
Avicol sl 340 Avicol-la 340
Avipron 336 A-vitamisyre 411
Avitoin 350 Avitoin 411
Avloclor (diphosphate) 336 Avosyl 366
Avril 405 Axiston 322
Ay 61 339 Ayellow t 407
Ayeramate 367 Ayerlucil 403
Ayoral 369 Azapren 326
Azionyl 339 Azo gantrisin 385
Azocline 403 Azodine 385
Azol 405 Azol polvo 405
Azol pomada 405 Azolid 390
Azophen 385 Azophene 385
Azoseptale 405 Azotrex 403
Azucaps 386 Azucrona 341
Azudoxat 347 Azur 399
B 3014 407 B 7509 396
Ba-16038 322 Babix-rectal 372
Babrocid 378 Babypasmil 344
Babyspasm 344 Babyspasmil 344
Bacarate 386 Bacteriostat cs-1 328
Bactol 338 Bada 356
Bajumol 385 Bakersed 387
Balbion 322 Balkamycin 333
Balmini 401 Balpiren 399
Balutox 413 Bamo 400 367
Banatol 350 Baneopol 375
Ban-o-pain 383 Banotil 406
Baralgin 369 Baralgine 369
Barbamyl 324 Barbellen 387
Barbenyl 387 Barberine 387

473
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Barbilletae 387 Barbiphenyl 387
Barbipil 387 Barbita 387
Barbityral 383 Barbivis 387
Barbopent 383 Barcole 387
Barnetil 406 Barnotil 406
Barophen 387 Barquinol 338
Barquinol hc 338 Barriere-mycin 375
Barsedan 322 Basoquin 325
Bassado 347 Bastu-angin 375
Baukal 399 Baukal 322
Baukal suppositories 322 Baxal 363
Bay-ase 387 Baycyclomine 344
Bayer 1387 369 Bayer 1387 p 322
Bayer select 359 Bayer select ibuprofen pain reliever 359
B-cpct 333 Beatol 324
Bebealjin 369 Bebigut 369
Bebtoyl 387 Bebulin 351
Beca furazona 378 Becantal 401
Becantex 401 Bechisan 401
Bedermin 100 375 Bediphen 387
Beelin 330 Belatropin 369
Belergamin 387 Belflex/2 369
Bellademal s 387 Belladenal 387
Bellapront 390 Bellasectal 387
Bellastal 387 Bellasthman 361
Bellergal 387 Bellergal s 387
Belllumal 387 Belloform 381
Bel-zine 394 Bemacol 333
Bemaphate 336 Bemperil 406
Benacol 344 Benafed 336
Benamine 389 Benatuss 336
Benaznyl 337 Bencard skin testin solutions 320
Bencard-a 320 Bendectin 344
Beneficat 411 Benestermycin 375
Beneurin 369 Benflogin 359
Benhexachlor 364 Benhur 327
Benilen 353 Benjor 362
Benolat 327 Benoral 327
Benorile 327 Benortan 327
Benorylate 327 Benotamol 327
Benoxapran 327 Benpredil 354
Bentomine 344 Bentudor 352
Bentum 327 Bentyl 344
Bentylol 344 Benyphed 336
Benzarin 327 Benzease 356
Benzebar 321 Benzedrex 399
Benzedrine 321 Benzenol 389

474
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Benzolone 321 Benzone 390
Bequitussin 379 Berberal 328
Berbericine 328 Berberil 328
Bergofen 387 Berlicetin 329
Berlicetin 333 Berotec 352
Beserol 369 Betadine 396
Betadrin 329 Betagesic 359
Betaine digestive aid 382 Betaisod 396
Betalactam 363 Beta-pebg 386
Betaprofen 359 Betazed 390
Betnorate-c 338 Bexedyl dibunaat 401
Bexedyl dibunaat expectasans 401 Bexobolic 375
Bexon 329 Bexophene 383
Bexopirona 369 Bexopron 327
B-fsudi 353 B-gf 355
Bicillin 328 Bicillin all purpose 328
Bicor 408 Bidiphen 328
Bifed-20 392 Bifentamin 321
Biforon 330 Bifuran 378
Bigram 327 Bigunal 330
Biivectan 381 Bilevon 356
Biliboldo 396 Bilvon vet 356
Bimalong 404 Bimaran 411
Binoctal 324 Binovum 379
Bio hubber 402 Bio hubber 375
Bio hubber 382 Bio hubber fuerte 382
Bio hubber fuerte 402 Bio hubber simple 403
Bio hubbersimple 402 Bioarterol 326
Biobamat 367 Biobamate 367
Biocapton 352 Biocefalin 400
Biocetin 333 Biocleran 339
Biocorn 404 Bio-cron 404
Biodry 375 Bio-exazol 349
Biofeniol 333 Biofradin 375
Biofur 375 Biogamma2 369
Bioglan m/q 366 Biometran 349
Biomicron 349 Biontabol 400
Bio-pectodil 404 Biophenicol 333
Biophtas 333 Bioscleran 339
Biosol 375 Biosol-m 375
Biostrep 345 Bio-tab 347
Biotangin 369 Bio-testiculina 408
Biotocap 333 Biovital 407
Bio-vitastrept 375 Bioxurin 394
Bipasmin compuesto 369 Bipheramine 343
Biphetane 392 Biphetap 392
Bipiquin 336 Biquinal 330

475
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Bisflatan 381 Biskapect 382
Biskapect 362 Bismodyne 356
Bismophenyl 333 Bisolvon compositum 379
Bit 328 Bitencyl 333
Bithin 328 Bitin 328
Bi-uglucon ud87 386 Bivacyn 375
Bizolin 20 390 Bizolin 700 390
Black and white 358 Blastoestimulina 375
Blesin 343 Blox 364
Bluboro 329 Bludex 324
Blu-hist 392 Blu-phen 387
B-neuron 327 Bock-ase 387
Bold laxine 389 Bolinan 396
Bolvidon 373 Bom-bon 389
Bon korets 396 Bonamina 365
Bonamine 365 Bonanza 330
Bon-bon 389 Bonbrain 409
Bonexyl 387 Bonifen 400
Bonifwn 400 Bonine 365
Bonol 400 Bonpyrin 369
Bon-sonnilal 372 Bontril 386
Bonumin 321 Bordol 406
Bor-ind 360 Boroformal 329
Borogal 329 Borsyre viskos 329
Bort 369 Boxogetten 381
B-piperazine 394 Brantina 341
Brantine 341 Breezeazy 385
Brek 364 Brenalalit 321
Brendalit 321 Brevicon 379
Brevinor 379 Brexin 371
Bridine 396 Brirel 394
Bristacilia 369 Bristamycin 349
Britaderm 338 Britadex-vioform 338
Britercina 369 Brocatine 381
Brocon cr 392 Brodiar 330
Brofen 200 mg 359 Brofen 400 mg 359
Bromadryl 387 Bromalgin 369
Bromalgon 369 Bromanate 392
Bromed 329 Bromepaph 392
Brometapp 392 Bromo quinina 383
Bromo seltzer 383 Bromophen 392
Bromoxin 330 Broncha-tulisan eucalyptol 379
Bronchisan 322 Broncho-rivo syrup 336
Broncho-tetracycline 348 Broncho-tulisan eucalyptol 379
Broncofenil 369 Broncolysin 369
Bronco-quintoxil 392 Broncosmin 387
Broncozina 413 Bronkaid mistometer 348

476
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Brontin 341 Bronx 413
Brophylline 327 Brosolin-rectocap 379
Brotazona 352 Brufaneuseol 322
Brufaneuxol 322 Brufanic 359
Brufen 359 Brufert 359
Brufort 359 Bryrel 394
Bs-5892 330 B-tonin 350
Buborone 359 Bucarboxal 369
Buco pental 405 Buco regis 405
Bucosol 405 Budirol 399
Budoform 338 Bufedon 359
Bufemac 330 Bufexamac-ratiopharm (r) creme 330
Bufexine 330 Bufexine ratiopharm(r) f-sable 330
Buff-a-comp 383 Bufigen 359
Bufonamin 330 Bulbonin 330
Bumadizon 331 Bumaflex 331
Bunaiod 331 Buniodyl 331
Buprenex 331 Buprex 331
Buprx 331 Burana 359
Burnazone 378 Burtylonel 383
Buscapina comp. 369 Buscapina compuesto 369
Buscapina compuestum 369 Buscol compositum 369
Buscopan composto 369 Buscopan compostum 369
Buscopina compostum 369 Buta lyseen 374
Buta pirone 381 Butacal 390
Butacol 390 Butacompren 390
Butacote 390 Butadilat 390
Butadin 390 Butadion 390
Butadiona 390 Butadyne 390
Butafenil 390 Butaflogin 381
Butaflogin 380 Butagesic 390
Butagros 390 Butakvertin 390
Butal compound 383 Butalan 390
Butalgin 390 Butalgina 390
Butalgine 369 Butaluy 390
Butaparin 390 Butaphen 390
Buta-phen 390 Butapirazol 390
Butapirone 380 Butapyrine 322
Butarex 390 Butartiril 390
Butatril 390 Butazina 390
Butazolidin 390 Butazolidin alka 390
Butazolidina 390 Butazone 374
Butazone 390 Butazonic 380
Butenemal 413 Buteril 380
Buteril 381 Butial 390
Butidiona 391 Butilene 381
Butilene 380 Butinol 391

477
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Butiwas 391 Buto beta 391
Butofen 381 Butolfen 381
Butone 391 Butorinal 383
Butoroid 391 Butoroid cream 391
Butoz 391 Butrex 391
Butylenin 359 Butylone 383
Butylpan 369 Buvetzone 391
Buzon 391 B-voltaren 343
Bydolax 381 Bykanula 375
Bykomycin 375 Byladoce 369
C "5" 355 C 147 387
C. o fluo-fenicol 333 C. o hidrocor-clora 333
C.i. 19140 407 C.i. 77320 341
C.i. acid yellow 23 407 C.i. food yellow 4 407
C-16038-ba 322 Cacimag 329
Caclcifor 329 Cadraten 331
Cadraten 21 cpr 20 mg 331 Cadraten 30 cpr 10 mg 331
Cadraten 30 cpr 15 mg 331 Cadratin 331
Cadrilan 331 Caf 333
Cafenolo 333 Cafergot p.b. 383
Caffalgina 399 Caladryl 333
Caladryl 332 Calavon 324
Calcamyl-24 329 Calcibenzamin 329
Calcocid yellow mcg 407 Calcocid yellow xx 407
Calgayan-c 369 Calibene 407
Californit 380 Californit 381
Calinador 414 Calmaderm 330
Calmador 414 Calmante muri 383
Calmasmin 385 Calmax 337
Calmax 367 Calmetron 369
Calmina 333 Calminal 387
Calmiren 367 Calmonal 365
Calocain 373 Calpental 383
Cam 333 Camilca 329
Camizol 369 Camoplex 399
Camoquin 325 Campiol 333
Campozim 380 Canaural 375
Cancert tartrazine 407 Candizine 394
Canidis-anti-diarr 393 Caniquin 325
Canisan 389 Canoral 375
Canquil-400 367 Cantacin 399
Caosol 333 Cap 333
Capacetyl 383 Cap-o-tran 367
Capramin 383 Caps dr knapp 383
Capsula dr. knapf 319 Capsula dr. knapp 383
Capsyka dr knapf 322 Captagon 352
Captagon cpr nsfp 352 Capval 379

478
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Capysal 322 Carb-a-med 367
Carbaxin 367 Carbidiar 393
Carboform 338 Carbolic acid 389
Carbopuradin 353 Carbotalin 393
Carbrital 383 Card-fludilat 326
Cardiol 398 Carditan 401
Cardophyllin 323 Cardophylline 323
Carena 323 Caribium 379
Carine 323 Carnigol 341
Carpantin 341 Cartagyl 339
Carudol 394 Carudol 391
Catergen 337 Cateudyl 372
Catilan 333 Caudaline 410
Causalon 369 Causyth 399
Cavumycetina 333 Cb 304 326
Cb 311 401 Ccombinado balsamico 333
Ccorticol 333 Ce 10010 387
Ceachin 383 Cebemyxine 375
Cebenicol 333 Cebutid 355
Ceepa 387 Cefalogen 400
Cefeno 337 Cefinal 383
Cefrocyn 375 Cegramine 321
Ceilipen 328 Celeka 397
Celestalgon 391 Celestazone 391
Cemealonal 387 Cenadex 392
Centedrin 373 Centramina 321
Cepalorin 332 Cepastat 389
Ceporin 332 Cequinyl fort 383
Cerebro 406 Cerebrol 399
Cerebrotrofina 400 Cerebroxine 413
Cerm-3024 413 Cerozalol 363
Certecol tartrazol yellow s 407 Certolax 389
Cervitalin 400 Cesamet 374
Cesra 359 Cessantyl 369
Cetal 413 Cetanest 348
Cetavister 398 Cetedrin 373
Cetina 333 Cetonax 363
Cetussan 385 Cg 3224 375
Cgp 9194 343 Chebutan 362
Chelafrin 348 Chembutazone 391
Chemiartrol 374 Chemibal 333
Chemicetin 333 Chemicetina 333
Chemiovis 405 Chemiovis 405
Chemochin 336 Chemofuran 378
Chemosept 405 Chemthromycin 349
Chemyzin 333 Chendol 332
Chenracol 336 Chepirol 362

479
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Chetazol 362 Chetazolidin 362
Chetil 362 Chetopir 362
Chetosol 362 Chibro 329
Chiclida 365 Children's advil 359
Children's motrin 359 Chini-med 369
Chinopyrin 322 Chinosol 356
Chitosamine 355 Chlofel 381
Chloferex 340 Chlomin 333
Chlomycol 333 Chloracet 383
Chloramex 333 Chloramfenicol 333
Chloramficin 333 Chloramfilin 333
Chloramol 333 Chloramphenicol cinnamate 333
Chloramphenicol intervetra 333 Chloramphenicol sodium succinate 333
Chloramphenicol-pos 333 Chloramphycin 333
Chloramplast 333 Chloramsaar 333
Chloramson 333 Chloranfeni-mck 333
Chloranfeni-opipno 333 Chloranfeni-otico 333
Chloranfeni-ungena 333 Chloraseptic 389
Chloraseptic dm 389 Chlorasol 333
Chlora-tabs 333 Chloreptic 333
Chlorgyl 343 Chlor-histine 336
Chlorical 333 Chloricol 333
Chlornitromycin 333 Chloro-25 vetag 333
Chloroantibion 333 Chlorocaps 333
Chlorochin 336 Chlorocid 333
Chlorocide 333 Chlorocidin c 333
Chlorocidin c tetran 333 Chlorocortal 333
Chlorofair 333 Chloroject l 333
Chloroject s 333 Chloromex 333
Chloromik 333 Chloromimyxin 333
Chloromycetin 333 Chloromycetin kapseals 333
Chloromycetin palmitate 333 Chloromycetin sodium succinate 333
Chloronaftina 336 Chloronitrin 333
Chloropect 382 Chloropect 362
Chloropent 383 Chloroptic 333
Chloroptic p. oint. 333 Chlorosol 333
Chlorostrep 333 Chlorotin 333
Chlorotyxin 333 Chlorovules 333
Chlor-rest 392 Chlorsig 333
Chlorvescent 397 Chlotaon 333
Chocolax 389 Cholal modifico 398
Cholal simple 398 Cholstat 332
Choragon 396 Choriantin 396
Choritropin 396 Chorulon 396
Chp-depot 399 Chrlich 594 319
Chur-lax 381 Cibalgin 322
Cibalgina 399 Cibazol 405

480
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Cicatrex 375 Ciclazon 322
Ciclepen 333 Cidal 356
Cidan 328 Cidan est 402
Cidanchin 336 Cidan-cilina 328
Cidocetin 333 Cifoform 338
Cilefa yellow t 407 Cilipen 328
Cimetrin 349 Cinchophene 337
Cinconal 337 Cincosal 337
Cinnamin 326 Cinnarizin 339
Cinnopropazone 326 Cintaverin compuesto 369
Cinthol 356 Cinturex 392
Ciperazin 394 Ciplactin 341
Ciplamycetin 333 Cipractin 341
Cipro 341 Cipro n 341
Ciprocort 341 Ciracen 381
Circleton 406 Cirotex 381
Cirotyl 381 Cirpon 367
Cirponyl 367 Cirramina 337
Cisapid 337 Cismotil 337
Citalgan 369 Citestrol 366
Citexal 372 Citiflus 339
Citizeta 413 Citocard 410
Citodon 357 Cito-guakalin 401
Citopan 357 Citra-fort 383
Citramol 383 Citrazine 394
Clareden 339 Claresan 339
Claripex 339 Claripex cpib 339
Clemanil 337 Clemastin fumerate syrup 337
Clemodril 387 Cleniderm 375
Clenisep 356 Cleocin 338
Cletanol 392 Climatost 398
Clinafenol 333 Clindoorm 367
Clinidine 396 Clinit 374
Clinit 322 Clinovie 342
Cliovir 342 Cliquinol 338
Clisemina 347 Clistanol 384
Clizim 369 Cloberab 339
Cloberat 339 Clobrat 339
Clobrate 339 Clobren 339
Clobren-5 f 339 Clof 339
Clofenal 333 Clofenit 339
Clofexan 369 Clofibral 339
Clofibrase 333 Clofibrat 339
Clofibrate ayerst 339 Clofibrate compose 339
Clofibrato ayerst 339 Clofibrato procaps 339
Clofibrem 339 Clofimide 339
Clofini 339 Clofin-icn 339

481
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Clofinit 339 Clofipront 339
Clofipront 5000 339 Clofirem 339
Clofirin 339 Clofi-t 339
Clomiazin 340 Clomicin enzym 333
Clomin 344 Clopin 339
Cloramex 333 Cloramfen 333
Cloramicol 333 Cloramidina 333
Cloran 333 Cloran 347
Cloranfenicol-mck 333 Cloranfeni-opifno 333
Cloranfeni-otico 333 Cloranfeni-ungena 333
Cloransul 333 Clorbiotina 333
Clorbis supp. 333 Clorfentermina 336
Clorochina 336 Clorocyn 333
Clorofenicina 334 Cloromicetin 334
Cloromisan 334 Cloromoin 334
Cloromycetin 334 Cloroptic 334
Cloroptic farmicetina 334 Clorosyntex 334
Cloro-yodo-hidroxi 338 Clorpine 338
Clozaril 341 Co dox 347
Coadvil 359 Coaxil 410
Cobalt-59 341 Cobinamide 365
Cocresol 352 Codacol 336
Codafen 359 Codafen continus 359
Codalgin 385 Codalgin 369
Codasal injetavel 369 Codempiral 384
Codicept 341 Codimal 392
Codimal dm 336 Codipect 379
Codol 341 Codopyrin 384
Codral 384 Codyl 379
Codyl cum expectoras 379 Co-ervonum 366
Cofen 369 Coffan 322
Coffecodin 387 Cofpac 392
Col 180 339 Cold cap 392
Coldecon 392 Col-decon 392
Colepur 330 Colfezone 391
Colfin 350 Colgenol 369
Colicitina 393 Coliclase 393
Colidene 334 Colifelin 364
Colifilm 364 Colimy-c 334
Colipar 330 Coliriocilina 328
Coliseptale 403 Colix 344
Collarsin 319 Collo-bo 398
Collodyne 362 Collodyne 382
Colonofilin 323 Comaril 5000 369
Combias 338 Combiquens 366
Commotional 399 Complexobiotico 345
Compound 90459 327 Compral 322

482
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Compralgyl 319 Compralgyl 384
Comycetin 334 Conac 371
Conceplan 379 Conderm 375
Condilomin 396 Condyline 396
Coneolent 329 Conex-grippe 392
Conjuctilone 375 Conjuvac two grass 320
Conmel 369 Conta-schmerz 384
Contax 381 Contergan 409
Continal 383 Contop 392
Contradouleur 384 Contra-lipide 339
Contraneural 359 Contrneural 359
Control 392 Controlgras 321
Conturex 372 Coopane 394
Coopaphene 356 Cope 359
Copirene 362 Copover 338
Coprobate 367 Corafen 339
Coralgil 345 Coralgina 345
Coralgyl 345 Corapamil 354
Cor-asthmolyticum 387 Coratose 361
Corbuvit 391 Cordes vas 411
Cordialina 398 Cordocel-h 356
Corfilamine 323 Coricidin 384
Coricidin f 392 Coricidin f 384
Coriforte 384 Corilin pediatric 369
Cornemin 375 Corophyllin 323
Corophylline 323 Corphyllamin 323
Corpormon 401 Corsym 392
Cortasmyl 387 Cortempirol 369
Cortex 338 Corti-anartril 355
Cortican 334 Corticreme 338
Cortidermale 334 Corti-glottyl 338
Cortimisin 334 Cortinen 375
Cortiphenicol 334 Cortison-quemicet 334
Cortitracin 369 Cortivert 334
Cortol 334 Corto-tavegil 338
Cortrifosal 408 Corverum 387
Coryban-d 384 Coryza 405
Coryzium 353 Coryztime 392
Coscopin 379 Coscotab 379
Co-specto 336 Cotofilm 356
Cotradol 384 Cotrol-d 336
Coumadin 413 Coumadine 413
Coverject 320 Coxigon 327
Coxistat 378 Cp 3438 328
Cp 556s 406 CP-34089 406
Cp-cap 356 Cph 334
Cr/085 339 Crema antisolar evanescente 385

483
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Cremacoat 392 Crematalil 393
Creme des 3 fleur d'orient 358 Cremo-merazine 403
Cremophor rh40 396 Cremophor rh60 396
Cremo-quin 338 Cremothalidine 393
Crermomethazine 403 Crescormon 401
Cresophene 332 Cresophene 356
Cresoxydiol 366 Crestanil 367
Crinohermal fem 344 Crionil 405
Crisocilin-g 328 Cristapen 328
Critex 381 Crk 635 401
Crocin 382 Cronoformin 386
Cronopen balsamico 369 Crospovidone 396
Crovaril 380 Crystamycin 328
Crystapen 328 Crystapen g 328
Crytraden 322 Csp 500 405
Csp-250 405 Ct-diclo 343
Ct-spiro 401 Cuait 411
Cuaot 324 Cuisialigil 359
Cunil 359 Cuprofen 359
Curban 343 Curolax 381
Curon 407 Curretab 342
Curythan 366 Cusayth 322
Cusimicina balsamica 349 Cusitan 367
Cutaden 329 Cutispray no. 4 334
Cv 58903 413 Cycladiene 344
Cyclarin 341 Cyclexedrine 399
Cyclidox 347 Cyclobex 344
Cyclocen 344 Cyclonal 357
Cyclonal sodium 357 Cyclopan 357
Cyclopar 409 Cydril 363
Cyphenicol 334 Cyprol expectrant 336
Cypromin 341 Cyprostol 374
Cyrasarl 341 Cyrpon 367
Cysticat 334 Cytadren 322
D & m tablets 389 D & m tablets 327
D 237 340 D and c yellow no. 5 407
D bretard 386 D epinefrin 348
D.i.m. 346 D.i.p. 321
D.i.p.n 321 D.v. 344
Da 2370 352 Dabical 339
Dafodil 387 Dak 394
Dalca 392 Dalet 336
Dalzic 398 Damapo 375
D-amfetasul 343 Damoral 387
Danaden 400 Danalon om 407
Danfenona 352 Danilon 407
Danilon 359 Danol 342

484
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Dansida 359 Dantrium 326
Danylen 321 Daopar 386
Dapaz 367 Dapecfuran 353
Dapex 390 Daprisal 384
Dap-test 396 Daritran 367
Darkene 353 Darkeyfenac 320
Darmol 389 Darmoletten 381
Daromid 405 Darostrep 402
Dartranol 391 Darvocomp-n 384
Darvon compound 384 Darvon compuesto 65 384
Darvon n compuesto 384 Daserd 366
Daserol 366 Dasikon 384
Dasin 384 Dasin 332
Dasin ch 384 Dasten 365
Dastonil 398 Daturmed 399
Davimycin 375 Davosin 404
Davosin suspension 404 Davuron sedante 334
Day nurse 392 Db comb. 386
Db retard 386 Dbi 386
Dbnf 384 Db-retard 386
D-chloramphenicol 334 Ddd 332
De be 386 Deandros 398
Deba 326 Debej 386
Debendox 344 Debeon 386
Debinyl 386 Debnal m 403
Debutazon 391 Decabis 342
Decabolin 374 Deca-durabol 374
Deca-durabol 375 Decadurabolin 375
Deca-durabolin 375 Deca-durabolin 374
Deca-durabolin decanoate 374 Deca-hybolin 374
Deca-noralone 374 Decidex 392
Decomine 392 Decontractyl 366
Decontracyl 366 Decontracyl-baum 366
Dectamicina 334 Dectolin 353
Dectuss 336 Decycline 409
Defolgin 380 Defonamid 405
Degonon 365 Degoran 379
Degramycin 375 Degripol 399
Dehydrobenzperidol 348 Dehydrostilboestrol 344
Deililax 381 Dejo 346
Deladine 403 Delagil 336
Delgamer 321 Delipid 339
Deliva 339 Delmofluvina 355
Delmofulvina 355 Delphimix 343
Delta optil 334 Delta pimafucort 356
Delta-butazolidin 391 Delta-demoplas 391
Delta-myogit 391 Delta-tomanol 391

485
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Deltavagin 404 Deltawaukobuzon 391
Deltricin 369 Delvex 346
Delvinal 413 Delvinal sodium 413
Demazine 392 Demolpas 322
Demoplas 391 Demosa casi penicilina 328
Demovermil 394 Dentigoa 322
Dentigoa 359 Dentigoa forte 359
Dento-caine 348 Dentocaps 384
Dentocaps a 399 Deoxymykoin 347
Dep0-clinover 342 Dep0-map 342
Depcorlutin 342 Dependal 338
Dephimixn 391 D-epifrin 348
Depinefrin 348 Depiral c 322
Depo-prodasone 342 Depo-progevera 342
Depo-promone 342 Depo-provera 342
Deporone 342 Depovernil 404
Deprax 411 Deprecstop 392
Deprelio 324 Deprestal 324
Deprex 343 Deptavac hvt 356
Deptran 347 Dequacaine 342
Dequafungan 342 Dequin 342
Deramix 321 Derbitan antibiotico 375
Derbitan antibiotico 402 Dereuma 322
Derfon 321 Derivative 356
Derivatives 410 Derl 356
Derma 10 356 Derma cas 389
Derma leaf 356 Dermacid 356
Dermacytostat 396 Dermadex 338
Dermairol 411 Dermalex 356
Dermaspray 327 Dermicema 375
Dermo sonerge 375 Dermobion 378
Dermoclar 411 Dermoface 375
Dermohex 356 Dermojuventas 411
Dermolle 356 Dermoplast 356
Dermo-quinol 338 Dermosa cusipenicilina 328
Dermosan 375 Dermovate-nn 375
Dermozolan 338 Derobion 375
Derugin 411 Descresepet 325
Deselmine 346 Desinflam 320
Desoblit 326 Desopimon 336
Desoxyn 368 Desphen 334
Desqyam-x 350 Desulfon 404
Desuric 327 Desyrel 411
Detal 328 Detaril 395
Detensitral 367 Detreomycin 334
Dettuso 379 Devaguanil 403
Devalgin 369 Devamycetin 334

486
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Devegan 319 Deverol 401
Devidone 411 Dewitt's pills for backache and joint pains 398
Dexa butarin 369 Dexa escopyrin 322
Dexa tomanol 391 Dexaamisolone-n 375
Dexa-attritin 391 Dexa-biofinicol 334
Dexabiotan 375 Dexabolin 351
Dexacidin 375 Dexadrine 343
Dexa-escopyrin 391 Dexalocal 338
Dexamed 343 Dexamed 391
Dexamin 343 Dexamin 321
Dexamist 375 Dexampex 343
Dexapirilene 371 Dexaspan 324
Dexa-tavegil 338 Dexatrim 392
Dexatrine 321 Dexatrzona 391
Dex-a-vet 327 Dexavetaderm 375
Dexedrina 343 Dexedrine 343
Dexinca 382 Dexital 324
Dexolan 356 Dexophrine 368
Dexoval 368 Dexten 343
Dextophan 343 Dextromycetin 334
Dextrophen 343 Dextro-profetamine 343
Dey-dose 361 d-Fenfluramine 343
Dha 51 322 Dha-s (prasterone) 398
Dhsm 345 Diaban 338
Diabis 386 Diabrin 330
Diacalm 382 Diacin 375
Diacolin 393 Diacta 403
Diadin 374 Diadril 365
Diaformin 386 Diafuron 353
Diagnorenol 372 Diaguard 382
Diaguard forte 362 Diaguard forte 382
Dia-ject 375 Dial toilet soap 356
Dialidene 353 Dialose plus 381
Dialpyrin 322 Diandron 398
Diandrone 398 Diapatal 324
Diapenin 3 345 Diapenin balsamico 345
Diaperidol 348 Diaphylline 323
Di-ap-trol 386 Dia-quel 380
Diarest 375 Diarexin 353
Diareze 382 Diareze 364
Diarin 353 Diarphem 346
Diarrest 344 Diarrest 341
Diarrestival 345 Diarrhosan d 382
Diarsed 346 Diarsed-neomycin 346
Diasatin 381 Diastat 382
Diastat 362 Diastat 402
Diatensec 401 Diatesurico 394

487
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Diatro 346 Di-bal-rone 369
Diban 400 Diban 382
Diban diet complex 1500 382 Di-barbs 383
Dibein 386 Dibein retard 386
Dibenide 386 Dibenyline 390
Dibenzyline 390 Dibenzyran 390
Dibetos 330 Dibinyl 386
Dibiraf 386 Dibolin 386
Dibophen 386 Dibotin 386
Dibromoksin 330 Dibromoquin 330
Dibromoxin 330 Dibromoxine 330
Dibun 386 Dibuzon 391
Dicandiol 367 Dicevermin 394
Dichinalex 336 Dichloronic 343
Dichronic 343 Diclo attritin 343
Diclo spondril 343 Diclo-attritin 343
Diclo-burg 343 Diclofur 353
Diclophen 344 Diclo-phlohont 343
Diclo-puren 343 Diclo-recip 343
Dicloreum 343 Diclo-spondyril 343
Diclo-wolf 343 Dicortineff 375
Dicton-retard 348 Dicyclomine 344
Dicycloverin 344 Didromycin 345
Didrothenate 345 Diebin 386
Diebin retard 386 Diemal 326
Dienoestrol 344 Dienol 344
Dienostrol cream 344 Dienstrogen 344
Dienterol 375 Dietec 321
Dietelmin 394 Dietene 332
Dietil retard 321 Dietil-retard 321
Dietrol 386 Diet-trim 382
Diffu-k 397 Diffusin 358
Difimetus 379 Difimetus compositum 379
Diflarex 410 Diflurex 410
Difmedol 380 Digenol 337
Digesan 394 Digesept 330
Digi-aldopur 401 Digibutina 391
Digi-pulsnorma 387 Digisab 322
Digiseb 319 Dignoflex 359
Diguabet 386 Dihydrocidan sulfato 345
Dihydrodiethylstilbestrol 357 Dihydrostreptofar 345
Dihydrostreptom 345 Diidro-pantostrept 345
Dilakton 401 Dilangio 326
Dilangio caposium 326 Dilapres 326
Dilaurazine 394 Dilectus 339
Dilombrine 346 Diloxol 366
Dimametten 322 Dim-antos 399

488
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Dimapyrin 322 Dimetane 392
Dimetap sinus 359 Dimethedon 369
Dimezathine 403 Dimicina 375
Dimidin 403 Dimidon 359
Diminal 413 Dimopyrin 322
Dimotane 392 Dinestrol 344
Dinol 344 Dinopirina 369
Dinovex 344 Diocimex 347
Dioctin 345 Diocyl 344
Dioderm 338 Dioderm c 338
Dioderm c-c 338 Diodotracin 338
Dioloxol 366 Diomeride 343
Dioquinol 338 Diossidone 391
Dioxadol 369 Dipar 386
Dipental 383 Dipirin 322
Dipiron 369 Dipirona 369
Dipirone 369 Diprin 322
Diprivan 399 Diprofarm 369
Diproform 338 Dipyrin 322
Dipyrine 322 Dipyrivo 369
Dipyrone 369 Dira 401
Direstop 391 Direver 402
Direver 393 Dirkan 403
Diromo 330 Diron 367
Dirorno 330 Disenterol 393
Disipan 354 Dismenodl n 359
Disoprivan 399 Dispalgine 369
Disparicida 319 Dispermin 394
Disphex 396 Dispos-a-med 361
Disprofol 399 Dissenten 364
Dissenter 364 Dissol 329
Distaval 409 Distilbene 345
Distocid 356 Distonocalm 383
Distraneurin 340 Distraneurine 340
Distreptopab 345 Dital 386
Dithene-r 387 Dithiazine (dye) 346
Ditinil 381 Ditmedol 381
Ditrone 391 Diudorm 372
Diurazina 394 Divalvon-d 400
Divarin 369 Divarmin 369
Divermex 394 Divinoctal 372
Dizan 346 Dizenterol 338
Dk 2 356 Do-ba-rone 369
Dobeom 386 Dobesin 321
Dobetin 369 Doboiosol 349
Docabolin 374 Docabolin 375
Docostyl 347 Doctamicina 334

489
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Doctofril 391 Doctus 339
Doksapan 347 Dolafort 384
Dolaren 343 Dolaren 369
Dolat 347 Dolatets 369
Dolazon 369 Dolemicin 369
Dolene 384 Doleron novum 385
Dolgenal 414 Dolgirit 359
Dolgit 359 Dolibral 399
Dolibrax 399 Doline 327
Dolispan 369 Dolispasmo 369
Dolkwal tartrazine 407 Dolo adamon 369
Dolo baralgine 369 Dolo buscopan 369
Dolo nerv 369 Dolo neurobion 369
Dolo neurobion forte 369 Dolo pangavit 369
Dolo raptalgin 369 Dolo spasuret 370
Dolo-attirin 322 Dolobasan 343
Dolocyl 359 Dolo-dolgit 359
Dolo-eupaco 387 Dologesic 359
Dolojudolor 370 Dolo-med-much 385
Dolo-mineuron 399 Dolomo 384
Dolo-neos 359 Dolo-neurobion 370
Dolo-optineural 322 Dolo-phlogase 380
Dolopirina 370 Dolo-prolixan 326
Dolo-puren 359 Dolorphen 322
Doloscopin 370 Dolosin dexa 391
Dolostop 384 Dolo-tandril 380
Dolotrem 343 Dolovisano 367
Dolovosano 322 Doloxene comp forte, capsules 384
Dolpirina 391 Dol-stop 385
Doltibil 359 Dolven 359
Dolviron 384 Dolwas 414
Domeform 338 Domical 324
Dona 200-s 355 Dona compositum 355
Donibin 387 Donjust-b 359
Donna 200 355 Donnage 382
Donnagel 382 Donnagel 362
Donnagel 400 Donnagel pg capsule 382
Donnagel pg liquid 362 Donnagel-mb 382
Donnagel-mb 362 Donnagel-pg 362
Donnagel-pg 382 Donnagel-pg 400
Donna-lix 387 Donnaplex 387
Donnatal 387 Donnatal 400
Donobin 322 Dopiral 370
Doragon 343 Doredin 322
Doregrippin 384 Doreplaston/doser/f 375
Doreplston 353 Dorflex merrell 370
Dorico 357 Dorico soluble 357

490
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Doriden 355 Doridene 355
Doriden-sed 355 Doridine 355
Dorimid 355 Dorimide 355
Dorithicin 376 Dorival 359
Dorlisin 370 Dorlotyn 324
Dormabrol 367 Dormigoa 372
Dormigoa-schlafmittel 372 Dormileno 326
Dormilfo n 367 Dormin 371
Dorminal 324 Dormir 372
Dormiral 387 Dormisedilal 372
Dormogen 372 Dormol 389
Dormon 326 Dormonal 326
Dormutil 372 Dormytal 324
Doron 370 Dorscopena 370
Dorsec 403 Dorsec 334
Dorsec 405 Dorsedin 370
Doryx 347 Doryxas 379
Dosberotec 352 Doscafis 384
Doscalun 387 Dosil 347
Doss 342 Dotur 347
Double-t 409 Dovaso 357
Dovenix 379 Doviron 384
Dowmicyn 349 Dowzene 394
Doxal 347 Doxatet 347
Doxedyn 347 Doxepin hcl 347
Doxi sergo 347 Doxicento 347
Doxidan 389 Doxifin 347
Doxilen 347 Doximycin 347
Doxin 347 Doxina 347
Doxinate 347 Doxiten bio 347
Doxivis 347 Doxy 347
Doxy-100 347 Doxy-basan 347
Doxybiocin 347 Doxychel 347
Doxycyl 347 Doxy-diolan 347
Doxydyn 347 Doxyfed 368
Doxyfim 347 Doxygram 347
Doxylag 347 Doxylan 347
Doxylar 347 Doxylets 347
Doxylin 347 Doxymycin 347
Doxyn 368 Doxy-p 347
Doxytem 347 Doxy-wolff 347
D-pron 370 Dradril 365
Dreiciclina balsamica 345 Dreimicina 349
Drenoliver 337 Drinacet 384
Drinalfa 368 Drinamyl 343
Dristan 399 Dristan sinus 359
Dropenzil 394 Droxan 330

491
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Droxarol 330 Droxaryl 330
Droxaryl zalf 50 mg 330 D-sinus 392
Dst 345 Dtdc 346
D-threo-chloramphenicol 334 Duerin 322
Dufemine 344 Dugen 342
Dulasi 406 Dulcicortine 376
Duloctil 406 Dumalgin 370
Dumoxin 347 Duneryl 387
Duo-autohaler 361 Duohist 371
Duo-medihaler 361 Duonale-e 350
Duo-tussin 371 Duovent 387
Duovent 352 Duozplin vitaminado 349
Duphacerate 376 Duphaspasmin 327
Duphenicol 334 Duplibiot 364
Duplinal 339 Durabol 374
Durabolin 374 Durabolin 375
Durabolin phenpropionate 375 Durabolin-o 351
Duraboral 351 Duraclofibrate 339
Duradermal 330 Duradoxal 347
Duradyne 359 Dura-ibu 359
Duralbuprofen 359 Duralnordin 370
Duraphyllin 323 Duraspiron 401
Durasul 404 Durasul jarabe 404
Durateston v 408 Duravolten 343
Duremesan 365 Durium 327
Duromin 390 Duromine m 40 372
Durophet 343 Durophet 321
Durophet-m 343 Durox 404
Durules-k 397 Dushel 353
Dutformin 330 Duvavotten 344
Duvium 327 Dv 344
Dv 201 376 Dya-tran 370
Dye yellow lake 407 Dylhista 371
Dymazone 378 Dynabalon 375
Dynabiotal 349 Dynarsan 319
Dyrex 394 Dyrexan-od 386
Dysdolen 359 Dysentrocym 330
Dysmalgin 399 Dysmensan 322
Dysne-inhal 348 Dyspas 344
Dyspnoesan 361 Dystoid 367
E 102 407 E 102 (dye) 407
E.e.s 349 E-217 409
Ear-dry 329 Eastman 7663 346
Eatan 372 Eatongel 344
Ebufac 359 E-caprine 348
Ecatrol 343 Eclipse 327
Ecobutazone 391 Econoclor 334

492
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Ecoprofen 359 Ecosan 394
Ecto pellicur 357 Ectobutazone 391
Ectofum 357 Ectofural 378
Ecuanil 367 Eczecidin 338
Edental 367 Edgartet 370
Edicol supra tartrazine n 407 Edifeno 405
Ediluna 359 Edoiacolo 319
Edrisal 384 Ees-200 349
Ees-400 349 Eeskabarb span 387
Eespanal 370 Efamast 354
Efatin 350 Efed ii 392
Effederm 411 Effekton 344
Effox 337 Eficol 392
Ef-micin 393 Efo-dine 396
Efroxine 368 Egg yellow a 407
Eggobesin 399 Ego psoryl 389
Egomycol 389 Egosol-bs 329
Ehrlich 594 319 Eiproheptadine 341
Ejcopyrin 399 Ejificol 334
Ejificol strept 334 Ejificol sulfa 334
Ejor 362 Ekluton 396
Elase chloromycel 334 Elastonon 321
Elatrol 324 Elatrolet 324
Elavil 324 Elavil plus 324
Elcoman 364 Eldopaque 358
Eldopaque forte 358 Eldoquin 358
Eldoquin forte 4% cream 358 Eldox 346
Eleudron 405 Elibese 387
Elipten 322 Elix 404
Elkosin 406 Ellemger 340
Elmedal 391 Elmigrin 387
Elmizin 346 Elphemet 386
Elpi 340 Elrodorm 355
Eludril 336 Emaform 338
Emagrin 387 Embacetin 334
Embutal 383 Embutol 350
Emcortina 376 Emd 15700 377
Emedrin 348 Emerin 403
Emetin 348 Emetina 348
Emetocamphrol 348 Emetren 334
Emineurina 340 Emitrip 324
Emlab 357 Emodin 359
Emorex k berna 376 Empiral 384
Empirin compound 384 Emprazil 384
Emprazil-c 384 E-mycin 349
E-mycine 349 Enarmon 408
Enarmon-oil 408 Enbacin 376

493
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Enbol 400 Enbrel 350
Encefabol 400 Encefort 400
Encephabol 400 Encerbrovit 400
Encerebron 400 Encilcort 408
Endal 392 Endamal 336
Endecon 392 Endep 324
Endex 392 Endocorion 396
Endoeritrina 349 Endometril 365
Endomixin 376 Endorid 394
Endrine 332 Endyne 360
Enerbol 400 Energital 375
Enerzer 361 Enicol 334
Enosept 330 Enovil 324
Ensobarb 387 Ensulfa 404
Entacyl 394 Entazin 394
Enteral 338 Enteramida 393
Enterar 353 Entera-strept 345
Entercol 379 Enteritan 338
Ente-rivo 338 Ente-rivo simplex 403
Enterocalme 393 Enterocol 379
Entero-hermes 393 Enterokin 338
Enterokvin 330 Enterolyte 382
Enteromac 376 Enteromycetin 334
Enteropast 376 Entero-red 393
Enterosan 362 Enterosan 338
Enterosept 338 Enteroseptol 338
Enterosintex 376 Enterosteril 393
Entero-sulfina 393 Entero-toxan 393
Entero-valodon 338 Entero-vioform 338
Entero-vioformio 338 Entero-vioformo 338
Enteroxon 353 Enterozol 338
Enterquinol 338 Entexidina 393
Entox 338 Entrafon-210 324
Entrafon-2-10 324 Entrafon-2-25 324
Entrafon-a 324 Entrafon-forte 324
Entrasorb 338 Entrokin 338
Entrokinol 338 Entromone 396
Enttocetrin 334 Enzipan combinado 370
Ephedrobarbital-t 387 Ephestmin 387
Epi-aberel 411 Epib 340
Epiboran ofteno 348 Epidormb 387
Epifrin 348 Epiglaufrin 348
Epikur 367 Epilantin 387
Epinal 320 Epinephrine hcl 348
Epinephrine pediatric 348 Epineramine 348
Epipen 348 Epirenan 348
Epitrate 348 Epivetol 389

494
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Epizon 399 Epobron 359
Epocan 400 Epocler 358
Epogam 354 Epragen 384
Epsylone 387 Equanil 367
Equi bute 391 Equiner 367
Equinil 367 Equipalazone 391
Equipur 413 Equithesin 350
Equizole-a 394 Equqtrqte 367
Eraldin 398 Eraldina 398
Eramid 340 Eraverm 394
Erbaplast 334 Erdol 406
Erestol 336 Ergobel plus 383
Ergojuvan 387 Ergo-lonarid 324
Eributazone 391 Erimec 349
Erio tartrazine 407 Erio yellow t supra 407
Erirobios 349 Eriscel 349
Eritrazol 349 Eritrobios 349
Eritrobiotic 349 Eritrocin 349
Eritrodes 349 Eritroger 349
Eritronicol 349 Eritropan 349
Eritroveinte 349 Eritrovienite 349
Eritrowolf 349 Eritro-wolf 349
Erittronicol 334 Ermysin 349
Eromycin 349 Erteilen 334
Ery derm 349 Eryc 349
Erydin 361 Erymycin 349
Erypar 349 Eryped 349
Erysan 336 Ery-tar 349
Erythrocin 349 Erythromictine 349
Erythromid 349 Erythro-prat 349
Ery-toxinal 349 Erytrarco 349
Erytrodol 349 Erytro-prot 349
Eryt-toxinal 349 Esadoxi 347
Escoderm 326 Escofuran 378
Escofuron 378 Escomen 399
Escophylline 323 Escopon 380
Escopyrin 391 Escopyrinus 322
Escovermin 394 Esentil 344
Eskabarb 387 E-son 392
Esoterica 358 Esoterica facial 358
Esoterica regular 358 Esoterica sensitive skin 358
Esoterica sunscreen 358 Espafren 387
Espasfher 370 Espasmir 370
Espasmo-cibalgina 370 Espasmo-giliganan 354
Espasmoqual 370 Espasmotex 370
Espasmoviral 370 Espasnatex 322
Espimina 349 Espornade spansule 392

495
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Espotabs 381 Espotabs 389
Esprenit 359 Espril 377
Espyre 370 Estelapar 411
Esteraplidin mag 393 Esterofenil 334
Esteropipate 394 Estesina 399
Estevecicina cloranfenico 334 Estialim 341
Estimal 324 Estimina 349
Estomicina 350 Estomiicina 350
Estomycin 350 Estraguard 344
Estrepromade 402 Estrepromicina 402
Estrepto e 402 Estrepto level 402
Estrepto ph 402 Estrepto wolner 402
Estreptokectil 382 Estreptoluy 346
Estreptomicina normon 402 Estreptonetrol 382
Estreptoral 382 Estreptosirup 346
Estreptosirup 382 Estrifen 384
Estrodienol 344 Estroral 344
Etamyl 324 Etaphylline (acetyllinate) 394
E-tapp 3 392 Etarfon 324
Etbutol 350 Ethaminal 383
Ethibute 391 Ethophylline 323
Ethril 350 Ethylnandrol 351
Etrafon-a 324 Etrafon-forte 324
Etretin 319 Eubetal 334
Euchessina 389 Euchessinia 389
Euciton 347 Eudiamine 323
Eudyna 411 Eufibran 322
Eufibron 399 Eufilina 323
Euflavin 320 Eugeniteed 393
Eulaxin 381 Eumatol 331
Eunalgit 322 Eunoctal 324
Euphozid 361 Euphrodinal 368
Euphyllin 323 Euphyllin 0.48 323
Euphyllin retard 323 Euphylllin cr 323
Euphylllina 323 Euplit 324
Euprogan 322 Eurocert tartrazine 407
Europan 399 Euspiran 361
Eustoporin 376 Eusulfa 404
Euteberol 401 Euvasal 406
Evac-q-tabs 389 Evac-qwik tablets 389
Evactil 389 Evac-u-gen 381
Evac-u-gen 389 Evac-u-lax 381
Evasprin 359 Evazol 342
Eventin 399 Evercil 329
Eviderm 357 Evipal 357
Evipal sodium 357 Evipan 357
Evipanl 357 Evixub 347

496
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Ex-adipos 390 Exadrin 349
Exazol 404 Exazole 404
Excedrin ib 359 Exelmin 394
Exidol 354 Exidol 359
Ex-lax 381 Ex-lax 389
Ex-lax pills 381 Exlutena 365
Exlution 365 Exluton 365
Exluton (a) 365 Exlutona 365
Exneural 359 Exofene 357
Exolise 331 Exopin 394
Exoseptoplix 405 Expec-c 336
Expect-blacken-pastillen n 401 Exponcit 332
Expseptoplix 405 Exraheudon 391
Exrheudon 391 Extracicilina 334
Extracort 376 Extrovent 387
Exyphen 392 E-z scrub 357
F 190 319 F 650 391
Factorate 351 Factus 392
Faderma 405 Fadfilina 323
Fadormir 372 Fagolipo 365
Fago-paraxin 325 Fago-praxin 334
Falaper 328 Famet 403
Famodil 351 Farbinol 370
Farectil 406 Faredina 332
Farinffnicol 404 Faringina 342
Farlurin 342 Farlutal 342
Farlutale 342 Farmacyrol 345
Farmicetina 334 Farmodoxi 347
Farmolisina 370 Fas-cile 200 367
Fasconal 388 Fast yellow 5g 407
Fastin 390 Faverin 353
Faw 76 327 Fd 8 399
Fd and c yellow no. 5 407 Febral 399
Febren 322 Febrinina 322
Febrizene 376 Febron 322
Febrosolvin 322 Febutolo 381
Feclan 352 Fedrilum 388
Fedrinal 388 Feen-a-mint 389
Feguanide 386 Feloran 344
Felsol 385 Femafen 359
Femagest 366 Femakzem 405
Femapirin 359 Femcaps 384
Femidol 359 Fenacetina 384
Fenadin 408 Fenalgic 359
Fenalgin 388 Fenartril 374
Fenascor 384 Fenasprate 327
Fenazo yellow t 4 407 Fenazone 385

497
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Fenbid 359 Fenbutal 384
Fenemal 388 Fenfoduron 386
Fenformin 386 Fenguanide 386
Fenibutasan 391 Fenibutina 391
Fenibutol 391 Fenicado 389
Fenicol 334 Fenidina 384
Fenilcal 388 Fenilor 330
Fenina 384 Fenint 360
Feniprenazone 352 Fenisan 381
Fenlong 359 Fennosan h 30 356
Fenobolin 375 Fenodon 322
Fenodone 322 Fenofan 337
Fenoflam 344 Fenormin 386
Fenosed 388 Fenosed bitabs 388
Fenotone 391 Fenox 392
Fensol 352 Fepramole 352
Fercasulf 404 Fermakzem 329
Ferndex 343 Fertabolin 351
Fertagyl 327 Ferti-cept 396
Fesmicina 350 Festamoxin 363
Fetonal 363 Fevarin 353
Fever 322 Feverall 370
Fevonil 370 Fherbolico 375
Fherbolico 374 Fiblet 382
Fibramid 340 Fibrolynt 340
Fibutrox 380 Fibutrox 381
Filon 387 Fim-a-mint 381
Final step 396 Finam 321
Fin-a-mint gum 381 Finedal 339
Finibron 331 Finigripp 399
Finipect 379 Fiorinal 384
Fipexitum 352 Fipexium 352
Firtasec 364 Fisiolax 381
Fisioquens 365 Fisohen 357
Fisohexx 357 Fissan 362
Fissan 376 Fitazil 393
Fitty derm 357 Fk-tussex 336
Fl 6321 n 376 Flamilon 407
Flanaril 380 Flavoquin 325
Flavoquine 325 Flebosil 391
Flecaine 352 Flenac 352
Flenaphthol 357 Flexalgit 384
Flexazone 391 Flex-care 329
Flib 518 381 Flivalgin 322
Flofos 407 Floghene 380
Flogicid 330 Flogistin 380
Flogistin 381 Flogitolo 380

498
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Flogitolo 381 Flogocid 376
Flogocid 330 Flogocid gel n.n 330
Flogocid sable 330 Flogodin 381
Flogodin 380 Flogofenac 344
Flogogenac 344 Flogolisin 370
Flogoril 380 Flogos 407
Flogosan 360 Florital 384
Flosin 360 Flosine 360
Flosint 360 Flosyn 360
Floxicam 362 Flubenil 359
Fludilat 326 Fludilat (r)-dti 326
Fludilat amp 50 mg 326 Fludilat drag 100 mg 326
Fludilat dragee 326 Fludilat retard 326
Fludilat tropfen 326 Flugolin 355
Flumamine 405 Flumil 322
Flumipam 353 Flunipam 353
Fluocinova 325 Fluonid 376
Fluorobioptal 334 Fluorobioptal 378
Flurofen 355 Fluryl 319
Flussema 326 Fluversin 406
Fluvisco 406 Fluxema 326
Fml-neo-liquifilm 376 Focus 359
Foille 376 Follidiene 345
Follormon 345 Follutein 396
Fomulex 344 Fonal 384
Food dye yellow 4 407 Food orange 8 332
Food yellow 4 407 Food yellow no. 4 407
Foragynol 345 Forbesotic 376
Forgenac 344 Formatrix 370
Formosa camphor 389 Formotablin antidiarreico 405
Formula 888 376 Formulex 344
Fornagest 392 Foroxon 353
Foroxone 353 Fortabolin 374
Fortacyl 384 Fortagesic 382
Fortal 382 Fortalgesic 382
Fortalidon 322 Fortasec 364
Forte 376 Forte 386
Forte 392 Forte 366
Forticillin 376 Fortral 382
Fortralin 382 Fortwin 382
Fourneau 190 319 Fr 3068 410
Fractines vichy 389 Fractine-vichy 389
Fractolon 396 Fradyl 376
Fragivix 327 Fragivix (r) forte 327
Frakidex 376 Frakitacine 376
Framenterol 353 Framidone 322
Fraquinol 338 Frein 345

499
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Frekentine 321 Frenal composium 361
Frenapyl 340 Frepp 396
Frepp/sepp 396 Fricton 405
Fridol 384 Fringanor 386
Friocellin 384 Froben 355
Fructines-vichy 389 Ft 15 353
Ftalazon 322 Ftalil-esteve 393
Ftalil-septol 393 Ftalil-tiazol 393
Ftalysept 393 Fts 375
Fugoa n 392 Fulcin 355
Fulcine 355 Fulcine-125 355
Fulcine-s 355 Fulneurina 400
Fultrexin 378 Fuluminol 338
Fulvicin 355 Fulvicin p/g 355
Fulvicin u/f 355 Fulvicina 355
Fumarsutin 338 Funapann 384
Funapon 322 Funed 409
Fungarest 363 Fungarol 363
Fungistat 408 Fungivin 355
Fungo-hubber 363 Fura 378
Furaberin 353 Furacilinum 378
Furacin 378 Furacinas 378
Furacine 378 Furacinethin 378
Furacinetten 378 Furacin-sol 378
Furacin-streusol 378 Furacoccid 378
Furacocid 378 Furacol 378
Furacol l 334 Furacol l. 353
Furacort 353 Furaderm 378
Furalatin p. 353 Furaldon 378
Furalidan 353 Furaliqua 353
Furall 353 Furalone 378
Furamecetil alpha magna 334 Furamecetil magna 334
Furan 378 Furan 378
Furan-ofteno 378 Furaplast 378
Furaseptin 378 Fura-septin 378
Furaskin 378 Furatone 346
Furatrimon 334 Fura-vet 378
Furazin 378 Furazina 378
Furazol 353 Furazol w 378
Furazon 353 Furea 378
Furesan 378 Furesol 378
Furokatin 334 Furosem 378
Furotalgin 378 Furovag 353
Furovol 378 Furox 353
Furoxal 353 Furoxane 353
Furoxon 353 Furoxona 353
Furoxona-cp 353 Furoxone 353

500
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Furoxone swine mix 353 Fusalor-yodocloro 338
Fuvitan 353 Fuxol 353
Fuzatyl 353 Fyloxxal 338
Fysiognens 365 Fysionorm 365
Fysioquens 365 G.r. ulix compuesto 370
G-11 357 Gabaphore 398
Gabbroral 382 Gabren 398
Gabrene 398 Gadexyl 367
Gagaril sulfamida 405 Galacid 353
Galanrent 408 Galenopyrin 322
Galinid 407 Gamafin 402
Gamafur s. 353 Gamex 364
Gamma benzene 364 Gammachetone 362
Gammaphenicol 334 Gamophen 357
Gamophen surgical soap 357 Ganda 349
Ganex p 804 396 Ganidan 403
Ga-pvp-101 396 Gardax 392
Gardenal 388 Gardenale 388
Gardepanyl 388 Gardstat 368
Gargilon 342 Gastromycin 376
Gastrop 388 Gastrosilane 344
Gebriazol 340 Gefulvine 355
Gelonida 384 Gene-bamate 367
Geno-sal 366 Genpril 359
Genservet 370 Gentarol 388
Gentiazina 394 Gentil 370
Geralgine 370 Geri-70 340
Geribolina 400 Germax 378
Germex 378 Germibon 357
Gerobit 368 Gerodryl 395
Geromid 340 Gerontabol comp. 400
Geronyl 368 Gerostop 340
Gesic 384 Gesinal 342
Gesta plan 379 Gestafortin 335
Gestapuran 342 Gestapuron 342
Gestrol 365 Gevilon 354
Gewodin 384 G-farlutal 342
Ghimadox 347 Giardil 353
Giarlam 353 Giarlin 353
Gidalon 352 Gifaril 370
Gilex 347 Gill soap 357
Ginarsol 319 Ginejuvent 378
Ginetris 334 Gino-dectacil 334
Ginsopan 392 Ginvel 353
Giolate 388 Glafezon 354
Glaucadrin 349 Glaucadrine 329
Glaucadrine 349 Glaucoaicon 349

501
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Glaucon 349 Glauconin 349
Glaucosan 349 Glaucotahil 349
Glifadex 354 Glifan 354
Glifanan 354 Glifarelax 354
Glimid 355 Gliporal 330
Gliscol 334 Globenicol 334
Globveticol 334 Glorous 334
Gluciferne 386 Glucifrene 386
Glucocalcium 329 Glucopirina 322
Glucopitina 322 Glucopostin 386
Glucopstin 386 Gludorm 355
Glukopostin 386 Glupan 409
Glusac super 341 Glutanon 409
Glutisal 370 Glyanphen 388
Glybigid 330 Glycerinated skin testing solutions 320
Glycirenan 349 Glycopiparsol 394
Glycyl 391 Glykresinum 366
Glyotol 366 Glyphen 386
Glyptol 366 Glyuferal 388
Gmd 338 Godafilin 323
Golaman 352 Gonabion 396
Gonadex 396 Gonadoplex 396
Gonafollin 396 Gonagestrol 396
Gonault 396 Gondrone 408
Gonoper 328 Gontochin 336
Goticas 334 Gotimycetin 334
Gourmase 388 Goyl 319
Gp 40705 380 Gram-val 347
Granidan 403 Granudoxy 347
Gratsidin 387 Gratusminal 388
Gravimun 396 Gregoderm 376
Greosin 355 Greplicina belsa 370
Grfulvin v 355 Gricin 355
Grifulin 355 Grifulvin 355
Grifulvin v 355 Gripanidan 384
Grippocaps 399 Grisactin 355
Grisaltin 355 Grisefalin 355
Grisefulin 355 Grisefulvin 355
Griseo 355 Griseomed 355
Griseostatin 355 Grisol 355
Grisona 352 Grisovin 355
Grisovina 355 Grisovina fp 355
Grisovine 355 Grisovin-fp 355
Grisowen 355 Gris-peg 355
Grocreme 342 Grom hgh 396
Grorm 401 Grysio 355
Gt-250 409 Guamide 403

502
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Guanicil 403 Guanidan 403
Guanimycin 403 Guanor 336
Guanosept 338 Guanowept 403
Guasept 403 Guildprofen 359
Gum camphor 389 Gustibon 376
Gynaedron 405 Gynedron 329
Gynedron 406 Gynefollin 345
Gyne-sulf 405 Gyno-bidex 396
Gynodian 398 Gynoplix 319
Gyno-terazol 408 Gyno-terazol 408
Gyn-sulf 405 H 116 370
H 117 370 H 118 370
H plus n 376 H.e.c 382
Haelan-c 338 Haemostasin 349
Haemovin 357 Hagalgin 370
Hagrosept 376 Haimaplex 351
Haitmin 330 Halcion 412
Halicomb 376 Halidor 326
Halog 376 Halogabide 398
Halprin 359 Haltran 359
Harbureta 384 Harmonin 367
Hartol 367 Hasain 370
Hasp 388 Hava-span 403
Hcg 396 Hcg standard tablets 396
Hcp 357 Hd tartrazine 407
Hd tartrazine supra 407 Headway 392
Healthstyle 340 Heaven 399
Hederix 379 Heksaden 357
Heksapar 394 Hektalin 349
Heliomycort 376 Helle-strep-forte 346
Helmacid 394 Helmezin 394
Helmicide 394 Helmifren 394
Helmipar 394 Helmirazine (adipate) 394
Helmirazine (citrate) 394 Helmitin 394
Helmizin 394 Helvagit 384
Helvagit-f 322 Helvedoclyn 347
Hemagene taylor 384 Hemicraneal 322
Hemineurin 340 Hemineurine 340
Heminevrin 340 Hemisine 349
Hemoantin 406 Hemodesis 396
Hemodez 396 Hemofil 351
Hemometina 348 Hemostatin 349
Hepabuzon 391 Hepadist 357
Hepa-obaton 375 Heptadorm 356
Herb royal round worm treatment 394 Heriat 356
Hermo m 408 Herpevac 356
Herpevax 356 Herpevax hvt 356

503
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Herphonal 412 Hesse-sulfon 404
Hexabalm 357 Hexacert yellow no 5 407
Hexachloride 364 Hexacol tartrazine 407
Hexadespon 357 Hexal 357
Hexalacton 401 Hexanal 357
Hexanastab 357 Hexanastab oral 357
Hexanthelin 394 Hexaph 357
Hexaphenyl 357 Hexaphenyl(1&b) 357
Hexascrub 357 Hexatrol 357
Hexenal 357 Hexidol 356
Hexocreme 357 Hexosan 357
Hex-o-san 357 Hf 1927 343
Hgh 401 Hichillos 362
Hi-enterol 338 Hiliopar 336
Hilomid 356 Hipnosedon 353
Hipolixan 354 Hiposedon 353
Hippuzon 409 Hiroval 363
Hisense-p 322 Hismanal 325
Hispacid fast yellow t 407 Histabid 392
Histade 392 Histadyl 371
Histadyl ec 371 Histalix 336
Histamanal 325 Histatapp 392
Histatets 341 Hitalones 371
Hizeneck-d 350 Hjorton's powder 384
Hocacorten-vioform 338 Hocophen 384
Hoe 15239 330 Hoe 984 379
Hokulaton 401 Hokuraton 401
Holbamate 367 Holodorm 372
Homandren 408 Homosterone 408
Honkon-n 350 Hormocillin forte 328
Hormofemin 345 Hormoteston 408
Hosta-500 409 Hostalival 379
Hourbese 386 Hp 48 346
Hsp 540 392 Humafac 351
Humagel 382 Humagel 382
Human groth hormone 401 Human growth hormon 401
Humanate 351 Humatin 382
Humatrope 401 Hyasorb 328
Hyate:c 351 Hybolin decabiate 375
Hybolin improved 375 Hybolin-decanoate 374
Hyclorate 340 Hydraplex 327
Hydrazine yellow 407 Hydril 336
Hydrocortiderm 376 Hydroform 338
Hydro-neo oculos 376 Hydrospiron 401
Hydroxine yellow l 407 Hydroxybenoxopyridine 356
Hydroxybenzene 389 Hylase 358
Hyminal 372 Hyonol 388

504
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Hyparon 322 Hypnaletten 388
Hypnodorm 353 Hypnogene 326
Hypnol 383 Hypnolone 388
Hypnomidat 351 Hypnomidate 351
Hypnomidate concentrate 351 Hypnomidate injection 351
Hypnosedon 353 Hypnotal 383
Hypnox 326 Hypocol 372
Hypromidate 351 Hyptonal 383
Hyptor 372 Hyptor base 372
Hyrex 386 Hyrex-105 386
Hysone 338 Hysron 342
Hysteps 388 I fomula 378
Ia-but 391 Iangene 406
Iap 385 Ibenon 359
Ibisul 406 Ibol 359
Ibosure 359 Ibruthalal 359
Ibu-attritin 359 Ibucasen 359
Ibu-cream 359 Ibufac 359
Ibufen tablets 359 Ibufen-l 359
Ibufug 359 Ibugel 359
Ibugesic 359 Ibuhexal 359
Ibular 359 Ibulav 359
Ibuleve 359 Ibulgan 359
Ibumetin 359 Ibuphlogont 359
Ibupirac 359 Ibuprin 359
Ibuprocin 359 Ibuprofen 200 359
Ibuprohm 359 Ibu-slo 359
Ibu-slow 359 Ibusure 359
Ibu-tab 359 Ibutad 359
Ibutid 359 Ibutop 359
Ibuvivimed 359 Ibux 359
I-caps 376 Ichthoseptal 334
Ici 28257nt 340 Icladox 347
Icn 65 384 Icramin 344
Idemin 367 Idepa 376
Idocyklin 347 Ido-op 376
Idrolatton 401 Idrolattone 401
Iebolan 374 Ifenin 324
Ifrasarl 341 Ii formula 378
Ila-med 388 Ilcocillin 328
Ilentazol 393 Ilgon 341
Iloramina 326 Iloson 350
Ilosone 350 Ilosone pulvules 350
Ilosone ready-mix 350 Ilothycin 350
Ilotycin 350 Iltazon 380
Iltoxon 380 Ilvin 392
Imagon 336 Imben 359

505
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Imbun 381 Imbun 380
Imbun 359 Imidan 409
Immenoctal 400 Imodium 364
Imosec 364 Impremial 352
Impromin 341 Imuprel 361
Inabrin 359 Inbestan 338
Incefal 359 Incramin 344
Incron 344 Inctacol-c 344
Indemin 367 Indextron 370
Infantex 399 Inflam 359
Inflamac 344 Inflamid 327
Inflamil 380 Inflazone 391
Influbene 370 Influenza tabs 384
Influnal depot 322 Influvit 399
Ingalipt 405 Ingamid 402
Ingamid ophtal 402 Ingelan 361
Injectin 402 Injecur 353
Inlax 381 Inonamin 390
Inophylline 323 Inopsin 348
Inorgan 403 Inoven 359
Inrestibla strepto 393 Insacial 332
Insom rapido 383 Insoral 386
Inst 322 Instana 336
Instilin 405 Insulamin 330
Intal compositum 361 Intalbut 391
Intefuran 353 Inter-con 341
Intestiazol 393 Intestopan 330
Intestopan-q 330 Intestovet 403
Intex 342 Intrabutazone 391
Intrabuzone 391 Intradermo caf 376
Intradin 403 Intramycetin 334
Intranefrin 349 Intrazone 391
Inza 359 Iodentero0neomicina 376
Iodenterol 338 Iodentero-neomicina 393
Iodochlorhydroxyquinol 338 Iodo-cortifair 338
Iodocortindon 338 Iodoenterol 338
Iodo-max 338 Iodopiron 397
Ionakraft 390 Ionamin 390
Ionamine 390 Ipebutona 381
Ipercron 392 Ipnofil 372
Ipolipid 354 Ipolipid 340
Ipren 359 Iprenol 361
Iproben 359 Ipropran 361
Iprox 341 Irfen 359
Irgamid 402 Irgapyrine 322
Iridil 381 Iridil 380
Iriphan 337 Irs 109 a 367

506
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Irs 109a 388 Iruxol 334
Iruxolum 334 Isaaxan 381
Isacen 381 Isaphen 381
Isaphenyn 381 Isdol 359
Isicetina 334 Isindone 360
Isinok 379 Isisfen 359
Ismicetina 334 Ismiverm 394
Isoamitil sedante 324 Isoamyn 321
Isoamytal 383 Iso-autohaler 361
Isobarb 383 Isobec 324
Isobutil 380 Isobutil 381
Isocrin 381 Isoderm 338
Isodienestrol 345 Isodine 397
Isoftal 322 Isoline 397
Isollyl 384 Isom rapido 383
Isomenyl 361 Isomidon 384
Isomin 409 Isomyl 324
Isomyn 321 Isomytal 324
Isonal 325 Isonal 324
Isonorin 361 Isonox 372
Isopap 371 Isoplasma 397
Isoprel 361 Isoprel-neomistometer 361
Isopronazon 399 Isoprop 361
Isopto epinefrina 349 Isopto fenicol 334
Isopto frin 392 Isorenin 361
Isospamex 344 Isosulf 406
Isotamine 361 Isotretinoin 362
Isovon 361 Isuprel 361
Itamidone 322 Iterco 367
Itinerol 365 Itro 376
Iturate 383 Izal 389
Izal germicide 389 Izaman 381
Jaa aminophylline 323 Jabon antiseptico 357
Jacosulfon 405 Jalonac 324
Janes liquid permifu 394 Japan camphor 389
Japan yellow no. 4 407 Jarabe neox 394
Jatrosom 411 Jaun tartrique 407
Jeifer-old 408 Jenomycin 376
Jetsan supp. (adipate) 394 Jodoplex 397
Jovapyrin 374 Junifen 359
Juniormen 400 Jurmun 372
Justalmin 394 Juvamidon 367
Juvamycetin 334 Juvanesta 328
K 115 397 K 15 397
K 25 397 K 30 397
K 4277 360 K 60 397
K 90 397 Kabolin 375

507
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Kabolin 374 Kadalex 397
Kadiur 397 Kadol 391
Kafa 384 Kako tartrazine 407
Kalacid 357 Kalimalterin 389
Kalinorm 397 Kalipor 397
Kalitabs 397 Kalium durules 397
Kalma 359 Kalma 364
Kalmin 384 Kalmine 322
Kalopsis 385 Kalopsisi 329
Kalpec-f 353 Kamaver 334
Kamfomen 378 Kanrenol 397
Kantrexil 382 Kaodinnon-narcotic 362
Kaolin w/pectin 362 Kaologeais 367
Kaomagma 382 Kaomagma with pectin 362
Kaomagma with pectin 382 Kaomycin 376
Kaomycin 362 Kaomycin 382
Kaon-cl 397 Kaoneo 362
Kaoneo 382 Kaopectate 362
Kaopectate 382 Kaopectate n 382
Kaopectate n 362 Kaopectate n 376
Kaopectin 382 Kaoprompt-h 382
Kaoprompt-h 362 Kao-spen 362
Kao-spen 382 Kaostaten 382
Kapetolin 362 Kapron 384
Kapsitrin 350 Kataglicina 386
Katagrip 384 Katareuma 322
Ka-thal-pec 380 Kato 397
Katwilon n 361 Kavapyret 399
Kavipe 334 Kayaku food colour yellow no. 4 407
Kayaku tartrazine 407 Kay-cee-l 398
Kb-502 370 Kc 362
Kca foodcol tartrazine pf 407 Kca tartrazine pf 407
K-contin 398 K-dur 398
Kefren 370 Kemicetine 334
Kencaps 366 Kenedes 388
Kenmin-s 328 Kennel-maid 394
Kentan 362 Kentan-s 362
Kenta-s 362 Kentuss 336
Kenzon r 362 Keralyt 350
Kerapos 329 Keratyl 375
Keratyl 374 Kesan 370
Kesso-bamate 367 Kesso-mycin 350
Kest 389 Kesten 346
Ketanol 362 Ketazon 362
Ketazone 362 Ketiak 404
Ketobutane-jade 362 Ketocidin 363
Ketoderm 363 Ketofen 362

508
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Ketoisdin 363 Ketonan 363
Ketoral 363 Kevadon 409
Kevadone 409 Keypyrone 370
Kharophen 319 Kharophene 319
Khlorlinkotsin 338 Kidoline 349
Kihomato 394 Killgrip 370
Kinavosyl 366 Kindrog 378
Kinosin s 328 Kinotomin 338
Kipyrone 370 Kiron 404
Kitax alpha 370 Kitax n 370
Kiton yellow t 407 Klast 344
K-lease 398 Klianyi forte 345
Klianyl 345 Klinicin 338
Klinomycin 374 Kln 362
Kln 382 Klodin 410
Klofibrat 340 Klofiran 340
K-long 398 K-lor 398
Kloramfex 334 Klor-con 398
Klorita 334 Klorocid s 334
Kloromicin 334 Klort 367
Klorvess 398 Klotrix 398
K-lyte/cl 398 K-norm 398
Koate 351 Kodomo smarin 329
Kolanticon 344 Kolantyl 344
Kollidon 397 Kollidon 12pf 397
Kollidon 17 397 Kollidon 25 397
Kollidon 30 397 Kollidon 90 397
Kollidon ce 50/50 397 Kollidon k 25 397
Kollidon k 30 397 Kol-tac 392
Kombiquens 366 Kometileneamin 341
Komex 329 Kompleteron 375
Kondremul with phenolphtalein 389 Konitan 370
Kontalipide 340 Kontexin 392
Kontipar 394 Kontrast 372
Kontrast u 341 Koprol 389
Koronar 388 Kortikiod mepha 376
Koryza 392 Kos 359
Krebon 330 Kriplex 344
Kryobulin 351 K-tab 398
Kubarsol 319 Kuronde 399
Kw 5338 347 Kymalzone 380
Kynex 404 Kynex acetyl 404
L yellow z 1020 407 La 96 381
Labamicol 334 Labamicol-bismuth 334
Labosept 342 Labymetacincpo 370
Lacalmin 402 Lacdene 402
Lacilactone 402 Lacolysat 353

509
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Lacondan 359 Lacretin 338
Lactismine 329 Lactmicina 370
Lagaflex 322 Lagalgin 370
Lagalgine 370 Lagaquin 336
Lagasediv 344 Lagaspasm 388
Lake yellow 407 Lallamin 371
Lamboxil 394 Lamidon 359
Lamoryl 355 Lamoryl-novum 355
Lamoyl 355 Lamprcsnum 370
Lanbiotic 376 Lanceotic 385
Lan-dol 367 Laniazid 361
Lantanon 373 Lapalgine 370
Laractone 402 Laralmin 402
Lardet 388 Larmicin 376
Larodon 399 Laroxal 324
Laroxyl 324 Larozyl 324
Larq 731 370 Larten 367
Lasacilina 328 Lasain 370
Lasilacton 402 Lasiren 397
Lasitone 402 Latepyrine 322
Latodurin 376 Latorex 332
Latoxacet 363 Laucetin 350
Laurel camphor 389 Lauridin 332
Laurilin 350 Lauritran 350
Lauroanginol 322 Lauromicina 350
Lavaciclina 370 Lavema 381
Laveman 381 Lavylgan 385
Laxante yer 389 Laxan-vomoxin 381
Laxaseptol 381 Laxatabs 389
Laxatone 389 Laxem 381
Laxen busto 389 Laxin 389
Laxnormal 381 Laxocol 381
Laxocoleva 381 Laxogen 389
Laxo-isatin 381 Laxon 381
Laxos 381 Laxyl 381
L-caine 349 Lecortin 338
Leder 392 Lederderm 374
Lederform-d 338 Lederkyn 404
Legatin 388 Lekasin 384
Lekosept 338 Lemobese 368
Lemoderm 338 Lemon yellow a 407
Lemon yellow a geigy 407 Lenicor 367
Lennacol 334 Lenoprel 361
Lentac 404 Lentizol 324
Lentobetic 386 Lento-kalium 398
Lentosulfa 404 Leo k 398
Leonal 359 Leonar 400

510
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Lepetown 367 Lepinal 388
Lepinaletten 388 L-epinephrine 349
Leponex 341 Leponox 341
Leptidrol 395 Lerivon 373
Letaquine 336 Leuchlon 334
Leukamycetin 334 Leukomyan 334
Leukomycin 334 Leutrophin 401
Levacide-c 341 Levapa 370
Levat 324 Levate 324
Levatram 340 Levatrom 340
Levismon 370 Levocycline 334
Levomanilin 334 Levomethadylacetate 363
Levomicetina 334 Levomicin 334
Levomitsetin 334 Levomycetin 334
Levomycetina 334 Levoninizol 334
Levopa 334 Levophed 364
Levorenine 349 Levoreninl-adrenaline 349
Levosin 334 Levovetin 334
Levovinizol 350 Levum 390
Lf 530 357 Lg 335 379
Lh 5000 396 Liademycin 328
Liapten 340 Libelins 353
Libiolan 367 Librofem 359
Librofen 359 Licasol 338
Licothionil 349 Lidazon 327
Lidifen 359 Lidoacton 349
Lidor 326 Lifabiotico 334
Life 400 Liferitrin 350
Lifuzol 378 Likuden 355
Likuden m 355 Lilly 3794 327
Lilly 90459 327 Lilo 389
Limarsol 319 Limbatarail 324
Limbatral 324 Limbitryl 324
Limit 386 Limitrol 324
Linarol 384 Linctuss 336
Lindemil 329 Linder 404
Lindiol 2.5 365 Lineal-plus 321
Lineal-rivo 321 Lineal-valeas 321
Linea-valeas 321 Linitut 376
Linola 338 Linyl 390
Lipamone 345 Liparil 340
Lipaten 340 Lipavil 340
Lipavlon 340 Lipavlon 500 340
Lipese 365 Lipicidon 340
Lipidicon 340 Liple 320
Lipobay 332 Lipociden 340
Lipofacton 340 Lipomid 340

511
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Lipomin 321 Liponorm 340
Lipopill 390 Liporan 340
Liporeduct 340 Liporil 340
Liposan 364 Liposid 340
Lipo-sinahist 392 Liposlim 321
Liprin 340 Liprinal 340
Liptan 359 Liptrinal 340
Lipur 354 Liquichlor 334
Liquital 388 Lircapil 388
Lisador 370 Lisagal 381
Lisalgil 370 Lisi-budol 359
Lisoprecol 334 Lissephen 366
Liticon 382 Lixophen 388
Lm 5008 360 Lobetrin 340
Locacid 411 Locacorten-vioform 338
Locomycetine 334 Locorten 376
Locorten 338 Locorten-vioform 338
Loctidon 406 Locton 406
Loderm 350 Loftyzon 357
Logen 346 Logical 393
Logisul jarabe 404 Logos 400
Lokalin 327 Lom 394
Lomanate 346 Lomax 346
Lombricida tropico 394 Lombrifher 394
Lombrikal 394 Lombrimade 394
Lomecetina 334 Lomine 344
Lomotil 346 Lomotil liquid 346
Lonarid n 324 Longamid 404
Longevital 5000 398 Longisul 404
Longopax 324 Lonox 346
Lopemid 364 Lopemin 364
Loperam 364 Loperan 364
Loperin 364 Lopermid 364
Loperyl 364 Lopid 354
Loractone 402 Loromisin 334
Lorothidol 328 Lorothiodol 328
Lostat 340 Loxaryl 324
Lrcl 3794 327 Ls 6030 386
Lu 403 Lubergal 388
Lubomycina 350 Lubomycine 350
Lucatyl 403 Lucofen 337
Lucofen retard 337 Lucofen sa 337
Lucosil 403 Ludilat 326
Ludilat dti 326 Luf-iso 361
Lullamin 371 Lumbrical 394
Lumcalcio 388 Luminal 388
Lunadon 388 Lunerin 392

512
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Luteocrin orale 342 Luteodione 342
Luteos 342 Luteovet 396
Luteran 335 Lutoporal 342
Lutoral 342 Luvion 397
Luvion 332 Luviskol 397
Luviskol k 17 397 Luviskol k 25 397
Luviskol k 30 397 Luviskol k 90 397
Luvisteol 397 Lyabex retard 379
Lyman tabs 320 Lyn_ratiopharm 365
Lyn_ratiophram_sequenz 365 Lyndeol 365
Lyndile tt 365 Lyndiol 365
Lyndiol e 365 Lyndiol e. 365
Lyndiolett 365 Lynoenstrenol 365
Lyn-ratiopharm 365 Lyobex 379
Lyodrin 349 Lyophrin 349
Lysadestal 388 Lysadestat 399
Lyspafen 345 Lyspofen 345
Lyspofenac 345 M.a.s. 367
M.p. 371 M.p. trantabs 367
Macaldex 329 Macmiror 378
Mactam 363 Madinex 327
Madrine 368 Magdor 370
Magic herb 348 Magnalsa 370
Magnemidon 370 Magnol 370
Magnopyrol 370 Magrene 321
Magrilan 365 Maikohist 338
Maind 400 Makatussin 401
Makatussin 332 Makrocyklina 350
Malaraquin 336 Malarex (diphosphate) 336
Malariron (diphosphate) 336 Maldocil 406
Malex 384 Malgesic 391
Malipuran 330 Mallermin 338
Malogen 408 Malogen in oil 408
Malonal 326 Malotrone 408
Malquin 336 Maltyl 342
Mamallet-a 322 Mamaslu 399
Mamex 357 Mamiesan 344
Mammanopen 376 Mammex 378
Mammiject 378 Mammphenicol 334
Mammyl 391 Mamomit 322
Manasul 384 Mandrax 372
Manegan 411 Manilina 350
Manslu 322 Mantacido 357
Maoa 372 Mapiprin 394
Mapir 370 Maple tartrazol yellow 407
Mar-bate 367 Marcaom 349
Marcoeritrex 350 Mardon 384

513
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Mardram 392 Mareline 324
Marevan 413 Margaris 367
Marimune 356 Marocid 350
Marplan 361 Marplon 361
Marsilid 361 Marsin 387
Marsthine 338 Masenate 408
Maskito 394 Masletine 338
Massotalil 393 Masterfen 406
Mastidol 378 Mastigun 346
Mastiphen 334 Mastisept 353
Mastofuran 378 Mastrinal 376
Maxepa 398 Maxibolin 351
Maxicam 362 Maxiton 343
Mazanor 365 Mazanor tablets 365
Mazeldene 365 Mazinil 365
Maznor 365 Mazur-a 388
Mc 3 336 M-cillin b 328
Mcn 2783 414 Mcn 2783-21-98 414
Mcn 742 323 Md 1020 388
Mebacid 403 Mebubarbital 383
Mecazine 365 Mecodrin 321
Mecoten 370 Med liquide san t 357
Medapan 356 Medaron 353
Medeyol 405 Mediamycetin 334
Mediatric 368 Medichol 334
Medicol 334 Medicon 379
Medicone derma-hc 356 Medicort 397
Medicycline 409 Medifenac 320
Medihaler-duo 361 Medihaler-epi 349
Medihaler-iso 361 Medipect 362
Medipect 382 Mediphen 388
Medipren 359 Mediprofen 359
Medisec neo 376 Medisec-cloxa 376
Medispanmin 322 Meditran 367
Medi-trol 324 Med-laxan 381
Medomin 356 Medomina 356
Medomine 356 Medri-biotic 376
Mefentil 366 Megace 366
Megacillin 328 Megal 326
Megal 370 Megazone 391
Megecat 366 Megeron 366
Megestat 366 Meimyd 376
Melabon 319 Melabon 384
Melaforte 322 Melanex 358
Melanex topical sollution 358 Melfen 359
Melfiat 386 Meliplus 334
Meloda 368 Meloka 322

514
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Melpaque hp 358 Melpen 370
Melqui hp 358 Melsed 372
Melsedin 372 Melsedine base 372
Melsomin 372 Meltrol 386
Memphenesin 366 Menabil complex 381
Menaderm antiacne 376 Menado ibuprofen usp 359
Menalgine 370 Menidrabol 375
Menocil 323 Menonorm 379
Menophase 379 Menoquens 366
Menospasm 344 Mentalormon 398
Mentol sedans sulfamidad 329 Mentol sedans sulfamidad 405
Mentol sedans sulfamidad 332 Menutil 321
Mepalgic 372 Mepantin 367
Mepavlon 367 Mep-e 367
Mephabutazon 391 Mepha-butazone 391
Mephadexamine-r 343 Mephadexamin-r 343
Mepha-gesic 366 Mephenicol powder 334
Mepherol 366 Mephesin 366
Mephesol 366 Mephson 366
Meposed 367 Meprate 342
Meprate 367 Mepriam 367
Meprin 367 Meprindon 367
Mepro 367 Meprobadal 367
Meprobamat 367 Meproban 367
Meprobil 367 Meprobit 388
Meprocompren 367 Meprocon cmc 367
Meprodil 367 Meprogesic q 367
Meprol 367 Meprolin 367
Mepron 367 Mepronel 367
Mepronil 367 Mepropon 388
Mepropyrin 391 Meprosa 367
Mepro-secergan 400 367 Meproserpina 367
Meprospan 367 Meprospan 400 367
Meprotabs 367 Meproten 367
Meprotil 367 Meproyrin 367
Meprozine 367 Meptran 367
Mequal 372 Mequelon 372
Mequin 372 Merastat 389
Meratonic 395 Meratran 395
Meravil 324 Merbantal 344
Merbentyl 344 Merck skin testin solutions 320
Mercuro clinico 368 Mercurocol 368
Meridil 373 Meriprobate 367
Merital 379 Merival 379
Merizone 391 Mertestate 408
Mervan 320 Mervan 413
Mescomine 358 Mesconit 358

515
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Mesmar 367 Mespafin 347
Mesylith 336 Metabolite i 380
Metactiv 406 Metadin 395
Metadorm 372 Metakualon 372
Metakvalon 372 Metamit 404
Metamsustac 368 Metanephrine 349
Metapirazone 322 Metapyrin 370
Metaqualon 372 Metazina 404
Meterdos-iso 361 Methadorm 372
Methampex 368 Methampyrone 370
Methaquaion 372 Methaqualoneinone 372
Methased 372 Methasedil 372
Methazol 403 Methedrinal 368
Methedrine 368 Methexenyl sodium 357
Methidate 373 Methistaline 371
Methisul 403 Methoxyverapamil 354
Methozin 385 Methrazone 352
Methril spansul 371 Methybol 374
Methybol-depot 375 Methybol-depot 374
Methylaminoethanolcatechol 349 Methylarterenol 349
Methylmorphin 341 Metigestene 342
Metigestrona 342 Metilon 370
Metisept 334 Metodril 372
Metodril 2 372 Metodril napa 372
Metolquizolone 372 Metranquil 367
Metrazone 352 Metrijet 338
Metrityl 338 Metrojen 388
Metuzina 404 Mevan 320
Mexafermento 338 Mexafom 338
Mexaform 338 Mexnex 368
Mf 218d 402 Mi 540 391
Mialgan 370 Mialgone 388
Miansan 373 Miantor 360
Micloretin 334 Micoclorina 334
Micoclorine 334 Micodry 334
Micofilina 334 Micogamma 357
Miconor 379 Micoral 363
Micotek 363 Micoticum 363
Micrainin 367 Microbamat 367
Microcetina 334 Microcid 404
Microcidal 355 Micro-sterandryl 408
Microsul 403 Mictrol 408
Micturin 408 Micturol ampicilina seda 403
Midicel 404 Midikel 404
Midisalb-m 366 Midixin 367
Midol 360 Midol 200 advanced pain formula 360
Midol ib 360 Mifegyne 373

516
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Mig-antos 385 Migen 320
Migesic 384 Migrafen 360
Migrane-dolviran 388 Migranin 385
Mikrozid 350 Milneuron 399
Milspan 367 Miltaun 367
Miltown 367 Miltown s-r 367
Minadol 360 Minalgin 370
Minalgine 370 Mindaril 334
Mindaril 380 Minette 365
Mini pregnon 365 Minifol 365
Minikel 404 Minilax 389
Minilip 337 Mini-lix 323
Minilyn 365 Minims 334
Minims 392 Minims chloramphenicol 334
Miniquine 336 Miniscap 332
Ministat 365 Mino-50 374
Minobese 390 Minobese forte 390
Minocin 374 Minomycin 374
Minoval 370 Minprog 320
Minprog pad 320 Minprostin 346
Mintal 383 Minus 386
Minusin depot 332 Minus-x 392
Miocitalgan 370 Miopotasio 398
Miraclin 347 Miranil 414
Mirapront 390 Mirapront n 332
Mironal 384 Mirsol 413
Mirvan 320 Mirvan a 320
Miscleron 340 Misedant 367
Misetin 334 Mistabron 368
Mistabron co 368 Mistabronco 368
Mistalon 368 Mistral 350
Mitrol 408 Mitsui tartrazine 407
Miucurin 408 Mixtencillin 346
Miyadril 380 Mobilat 360
Mobutazone 374 Mobuzon 374
Modane 389 Modane plus 389
Moderatan 321 Moderatan diffucap 321
Modicon 379 Modirit 388
Mofasal 374 Mofenar 330
Mofesal 374 Molipaxin 411
Mollinox 372 Molycu 397
Moment 360 Monacet 384
Monargan 319 Monatuss 392
Monazan 374 Monazone 374
Monbutina 374 Monobutina 374
Monobutyl 374 Monocillin 328
Monocline 347 Monodox 347

517
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Monodoxin 347 Monofen 374
Monoflam 344 Monomil 374
Monomycin 350 Monophenol 389
Monoprine 374 Monorheumetten 374
Monosan 352 Monozon 374
Monydrin 392 Moperidona 347
Morbam 367 Mornidine 394
Motilium 347 Motilix 364
Motofen 345 Motolon 372
Motrin 360 Motrin ib 360
Moxacef 363 Moxalactam 363
Moxam 363 Moxatres 363
Mozambin 372 Mozol 374
M-p 371 Mtq 372
Muaban d 324 Mucidrina 349
Mucinum 389 Mucofluid 368
Mucolene 368 Mucolyt-expecto 392
Mucorama 392 Mudeka 324
Mudrane 323 Mudrane gg 323
Muflin 336 Muldacin 378
Multifuge 394 Multifuj 394
Multi-med 2 353 Multi-med 3 353
Multi-med 6 354 Mundidon 397
Mundiphyllin 323 Muracin 334
Muracine 409 Musa 400
Musettamycin 379 Musilaks 389
Mutaban a/d/f 324 Mutabase 324
Muxol 381 My 101 320
Myacyne 376 Myanesin 366
Myasul 404 Mycerin 376
Mycetin 334 Mycetobis 334
Mychel 334 Mychel-s 334
Mychel-vet 334 Mycidex 376
Mycifradin 376 Myciguent 376
Mycimist 376 Mycinol 334
Mycipo 376 Myci-spray 371
Myclocin 334 Mycochlorin 334
Mycoquin 338 Mycotol 346
Mydfrin 392 Mydocalm 344
Mydriaticum 394 Myelotrast 372
Mylis 398 Mylodorm 324
Mylodorm sustrel 324 Mylofanol 337
Mylophanol 337 Mylosul 404
Mynocine 374 Myocalm 366
Myocardon 388 Myocardon 323
Myocuran 366 Myo-europan 399
Myogit 344 Myolate 384

518
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Myolisysin 366 Myoxane 366
Myprodol 360 Mysite 380
Mysteclin-f 409 My-trans 367
Mytrex 376 N8 324
Nabac 357 Nadalgine 370
Nadigest 342 Nadozone 391
Naftalgin 370 Nafticlorina 336
Nagalyn 336 Naidoretico 341
Nalador 406 Naleran 381
Nalgol 351 Naloven 352
Naltrium 370 Nandrobolic 375
Nandrolin 375 Nandrolone decanoate 374
Nanormin 401 Nanormon 401
Naoven 352 Napasone 370
Napental 383 Naphthylamine mustard 336
Naphtocard yelow o 407 Napionate 408
Narcoren 383 Narcosan soluble 358
Narcotussin 379 Narcozep 353
Narfen 360 Naron 370
Nartate 370 Nasdol 408
Nasello 338 Nasello 332
Nasomixin 376 Naso-neomicin 376
Nasopomada 409 Nasopomada 405
Nasydrin 376 Natralgin 370
Natric 370 Natricilin 328
Natt-lunedon 385 Naupax 391
Nausidol 394 Nauzelin 347
Navicalm 365 Naxogin compositum 334
Nazona 352 Nci-c01741 386
Nd-hist 392 Nea-vermiol 394
Nectatussin 392 Nefco 378
Nefluan 376 Neforox 354
Neforox alpha cpto 354 Neftin 354
Neftivit 354 Nefurofan 402
Nefurox 338 Negalip 340
Neimicina roger 376 Nekel 346
Neklacid yellow t 407 Neko 368
Nemadital 394 Nemafugan 394
Nemasin 394 Nematocton 394
Nematorazine 394 Nembudeine 383
Nembutal 383 Neo decaderm 376
Neo epinine 361 Neo fulcin 355
Neo lyndiol 365 Neo-analsona 376
Neoaristovet 376 Neoatromid 340
Neo-atromid 340 Neobacimyx-h 376
Neobes 321 Neobicin 376
Neobiotic 376 Neobrettin 376

519
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Neobristan 376 Neobrofen 360
Neobrufen 360 Neo-cantil 376
Neocervulax 381 Neocetin 334
Neocidin 376 Neocillin 376
Neoclox 376 Neocon 379
Neocones 376 Neodalit 343
Neodecasone 376 Neo-delpregnin 366
Neo-delta-cortef 376 Neo-dexoclin 334
Neodistreptotab 402 Neodit 343
Neodorm 383 Neodrine 368
Neodrine-triple 368 Neodualtrepto 402
Neo-durabolic 375 Neodurabolin 351
Neo-erycinum 350 Neo-farmadol 380
Neo-favmadol 381 Neo-felsol 385
Neo-filcin 355 Neofluid 376
Neogonadil 396 Neo-hombreol 408
Neo-hydro 376 Neo-ifusa 394
Neo-ilolycina 350 Neo-iloticina 350
Neointestin 376 Neo-istafenc 365
Neo-istafene 365 Neojodin 397
Neolate 376 Neo-lindiol 365
Neo-lynobol 365 Neo-m 376
Neomac 376 Neo-mantle 376
Neo-mastitar 376 Neo-melubrim 370
Neo-melubrin 370 Neo-melubrina 370
Neo-melubrine 370 Neomin 376
Neomix 376 Neomycane 376
Neo-myx 376 Neo-nervostal 367
Neo-nervostat 388 Neo-nilorex 386
Neo-oestrogenine 345 Neo-otosol-hc 376
Neo-oxipen 370 Neo-panalgyl 362
Neopec 382 Neopec 376
Neopellis 328 Neopenol 376
Neoprunex 389 Neopt 376
Neopurghes 389 Neopyrine 384
Neoquess 344 Neo-remusin 376
Neo-rybarex 349 Neosal-n 370
Neo-smarin dia 329 Neosoldana 392
Neo-soldana 381 Neo-soldana 332
Neosoldina 370 Neo-sombraven 372
Neosten 320 Neoston 320
Neostrata aha gel 358 Neostrata hq 358
Neostrep 376 Neosule 376
Neosulf 376 Neo-sulfazon 393
Neosutrin 405 Neo-synephrine 392
Neo-tetrine 409 Neotigason 319
Neotigason (r) 10 319 Neotigason roche 10 mg 319

520
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Neotigason sauter kapsein 25 mg 319 Neotizol 350
Neoton 321 Neo-tran 367
Neotrizine 403 Neotrizine 403
Neo-vagex 319 Neo-vagipurin 329
Neovagon 378 Neovamin a acid 362
Neovitamin a acid 362 Neox 394
Neo-xoline-m 366 Neo-zine 387
Neo-zoline 391 Nephenalin 361
Nephridine 349 Nerfactor 361
Neriodin 344 Nerobil 375
Nerobolil 375 Nerobolin 375
Nerofen 360 Nerufatin 409
Nervisal 325 Nervonus 367
Nessazona 352 Nestosyl 357
Neta662 347 Netocyd 346
Netsusarin 322 Netto-longcaps 390
Neufenil 362 Neuphenyl 362
Neuramate 367 Neuramin 399
Neur-amyl 324 Neuridal 399
Neuro 367 Neuro a2 372
Neurobarb 388 Neurocalm 367
Neurocotex 398 Neuro-demoplas 391
Neuro-demoplast 322 Neuro-effekton 344
Neuro-elmedal 391 Neurofenac 344
Neuro-fortamin 370 Neurolene 379
Neurosedyn 409 Neuro-spondryl 399
Neuro-voltaren 344 Neuroxin 400
Neutrosteron 375 Neuzoline m 391
Nevimune 377 Neviodin 344
Nevral vit b1 b6 384 Nevralgin 370
Nevralgina 370 New isomidon 330
Nexaam 392 Nf 180 354
Nfs 378 Nfz 1 378
Nfz mix 378 Nia 366
Niaestine 366 Niagestin 366
Niagestine 366 Nialamid 377
Niamid 377 Niamidal 377
Niamide 377 Niamycetin 334
Niapren 360 Niaquital 377
Niaquitil 377 Niazin 377
Nibiol 379 Nibratal 340
Nibratol 340 Nicaphlogyl 383
Nicene 379 Nicene 403
Nicolen 354 Nicolen r 354
Nidaxin 342 Nieraline 349
Nifedon 322 Nifucin 378
Nifulidone 354 Nifulin 354

521
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Nifuramicin 376 Nifuran 354
Nifuzon 378 Nikartrone 322
Nikinol 379 Nikopet 379
Nilacid 319 Nilatin 352
Nilspasm 388 Nimulid 377
Nioform 338 Nipaxan 379
Nipaxon 379 Niphridine 349
Nisidina 370 Nisocla 376
Nisoclyn 376 Nisodyn 376
Nitepax 379 Nitocetin 378
Nitrocetin 334 Nitrocol 334
Nitrocol plus 378 Nitrofan 378
Nitro-rea 378 Nitro-tromacardin 372
Nitrozone 378 Niux 350
Nivaquine 336 Nivaquine b' 336
Nivembin 336 Nivemycin 376
Nizcrem 363 Nizoral 363
Nizoral 2% shampoo 363 Nizoral 20% cream 363
Nizovules 363 Nizshampoo 363
Nlo conicilina balsamica 370 Nnormet 340
Nobacter 328 Nobadorm 372
Nobadorm compostium 372 Nobedorm 372
Nobelgin 370 Nobensin-75 321
Nobensine 321 Nobese 392
Nobesine 321 Nobesine-25 321
Nobfelon 360 Nobfen 360
Nobret 340 Nobrital 324
Nochyrol 366 Noctilene 372
Noctivane 358 Noctivane sodium 358
Noctulon 372 Noctynol 366
Nodiras 399 Nodryl 376
Nofenan 399 Nofenon 399
Nogest 342 Noidouble 402
Nokamycin 376 Nolotil 370
Nolotil composirum 370 Noludar 373
Nolurate 373 Nometan 394
Nomival 379 Nomocramp 344
Nomorytmin 399 Nonovulet 365
Noperil 376 Noptil 388
Nor 50 379 Norabol 375
Noracyclin 365 Noracyclin 22 365
Noracycline 365 Noradrec 364
Noralone 375 Norandrol 375
Norandros 375 Norane 371
Norbum 334 Nordecon 374
Nordox 347 Norephedrine 392
Norfemac 330 Norgesic 384

522
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Noric 399 Noriday 379
Norigest 379 Norimin 379
Norinolipol 340 Norisen 320
Norisen grass 320 Norisodrin aerotol 361
Norisodrin with calcium idodide 361 Noristerat 379
Norlutate acetate 379 Normalip 340
Normaln 324 Normax 342
Normet 340 Normet richter 340
Normetine 394 Normid 413
Normimycin v 334 Normi-nox 372
Normoc 376 Normoglucina 386
Normol 329 Normolipol 340
Normophasic 365 Normorest 372
Normotrytmin 399 Normotrytmin (r) 10 mg 399
Normud 413 Nornatane 392
Norodin 368 Norofluvin 355
Norolon 336 Noromon 375
Noroquinol 330 Norosodrine 361
Norphedrane 321 Nor-q-d 379
Norquentiel 379 Norquest fe 379
Norquinol 382 Norstenol 375
Nortesto 375 Nor-tet 409
Norval 373 Nosaclin 379
Noscalin 379 Noscapal 379
Noscapect 379 Noscarex 379
Noscatuss 379 Nosterolin 340
Nostress 322 Nostril 392
Notaba 378 Notensyl 344
Notermin 370 Notose 336
No-tripramine 412 Nourilax 381
Novacetol 384 Novacetol 341
Novacid 370 Novalcina 370
Novaldin 370 Novalgetol 370
Novalgin 370 Novalgin quinine 370
Novalgina 370 Novalgine 370
Nova-lyseen 370 Novambobarb 325
Novamidazofen 370 Novamidazophen 370
Novamideazophene 370 Novamidon 322
Novamina 370 Novaminophenazone 370
Novaminsulfon 370 Novaminsulfon ratiopharm 370
Novaminsulfone sodium 370 Novaminsulfonium 370
Novaminsulfonum 370 Novaminsulton 370
Nova-phenicol 334 Nova-pheno 388
Novapirina 344 Novaprin 360
Novaquin 366 Novarectal 383
Nova-rectal 383 Novazid 377
Novazolon dexametasona 370 Novelciclina 347

523
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Noveltex 370 Novemida 370
Novemina 370 Noventerol 382
Noventerol 362 Noveril 343
Novese 332 Novidorm 412
Noviel 353 Novil 370
Novo card-fludilat 326 Novobutazone 391
Novoclorocap 334 Novoderm 412
Novodon 388 Novodorm 412
Novo-doxepin 347 Novodrin 361
Novofibrate 340 Novogen 325
Novogent 360 Novokvens 366
Novolina 366 Novomato 367
Novomepro 367 Novomycetin 334
Novo-nastizol 325 Novopen 328
Novopentobarb 383 Novo-pentobarb 383
Novophenyl 391 Novoprofen 360
Novopuren 389 Novoquens 366
Novorythro 350 Novosephalgin 384
Novospasmin 388 Novospiroton 402
Novospirozine 402 Novosprioton 402
Novospriozine 402 Novostat 365
Novostrep 402 Novo-strep 402
Novosulfin 404 Novosulfina 393
Novotetra 409 Novo-tripramine 412
Novotriptyn 324 Novotryptin 324
Novo-tryptin 324 Novoxapin 347
Novulon 379 Novydrine 321
Novydrinene 321 Noxibiol 379
Noxine 379 Noxiurotan 394
Noxybel 372 Noxyron 355
Npa 376 Npp 375
Ntpp 375 Nuctane 412
Nu-ibuprofen 360 Nu-k 398
Nulobes 321 Numal 325
Nunol 388 Nuprin 360
Nuquin hp 358 Nuran 341
Nurdelin 341 Nuredal 377
Nurilaksi 381 Nur-isterate 379
Nurofen 360 Nuttriben 341
Nyazin 377 Nydrazid 361
Nyktogen 367 Nymfalon 396
Oasil 367 Oasil 388
Oasil procalmadiol 367 Obe_slim 325
Obe-del 386 Obedrin-la 368
Obelones 368 Obepar 386
Oberex 340 Obesan 386
Obesan-x 386 Obesin 321

524
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Obesine 321 Obesitab 321
Obesitex 321 Obe-slim 368
Obestat 392 Obestin 30 390
Obetrol 321 Obetrol 343
Obex la 386 Obex-la 386
Obezine 386 O-biol 329
Oblioser 372 Obotan 343
Obstecrim 338 Obstilax 381
Oby-trim 390 Octacaine 349
Octamet 406 Ocufen 355
Oculocidon 411 Ocu-vinc 413
Odamida 405 Odsil 10 367
Oestrasid 345 Oestrodien 345
Oestrodiene 345 Oestrodienol 345
Oestro-gyneadron 405 Oestro-gynedron 406
Oestro-gynedron 345 Oestro-gynedron 329
Oestroral 345 Oestrovis 345
Offitril 380 Oflamin 380
Oftalent 335 Oftan 335
Oftan flurekain 397 Oftlamin 370
Ogen 394 Ogyline 413
Oil of calamus 331 Okasa-mascul 408
Oktadrin 321 Okuside 394
Older 361 Oleomycetin 335
Olfano 384 Olfen 344
Oluprin 391 Omelip 340
Omnadren 327 Omniadol 384
Omnibex 390 Omni-passin 346
Omnyl 372 Ona-mast 390
Onco-provera 342 Opclor 335
Ophtalmin 329 Ophthaphenicol 335
Ophthlmycin 376 Ophthochlor 335
Opinsul 404 Oppazoen 391
Opren 327 Oprenal 327
Optairosol 348 Optalgin 370
Optalidon 322 Optalidon 360
Optazol 354 Opteron 410
Opthalon 335 Optifen 360
Optimal 380 Optimax 364
Optimil 372 Optineural(analgesic) 322
Optinoxan 372 Optipax 322
Optiprime opthcoat 376 Optison 376
Optisone 376 Optiverm 395
Optrin 335 Opturem 360
Orabilex 331 Orabilix 331
Orabolin 351 Oracolnal 366
Oractine 341 Oraflex 327

525
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Oragest 342 Orahesive 382
Oralcer 338 Oralcid 319
Oraleo 386 Oralmisetin 335
Oranixon 366 Orarsan 319
Orchiol 408 Orchisterone-p 408
Orchistin 408 Ordenol 403
Orecil 385 Oreton 408
Oreton-f 408 Orexigen 341
Org 485-50 365 Org gb 94 373
Orgabolin 375 Orgabolin 351
Orgaboral 351 Orgaguanidon 403
Orgaluton 365 Orgametil 365
Orgametril 365 Orgametrol 365
Oribiotic 376 Orimeten 322
Orkomin 341 Orlaam 363
Orlestrin 379 Ormeten 322
Ornacol 392 Ornatos 392
Ornex 392 Oromycosal 363
Oronazol 363 Orostat 327
Orostat 349 Orotenol 361
Orozl 404 Orphalginen 370
Ortedrine 321 Ortho 345
Ortho (cream) 345 Ortho dienestrol cream 345
Orthonal 372 Ortho-novum 379
Orthos kavident 336 Ortonal 372
Ortopirona 370 Or-trin 383
Or-tyl 344 Orulop 364
Osadrine 322 Osadrinim 391
Osarsal 319 Osarsol 319
Osarsole 319 Osiren 397
Osiren 402 Osirenol 397
Osmotipax 322 Osodent 354
Ossiurene 346 Osvarsan 319
Osyrol 397 Osyrol 402
Osyrol-lasix 397 Otachron 335
Oterna 376 Oticair 376
Otiprin 335 Otipyrin 320
Otipyrin 385 Oto vitna 376
Otobacid 399 Otocaina 405
Otocaina 329 Otocortison 376
Oto-flunal 376 Otomycin 376
Otonasal 405 Otone 380
Otone 381 Otophen 335
Otopred ear drops 335 Otorrilan 405
Otosan-sulfan 385 Oto-sinerbe 376
Otothricinol 385 Ovaban 366
Ovamezzo 365 Ovanon 365

526
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Ovanone 365 Ovanon-e 365
Ovarid 366 Ovariostat 365
Ovcon-50 379 Ovismen 379
Ovol 344 Ovoresta 365
Ovoresta m 365 Ovoresta micro 365
Ovosiston 379 Ovosiston 335
Ovosta 365 Ovostat 365
Ovostat-28 365 Ovostat-micro 365
Ovuthricinol 405 Ovysmen 379
Oxabar 388 Oxacef 363
Oxalid 380 Oxalid 381
Oxanal yellow t 407 Oxaprost 374
Oxazimedrine 387 Oxibutol 381
Oxidermiol 405 Oxin 356
Oxine 356 Oxiquiunazine 370
Oxiril syrup (hydrate) 395 Oxiuran (hydrate) 395
Oxiurasin 395 Oxiustip 395
Oxiustip elix 395 Oxivermin 395
Oxizin 395 Oxoids 388
Oxucid 395 Oxurasin 395
Oxuril 395 Oxybutazone 381
Oxybutazone 380 Oxybutol 380
Oxybuton 380 Oxygeron 413
Oxykin 356 Oxypaat 395
Oxyperol 380 Oxyphenbutone 380
Oxyphentamin 380 Oxypip 395
Oxyquin 338 Oxyquinoline-rhp 356
Oxytocin 381 Oxyzin 395
P 47 357 P.c. (citrate) 395
P.g.a. 328 P.s.b.p. 322
P-1-n forte 361 P2e1 349
P-50 328 Pabron gold 370
Pabron nose 392 Pacifan 383
Pacifene 360 Paclia g 328
Pacy 362 Pacyl 362
Padrax 395 Padudent 360
Palacaine 385 Palaprin forte 320
Palaran 323 Palaron 323
Paldona 372 Pallace 366
Pallacid 319 Pallidan 372
Paloxin 320 Palpent 383
Palprin 320 Pamin 344
Pamprin 384 Pamprin 360
Panacorn 392 Panacur 341
Panadyl 392 Panakiron 344
Panaldine 410 Panalvon 370
Panamor 344 Panax 370

527
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Panazone 391 Panbesy 390
Panformin 330 Panfungol 363
Panfuran 319 Panfuran s 346
Panfuran-s 346 Panfuran-troche 319
Pangul 409 Panmycin 409
Panosoma 336 Panotile 376
Panoxy 350 Panquil 367
Panrexin-m 386 Panshape 390
Pantesin 408 Pantofenicol 335
Pantopon 380 Pantosedive 409
Pantovernil 335 Pantrop 324
Pantrop 360 Panzon 345
Pao sole 389 Paoscle 389
Papatral 372 Papette 350
Papnin 384 Paradeines 389
Paradentol 357 Paraderm 330
Para-dien 345 Paradormalene 371
Parafenac 330 Parafenac (r) milch 330
Parafenac 5% creme 330 Parafenac basishad 330
Parafenac sable 330 Parafenal 330
Para-grip 384 Paralen 376
Paralgin 322 Paramette 384
Parametten 384 Paramiba 330
Paramibe 330 Paramibrodiar 330
Paramid supra 404 Paranephrine 349
Paraseptol 405 Paratodol 384
Paravermin 395 Paraxin 335
Parazine 395 Parazolidin 391
Parcyclin 335 Parenzyme 412
Parepectolin 362 Parepectolin 382
Parest 372 Parfenac 330
Parfenal 330 Parfenal creme derm 330
Pargesic compound 384 Parhist 392
Pariamate 395 Parid 395
Parilac 329 Parkeole 376
Parkestaf 327 Parkesteron 376
Parkestress forte 354 Parks-plus 324
Parlodel 329 Parmilene 372
Parmine 390 Parnate 411
Parnate tylciprine 411 Parnetene 411
Parodyne 385 Paroxyl 319
Parsal 344 Parsal 360
Parstelazin 411 Parstelin 411
Partapp 392 Par-tega 395
Partel 346 Partusisten 352
Partuss 392 Parzolidon 391
Pasadex 384 Pasirheuman 391

528
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Pasta antisola 385 Pastillas koki 401
Pat 380 Patalgin 370
Patosica 328 Pavadel 388
Paxidorm 372 Paxin 367
Paxofen 360 Payzone 345
Pbi 386 Pbz 391
Pcr 5332 410 Pe 349
Peba 388 Peccocode 403
Pecnon 362 Pecram 323
Pecran 323 Pectigels 382
Pectinfant 348 Pectolin 382
Pectolin 362 Pectrolyte 362
Pectrolyte 382 Pedg 386
Pediamycin 350 Pediaprofen 360
Pedi-cort 338 Pedigel 384
Pedimycetin 335 Pedivol 356
Pedoz 329 Pedroacal 394
Pels 350 Pembul 383
Penantin 402 Penbar 383
Penbon 383 Pencardin 388
Penetradol 391 Penibiot 328
Penicilina klari 328 Penilevel 328
Penimiluy 328 Peniroger 328
Penitasa "450" simple 328 Pen-nitate 388
Pensive 367 Pentafen 382
Pental 405 Pental 383
Pental forte 405 Pentalgin 383
Pentalgina 382 Pentalmicina 376
Pentalmicina 405 Pentamycetin 335
Pentanca 383 Pentaneural 367
Penta-zine 336 Pentids 328
Pentobarb 383 Pentocetina 335
Pentodorm 383 Pentodormol 383
Pentogen 383 Pentolos 383
Penton 383 Pentone 383
Pentosol 326 Pentran 388
Pentrodin 370 Pentymal 325
Peplax 389 Pepsidac 351
Peragal st 397 Peral 371
Perandern 408 Peratran 395
Perborate 329 Percobarb 384
Percodan 384 Percomon 321
Percural 338 Percutacrine androgenique 408
Perduretas anfetamina 321 Peremesin 365
Perequil 367 Perfamone 321
Periactin 341 Periactine 341
Periactinol 341 Periactol 341

529
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Perideca 341 Peridon 347
Peridys 347 Perin 395
Periston 397 Periston-n 397
Periston-n-toxobin 397 Peritol 341
Perlutest 342 Perlutex 342
Permatrim 392 Permucal 357
Pernomol 389 Perphyllon 388
Persantinat 340 Pertaril 335
Pertesis 408 Pertonal 384
Pertranquil 367 Pervet 376
Pervincamine 413 Pervitin 368
Petab 383 Peterpect 362
Peterpect 382 Peterphylin 323
Petogen 342 Petonel 383
Petrisul 404 Petrolaglar emulsion 389
Petro-mul-phen 389 Pevidine 397
Peviston 397 Pexaqualone 372
Pf 185 364 Pfeil 399
Pfeil 360 Pfizer-e 350
Pfizerpen 325 Pfizerpen 328
Pfizerquin 336 Phaisohex 357
Phanalgin 370 Phanurane 397
Pharmalgen 320 Pharmalgine 370
Phasca 357 Phasicon 365
Phebuzin 391 Phedrisox 368
Phelantin 368 Phelloverin a 328
Phen bar 388 Phenacet 384
Phenacetine powder 384 Phenacetinum 384
Phenacitin 384 Phenacol-dm 336
Phenacon 384 Phenacon 337
Phenacon 400 Phenaemal 388
Phenalgin 319 Phenapap 392
Phenaphen 384 Phenaphen plus 384
Phenatuss 336 Phenazetin 384
Phenazetina 384 Phenazine 386
Phenazo 385 Phenazon 385
Phen-bel 388 Phenbuff 391
Phenbutazol 391 Phenbutazone 391
Phenedina 384 Phenedrine 321
Phenemal 388 Phenformine 386
Phenformix 386 Phenicarbazide 385
Phenidin 384 Phenin 384
Phenipan 330 Phenlaxine 381
Phenmetrazine 387 Phenobar 388
Phenobarbyl 388 Phenobolin 375
Phenodyne 384 Phenogen 388
Pheno-gesic 388 Phenolax 389

530
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Phenolax 381 Phenonyl 388
Phenopromin 321 Phenopyridine 356
Phenoquin 337 Phenorial 384
Phenoro 332 Phen-ortis 338
Phental 388 Phentermyl 390
Phentral cratecil 388 Phenylarthrite 391
Phenylbetazone 391 Phenylic acid 389
Phenylon 385 Phenylon plus 391
Phenylone 391 Phenyzone 391
Phiaquin 358 Philcociclina 347
Phillips laxcaps 389 Philopon 368
Phiso scrub 357 Phisodan 357
Phisohex 357 Phisohex(winthrop) 357
Phiso-med 357 Phisoscrub 357
Phlebodine 357 Phlebolan 391
Phlogarol 336 Phlogase 380
Phlogase 381 Phlogistol 381
Phlogistol 380 Phlogont 380
Phlogont 381 Phloguran 380
Phloguron 362 Phob 388
Pholcolix 392 Pholcolix spansule 392
Phor pain 360 Phorac 357
Phoscanol 329 Phosohex 357
Phtalazol 393 Phtazol 393
Phylletten 342 Phyllocontin 323
Phyllotemp 323 Phynatol 401
Phyol 401 Phyoneon 401
Physiostat 365 Physistat 365
Phytacorcin 376 Phyteia schlankheitsdragees 332
Phytex 329 Piadarn 350
Piaverm 395 Piavermit 395
Piermap 342 Pigmanorm 358
Pigmanorm 411 Pilabutina 380
Piladren 349 Piloral 338
Pimabiciron 335 Pincet 395
Pincide 395 Pinimentac 335
Pinozan 395 Pinrou 395
Pinsirup 395 Pin-tega 395
Pipadox 395 Pipan 395
Pip-a-ray 395 Pipenin 395
Pipenzolate mb san 394 Piper 394
Piperacid 395 Piperamicin 395
Piperascat 395 Piperaskat 395
Piperasol 395 Piperate 395
Piperaverm 395 Piperazate 395
Piperazinal 395 Piperazine (adipate) 395
Pipercrean 395 Piperex 395

531
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Piperiod 395 Piperital od 395
Piperitol 395 Piper-jodina 395
Piperol fort 395 Piperone 395
Piperoverm 395 Pipertox 395
Piperver 395 Piperzinal 395
Pipeverm 395 Pipezol 395
Pipizan 395 Pipizan citrate 395
Pipracid 395 Piprazid 395
Piprazyl 395 Pipricide 395
Piptal 394 Piptal pediatrico 394
Piptal pediatrique 394 Piptalin 394
Piptelate 395 Pirabutil 391
Piracodid 322 Piradenil 322
Piradol 322 Piraflogin 381
Piraflogin 380 Piramidon 322
Piramidone 322 Piraminal 388
Pirarreumol-b 391 Pirarreumol-p 391
Pirasco 322 Piraseptolo 322
Pirasulfon 404 Piriditol 400
Piridol 322 Piridrol 395
Piririomin 400 Piritinol 400
Piritiomin 400 Piro rectal 322
Pirolacton 402 Pirolcaton 402
Piromidina 322 Piroreumal 322
Pituitrin 381 Pivalone 376
Piverma 395 Placidel 325
Placitabs 371 Placitate 367
Planphylline 323 Plarenil 402
Plasdone 397 Plasmadone 397
Plasmoid 397 Plasmosan 397
Plassint 397 Plastoderma 335
Plegine 386 Plegline 386
Plenish-k 398 Plenumil 400
Plexonal 326 Plivalgin 388
Pm 2 367 Pmb 4000 367
Pms isoniazid 361 Pms levazine 324
P-m-z 336 Pneumidex 392
Pneumol 323 Podiodine 397
Podofilm 396 Polcimut 393
Polemycin 376 Poliflogil 381
Polinalin 323 Polislerol 350
Polivasal 406 Pollinex 320
Polo-verm 395 Polvo sulfamida leti 405
Polvo sulfamida orrvan 405 Polvos wilfe 405
Polvos wilfe 405 Polybactrin-g 376
Polyclar at 397 Polyclar h 397
Polyclar l 397 Polydexa 376

532
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Polygris 355 Polygynax 376
Poly-gynedron 406 Poly-gynedron 329
Poly-karaya 397 Polyplasdone xl 397
Poly-pred 376 Polypyrine 384
Polyquil 395 Polyspecrin 376
Polyvidone-escupient 397 Polyvidonum 397
Polyvinyl pyrrolidone 397 Pomada heridas 405
Pomada heridas 385 Pomada wilfe 405
Pomada wilfe 405 Pomana a 382
Pona 355 Porbiot 370
Porcelana 358 Porcijec 376
Portaderm 372 Poscle 389
Posodolor 360 Postafen 365
Postafene 365 Postivas 320
Potasion 398 Potsilo 381
Povadyne 397 Povera 342
Povidone k 29-32 397 Poxy 384
Pplan 2500 371 Practon 402
Practon 50 402 Praecicalm 383
Praecirheumin 391 Praelutin forate 396
Pragmarel 411 Pragmazone 411
Praktol 398 Pralon 398
Pranzo 341 Praxis 360
Prebutex 391 Precirhemin 391
Preconativ 351 Preconsol 356
Predekzem 357 Prednefrin 385
Prednicidin 376 Prednirheumin 391
Predno-facilus haemota 325 Prednomycetine 335
Prefamone 321 Preferal 329
Prefin 331 Prefrin 392
Prefrin 385 Prefrin liquifilm 385
Prefrin z 385 Pregine 389
Pregnesin 396 Pregnon 365
Pregnon-28 365 Prelazine 387
Prelu-2 386 Preludin 387
Premesin 365 Preminal 388
Premineat 323 Prenakes 352
Prenazon 352 Prenazone 352
Prenomiser 361 Prenoxan 388
Pre-op 357 Prequil 367
Pre-sate 337 Presocyl 336
Pretulon 357 Prevenol 328
Prevotec 376 Priatan 385
Pribetal 388 Pricilone 364
Pricort cream 338 Prifunal 389
Primatene mist 349 Primolut 379
Primotest 408 Primotestone 408

533
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Primun 353 Prinalgin 320
Prinel 344 Priollat 363
Pripsen 395 Privadol 354
Privenal 358 Pro dorm 372
Probal 367 Pro-ban 409
Probaphen 371 Probasan 367
Probese-p 387 Probocon 393
Probromato 367 Procadolor 328
Procalmidol 367 Procijec 404
Procomp-65 384 Proct anex 357
Proculin 329 Procusulf 335
Procyclomin 344 Prodasone 342
Prodermopur 357 Prodigestan 384
Prodisan 326 Prodol 371
Prodolor 384 Prodormol 383
Profamina 321 Profasi hp 396
Profenade 393 Profilate 351
Profilnine 351 Proflavin 320
Proflex 360 Progesic 384
Progestalfa 342 Progevera 342
Proklar-m 404 Prolax 366
Prolekofen 399 Prolix 326
Prolixan 326 Prolixana 326
Promassolax 381 Promassoletten 381
Promate 367 Promex 336
Promone-e 342 Pronidin 390
Pronone 342 Prontablin 405
Prontalgin 360 Prontoformin 386
Prontylin 323 Propaderm-c 339
Propaderm-n 376 Propadrin 393
Propadrine 393 Propagest 393
Prophenatin 344 Prophyllen 385
Propiocine enfant 350 Propiokan 408
Propion 321 Propisamine 321
Proplex 351 Propriocin enfante 350
Proptan 343 Propynalin 361
Prospiocine 350 Prostadin 320
Prostaglandin E2 346 Prostalgin 374
Prostalgin 320 Prostandin 320
Prostarmon e 346 Prostavasin 320
Prostenon 346 Prostin e2 346
Prostin vr pediatric 346 Prostin vr pediatric 320
Prostin-vr 320 Prostivas 320
Protagent 397 Protaphane hm insulin 389
Protasma 325 Protectaderm 350
Protector 346 Protenol 361
Protension 384 Protercicline 335

534
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Proterytrin 350 Prothiazol 405
Prothromplex 351 Protopin 401
Protran 367 Protropin 401
Protylol 344 Prouvil 324
Provasa 340 Provera 342
Proverone 342 Provest 342
Proviodine 397 Provtovermil 395
Proxyfezone 391 Proydynam 391
Prulet 389 Prulet 381
Prulet liquitab 381 Prunetta 389
Prurivet 335 Prusol 381
Prydonnal 371 Psico-retard 367
Psicosterone 398 Psicronizer 379
Psychamine a 66 387 Psyco-retard 377
Psyton 379 Pt-1-5 386
Puberogen 396 Pugrante el aleman 389
Pulmo vinco 335 Pulmomas 350
Pulveodil 377 Pulvex 395
Pulvi bacteramide 405 Puradin 354
Puragaceen 381 Purex 389
Purga 389 Purgaceen 381
Purganol 389 Purganos-daguin 389
Purgant aleman 389 Purgante 389
Purgante orravan 389 Purgen 389
Purgenum 389 Purgestol 389
Purgoids 389 Purgophen 381
Purgyl 389 Purjen sahap 389
Purmycin 350 Purphen 388
Pvp 40 397 Pvp 50 397
Pvp0 397 Pvp-k 15 397
Pvp-k 25 397 Pvp-k 3 397
Pvp-k 30 397 Pvp-k 60 397
Pvp-k 90 397 Pvp-macrose 397
Pvp-macrox 397 Pvpp 397
Pydirone 371 Pyocidin hc 377
Pyodental 405 Pyodron 405
Pyradon 323 Pyraelmedal 323
Pyralgin 371 Pyralgine 371
Pyramidon 323 Pyramidone 323
Pyraphen 384 Pyrathyn 371
Pyrazophyl 385 Pyrbutal 391
Pyretin 371 Pyridiate 385
Pyridium 385 Pyril 371
Pyrilgin 371 Pyriligin 371
Pyrinistab 371 Pyrinistol 371
Pyrisan 371 Pyrodin 323
Pyrojec 371 Pyronium 385

535
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Pyrroxate 384 Quaalude 372
Quadrex 377 Quadriderm 339
Quadrochin 384 Quadronal 384
Quad-sed 388 Quaname 368
Quanil 368 Quarelin 371
Quemicetina 335 Quetimid 409
Quietidon 368 Quimpeamida 405
Quin 339 Quin iii 339
Quina band 339 Quinachlor 336
Quinambicide 339 Quinercyl 336
Quinexin 327 Quiniodochlor 339
Quinoderm 356 Quinoped 356
Quinophenol 356 Quinoseptyl 404
Quitaxon 347 Quitrase 335
Quitrase antibiotico 335 Qz 2 372
R 20 336 R 33812 347
R 4-1778/1 373 R0 22-6595 411
R-18553 364 Radenarcon 351
Radiographol 372 Radox 347
Rafen 360 Ralenta 404
Rangozona 352 Ranocor 391
Ranphenicol 335 Ranstrepcol 335
Raphetamine 321 Rapifen 320
Rapinovet 399 Rapostan 380
Rapostan 381 Rastenil 368
Raucherstop 5 ht 390 Raudazida 402
Rau-fridetten 388 Ravelon 365
Razinol 395 Realin 380
Reamine 337 Reasec 346
Reatos 379 Rebugen 360
Rebuso 372 Recade 340
Recheton 362 Reclor 335
Recolip 340 Recta medicone-hc 356
Recthormone 408 Recthormone testosterone 408
Rectofasa 391 Rectolmin bronquial 379
Rectoral 384 Rectulon 372
Recudik 360 Redicres 321
Redidropsol 335 Redomex 324
Reducto 386 Reducyl 390
Reduform 332 Redufrom 332
Reduzin 393 Refagan 384
Reflex rectal 371 Reflex-spray 328
Reformin 384 Regal 381
Regelan 340 Regelan n 500 340
Regenon 321 Regenon retard 321
Regibon 321 Regitol 323
Regium 368 Regulan 364

536
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Regulane 364 Regulex-d 342
Regulin 390 Reiderma 411
Rejam 371 Rekawan 398
Relaxar 366 Relaxil 366
Relaxil-g 366 Relaxin 368
Relcofen 360 Relexal compuesto 371
Remlomed 323 Remolmed 385
Renagladin 349 Renaglandin 349
Renaglandulin 349 Renaleptine 349
Renalina 349 Renarcol 366
Renasul 404 Renegen 335
Renoform 349 Renokab 377
Renostypticin 349 Renostyptin 349
Reocetin 335 Reomin 399
Reopin 391 Reostop 335
Reostral 368 Reparal carnitina 341
Repocal 383 Represil 352
Repriman 371 Repro 384
Repromix 342 Resichin 336
Resirol 388 Resochin (diphosphate) 336
Resol 332 Resoquine 336
Respilene 414 Respirase 414
Respirex 414 Respisane 388
Respritin 384 Resquim 371
Restenil 368 Rest-on 371
Restovar 365 Restrol 345
Restryl 371 Resulfon 403
Retabolil 374 Retalon 345
Retamex 399 Retard 386
Retardo 386 Retasulfin 404
Retens 347 Retet 409
Reticus 339 Retin a 411
Retin-a 411 Retmonorm 399
Reton 386 Retromyopen 346
Reu-bon 323 Reuchetal 362
Reufenac 320 Reumachlor 336
Reumanova 323 Reumasedina 323
Reumasyl 391 Reumatox 374
Reumazin 391 Reumilene 391
Reumo 362 Reumo termina 323
Reumofene 360 Reumoftal 323
Reumotranc 323 Reumuzol 391
Reupolar 391 Revonal 372
Revulex 323 Rewodina 344
Rexahisine 336 Rezulin 412
Rheaform 339 Rhematan 337
Rheofin 335 Rheopyrin 391

537
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Rheosolon 391 Rheufen 360
Rheuma 374 Rheuma-cur 374
Rheumalgen 344 Rheumanol 399
Rheumanoln 391 Rheumaorctat 374
Rheumapax 381 Rheumapax 380
Rheumaphen 391 Rheuma-spalt 371
Rheumatol 331 Rheumavincin 344
Rheumavincin-n 344 Rheumin 337
Rheumox 326 Rheumycalm 391
Rhex 366 Rhex "hobein" 366
Rhinalator 321 Rhinamide 405
Rhinazol 384 Rhindecon 393
Rhinergal 338 Rhinergal 393
Rhinergal tavegil 338 Rhinervert 393
Rhinicept 393 Rhinidrin 393
Rhinivict 399 Rhinocap 393
Rhinophenazol 329 Rhomex 395
Rhotrimine 412 Rhotromine 412
Rhumalgan 391 Ribelfan 379
Ribo-azauracil 326 Ric 272 372
Ridol 371 Rifamate 361
Rigenox 355 Rigesol 403
Rilan 384 Rilax 368
Rimactane 361 Rimafen 360
Rimifon 361 Rinexin 393
Ringl-s 330 Rini c 323
Rino 377 Rino glucol sulf 405
Rino vitna 377 Rinofilax 377
Rinojet 377 Rinomar 337
Rinomar 393 Rinoplex 323
Rinotussal 393 Rinurel 393
Rinurel 384 Rinurel lictus 393
Rinurel tablets 393 Rinutan 384
Rinutan 393 Riogon 396
Riopnol 353 Riporest 372
Risicordin 402 Ritalin 373
Ritalin sr 373 Ritaline 373
Ritromin 350 Rivadorm 383
Rivafurazon 378 Rivastatin 332
Rivodin 403 Rivodol 374
Rivolax 381 Rivomycin 335
Rivomycin sulfa 335 Rivoquin 336
Rm 526 372 Ro 10-9359 351
Ro 1-5488 411 Ro 4-3780 362
Ro 5-0831/1 361 Ro 66827 398
Ro 7-1554 361 Roaccutan 362
Roaccutane 362 Roaccutane 411

538
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Roacutan 362 Robamate 368
Robarb 325 Robaxisal-ph 384
Robaxisan-pm 384 Robese 343
Robimycin 350 Robitet 409
Robizone-v 391 Rocmuth 397
Rocopenstrep 346 Rofen 360
Rofenid 363 Rohipnol 353
Rohpinol 353 Rohpnol 353
Rohypnol 353 Roidenin 360
Roipnol 353 Rolactone 402
Rolactone microfine 402 Rolintrex 335
Rometin 339 Romphenil 335
Roncovita 335 Rondelim 395
Rondoxyl 395 Ron-drive 384
Ronglitazone 412 Ronphenil 335
Root bark oil 332 Roptazol 354
Rorer 148 372 Rorer 714 372
Roscomycin 335 Rotabromophen 393
Rotardon 404 Roulone 372
Rouqualone 372 Rovert-m 365
Rovicine 377 Rovictor 335
Rovonal 372 Roximycin 348
Roxo chemil 350 Roxochemil 350
Roxyne 348 Roychlor 398
Rp 2145 404 Rp 3602 366
Rp-mycin 350 Ru-486 373
Rubibacter 350 Rubifen 373
Rufen 360 Rufol 404
Rumalisine 371 Rumapax 380
Rumapax 381 Rumatral 320
Rumicine 384 Rumicine 319
Rum-k 398 Ruocil 403
Rupalgin 371 Rupton 393
Ru-tuss 400 Ru-tuss 393
Ru-vert-m 365 Rvc 319
Rx 099916 401 Rx 67408nac 352
Ryhmonorma 399 Rynatapp 393
Rynex 393 Rythmole 399
Rytmonorm 399 Ryza-gesic 393
S 611-3 388 S7 386
S antineuralgic 384 S fc 384
S.d.l. 320 S.d.m. 404
Sabari 365 Sabril 413
Sabril 412 Sabrilex 412
Sacadol 384 Sacietyl 393
Sadaspir 384 Saddle mate 329
Safersan 395 Sagisal 402

539
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Salestol 336 Saleto 360
Saleto-600 360 Saleton 346
Saleton 354 Saleton 377
Salgydal 384 Salicopil 385
Salicylin-p 396 Salimed compound 366
Salimol 404 Salinidol 356
Salipran 327 Salipran 319
Sali-spiroctan 402 Saluretin 402
Salvacolina nn 382 Salvacolina nn 377
Salviton 388 Salzone 391
Samaphenicol 335 Samecin 348
San ei tartrazine 407 Sanalgin 384
Sanalgine 384 Sanalgin-p 399
Sanapert 381 Sanasthmyl 385
Sanbosten 410 Sancilin 328
Sandocycline 330 Sandoin 330
Sandosten 410 Sandostene 410
Sanepil 388 Sanglin 323
Sanibiovit 377 Saniciline 328
Sanifur 378 Sanimix 377
Sanistress 377 Sanodormin 409
Sanoquin 336 Sanorex 365
Sansdolor 366 Sanstrepto 346
Santeprednisan a 371 Santoban 395
Santus 414 Sapilant 412
Sapo-chlor 357 Sapoderm 357
Sapos 388 Sapotera 323
Saratem 324 Saridon 385
Saridon neu 399 Saridone 399
Sarna 389 Sarodormin 355
Sarolax 389 Saroten 324
Sarotena 324 Sarotex 324
Sas 1060 402 Savedorm 372
Saventrine 361 Sawamin 344
Sawaxin 400 Sc 9420 402
Scandantin 378 Scanicol 335
Scanicoline 335 Scaniquine (diphosphate) 336
Scantrimon 354 Schemergen 391
Schiwanox 325 Schlafen 383
Schlakforte 411 Schokilax 381
Scieramycetin 335 Scintidin 400
Sclaventerol 354 Sclerovasal 340
Scopoderm tts 400 Scotatal 388
Scotuss 393 Scurenaline 349
Sd 13 397 S-dimidine 403
Sdv specific desentistising caccine 320 Sea-leg 365
Sebbafon 357 Sebo-cds 357

540
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Sebon 371 Sebo-psor 411
Sebryl 339 Secantol 377
Seclodin 360 Seconal 400
Seconal sodium 400 Secophen-c 388
Secron 393 Sectam 363
Seda baxacor 368 Sedabel 371
Sedacol 339 Sedacoral 388
Sedafamen 386 Sedafen 323
Seda-intestain 388 Seda-ko 388
Sedalgin 388 Sedalis 409
Sedalmerck 385 Sedalone 372
Sedanoct 372 Sedanoct 364
Sedanox 383 Sedans 324
Sedantosol 361 Sedanyl 368
Sedapar 388 Sedarel 371
Sedarene 341 Sedarene 371
Sedaspray 360 Seda-tablinen 388
Sedatin 385 Sedatine 385
Sedatyl 372 Sedaural 389
Sedaural 385 Sedavier 368
Sedazepane 371 Sedazil 368
Sedeval 326 Sedistal 346
Sednotic 325 Sedo corodil 388
Sedo-asmol 349 Sedobex 401
Sedonal 388 Sedonan 385
Sedophen 388 Sedopsic 388
Sedo-rythmodan 325 Sedospin 399
Sedoval 409 Sedragesic 388
Sedural 385 Seecoren 344
Segosin 372 Segudol 380
Segurex 400 Selacryn 410
Selbon-a 323 Selcryn 410
Seldiar 364 Selene 368
Selodorm 368 Selpiran 371
Selvicin 350 Semelciclina 348
Semenen 400 Semikon 371
Semori 356 Sensi-t 396
Sepp 397 Septa 377
Septex cream no. 2 405 Septicol 335
Septiftalil 393 Septo-canulase 339
Septomixine forte 377 Septoplix 405
Septosil 403 Septotryl 404
Septozol 405 Seranex 385
Serenade 368 Sergi-cen 357
Sergo-amigdalar 335 Sergozin 373
Serial 28 366 Seril 368
Serohinol 356 Serolipid 340

541
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Serorhinol 356 Serotinex 340
Sertalanalgesico 371 Servalgin 399
Serviclofen 335 Servilactone 402
Servipan 328 Serviprofen 360
Serviquin 336 Servistrep 402
Servizolidin 391 Serzone 375
Sestron 340 Setran 368
Sevenal 388 Severen 371
Severin 371 Sexadien 345
Sexadieno 345 Sgd 403
S-guanidan 403 S-guanidine 403
Sh 833 398 Shalvaton 368
Shhe 21 385 Shield 378
Shigatox 403 Shignol 344
Shigrodin 391 Shinaito 409
Shinnibrol 409 Shin-rheufen 320
Shiomalin 363 Shiomarin 363
Sibren 354 Sibul 351
Sicol 350 Sificetina 335
Sigadoxin 348 Siglatan 341
Sigloton 341 Sigma-elmedal 391
Sigmicilina 335 Silbesan 336
Silderm 377 Silic c 339
Silino 344 Silternum 372
Silubin 330 Silubin retard 330
Simpamina 321 Simpamina d 343
Simpatedrin 321 Simpatina 321
Simplene 349 Sinac 393
Sinacin 393 Sinalgex 371
Sinalgin 327 Sinan 366
Sinapet 321 Sincomen 402
Sincomen 397 Sincomen pro injectione 397
Sindesvel 372 Sindiatil 330
Sindomens 342 Sine-aid ib 360
Sinedal 385 Sinequan 347
Sinfat 337 Sinnamin 326
Sinosid 382 Sinquan 347
Sinquan concentrate 347 Sinquane 347
Sinquin 358 Sintabolin 375
Sintaverin 371 Sinteroid 340
Sintobutina 391 Sintomicetin 335
Sintomicetina 335 Sintomicetine r 335
Sintomitsin 335 Sintown 368
Sinubid 393 Sinudan 393
Sinu-lets 393 Sinus 393
Sinutab 385 Sinutab cough l 393
Sinutab ii 385 Sinvirol 371

542
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Sipraktin 341 Siprodin 341
Siquent neomycin 377 Siragon 336
Sirben 354 Siropar 395
Sirprogen 342 Sistalgin 371
Sk 65 compound 385 Sk 65 compound caps. 385
Sk-amitriptyline 324 Sk-bamate 368
Sk-erythromycin 350 Skf-62698 410
Skiodan sodium 373 Sklero 340
Sklerocip 340 Sklerolip 340
Skleromex 340 Skleromexe 340
Sklero-tablinen 340 Sklerovasal 340
Skopolate 358 Skopyl 358
Skopyle 358 Sk-penicillin g 328
Skrub kreme 357 Sk-tetracycline 409
Sl 76 002 398 Sladicin 341
Sleepan 409 Sleepinal 372
Sleepwell 358 Slim-plus 321
Slipro 409 Slow-k 398
Sly-ll 386 Slyn-ll 386
S-methizole 404 Smokerette 401
Smop 404 Snophenicol 335
Sobril 413 Sobril tab 25 mg 413
Sodaphilline 350 Sodelut 342
Sodelut "g" 342 Sodepyrine b 1 374
Sodiopen 328 Sodipen 328
Sodium narcosate 358 Sofan 377
Sofarin 344 Sofarin 413
Sofracaps 341 Softa man 350
Soft-care 397 Softenil 409
Softenon 409 Solaquin 358
Solaquin forte 358 Solaquin forte sun bleaching 358
Soldactone 397 Solielin 352
Solmycin 346 Solofoton 388
Soludactone 397 Soludectancil 335
Solufen 360 Solu-heks 357
Solupen 348 Solurol 407
Solustrep 402 Solvidont 328
Solvo-strep-s 402 Solvo-strept 346
Solvo-strept-s 402 Solvotest 408
Soma 385 Soma compound 385
Soma compuesto 385 Somacton 401
Somatonorm 401 Somatormone 401
Somatotrope choay 401 Somatrofin 401
Somatropin 401 Somberol 372
Sombucaps 358 Sombulex 358
Sombutol 383 Somid 355
Somnafac 372 Somnal 325

543
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Somnalert 358 Somnevrin 340
Somnex 372 Somnibel 372
Somnipron 325 Somnium 372
Somnofac 372 Somnomed 372
Somnopentyl 383 Somnophyt 383
Somnopyrin 323 Somnosan 372
Somnotol 383 Somnotropon 372
Somnytic tablets 326 Somonal 388
Somophyllin 323 Somophyllin-12 323
Somvit 325 Sonal 372
Sonalgin 385 Songar 412
Songarn 412 Soniphen 388
Sonistan 383 Sonotryl 399
Sooner 361 Soor-gel 342
Sopamycetin 335 Sopanil 368
Sopental 383 Sopor 372
Sorbitoxin 382 Sorbitoxin 377
Sorelmon 344 Soriatane 319
Sorot 342 Sosegon 382
Sotracarix 350 Soval 372
Sovelin 372 Soverin 372
Sovinal 372 Sowell 368
Soxympamine 368 Soy-dome 357
Spacin 385 Spactil 344
Spalt 319 Spalt 399
Spalt 385 Spalt n 385
Span r/d 390 Spanbolet 403
Spanbolet ii 403 Spandecon 393
Span-k 398 Spanor 348
Spantran 368 Spartoloxyn 366
Spascol 388 Spasdel 388
Spasdolsom 371 Spaslar 371
Spasmalgon 371 Spasmalones 388
Spasmin 371 Spasmindon 385
Spasmium-comp. 371 Spasmizol 371
Spasmobamat 368 Spasmoban 344
Spasmo-barbanub 323 Spasmo-compragyl 388
Spasmo-compralgyl 385 Spasmo-deterex 323
Spasmo-dimonil 323 Spasmodor 371
Spasmofen 379 Spasmofen 400
Spasmogentarol 388 Spasmo-harnosal 404
Spasmolyn 366 Spasmo-paraxin 335
Spasmopront 372 Spasmopyralgin 371
Spasmotal 388 Spasmothil 371
Spasmo-tropax 323 Spasmovalin 323
Spasmo-van 388 Spasmoveragin 388
Spasmoverlgin 323 Spasmus 323

544
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Spastil 344 Spastyl 388
Specilline 328 Specilline g 328
Spectralgen 320 Spectralgen pollens 320
Spedifen 360 Speroctan-m 397
Spersanicol 335 Spersapolymyxin dispersa 377
Spetrasone 350 Spierifex 327
Spike 363 Spiractin 402
Spiresis 402 Spiretic 402
Spiridazide 402 Spiridon 402
Spirit of camphor 332 Spirix 402
Spiro 402 Spiro comp 402
Spiro50-d 402 Spiroctan 397
Spiroctan 402 Spirodigital 402
Spiro-f 402 Spirolang 402
Spiron 402 Spironazide 402
Spironomocompren 402 Spironone 402
Spironothiazide 402 Spiropal 402
Spiroprop 402 Spirostada 402
Spiro-tablinen 402 Spirotone 402
Spirozid 319 Spofadazine 404
Spondyneuron 388 Spondyril 391
Spongamed 399 Sprx 105 386
Spulmako-lax 389 Srda 393
S-spac 383 Stabilat 391
Stablon 410 Stadadorm 325
Stadasan 360 Stamicina 348
Stangyl 412 Stanomycetin 335
Starisil 404 Starogyn 330
Statobex 386 Statobex-d 386
Steclin 409 Steladex 343
Stelapar 411 Stella micina 350
Stellacyl 385 Stellamicina 350
Stenabolin 374 Stenabolin 375
Stensolo 368 Stental extentabs 388
Steraskin 357 Steridermis 357
Steridermis washing cream 357 Sterobolin 374
Steroderm 339 Steros-anal 377
Sterotest 408 Ster-zac 357
Ster-zac antibacterial shaving foam 357 Ster-zac antibacterial soap 357
Ster-zac dc skin cleanser 357 Ster-zac powder 357
Sth 401 S-thalmic 377
Stie vaa 411 Stiedex 377
Stievaa 411 Stil-2 343
Stilalgin 366 Stilco 379
Stilphostrol 345 Stimolag fortis 395
Sto-caps 393 Stodex 386
Stodinox 358 Stollerine 388

545
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Stona 399 Stopayne 368
Stopp-15 383 Stovarsol 319
Stovarsolan 319 Strabolene 375
Strep-diva 402 Strepolin 402
Streptacillin 405 Streptamin 405
Streptan 402 Streptaquaine 402
Strepticine 335 Streptocal 402
Streptoduocin 346 Strepto-fatal 402
Streptoglobenicol 335 Streptomagma 362
Streptomagma 382 Streptomycin 402
Streptophenicol 335 Streptosol 25 402
Streptothenat 402 Streptotriad 405
Stretobretin 402 Strycin 402
Styptirenal 349 Subital supp. 335
Subtosan 397 Sucaryl 341
Sucaryl calcium 341 Sucaryl sodium 341
Sucrum 341 Sucrum 7 341
Sudil 406 Sudocrem 328
Sufenid 406 Sufonovin 371
Sugai tartrazine 407 Suganril 380
Suganyl 403 Sugracillin 328
Suigonan 396 Suismycetin 335
Suladyne 404 Sulamin 404
Sulc 406 Sulfa gram 404
Sulfa spirig 404 Sulfabon 404
Sulfacarbon 403 Sulfacetil 393
Sulfacromo 405 Sulfadazina 404
Sulfadepot 404 Sulfadin 404
Sulfadurazin 404 Sulfaglobenicol 335
Sulfaintensa 404 Sulfakeyn 404
Sulfalex 404 Sulfamethine 406
Sulfametin 404 Sulfametopyridazin 404
Sulfamizina 404 Sulfamul 405
Sulfamycetin 335 Sulfamyd 404
Sulfamyton-n 378 Sulfa-orzon 405
Sulfa-probocon 393 Sulfapyelon 404
Sulfapyrazin 404 Sulfatar 404
Sulfathalidine 393 Sulfavitina 405
Sulfazol 405 Sulfdurazin 404
Sulfentidine 403 Sulfex 405
Sulfhatose 405 Sulfintestin 405
Sulfix-6 377 Sulfocidan 404
Sulfogua 403 Sulfonamid 404
Sulfonamid spuman 405 Sulfonamide-spuman-style 405
Sulfonanilamid 405 Sulfonovin 371
Sulfopyrol 405 Sulforetent 404
Sulfo-rit 404 Sulfosellan-salbe 405

546
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Sulfour 405 Sulfstat 404
Sulftalyl 393 Sulfurine 404
Sulfzol 405 Sulgin 403
Sulka-s 403 Sul-mycin ii 402
Sulnac 405 Sulocton 406
Sulodene 406 Suloktil 406
Sulphamezathine 403 Sulphatriad 405
Sulphfmezatine 403 Sulpin 371
Sulpyrin 371 Sulpyrine 371
Sultirene 404 Sultrin 405
Sulvina 355 Sulzol 405
Sumasept 357 Sumital 325
Sumycin 409 Supadol 371
Supamidal 388 Super anahist 385
Super emegrin 321 Super koki 401
Super masticort 377 Super mastitare 377
Super sat 357 Superanabolon 375
Superbolin 375 Superfade age spot 358
Supergine 371 Superior pain medicine 360
Supermesin 365 Superminal 365
Superol 356 Superpyrin 320
Superseptyl 403 Suppnon 323
Suppoptanox 413 Supprestal 342
Suprabolin 375 Supracapsulin 349
Supracyclin 348 Supralgin 385
Supranephrane 349 Supranephrine 349
Supranol 406 Supraoxid 340
Suprapuren 402 Supra-puren 402
Suprarenaline 349 Suprarenine 349
Suprasec 364 Supraverm 395
Suprel 349 Supreme pain medicine 360
Supren 360 Suprexon 349
Suprexon 5 349 Suprimal 365
Suprol 406 Suracton 402
Surfex 406 Surg salve 357
Surge vet 357 Surgexl 377
Surgi-cen 357 Surmantil 412
Surmontil 412 Surofene 357
Surpyrine 371 Surrenine 349
Susano 400 Susano 388
Suscardia 361 Susiform ad is vet 330
Suspal 320 Susphrine 349
Sus-phrine 349 Suspren 360
Sustain iii 403 Sutanone 408
Sutidil 406 Svc 319
Sweet flag root 331 Swim-ear 329
Swim-eye 329 Swiss-kal sr 398

547
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Sy-dexam 325 Sylvemid 324
Symetra 386 Sympamine 321
Sympatedrin 321 Sympathin i 349
Sympatina 321 Symptrol 393
Synalar polyvalent 377 Synalar-c 339
Synalgos 385 Synalogos-dc 385
Synandrol 408 Synatan 321
Synatan 343 Syndian 381
Syndrox 368 Syneron 408
Synestrol 345 Synoestrol 345
Synoestrolum 357 Synovex-h 408
Synpyrin 399 Syntaverin 371
Synthomycetin 335 Synthomycetina 335
Synthomycetine 335 Synthophtone 335
Syntophyllin 323 Syntospon 388
Synureticum 402 Syptan 393
Syralbina 377 Syralbuna 354
Syrtussar 393 Th 385
T-712 321 Tabalon 360
Tabillin 328 Tabmint 401
Tabrien 352 Tacol 385
Taenifigin 395 Taf test 356
Taguinol 364 Taimoxin 350
Taizerl 365 Takamina 349
Talacen 382 Talamo 325
Talasa 414 Taleudron 393
Talidine 393 Talimol 409
Talisulfazol 393 Taloudron 393
Talwin 382 Talwin nx 382
Tamate 368 Tambocor 353
Tametil 347 Tamid 406
Tamil 393 Tampovagan 377
Tampovagan pss 405 Tanakan 336
Tanakan 354 Tanal 380
Tandacot 380 Tandacote 381
Tandalgesic 380 Tandalgesic 381
Tandearil 381 Tandearil 380
Tanderil 380 Tanderil 381
Tanderil-alka 381 Tanercept 350
Tangenin 328 Tanper 371
Tapal 371 Tapal 319
Taquidil 410 Tardilat 326
Tardolyt 325 Tardomyocel 335
Tardyl 355 Tarestin 344
Tariston 377 Taristop 378
Tartar yellow fs 407 Tartar yellow n 407
Tartar yellow pf 407 Tartar yellow s 407

548
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Tartran yellow 407 Tartraphenine 407
Tartrayellow 407 Tartrazin 407
Tartrazine a export 407 Tartrazine b 407
Tartrazine b.p.c. 407 Tartrazine c 407
Tartrazine extra pure a 407 Tartrazine fq 407
Tartrazine g 407 Tartrazine lake 407
Tartrazine lake yellow n 407 Tartrazine m 407
Tartrazine mcgl 407 Tartrazine n 407
Tartrazine ns 407 Tartrazine o 407
Tartrazine o specially pure 407 Tartrazine t 407
Tartrazine xx 407 Tartrazine xx especially pure 407
Tartrazine xxx 407 Tartrazine yellow 407
Tartrazol bpc 407 Tartrazol yellow 407
Tartrine yellow o 407 Tasnon 395
Tasvite 341 Tavegil 338
Tavegyl 338 Ta-verm 395
Taviset 393 Tavist 338
Tavist 1 338 Tavist tablets 338
Tavist-1 338 Tavist-d 338
Tavist-syrup 338 Taxagon 411
Tbp 328 Tbrien 352
Tcm 200 368 Tcm 400 368
Tcp 332 Tcp 410
Tears plus 397 Tebloc 364
Tedralan 388 Teebaconin 361
Tefamin 323 Tega-cetin 335
Tega-pyrone 371 Tegison 351
Telboc 364 Telestyl 377
Teletux 379 Telgin-g 338
Telidal 380 Telipex 408
Telmicid 346 Telmid 346
Telmide 346 Temagesic 331
Temasept 356 Temgesic 331
Temp 371 Tempil 371
Tempil 360 Tenalin 371
Tendar 360 Tendearil 380
Teneral 380 Teniver 395
Ten-k 398 Tenorac 354
Tenorac 365 Tensilence 326
Tensin 402 Tensoflex 402
Tensophoril 329 Tensophoril 325
Tensorelax 324 Tenuate 321
Tenuate dospan 321 Tenucap 321
Teofedrin 388 Teolaxin 388
Teophyllamin 323 Tepal 371
Tepanil 393 Tepanil 321
Tepcycline 409 Teperin 324

549
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Tepincal 340 Tepingal 340
Tequinophil 339 Teramine 390
Teramine 337 Teranol 398
Terazol 408 Terazol 408
Terazol 3 408 Tercospor 408
Terenac 365 Termonil 371
Terolin 408 Teronac 365
Teropicycline 409 Terracydin 385
Terramycin 355 Terrastatom 355
Tersaseptic 357 Tersulpha 403
Tersulpha 403 Tervalon 337
Teserene 345 Teslen 408
Tesrina 408 Testaform 408
Testanderogen 408 Testenat 408
Testex 408 Testigrmon 408
Testilen 408 Testirene 408
Testobase 408 Testodet 408
Testodrin 408 Testogen 409
Testoici 409 Testoidral 409
Testolets 409 Testonate 409
Testonique 409 Testopin 409
Testopinate 409 Testopropon 409
Testoral 409 Testo-retard 409
Testormol 409 Testosid 409
Testoviron 409 Testoviron (ampule) 409
Testoviron-10/-25/-50 409 Testoviron-depot-50/-100 409
Testovis 409 Testoxyl 409
Testrex 409 Testron 409
Tete-lax 381 Tetesept 332
Tetesept 342 Tetnor 391
Tetrabal-hosbon 371 Tetrabotic 409
Tetra-c 409 Tetracap 409
Tetracaps 409 Tetrachlorasone 335
Tetracid 404 Tetracol 335
Tetracyn 355 Tetracyn 409
Tetradox 348 Tetrafur 354
Tetralan 409 Tetram 409
Tetranfen 335 Tetraphenicol 335
Tetra-phenicol oculos 335 Tetrasan 348
Tetraspasmil 371 Tetrawest 403
Tetrex 409 Tetrex-apc 385
Tetrpsol 409 Tetrracydin 385
Tevcocin 335 Tevocodyn 391
Thalazole 393 Thalinil 393
Thalinol 389 Thalinol mrt 389
Thalistanin 393 Thalistatyl 393
Thalsin 328 Thefedral 388

550
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Thelmin 395 Thenatol 395
Thenylene 371 Theodrine 388
Theotabs 388 Thephorin a-c 385
Therapen-na 328 Therazone 391
Thiadyl 405 Thiazamid 405
Thiazamide 405 Thiazole 393
Thicataren 344 Thidicur 404
Thinz 332 Thioactacid 364
Thiobactal 410 Thiocondramine 355
Thionylan 371 Thiosulfil 404
Thiosulfil a 404 Thioxidil 366
Thittico 411 Thiuramide 405
Thodrox 323 Thombran 411
Thromban 411 Tiadexol 371
Tiadyl 405 Tiartan 371
Tiatral 320 Tibased 400
Tibutazone 391 Ticinil 391
Ticinil calcio 391 Ticinil calico 391
Ticlid 410 Ticlidan 410
Ticlobran 340 Ticlodix 410
Ticlodone 410 Ticlopedine 410
Ticlosan 410 Ticrex 410
Ticrynafen 410 Ticrynapen 410
Tidemol retard 330 Tifomycine 335
Tiframild 377 Tiframilk 335
Tigasan 351 Tigason 351
Tiiomapirina 385 Tiklid 410
Tiklyd 410 Tikofuran 354
Tilcid 410 Timazincum 329
Tinaroc 393 Tiosulfan 404
Tipolin 329 Tiqualone 372
Tiromycetin 335 Tivazine 395
Tkb 362 Tlargan 409
Tobinal 358 Tobispray 377
Todalgil 360 Todalgil 391
Togerin 350 Togiren 350
Togrien 350 Tolansin 366
Tolax 366 Tolbrtaphen 386
Tolcil 366 Toleran 358
Tolhart 366 Tolllluan 347
Tolosate 366 Toloxin andromaco 371
Toloxyn 366 Tolseram 366
Tolserol 366 Tolseron 366
Tolsin 366 Tolulexin 366
Tolulox 366 Tolvin 373
Tolvon 373 Tolyprin 326
Tolyprina 326 Tolyspaz 366

551
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Tomapiena 385 Tombran 411
Tomevit 400 Tonedron 368
Tonobrein 400 Tonocard 410
Tonomentis 400 Tonosan 323
Topazone 354 Tophol 337
Topic 332 Topic 328
Topicon 377 Topitasico 377
Topral 406 Toptic 339
Toquidil 410 Toquilone 372
Toracsol 357 Toraflon 372
Toramin 335 Torbetol lotion 357
Toriador 372 Torinal 372
Torofor 339 Toryxil 344
Tosinova 350 Tostrina 409
Totolin 393 Totrtasec 364
Touristic 347 Toxocan 395
Tr 1736 325 Tr 495 372
Trabar 391 Trabar 410
Trabit 391 Tracherine 356
Tramal 410 Tramensan 411
Tranatogen-ova 354 Trankilin 368
Trankvilan 368 Tranlisant 368
Tranmep 368 Tranoxa 378
Tranquil 368 Tranquilan 368
Tranquilax 368 Tranquiline 368
Transamin 411 Transaminase 411
Transaminase sgo 411 Transaminase sgp 411
Transamine 411 Transcop 400
Transepar 337 Transicetina 335
Transital 325 Transpulmycin 335
Traubofan 337 Trauma-dolgit 360
Traumasept 397 Trelenium 341
Trelmar 368 Trenteron 371
Trepiline 324 Trepulin 324
Tresaderm 377 Tresochin 336
Tretin m 411 Treupel 385
Triadapin 347 Triadol 327
Triartan 371 Triavil 324
Triazure 326 Tribiotic 377
Tribiotic 335 Tri-bow 377
Trichofuron 354 Tricho-gynedron 406
Tricho-gynedron 329 Trichovan 319
Tricilone 377 Tricofuron 354
Tricon 393 Tri-congestic 393
Tricoron 354 Tridezibarbitur 388
Trifurox 354 Trilax 389
Trimanyl 345 Trimcaps 386

552
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Trimeto 405 Trimo-san 356
Trimstat 386 Trimtabs 386
Trinalgen 371 Triniad 361
Tri-norinyl 379 Triofan 328
Triogesic elixir 393 Triominic 393
Triomone 409 Tri-optics 377
Triotussic 393 Triphenatol 388
Tripin 385 Triplex 385
Triplopen 328 Triptizol 324
Triptonal 324 Triptpane 324
Tri-reumo-campil 368 Trisulfaminic 403
Trisulfaminic 403 Trisulfaminie 403
Trisulpha 405 Trisulpha 403
Trisulvet 403 Tritane 393
Tritico 411 Trittico 411
Triva douch powder 356 Triva jel 356
Trivial 324 Trivial-4-10 324
Trivial-4-50 324 Troc 377
Trochin 336 Trodax 379
Trofodermin 377 Trogal 323
Tropax 388 Tropax 323
Tropax 400 Trophen 335
Tropoxin 350 Troymycetin 335
Truphylline 323 Trypsillin 412
Tryptan 364 Trysul 405
Tsefokon 323 Tsudohmin 344
Tsudomin 344 Tualone 372
Tuazole 372 Tuazolona 372
Tuazolone 372 Tucotin 379
Tuinal 400 Tuinal 325
Tumex 356 Tumisan globulina 371
Tuocurine 378 Turbispan 393
Turinabol 375 Turinabol-depot 374
Tuscapin 379 Tusolone 335
Tussamine plus 379 Tussanil n 379
Tusscalman 380 Tussicure 380
Tussilene-dm 393 Tussisedal 380
Tussoretard 380 Tweenal 377
Tycloran 335 Tydamine 412
Tylasul 405 Tylciprine 411
Tylenol 382 Tylinal 321
Tympagesic 323 Tympagesic 385
Tyrivac 320 Ubrocelan 377
Ucb 5062 365 Ucb 630 377
Ufa 902-duo 405 Ufa-cfo-400 354
Uga-no 385 Ultradine 397
Ultragim 371 Ultragin 371

553
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Ultra-k-chlor 398 Ultrapla 398
Ultraprin 360 Ultraquin 358
Ultraquin plaine 358 Ultrasul 404
Ultratiazol 393 Umbellatin 328
Umbellatine 328 Umprel 329
Unacil 348 Unagen 371
Unalgen hc 371 Ung. vemleigh 405
Uniad 361 Unicilina 328
Unicilina sodia 328 Unidiarea 339
Unidox 363 Unidox 348
Unimycetin 335 Uniprofen 327
Uniriod 377 Unisol 329
Unisulfa 404 Unisulfa dulcis 404
Unisvelt 389 Unitertracid yellow te 407
Uniteston 409 Uno 368
Upstene 360 Ura 389
Uractone 402 Urafadyn 378
Uratrac 404 Urbil 368
Urbilat 368 Urem 360
Uricida 395 Uridina 395
Uritrol 379 Uro-beniktol 377
Urobiotic 404 Uroclear (hexamine) 395
Urocoli 379 Uro-coli 379
Urocydal 404 Urodan (phosphate) 395
Urodiaton 404 Uro-gliscal 335
Uro-gliscal 500 335 Uroletten 378
Uroletten-s 335 Urolex 404
Urolucosil 404 Uroluxcosil 404
Urombal 373 Uromitexan 368
Uronal 326 Uro-nebactin 404
Uro-nebctin 377 Uronexitan 368
Uropeutic 404 Uroplex 404
Uroplex 4 335 Urosolvina 395
Urosonine 402 Urotrex 404
Uroz 404 Urusonin 402
Usacert yellow no 5 407 Ut forte 335
Uteroject 339 Uterojekt 354
Utovlar 379 Utrasul 404
Uvilon syrup (hydrate) 395 Uvomycin 335
Uzone 391 V cold 393
Vabrocid 378 Vadicate 413
Vagifurona 354 Vagipurin 319
Vagisep 319 Vagisept 335
Vagitrol 405 Vagival 319
Vagoflor 319 Valcophen 385
Valetan 344 Valetan 404
Validil 381 Valpin 388

554
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Valprin 360 Valproine 412
Valsera 353 Valseram 353
Vanadian 320 Vancid 328
Vancide bl 328 Vandar-65 385
Vanital 388 Vanpar (hydrate) 395
Vanseb 357 Vantal 388
Vantostol-p 409 Vantyl 337
Vaopin 389 Vapesin 352
Vapo-iso 361 Vaponefrin 349
Vaponephrine 349 Vapo-n-iso 361
Variaphylline 323 Varicella-rit 377
Varihesive 382 Variolan 335
Vas dexa 411 Vasco 327
Vascudil 406 Vasoc 327
Vasocalm 368 Vasoconstrictine 349
Vasoconstrictor 349 Vasodarkey 326
Vasodrine 349 Vasogesic 385
Vasotonin 349 V-cline 365
V-cortanmycetine 377 V-crayolan 335
Vectren 362 Vederon 412
Vefren 380 Veganine 385
Velaten 404 Veltane 393
Veltap 393 Venactone 397
Venagil 327 Venostasin retard 397
Ventribex 339 Veracolate 389
Verafen 342 Veramix 342
Veramix plus v 342 Verban 326
Verfactor 361 Vericap 396
Verinogen 326 Veripaque 381
Veripar 395 Veritab 366
Vermago 395 Vermazine 395
Vermenter 395 Vermicompren 395
Vermidol 395 Vermifug 395
Vermilass 395 Vermipan 395
Vermiphsarmette 395 Vermiquimpe 395
Vermiquimyc 395 Vermisit 395
Vermisol 395 Vermisol 364
Vermitox 395 Vermofrik 395
Vernate 393 Verocid 395
Verodon 326 Veroletten 326
Verolitten 326 Veronal 326
Veronigen 326 Verospiron 402
Verospirone 402 Veroxil 395
Verra-med 411 Versidyne 373
Versomnal 388 Vertizine 366
Verucid 350 Vetacalin-m 329
Vetalderm 357 Vetalgin 371

555
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Vetedine 397 Vetedol 327
Vetical 335 Veticar 346
Vetophenicol 335 Vetoprim 354
Vetoprim mi 405 Vetoryl 393
Vetroyl 377 Vetsovate 377
Vevesca 373 Veycil-as 346
Viadol 323 Viafen 330
Viafen u est.crema 40 g 330 Viagra 400
Viartril 355 Vibolin 351
Vibracina 348 Vibramicina 348
Vibramycin 348 Vibramycin hyclate 348
Vibramycine 348 Vibra-tab 348
Vibra-tabs 348 Vibraveineuse 348
Vibravenos 348 Vibravenosa 348
Vibriomycin 346 Viceton 335
Vicks action 500 385 Victoril 343
Viden 385 Vidipon 340
Viform 339 Vigilor 352
Vigilor 200 mg cpr msfp 352 Viklorin 335
Vimedel 340 Vimicon 341
Vinbarbiton 413 Vinca 413
Vinca minor 413 Vincacen 413
Vincapront 413 Vincavix 413
Vinces 404 Vincimax 413
Vini 397 Vinisil 397
Vintab 362 Vintop 362
Vio-bamate 368 Vioform 339
Vioform bolus 339 Vioform hydrocortisan 339
Vioform hydrocortisone 339 Vioforme 339
Viofuragyn 354 Viophan 337
Viosept 339 Viperone 371
Viramune 377 Viridite 398
Viridite k 398 Virogin 335
Viromon 409 Viropulver 378
Virormone 409 Virosterone 409
Visadron 392 Visano cor 368
Visceralgine forte 371 Viscerol 344
Viscope 358 Vistabamate 368
Vista-methasone n 377 Vistaminic 393
Visublefarite 385 Visubutina 380
Vitacid a 411 Vitaklorin 335
Vitalone 372 Vitamin a acid 411
Vivcet 399 Vk 53 404
Vocaline 340 Volidan 366
Volocid 404 Volplan 366
Voltaren 344 Voltarene 344
Voltarol 344 Vomaxine 366

556
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Vomisseis 366 Vondacid tartrazine 407
Voxin-pg 393 Vsf-medical g 15 354
Vsmpozim 335 V-softa 377
Vtg 44 404 Vulnusol spray 357
W 32 386 W 58 393
W 66 393 W7320 320
W-7320 320 W83 371
Wairmex 395 Walconesin 366
Wans 383 Waran 413
Warfilone 413 Wartec 396
Warticon 396 Wartkil 396
Wart-off 396 Wauco-sin 399
Waudobuzon 323 Waukobuzon 391
Wecontrin 399 Wehless 386
Weighttrol 386 Weingeist 350
Wekamine 321 Wesco hex 357
Wescohex 357 Wescomep 368
Wescozone 391 Westasept 357
Wigraine 385 Wigraine-pb 383
Willnestrol 345 Win 11450 327
Winolate 327 Winorlate 327
Winorylate 327 Winrolate 327
Wintetil 335 Wintracin 409
Wintrazol 405 Wiolate 327
Wndomethasone 363 Wofapyrin 391
Wood yellow 407 Worm-away 395
Wurmex 395 Wurmirazin 395
Wurmsirup siegfried 395 Wyamycin 350
Wyamycin e 350 Wyamycin s 350
Wyovin 344 X 112 antiadipo 393
Xani 326 Xaril 385
Xenalmine 413 Xenalone 402
Xenovis 413 Xerac 357
Xeracin 350 Xeualon 402
Ximicina 348 Xl 7 328
Xolamin 338 X-trozine 386
Xyduril 340 Xylene fast yellow gt 407
Xylestesin a 349 Xylotocan 410
Xylotox 364 Xylotox 349
Yalrocin 378 Yastyl 383
Yatrocin 378 Yellow lake 69 407
Yermonil 365 yhu TNFR: Fc 350
Yoclo 340 Yodiplexin 397
Yodomin 409 Zactirin compound-100 385
Zadorin 348 Zalpon 357
Zalpon antibacterial washing cream 357 Zedrine 321
Zeisin 340 Zelmid 413

557
 C. INDEX TO PHARMACUETICALS
BY AVAILABLE TRADE NAMES
TRADE AND BRAND NAMES PAGE TRADE AND BRAND NAMES PAGE
Zelmidine 413 Zepelin 352
Zerinol 393 Ziavetine 330
Zimovane 414 Zirkonorm 388
Zitoxil 414 Zolapelin 392
Zolidinium 392 Zomax 414
Zomaxin 414 Zonalon 347
Zontal 352 Zoontal 352
Zopirac 414 Zoppib spray blu 335
Zoppin spray blu 378 Zorprin 319
Zubirol 320 Zumaril 320
1 yellow 407 1409 yellow 407
16038 322 17-chetovis 398
17-hormoforin 398 190 f 319
22krl 401 292-comprimes 383
3 p maid 328 369, pulvules 383
3p bamte 367 3p bugesic 383
3p maid 389 3p methazol 403
3p pane 371 3p spas 387
4311 ciba 373 4-c-32 410
53-32-c 410 539 grippe-dragees 399
5-nitrok 379 8Omniflox 407
8Teflox 407 8Temac 407
90459 compound 327 99 armour formula 356

558
 Annex I
Relevant resolutions of the General Assembly
And the Economic and Social Council

General Assembly resolution 37/137

Protection against products harmful to health and the

environment

The General Assembly,

Aware of the damage to health and the environment that the continued
production and export of products that have been banned and/or permanently
withdrawn on grounds of human health and safety from domestic markets is
causing in the importing countries,

Aware that some products, although they present a certain usefulness in

specific cases and/or under certain conditions, have been severely restricted
in their consumption and/or sale owing to their toxic effects on health and
the environment,

Aware of the harm to health being caused in importing countries by the export
of pharmaceutical products ultimately intended also for consumption and/or
sale in the home market of the exporting country, but which have not yet been
approved there,

Considering that many developing countries lack the necessary information and
expertise to keep up with developments in this field,

Considering the need for countries that have been exporting the above-
mentioned products to make available the necessary information and assistance
to enable the importing countries to protect themselves adequately,

Cognizant of the fact that almost all of these products are at present
manufactured and exported from a limited number of countries,

Taking into account that the primary responsibility for consumer protection
rests with each State,

Recalling its resolution 36/166 of 16 December 1981 and the report on

transnational corporations in the pharmaceutical industry of developing
countries, 1 and acting in pursuance of Economic and Social Council resolution
1981/62 of 23 July 1981,

Bearing in mind in this context the work of the Food and Agriculture
Organization of the United Nations, the World Health Organization, the
International Labour Organisation, the United Nations Environment Programme,
the General Agreement on Tariffs and Trade, the United Nations Centre on

1
E/C.10/85.

____________________________________________________________________________________________________________
559
Transnational Corporations and other relevant intergovernmental
organizations,

1. Agrees that products that have been banned from domestic consumption
and/or sale because they have been judged to endanger health and the
environment should be sold abroad by companies, corporations or individuals
only when a request for such products is received from an importing country
or when the consumption of such products is officially permitted in the
importing country;

2. Agrees that all countries that have severely restricted or have not
approved the domestic consumption and/or sale of specific products, in
particular pharmaceuticals and pesticides, should make available full
information on these products with a view to safeguarding the health and
environment of the importing country, including clear labelling in a language
acceptable to the importing country;

3. Requests the Secretary-General to continue to ensure the provision of the

necessary information and assistance by the United Nations system in order to
strengthen the national capacities of developing countries to protect
themselves from the consumption and/or sale of banned, withdrawn, severely
restricted or, in the case of pharmaceuticals, non-approved products;

4. Requests the Secretary-General, based upon the work already being done
within the Food and Agriculture Organization of the United Nations, the World
Health Organization, the International Labour Organisation, the United
Nations Environment Programme, the General Agreement on Tariffs and Trade,
the United Nations Centre on Transnational Corporations and other relevant
intergovernmental organizations, to the maximum extent possible within
existing resources, to prepare and regularly update a consolidated list of
products whose consumption and/or sale have been banned, withdrawn, severely
restricted or, in the case of pharmaceuticals, not approved by Governments,
and to make this list available as early as possible and, in any case, not
later than December 1983;

5. Agrees that the consolidated list referred to in paragraph 4 above should

be easy to read and understand and should contain both generic/chemical and
brand names in alphabetical order, as well as the names of all manufacturers
and a short reference to the grounds and decisions taken by Governments that
have led to the banning, withdrawal or severe restriction of such products;

6. Decides, on the basis of the above-agreed criteria, to keep under review

the format of the consolidated list with a view to its possible improvements;

7. Requests Governments and the relevant organs, organizations and bodies of

the United Nations system to provide all the information and assistance
necessary for the prompt and effective fulfillment of the task entrusted to
the Secretary-General.

109th plenary meeting

17 December 1982

____________________________________________________________________________________________________________
560
 General Assembly resolution 38/149

Protection against products harmful to health and the environment

The General Assembly,

Recalling its resolutions 36/166 of 16 December 1981 and 37/137 of 17

December 1982,

Bearing in mind the oral report presented by the Secretariat with regard to
progress made in the implementation of resolution 37/1372

1. Takes note of the report of the Secretary-General on the exchange of

information on banned hazardous chemicals and unsafe pharmaceutical products,3
and of the work being carried out by the United Nations system of
organizations;

2. Notes with satisfaction that the work carried out in consultation with
organizations of the United Nations system on the consolidated list of
products whose consumption and/or sale have been banned, withdrawn, severely
restricted or, in the case of pharmaceuticals, not approved by Governments,
is in the process of being completed;

3. Requests the Secretary-General to make available the consolidated list, as

established on the basis of information supplied up to now in accordance with
the objectives of General Assembly resolution 37/137, and to bring it up-to-
date on a regular basis;

4. Urges the relevant organs, organizations and bodies of the United Nations
system, particularly the Food and Agriculture Organization of the United
Nations, the World Health Organization, the International Labour
Organisation, the United Nations Environment Programme, the General Agreement
on Tariffs and Trade and the United Nations Centre on Transnational
Corporations and other intergovernmental organizations, to continue to co-
operate fully in providing information for the consolidated list and for its
updated versions;

5. Appreciates the co-operation extended by Governments and urges all

Governments, in particular those that have not yet done so, to provide the
necessary information for inclusion in the consolidated list and its updated
versions, as well as comments and views that they deem relevant;

6. Urges non-governmental organizations to extend co-operation to the

Secretary-General regarding the preparation of the consolidated list,
particularly in the identification of potential sources of information among
national Governments and in obtaining governmental information on relevant
regulatory actions;

7. Requests the Secretary-General, for purposes of review by the General

Assembly at its thirty-ninth session, to submit a report on the
implementation of Assembly resolution 37/137, including the consolidated
list, taking into account the latest information and comments collected for
possible improvement of the list, as envisaged in paragraph 6 of resolution
37/137;

2
Official Records of the General Assembly, Thirty-eighth Session, Second Committee, 27th
meeting, paras. 1-7.
3
A/38/190-E/1983/67.

____________________________________________________________________________________________________________
561
8. Requests the Secretary-General to submit to the General Assembly at its
thirty-ninth session, through the Economic and Social Council, a report on
the exchange of information on banned hazardous chemicals and unsafe
pharmaceutical products identifying elements for possible further work in
this area in regard to the needs and capabilities of developing countries to
monitor and control those substances in the light of the relevant
observations in the report of the Secretary-General;

9. Requests the Secretary-General and the organs, organizations and other

competent bodies of the United Nations system to continue to provide, within
available resources, the necessary technical assistance to the developing
countries, at their request, for the establishment or strengthening of
national systems for better use by those countries of the information
provided with regard to banned hazardous chemicals and unsafe products, as
well as for an adequate monitoring of the importation of those products.

102nd plenary meeting

19 December 1983

General Assembly resolution 39/229

Protection against products harmful to health and the environment

The General Assembly,

Reaffirming its resolutions 37/137 of 17 December 1982 and 38/149 of 19

December 1983,

Taking note with satisfaction of the report of the Secretary-General on

products harmful to health and the environment,4

Bearing in mind the report of the Secretary-General on the exchange of

information on banned hazardous chemicals and unsafe pharmaceutical products,5
and welcoming the effort being made in various international forums with
regard to the exchange of information on such products,

1. Expresses its appreciation to the Secretary-General and commends him for

the distribution of the first issue of the consolidated list of products
whose consumption and/or sale have been banned, withdrawn, severely
restricted or, in the case of pharmaceuticals, not approved by Governments;

2. Reiterates its appreciation for the co-operation extended by Governments

in the preparation of the consolidated list, and urges all Governments that
have not yet done so to provide the necessary information for inclusion in
the updated versions of the list;

3. Notes with satisfaction the co-operation provided by the appropriate

organs, organizations and bodies of the United Nations system and other
intergovernmental organizations in the issuance of the list and urges them,
particularly the Food and Agriculture Organization of the United Nations, the
World Health Organization, the International Labour Organization, the United
Nations Environment Programme, the General Agreement on Tariffs and Trade and

4
A/39/452.
5
A/39/290-E/1984/120.

____________________________________________________________________________________________________________
562
the United Nations Centre on Transnational Corporations, to continue to co-
operate fully in the preparation of the updated versions of the list;

4. Expresses its appreciation for the co-operation provided by non-

governmental organizations in this regard, and urges them to continue to
extend co-operation to the Secretary-General in the preparation of the
consolidated list, particularly in the identification of potential sources of
information among national Governments and in obtaining governmental
information on relevant regulatory actions;

5. Decides that:
(a) An updated consolidated list should be issued annually and that the
data should be made available to Governments and other users in such a form
as to permit direct computer access to it;

(b) In order to keep costs to a minimum, the consolidated list should

be published and made available in all the official languages of the United
Nations in sets of alternating languages each year, with no more than three
languages per year and with the same frequency for each language;

(c) The format of the consolidated list should be kept under continuing
review with a view to its improvement, in accordance with General Assembly
resolution 37/137, in co-operation with the relevant organs, organizations
and bodies of the United Nations system, taking into account the
complementary nature of the list, the experiences obtained and the views
expressed by Governments on this matter, and that the next review should be
submitted by the Secretary-General to the General Assembly at its forty-first
session;

(d) The review of the consolidated list should cover particularly the
advantages and disadvantages of introducing to the list such information as
the legal, public health and commercial context of the regulatory actions, as
well as complementary information on safe uses of the products;

6. Urges importing countries, bearing in mind the extensive legal, public

health and safety information already provided to the United Nations Centre
on Transnational Corporations, the United Nations Environment Programme, the
International Labour Organisation, the Food and Agriculture Organization of
the United Nations, the World Health Organization and the General Agreement
on Tariffs and Trade, to avail themselves of the information provision
facilities of those organizations, which include, in some cases, direct
computer access;

7. Requests the Secretary-General, with the assistance of the appropriate

specialized agencies, to submit to the General Assembly at its forty-first
session a report on a review of the various information exchange schemes now
in operation within the United Nations system;

8. Requests the Secretary-General and the competent organs, organizations and

bodies of the United Nations system to continue to provide the necessary
technical assistance to the developing countries, at their request, for the
establishment or strengthening of national systems for managing hazardous
chemicals and pharmaceutical products, as well as for an adequate monitoring
of the importation, manufacture and use of those products;

9. Also requests the Secretary-General, through the Economic and Social

Council, to inform the General Assembly at its forty-first session and every
three years thereafter about the implementation of resolutions 37/137 and
38/149 and of the present resolution;

____________________________________________________________________________________________________________
563
10. Further requests the Secretary-General to take the necessary measures for
the implementation of the present resolution.

104th plenary meeting

18 December 1984

General Assembly resolution 44/226

Traffic in and disposal, control and transboundary movements of

Toxic and dangerous products and wastes

The General Assembly,

Recalling its resolutions 37/137 of 17 December 1982, 38/149 of 19 December

1983 and 39/229 of 18 December 1984, as well as its decision 41/450 of 8
December 1986,

Recalling also its resolution 42/183 of 11 December 1987 on traffic in toxic

and dangerous products and wastes,

Recalling further its resolution 43/212 of 20 December 1988, entitled

"Responsibility of States for the protection of the environment: prevention
of the illegal international traffic in, and the dumping and resulting
accumulation of, toxic and dangerous products and wastes affecting the
developing countries in particular",

Recalling Economic and Social Council resolutions 1988/70 and 1988/71 of 28

July 1988 and taking note of Council resolution 1989/104 of 27 July 1989,

Taking note of the report of the Secretary-General on products harmful to

health and the environment6 and Economic and Social Council decision 1989/177
of 27 July 1989,

Taking note also of decisions 15/28 and 15/30 of 25 May 1989 of the Governing
Council of the United Nations Environment Programme, 7

Welcoming the report of the Secretary-General on illegal traffic in toxic and

dangerous products and wastes,8

Taking note of the conclusion of the Basel Convention on the Control of

Transboundary Movements of Hazardous Wastes and their Disposal, 9

Inviting all States to consider signing the Basel Convention without

prejudice to the final positions to be taken by regional intergovernmental
organizations in this regard,

6
A/44/276-E/1989/78.
7
See Official Records of the General Assembly, Forty-fourth Session, Supplement No. 25
(A/44/25), annex I.
8
A/44/362 and Corr.1.
9
See UNEP/IG.80/3.

____________________________________________________________________________________________________________
564
Mindful of the growing threat to the environment and to human health and
safety posed by the improper management and the increased generation,
complexity and transboundary movement of hazardous wastes,

Convinced that illegal traffic in toxic and dangerous products and wastes
poses a severe threat to the environment and to human health and safety,

Also convinced that these problems cannot be resolved without adequate co-
operation among members of the international community,

Deeply concerned by the fact that cases of illegal transboundary movement and
dumping of dangerous products and wastes particularly harmful for the
environment and human health continue to occur, affecting, in particular,
developing countries,

Convinced of the need to assist all countries, particularly developing

countries, in obtaining all appropriate information concerning toxic and
dangerous products and wastes and in reinforcing their capacity to detect and
halt any illegal attempt to introduce toxic and dangerous products and wastes
into the territory of any State in contravention of national legislation and
relevant international legal instruments, as well as traffic not carried out
in compliance with internationally accepted guidelines and principles in this
field,

TRAFFIC IN TOXIC AND DANGEROUS PRODUCTS AND WASTES

1. Requests each regional commission, within existing resources, to

contribute to the prevention of the illegal traffic in toxic and dangerous
products and wastes by monitoring and making regional assessments of this
illegal traffic and its environmental and health implications, on a
continuing basis, in each region, and, in this context, in co-operation with
and relying upon expert support and advice from the United Nations
Environment Programme and other relevant bodies of the United Nations,
including the International Register of Potentially Toxic Chemicals, and Ad
Hoc Working Group of Experts on Prior Informed Consent and Other Modalities
to Supplement the London Guidelines for the Exchange of Information on
Chemicals in International Trade, and the Interim Secretariat of the Basel
Convention on the Control of Transboundary Movements of Hazardous Wastes and
their Disposal, without prejudice to the final position to be taken by
regional intergovernmental organizations on the Convention, and to report to
the Economic and Social Council at its second regular session starting in
1990;

2. Also requests the regional commissions to interact among themselves and

co-operate with the United Nations Environment Programme, with a view to
maintaining efficient and co-ordinated monitoring and assessment of the
illegal traffic in toxic and dangerous products and wastes;

3. Requests the Economic and Social Council to submit recommendations to the

General Assembly on the findings and conclusions of the regional commissions,
in their consideration of environmental issues;

4. Calls upon all countries to co-operate with their respective regional

commissions with the aim of preventing the illegal traffic in toxic and
dangerous products and wastes;

____________________________________________________________________________________________________________
565
 II

PROTECTION AGAINST PRODUCTS HARMFUL TO HEALTH AND THE ENVIRONMENT

1. Expresses its appreciation to the Secretary-General for his report on

products harmful to health and the environment, which contains a review of
the Consolidated List of Products Whose Consumption and/or Sale Have Been
Banned, Withdrawn, Severely Restricted or Not Approved by Governments;

2. Notes with appreciation the co-operative relationship established between

the United Nations, the World Health Organization and the United Nations
Environment Programme International Register of Potentially Toxic Chemicals
for the preparation of the Consolidated List;

3. Notes, in this context, the need to utilize also the work being done by
the Working Group on Export of Domestically Prohibited Goods and Other
Hazardous Substances established by the General Agreement on Tariffs and
Trade and those activities which are currently under way within the framework
of the United Nations Environment Programme and the Food and Agriculture
Organization of the United Nations in connection with implementation of prior
informed consent schemes for chemicals and pesticides in international trade
and which implement the system of information exchange envisaged by the
developers of the Consolidated List, as well as the work being done under
international agreements and conventions in related areas;

4. Expresses its appreciation for the growing co-operation by Governments in

the preparation of the Consolidated List, and urges all Governments that have
not yet done so to provide the necessary information for inclusion in updated
versions of the Consolidated List;

5. Requests the Secretary-General to ensure, within existing resources,

publication of the Consolidated List in English, French and Spanish, in
accordance with demand, bearing in mind its resolution 39/229;

6. Also requests the Secretary-General to undertake a special effort to

ensure effective and wider dissemination of the Consolidated List in all
appropriate circles;

7. Further requests the Secretary-General, in this context, to consider ways

and means of ensuring more effective involvement of non-governmental
organizations in promoting the dissemination and utilization of the
Consolidated List;

8. Requests the Secretary-General, in the context of the preparation of his

next scheduled report on the question:

(a) To make specific suggestions on ways and means of providing technical

co-operation, including through appropriate United Nations organizations, to
countries, in particular developing countries, to create and strengthen their
capacity to utilize the Consolidated List;

(b) To study all the pending issues, such as sustainable alternatives to

banned and severely restricted products and unregistered pesticides, with a
focus on improving the usefulness of the Consolidated List;

____________________________________________________________________________________________________________
566
 III

CONTROL OF TRANSBOUNDARY MOVEMENTS OF HAZARDOUS WASTES AND THEIR DISPOSAL

1. Recognizes the necessity of developing rules of international law, as

early as practicable, on liability and compensation for damage resulting from
the transboundary movement and disposal of hazardous wastes;

2. Requests the Executive Director of the United Nations Environment

Programme, in accordance with the resolutions adopted at the Conference of
Plenipotentiaries on the Global Convention on the Control of Transboundary
Movements of Hazardous Wastes, held at Basel, Switzerland, from 20 to 22
March 1989, to establish, on the basis of equitable geographical
representation and in consultation with Governments, an ad hoc working group
of legal and technical experts to develop, as early as practicable, elements
that might be included in a protocol on liability and compensation for damage
resulting from the transboundary movement and disposal of hazardous wastes
and to report to the preparatory committee of the United Nations conference
on environment and development and to the Governing Council of the United
Nations Environment Programme, in accordance with its mandate in this regard;

3. Invites the Executive Director of the United Nations Environment Programme

and the Secretary-General of the International Maritime Organization, in
consultation, as appropriate, with other relevant international
organizations, to review the existing rules, regulations and practices with
respect to the disposal of hazardous wastes at sea, in order to harmonize the
provisions of the relevant conventions as adopted in this regard;

4. Requests the Secretary-General, in co-operation with the Executive

Director of the United Nations Environment Programme, to report to the
General Assembly at its forty-sixth session, through the Economic and Social
Council, on the progress achieved in the implementation of the provisions of
the Basel Convention on the Control of Transboundary Movements of Hazardous
Wastes and their Disposal and of the present resolution.

85th plenary meeting

22 December 1989

____________________________________________________________________________________________________________
567
 Economic and Social Council resolution 1998/41

Protection against products harmful to health and the environment

The Economic and Social Council,

Recalling General Assembly resolutions 37/137 of 17 December 1982, 38/149 of

19 December 1983, 39/229 of 18 December 1984 and 44/226 of 22 December 1989,
as well as Assembly decisions 47/439 of 22 December 1992 and 50/431 of 20
December 1995,

Taking note of the report of the Secretary-General on products harmful to

health and the environment, 10 which contains a review of the Consolidated List
of Products Whose Consumption and/or Sale have been Banned, Withdrawn,
Severely Restricted or not Approved by Governments,

Noting with satisfaction the continued close collaboration between the United
Nations, the Food and Agriculture Organization of the United Nations, the
World Health Organization and the United Nations Environment Programme in the
preparation of the Consolidated List,

Taking note of the successful conclusion of the negotiations to develop a

legally binding instrument for the application of the prior informed consent
procedure for certain hazardous chemicals and pesticides in international
trade (Rotterdam Convention),

1. Welcomes the report of the Secretary-General on products harmful to health

and the environment and notes the progress being achieved in increasing the
number of countries that participate in the preparation of the Consolidated
List of Products Whose Consumption and/or Sale have been Banned, Withdrawn,
Severely Restricted or not Approved by Governments;

2. Expresses its appreciation for the cooperation extended by Governments in

the preparation of the Consolidated List and urges all Governments, in
particular those that have not yet done so, to provide the necessary
information to relevant organizations for inclusion in future issues of the
Consolidated List;

3. Requests the Secretary-General to continue to prepare the Consolidated

List focusing on chemicals and pharmaceutical products in alternate years,
with the same frequency for each official language in publishing the
Consolidated List as was envisioned in General Assembly resolutions 39/229
and 44/226;

4. Also requests the Secretary-General to continue to provide the necessary

technical assistance to developing countries, at their request, for the
establishment and/or strengthening of national capacity for managing
hazardous chemicals and pharmaceutical products;

5. Urges the adoption of the agreed text of the Rotterdam Convention at the
diplomatic conference to be held in Rotterdam, the Netherlands, on 10 and 11
September 1998 and calls for a speedy ratification by the signatories of the
Convention, aimed at its early entry into force;

6. Emphasizes the need to continue to utilize the work being undertaken by

relevant organizations of the United Nations system and other

10
A/53/156-E/1998/78.

____________________________________________________________________________________________________________
568
intergovernmental organizations in this area, as well as that being carried
out under international agreements and conventions in related areas in
updating the Consolidated List;

7. Requests the Secretary-General to continue to report every three years, in

accordance with General Assembly resolution 39/229, on the implementation of
the present resolution and of previous Assembly resolutions on the same
subject.

46th plenary meeting

30 July 1998

Economic and Social Council resolution 2001/33

Protection against products harmful to health and the environment

The Economic and Social Council,

Recalling General Assembly resolutions 37/137 of 17 December 1982, 38/149 of

19 December 1983, 39/229 of 18 December 1984 and 44/226 of 22 December1989,
General Assembly decisions 47/439 of 22 December 1992 and 50/431 of
20December 1995, and Council resolution 1998/41 of 30 July 1998,

Having considered the report of the Secretary-General on products harmful to

health and the environment, 11 which contains a review of the Consolidated
List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn,
Severely Restricted or Not Approved by Governments, 12

Taking note of the fact that an increasing number of countries participate in

the preparation of the Consolidated List,

Noting with satisfaction the continued close collaboration between the United
Nations, the Food and Agriculture Organization of the United Nations, the
World Health Organization, the United Nations Environment Programme and the
World Trade Organization in the preparation and dissemination of the
Consolidated List,

1. Expresses its appreciation for the cooperation extended by Governments in

the preparation of the Consolidated List of Products Whose Consumption and/or
Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by
Governments, 13 and urges all Governments, in particular those that have not
yet done so, to provide the necessary information to relevant organizations
for inclusion
in future issues of the Consolidated List;

2. Requests the Secretary-General to prepare each of the two issuances of the

Consolidated List, pharmaceuticals and chemicals, in all official languages —
the English version in the already established format, and the versions in

11
A/56/115-E/2001/92.
12
For previous issues of the Consolidated List, see United Nations publications, Sales Nos.
E.84.IV.8, E.87.IV.a, E.91.IV.4, E.94.IV.3 and E.97.IV.2.
13
UNEP/FAO/PIC/CONF/5, annex III.

____________________________________________________________________________________________________________
569
the other languages as a text file. In this connection, the Consolidated List
should continue to include previously collected data, while at the same time
making distinct entries for
those products covered in the interim prior informed consent procedure, in
line with the Rotterdam Convention on the Prior Informed Consent Procedure
for Certain Hazardous Chemicals and Pesticides in International Trade, and
should consequently keep updating the information contained therein, in
accordance with relevant action being taken by the Convention;

3. Invites multilateral and bilateral agencies to continue to strengthen and

coordinate their activities for improving the capacity-building of developing
countries, particularly least developed countries, including innovative
methodologies for earmarking, assessing and monitoring technical assistance
in the area of the sound management of hazardous chemicals and dangerous
pharmaceutical products;

4. Emphasizes the need to continue to utilize the work being undertaken by

relevant organizations of the United Nations system and other
intergovernmental organizations in this area, as well as that being carried
out under international agreements and conventions in related areas in
updating the Consolidated List;

5. Requests the Secretary-General to continue to report every three years, in

accordance with General Assembly resolution 39/229, on the implementation of
the present resolution and of previous Assembly resolutions on the same
subject;

6. Requests the Secretary-General, within existing resources, to continue to

disseminate the list as widely as possible and to look at the possibility of
using online dissemination in collaboration with the World Trade
Organization, the Food and Agriculture Organization of the United Nations,
the World Health Organization and the United Nations Environment Programme.

43rd plenary meeting

26 July 2001

Economic and Social Council resolution 2004/55

Protection against products harmful to health and the environment

The Economic and Social Council,

Recalling General Assembly resolutions 37/137 of 17 December 1982, 38/149 of

19 December 1983, 39/229 of 18 December 1984 and 44/226 of 22 December 1989,
Assembly decisions 47/439 of 22 December 1992 and 50/431 of 20 December 1995,
and Economic and Social Council resolutions 1998/41 of 30 July 1998 and
2001/33 of 26 July 2001,

Having considered the report of the Secretary-General on products harmful to

health and the environment, 14 which contains a review15 of the Consolidated

14
A/59/81-E/2004/63.
15
Ibid., sect. II.

____________________________________________________________________________________________________________
570
List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn,
Severely Restricted or Not Approved by Governments,16

Taking note of the fact that an increasing number of countries participate in

the preparation of the Consolidated List,

Noting with satisfaction the continued close collaboration among the United
Nations, the Food and Agriculture Organization of the United Nations, the
World Health Organization and the United Nations Environment Programme in the
preparation and dissemination of the Consolidated List,

Taking note of commitments made and targets established regarding

environmentally sound management of chemicals in the Plan of Implementation
of the World Summit on Sustainable Development (“Johannesburg Plan of
Implementation”),17 adopted by the Summit on 4 September 2002,

Noting the coming into force, in early 2004, of the Rotterdam Convention on
the Prior Informed Consent Procedure for Certain Hazardous Chemicals and
Pesticides in International Trade 18 and the Stockholm Convention on Persistent
Organic Pollutants,19

1. Takes note of the report of the Secretary-General on products harmful to

health and the environment and notes the online availability20 of the
Consolidated List of Products Whose Consumption and/or Sale Have Been Banned,
Withdrawn, Severely Restricted or Not Approved by Governments;

2. Expresses its appreciation for the cooperation extended by Governments in

the preparation of the Consolidated List, and urges all Governments, in
particular those that have not yet done so, to provide the necessary
information to relevant organizations for inclusion in future issues of the
Consolidated List;

3. Requests the Secretary-General to continue to update the electronic

version of the Consolidated List, alternating between chemicals and
pharmaceuticals every year, while printing only new data to complement
previously printed issues for the benefit of those, particularly in
developing countries, who may not have easy access to the electronic version;

4. Urges all Governments to participate fully in the process of developing a

strategic approach to international chemicals management by 2005, in order to
achieve the 2020 target of the World Summit on Sustainable Development, as
set out in paragraph 23 of the Plan of Implementation of the World Summit on
Sustainable Development (“Johannesburg Plan of Implementation”), pursuant to
which chemicals would be used and produced in ways that lead to the
minimization of significant adverse effects on human health and the
environment, using transparent science-based risk assessment procedures and
science-based risk management procedures, taking into account the
precautionary approach, as set out in principle 15 of the Rio Declaration on

16
United Nations publications, Sales Nos. E.03.IV.9 and E.04.IV.2. For previous issues of the
Consolidated List, see United Nations publications, Sales Nos. E.84.IV.8, E.87.IV.1, E.91.IV.4,
E.94.IV.3, E.97.IV.2, E.02.IV.3 and E.03.IV.3.
17
Report of the World Summit on Sustainable Development, Johannesburg, South Africa, 26 August -
4 September 2002 (United Nations publication, Sales No. E.03.II.A.1 and corrigendum), chap. I,
resolution 1, annex. 5 Text available from http://www.pic.int/en/ViewPage.asp?id=104 (accessed 22
July 2004).
18
Text available from http://www.pic.int/en/ViewPage.asp?id=104 (accessed 22 July 2004).
19
Text available from http://www.pops.int/. (accessed 22 July 2004).
20
Available from www.un.org/esa/coordination/ecosoc/Path:Publications (accessed 22 July 2004).

____________________________________________________________________________________________________________
571
Environment and Development,21 and support developing countries in
strengthening their capacity for the sound management of chemicals and
hazardous wastes by providing technical and financial assistance, and calls
for a more coordinated use of existing international instruments in this
field, taking into account the work undertaken by the United Nations system
in this regard;

5. Encourages countries to implement the new Globally Harmonized System of

Classification and Labeling of Chemicals 22 as agreed in paragraph 23 (c) of
the Johannesburg Plan of Implementation as soon as possible, with a view to
having the system fully operational by 2008;

6. Urges all Governments that have not yet done so to consider ratifying the
Rotterdam Convention on the Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in International Trade and the Stockholm
Convention on Persistent Organic Pollutants and to fully implement them;

7. Invites multilateral and bilateral agencies to continue to strengthen and

coordinate their activities for improving the capacity-building of developing
countries, particularly least developed countries, as well as countries with
economies in transition, inter alia, through technical assistance in the area
of the sound management of hazardous chemicals and dangerous pharmaceutical
products;

8. Emphasizes the need to continue to utilize the work being undertaken by

relevant organizations of the United Nations system and other
intergovernmental organizations in this area, as well as that being carried
out under international agreements and conventions in related areas, in
updating the Consolidated List;

9. Requests the Secretary-General to continue to report every three years, in

accordance with General Assembly resolution 39/229 of 18 December 1984, on
the implementation of the present resolution, taking into account previous
Assembly resolutions on the same subject, as appropriate.

50th plenary meeting

23 July 2004

21
Report of the United Nations Conference on Environment and Development, Rio de Janeiro, 3-14
June 1992, vol. I, Resolutions Adopted by the Conference (United Nations publication, Sales No.
E.93.I.8 and corrigendum), resolution 1, annex I.
22
United Nations publication, Sales No. E.03.II.E.25.

____________________________________________________________________________________________________________
572
 Annex II
Criteria for the inclusion of pharmaceutical and chemical
products in the Consolidated List

A. Pharmaceutical productsa

a) "Banned product"
A product that has been withdrawn from use and/or sale nationally in one or more
countries by order of the competent national authority, having regard to its safety in
relation to its intended use.

b) "Voluntary product"
A product that has been withdrawn from use and/or sale nationally in one or more
countries by voluntary action of the manufacturer, having regard to its safety in relation to
its intended use.

c) "Severely restricted"
A product containing:
(a) A substance that is controlled more rigorously than is provided for under
the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic
Substances or that is subjected to analagous control at the national level before it has been
considered for international scheduling,

(b) A substance that may be incorporated in pharmaceutical dosage forms only

within the specific limits determined by statute;

(c) A substance that is approved by a competent national authority and is

subsequently subjected to restrictions that exclude its use in a substantial proportion of
the potential target population of patients having regard to its safety. A substance which
from the outset has been severely restricted in its indications having regard to the known
balance of safety and efficacy is excluded.

d) "Non-approved"
A product that has been formally submitted for registration by a manufacturer to a
national competent authority and which has been rejected on grounds of safety.

B. Chemical products
a) "Banned"
A product that has been prohibited for all uses nationally in one or more
countries by final government regulatory action because of health or
environmental reasons.

b) "Withdrawn"
A product formerly in commerce that has been withdrawn for all uses
nationally in one or more countries by final voluntary action of the
manufacturer because of health or environmental reasons.

c) "Severely restricted"
A product for which virtually all uses have been prohibited nationally in
one or more countries by final government regulatory action because of health
or environmental reasons, but for which certain specific uses remain
authorized.

a
Products, which are in illicit trade only, would not be considered.

_________________________________________________________________________________________
573
 Annex III

List of references cited in the regulatory text

AARNO MINISTRY OF HEALTH

LAGOS, NIGERIA

ARGANM ADMINISTRACIÓN NACIONAL DE MEDICAMENTOS Y TECNOLOGIA MEDICA

MINISTERIO DE SALUD
BUENOS AIRES, ARGENTINA

ARGBO ADMINISTRACIÓN NACIONAL DE MEDICAMENTOS Y TECNOLOGIA MEDICA

TECNOLOGIA MEDICA, MINISTERIO DE SALUD
BUENOS AIRES, ARGENTINA

ARGFDM FOOD, DRUG AND MEDICAL DEVICES AGENCY (ANMAT)

MINISTRY OF HEALTH
BUENOS AIRES, ARGENTINA
www.anmat.gov.ar

ARMCW ARMENIAM DRUG AND MEDICAL TECHNOLOGY AGENCY

MINISTRY OF HEALTH
YEREVAN, ARMENIA

ASTRA ASTRA-ZENECA
15 STANHOPE GATE
LONDON W1K 1LN
UNITED KINGDOM

AUDEC REPORT OF THE AUSTRALIAN DRUG EVALUATION COMMITTEE

COMMONWEALTH DEPARTMENT OF HEALTH
WODEN, P. O. BOX 200, ACT, 2606
AUSTRALIA

AUSADR ADVERSE DRUG REACTIONS UNIT

THERAPEUTIC GOODS ADMINISTRATION,
DEPARTMENT OF COMMUNITY SERVICES AND HEALTH
WODEN, AUSTRALIA

AUSMDR THERAPEUTIC GOODS ADMINISTRATION,

DEPARTMENT OF COMMUNITY SERVICES AND HEALTH
WODEN, AUSTRALIA
www.health.gov.au

AUSPRE AUSTRALIAN PRESCRIBER

DEAKIN ACT 2600
AUSTRALIA
www.australianprescriber.com

AUSTGA THERAPEUTIC GOODS ADMINISTRATION,

DEPARTMENT OF COMMUNITY SERVICES AND HEALTH
WODEN, AUSTRALIA

AUTMH MINISTRY OF HEALTH

574
 List of references cited in the regulatory text
VIENNA, AUSTRIA

AUTGB BUNDESGESETZBLATT FUR DIE REPUBLIK OESTERREICH

DIRECTORATE GENERAL OF PUBLIC HEALTH
FEDERAL CHANCERY DEPT VI (PUBLIC HEALTH)
2, RADETZKYSTRASSE
VIENNA, 1031
AUSTRIA

BDSMHS MEDICAL AND HEALTH SERVICES HEADQUARTERS

MINISTRY OF HEALTH
BRUNEI DARUSSALAM

BDSOL MINISTRY OF HEALTH

BRUNEI DARUSSALAM

BELAP ANNALES PHARMACEUTIQUES BELGES

BRUXELLES, BELGIQUE

BELAR ARRETE ROYAL

INSPECTION GENERALE DE LA PHARMACIE,
MINISTERE DE LA SANTE ET DE LA FAMILLE
CITE ADMINISTRATIVE DE L'ETAT
QUARTIER VERSALE
1010 BRUXELLES, BELGIUM

BELARD BELGIAN CENTRE FOR MONITORING OF ADVERSE REACTION TO DRUGS

BRUSSELS, BELGIUM

BELGPI GENERAL PHARMACEUTICAL INSPECTOR ATE

MINISTRY OF PUBLIC HEALTH AND ENVIRONMENT
BRUSSELS, BELGIUM

BELMD MINISTERIAL DECREE

MINISTERE DE LA SANTE PUBLIQUE ET DE L'ENVIRONNEMENT
BRUSSELS, BELGIUM

BFOLP "FOLIA PHARMACOTHERAPEUTICA"

CENTRE BELGE D'INFORMATION PHARMACOTHERAPEUTIQUE
MINISTERE DE LA SANTE PUBLIQUE ET DE LA FAMILLE
ADMINISTRATION DE L'HYGIENE
1010 BRUXELLES, BELGIUM

BGDCO "THE DRUGS (CONTROL) ORDINANCE 1982, ORDINANCE NO. VIII"

OFFICE OF THE DIRECTOR
HEALTH MANPOWER DEVELOPMENT
105/106 MOTIJHEEL COMMERCIAL AREA
DACCA 2, BANGLADESH

BGDDDA DIRECTORATE OF DRUG ADMINISTRATION

MINISTRY OF HEALTH AND FAMILY WELFARE
DACCA, BANGLADESH

575
 List of references cited in the regulatory text
BGHBL BUNDESGESUNDHEITSBLATT
BONN, GERMANY

BGNDI MINISTRY OF HEALTH

DACCA, BANGLADESH

BGRBDA BULGARIAN DRUG AGENCY

MINISTRY OF HEALTH
SOFIA, BULGARIA

BHRCW PHARMACY AND DRUG CONTROL DEPARTMENT

MINISTRY OF HEALTH
P. O. BOX 12
BAHRAIN

BIFTI BOLLETINO D'INFORMAZIONE SUI FARMACI

GENERAL DIRECTOR
PHARMACEUTICAL DIVISION
VIALE DELLA CIVILTA ROMANA 7
00144 ROMA, ITALY

BMCHL DEPARTAMENTO CONTROL NACIONAL

INSTITUTO SALUD PUBLICA DE CHILE
MINISTERIO DE SALUD
MARATHON 100, SANTIAGO
CHILE

BMJOAE BRITISH MEDICAL JOURNAL

BRITISH MEDICAL ASSOCIATION
TAVISTOCK SQUARE
LONDON WCIH 9JR, ENGLAND

BNIPH BULLETIN OF THE NATIONAL INSTITUTE OF PHARMACY 1984

NATIONAL INSTITUTE OF PHARMACY
ZRINYI U.3
H-1051, BUDAPEST, HUNGARY

BRACVS CENTRO DE VIGILANCIA SANITARIA

MINISTRY OF HEALTH
RIO DE JANEIRO, 21 040
BRAZIL

BRADMS DIARIO OFICIAL MINISTERIO DA SAUDE

RIO DE JANEIRO 21 040
BRAZIL

BRAPT PORTARIA DO SERVICO PUBLICO FEDERAL

MINISTRY OF HEALTH
RIO DE JANEIRO, 21 040
BRAZIL

BRARES NATIONAL HEALTH SURVEILLANCE AGENCY

MINISTRY OF HEALTH
BRASILIA, BRAZIL

576
 List of references cited in the regulatory text
BRASVS MINISTERIO DA SAUDE
RIO DE JANEIRO 21 040
BRAZIL

CANBMS BRISTOL-MYERS SQUIBB

CANADA
www.hc-sc.gc.ca

CANDHP BAYER PHARMACEUTICAL DIVISION

www.hc-sc.gc.ca/

CANGZ CANADA GAZETTE

CANADIAN GOVERNMENT PUBLISHING CENTER
OTTAWA, ONTARIO K1A OS9
CANADA

CANHW CANADA HEALTH AND WELFARE

OTTAWA, ONTARIO
CANADA

CANPR HEALTH CANADA

OTTAWA, ONTARIO K1A 0K9
CANADA

CANWHC HEALTH CANADA

OTTAWA, ONTARIO K1A 0K9
CANADA
www.hc-sc.gc.ca

CECC COMMISSION OF THE EUROPEAN COMMUNITIES

200, RUE DE LA LOI
BE - 1049 BRUXELLES, BELGIUM

CFRUS CODE OF FEDERAL REGULATIONS

OFFICE OF THE FEDERAL REGISTER
NATIONAL ARCHIVES AND RECORDS SERVICE
US GOVERNMENT PRINTING OFFICE
GENERAL SERVICES ADMINISTRATION
WASHINGTON, DC 20402, USA

CGPR PRESS RELEASE FROM CIBA-GEIGY

CHBCM BULLETIN MENSUEL

ORGANISATION INTERCANTONALE DE CONTROLE DES MEDICAMENTS
BERNE, SWITZERLAND

CHEAZ SCHWEIZER APOTHEKER ZEITUNG

SWITZWERLAND

CHEOCM INTERCANTONAL OFFICE FOR THE CONTROLOF MEDICINES

BERNE, SWITZERLAND

577
 List of references cited in the regulatory text
CHEPR SWISS AGENCY FOR THERAPEUTIC PRODUCTS
FEDERAL DEPARTMENT OF HOME AFFAIRS
BERNE, SWITZERLAND
www.swissmedic.ch

CHLCW PUBLIC HEALTH INSTITUTE OF CHILE

MINISTRY OF HEALTH
SANTIAGO, CHILE

CHLMS MINISTERIO DE SALUD

SANTIAGO, CHILE

CHLRS INSTITUTE OF PUBLIC HEALTH

AVDA MARATHON 1000
SANTIAGO, CASILLA 48
CHILE

COECI COUNCIL OF EUROPE

STRASBOURG
FRANCE

COLVMA INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOS Y ALIMENTOS

MINISTERIO DE SALUD
BOGOTA, COLOMBIA

CPMPAR COMMITTEE ON PROPRIETARY MEDICINAL PRODUCTS

EUROPEAN COMMISSION
BRUSSELS

CPMPDP COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS

COMMISSION OF THE EUROPEAN COMMUNITIES
LUXEMBOURG

CPMPPO COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS

COMMISSION OF THE EUROPEAN COMMUNITIES
LUXEMBOURG

CPMPPP COMMITTEE ON PROPRIETARY MEDICINAL PRODUCTS

EUROPEAN COMMISSION
BRUSSELS

CPMPPS COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS

COMMISSION OF THE EUROPEAN COMMUNITIES
LUXEMBOURG

CRDDL COMMUNICATION FROM ROUSSEL ENCLOSING “DEAR DOCTOR LETTER”

UNITED KINGDOM

CRU COMMUNICATION TO WHO

ROUSEL UCLOF
PARIS, FRANCE

CUBCDQ CENTRE FOR STATE CONTROL OF DRUG QUALITY (CECMED)

578
 List of references cited in the regulatory text
MINISTRY OF HEALTH
HAVANA, CUBA

CYPPS MINISTRY OF HEALTH

NICOSIA, CYPRUS

DAZ DEUTSCHE APOTHEKER ZEITUNG

GERMANY

DCCKB DRUG COMPANY COMMUNICATION

KABI PHARMACIA

DCCSKB DRUG COMPANY COMMUNICATION

SMITH KLINE BEECHAM
BRENTFORD, UNITED KINGDOM

DCCUJC NEWS RELEASE

THE UPJOHN COMPANY
KALAMAZO, MI 49001
UNITED STATES

DENBH DANISH NATIONAL BOARD OF HEALTH

COPENHAGEN, DENMARK

DEUAB DEUTSCHES AERTZTEBLATT

GERMANY

DEUCDC DRUG COMMISSION OF THE GERMAN MEDICAL PROFESSION

BERLIN, GERMANY

DEUCFI FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES

BERLIN, GERMANY

DEUCW FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES

BERLIN, GERMANY

DEUFHO FEDERAL HEALTH OFFICE

BERLIN, GERMANY

DEUNFI FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES

BERLIN, GERMANY

DEUPD BGA PRESSEDIENST

BUNDESGESUNDHEITSAMT (FEDERAL HEALTH OFFICE)
BERLIN (WEST) 65, POSTFACH 33 00 13, D-1000
GERMANY

DEUPM BERLIN, GERMANY

DEUPZ PHARMAZEUTISCHE ZEITUNG

BERLIN, GERMANY

579
 List of references cited in the regulatory text
DEURFI FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES
BERLIN, GERMANY

DWM DEUTSCHES WICHTIGE MITTEILUNGEN

BERLIN, GERMANY

EGYDC EGYPTION TECHNICAL COMMITTEE FOR DRUG CONTROL

MINISTRY OF HEALTH
CAIRO, EGYPT

EGYDI EGYPTION PHARMACOPOEIAL INFORMATION CENTRE

MINISTRY OF HEALTH
CAIRO, EGYPT

EMEAPR EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINES

LONDON, UNITED KINGDOM

EMEAPS EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINES

LONDON, UNITED KINGDOM
www.emea.eu.int

ESPAES AGENCIA ESPAÑOLA DE MEDICAMENTO

MINISTERIO DE SANIDAD Y CONSUMO
MADRID, SPAIN

ESPCDR EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS

LONDON, UNITED KINGDOM
www.msc.es/agemed

ESPCR MINISTRY OF HEALTH AND CONSUMER PRODUCTS

MADRID, SPAIN

ESPINS INFORMACION TERAPEUTICA DE LA SEGURIDAD SOCIAL

INSTITUTO NACIONAL DE LA SALUD
MADRID
SPAIN

ESPITS INFORMACION DE LA TERAPEUTICA DEL SISTEMA NACIONAL DE SALUD

MADRID
SPAIN

ESPMAD SPANISH MEDICINES AGENCY

MINISTRY OF HEALTH
MADRID, SPAIN

ESPMC PROGRAMA SELECTIVO DE REVISION DE MEDICAMENTOS

MINISTERIO DE SANIDAD Y CONSUMO
MADRID
SPAIN

ESPOR MINISTERIO DE SANIDAD Y CONSUMO

DIRECCION GENERAL DE INSPECCION DEL CONSUMO
MADRID, SPAIN

580
 List of references cited in the regulatory text

ESPSMA SPANISH AGENCY FOR MEDICINES AND MEDICAL DEVICES

MINISTRY OF HEALTH AND CONSUMER PRODUCTS
MADRID, SPAIN
www.agemed.es

ESPSPS SPANISH PHARMACOVIGILANCE SYSTEM

MINISTRY OF HEALTH AND CONSUMER PRODUCTS
MADRID, SPAIN

FDADB US DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL CENTRE FOR DRUGS & BIOLOGICS
FOOD AND DRUG ADMINISTRATION
5600 FISHERS LANE
ROCKVILLE, MD, 20857, USA

FDAMB FOOD AND DRUG ADMINISTRATION

WASHINGTON D.C.
USA

FDATP FOOD AND DRUG ADMINISTRATION

WASHINGTON, D.C.
USA
www.fda.gov

FDATPW FOOD AND DRUG ADMINISTRATION

WASHINGTON, D.C.
USA

FDAWWW FOOD AND DRUG ADMINISTRATION

WASHINGTON, D.C.
USA

FEREAC US GOVERNMENT PRINTING OFFICE

SUPERINTENDENT OF DOCUMENTS
WASHINGTON, D.C. 20402
USA

FINAWH NATIONAL AGENCY FOR WELFARE AND HEALTH

HELSINKI, FINLAND

FINNAM NATIONAL AGENCY FOR MEDICINES

HELSINKI, FINLAND

FMOPL LE MONITEUR DES PHARMACIES ET DES LABORATOIRES

15 RUE GODEFROY-CAVAIGNAC
75011 PARIS, FRANCE

FRAAM JOURNAL OFFICIEL DE LA REPUBLIQUE FRANCAISE

PARIS, FRANCE

FRAAMA AGENCE DU MÉDICAMENT

SAINT-DENIS, FRANCE

FRAAMC AGENCE DU MÉDICAMENT

581
 List of references cited in the regulatory text
SAINT-DENIS, FRANCE

FRAAMI AGENCE DU MÉDICAMENT

SAINT-DENIS, FRANCE

FRAAMN AGENCE DU MÉDICAMENT

SAINT-DENIS, FRANCE

FRAAMP AGENCE DU MÉDICAMENT

SAINT-DENIS, FRANCE
www.agmed.sante.gouv.fr

FRAAMR AGENCE DU MÉDICAMENT

SAINT-DENIS, FRANCE

FRAARN PARIS, FRANCE

FRACCE COMMISSION DES COMMUNAUTÉS EUROPÉENNES

LUXEMBOURG

FRACW AGENCE DU MÉDICAMENT

SAINT-DENIS, FRANCE

FRADRA PARIS, FRANCE.

FRAMH MINISTRY OF SOLIDARITY, HEALTH AND SOCIAL PROTECTION

PARIS, FRANCE

FRAMHH MINISTRY OF HEALTH AND HUMANITARIAN ACTION

PARIS, FRANCE

FRAMHS MINISTRY OF HEALTH AND SOCIAL AFFAIRS

PARIS, FRANCE

FRAMS MINISTRY OF SOCIAL AFFAIRS AND INTEGRATION

PARIS, FRANCE

FRAMSS MINISTRY OF SOCIAL AFFAIRS AND SOLIDARITY

PARIS, FRANCE

FRAPC MINISTRY OF HEALTH AND FAMILY AFFAIRS

1, PLACE DE FONTENOY
PARIS 75700
FRANCE

FRARP LA REVUE PRESCRIRE

PARIS
FRANCE

FRGGH BUNDESGESUNDHEITSAMT
BERLIN (WEST)
GERMANY

582
 List of references cited in the regulatory text
GAZIE CONTROLLER OF PUBLICATIONS
MINISTRY OF HEALTH AND FAMILY WELFARE
NEW DELHI, 110054 INDIA

GBCHL MEDICINES DIVISION

DEPARTMENT OF HEATH AND SOCIAL SECURITY,
MARKET TOWERS
1 NINE ELMS LANE
LONDON SW8 5NQ
UNITED KINGDOM

GBMIL DEPARTMENT OF HEALTH AND SOCIAL SECURITY

MARKET TOWERS, 1 NINE ELMS LANE
LONDON SW8 5NQ
UNITED KINGDOM

GBPHA MEDICINES DIVISION

DEPARTMENT OF HEALTH AND SOCIAL SECURITY,
MARKET TOWERS
1 NINE ELMS LANE
LONDON SW8 5NQ
UNITED KINGDOM

GBRCPP COMMITTEE ON SAFETY OF MEDICINES

MEDICINES CONTROL AGENCY
DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM

GBRCSM COMMITTEE ON SAFETY OF MEDICINES

MEDICINES CONTROL AGENCY
DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM

GBRCW COMMITTEE ON SAFETY OF MEDICINES

MEDICINES CONTROL AGENCY
DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www. mhra.gov.uk

GBRDPR LONDON, UNITED KINGDOM

GBRDSI COMMITTEE ON SAFETY OF MEDICINES

MEDICINES CONTROL AGENCY
DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www.mca.gov.uk

GBRISM MEDICINES CONTROL AGENCY

DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www.open.gov.uk

GBRKPR MEDICINES CONTROL AGENCY

583
 List of references cited in the regulatory text
DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM

GBRLFC COMMITTEE ON SAFETY OF MEDICINES,

LONDON, UNITED KINGDOM
www.mhra.gov.uk

GBRMCA MEDICINES CONTROL AGENCY

DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM

GBRMI UK MEDICINES INFORMATION (UKMi)

NATIONAL HEALTH SERVICES (NHS)
LONDON, UNITED KINGDOM
www.medicines.mhra.gov.uk

GBRMRS MEDICINES CONTROL AGENCY

DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www.mca.gov.uk

GBRNBA NATIONAL BLOOD AUTHORITY

LONDON, UNITED KINGDOM

GBRNUP MEDICINES CONTROL AGENCY

DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www.mca.gov.uk/whatsnew

GBRPHJ THE PHARMACEUTICAL JOURNAL

UNITED KINGDOM

GBRPR HOME OFFICE

LONDON, UNITED KINGDOM

GBRSIN MEDICINES CONTROL AGENCY

DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM

GBRSKB SMITHKLINE BEECHAM

BRENTFORD, UNITED KINGDOM

GBRSMU COMMITTEE ON SAFETY OF MEDICINES

MEDICINES CONTROL AGENCY
DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www.mca.gov.uk

GBRSTE MEDICINES CONTROL AGENCY

DEPARTMENT OF HEALTH
LONDON, SW1A 2NL, UNITED KINGDOM
www.mca.gov.uk

584
 List of references cited in the regulatory text

GENMB "GENEESMIDDELENBULLETIN"
(DRUG INFORMATION BULLETIN)
MINISTRY OF WELFARE, HEALTH & CULTURE
POSTBUS 439
2260 AK LEIDSCHENDAM, NETHERLANDS

GHAPDR PHARMACY AND DRUGS (BANNED DRUGS) REGULATIONS,

LEGISLATIVE INSTRUMENTS
ACCRA, GHANA

GLAXO GLAXO RESEARCH AND DEVELOPMENT LTD

GREENFORD, MIDDLESEX
UNITED KINGDOM

GRAGA MINISTRY OF HEALTH

ATHENS, GREECE

GRANDO NATIONAL DRUG ORGANIZATION

ATHENS, GREECE

HHSNS DEPT. OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MARYLAND 20857
USA

HINDU THE HINDU

INDIA

HNDSP SECRETARIA DE ESTADO EN LOS DESPACHOS DE SALUD PUBLICA

DIRECCION GENERAL DE SALUD
TEGUCIGALPA, HONDURAS

HUNIH NATIONAL INSTITUTE OF OCCUPATIONAL HEALTH

BUDAPEST, HUNGARY

HUNIP NATIONAL INSTITUTE OF PHARMACY

BUDAPEST, HUNGARY

IARCCD INTERNATIONAL AGENCY FOR RESEARCH ON CANCER

150, COURS ALBERT THOMAS
F-69372 LYON CEDEX 08
FRANCE

IDMH MINISTRY OF HEALTH

JAKARTA, INDONESIA

IDMHD MINISTERIAL DECREE

MINISTRY OF HEALTH
JAKARTA, INDONESIA

IDNCW NATIONAL AGENCY FOR DRUG AND FOOD CONTROL (NADFC)

MINISTRY OF HEALTH
JAKARTA, INDONESIA

585
 List of references cited in the regulatory text

INDC DIRECTOR GENERAL OF HEALTH SERVICES

MINISTRY OF HEALTH AND FAMILY WELFARE
NEW DELHI 100 011, INDIA

INDDHS DIRECTORATE OF HEALTH SERVICES

MINISTRY OF HEALTH AND FAMILY WELFARE
NEW DELHI 100 011, INDIA

INDEPH THE EASTERN PHARMACIST

INDIA

IRDAB NATIONAL DRUGS ADVISORY BOARD

63-64 ADELAIDE ROAD
DUBLIN 2, IRELAND

IRDAP ANIMAL PHARM

DUBLIN, IRELAND

IRDDS THE IRISH MEDICINES BOARD

DUBLIN, IRELAND

IRLCN THE IRISH MEDICINES BOARD

DUBLIN, IRELAND
www.imb.ie

IRLPSI PHARMACEUTICAL SOCIETY OF IRELAND

DUBLIN, IRELAND
www.pharmaceuticalsociety.ie

IRQMH STATE COOPERATION FOR DRUGS AND MEDICAL EQUIPMENT

MINISTRY OF HEALTH
BAGHDAD, IRAQ

ISLCP COMMITTEE ON PHARMACEUTICALS

REYKJAVIK
ICELAND

ISLSCP STATE COMMITTEE ON PHARMACEUTICALS

REYKJAVIK, ICELAND

ISRDB MINISTRY OF HEALTH

JERUSALEM
ISRAEL

ISRMDR MINISTRY OF HEALTH

JERUSALEM, ISRAEL
www.ogs.com

ITADMS DECREE OF THE MINISTERO DELLA SANITA

ROME, ITALY

ITAMD MINISTRY OF HEALTH

586
 List of references cited in the regulatory text
VIALE DELLA CIVILTA ROMANA, 7
ROME, I - 00144
ITALY

JAMMHS MINISTRY OF HEALTH

STANDARDS AND REGULATION
KINGSTON, JAMAICA

JORF JOURNAL OFFICIEL DE LA REPUBLIQUE FRANCAISE

PARIS, FRANCE

JORMH MINISTRY OF HEALTH

P.O. BOX 86
AMMAN, JORDAN

JORPCC PHARMACOVIGILANCE CENTRE

FOOD AND DRUG ADMINISTRATION
MINISTRY OF HEALTH
AMMAN, JORDAN

JPNARD PHARMACEUTICAL AFFAIRS BUREAU

MINISTRY OF HEALTH AND WELFARE
TOKYO, JAPAN

JPNMHC MINISTRY OF HEALTH AND WELFARE

TOKYO, JAPAN

JPNPAC MINISTRY OF HEALTH AND WELFARE

TOKYO, JAPAN

JPNPH PHARMA JAPAN

TOKYO, JAPAN

JPNPMB PHARMACEUTICAL AND MEDICAL SAFETY BUREAU

MINISTRY OF HEALTH AND WELFARE
TOKYO, JAPAN

JPNSWP SCRIP WORLD PHARMACEUTICAL NEWS

LONDON, UNITED KINGDOM
www.pjbpubs.com/scrip

KRMHSA MINISTRY OF HEALTH AND SOCIAL AFFAIRS

SEOUL, REPUBLIC OF KOREA

KTMD MINISTRY OF HEALTH

P. O. BOX 5
SAFAT, KUWAIT

LANCET THE LANCET

32 JAMESTOWN ROAD
LONDON, NW1 7BY
UNITED KINGDOM

LBNMHD MINISTRY OF HEALTH AND SOCIAL AFFAIRS

BEIRUT, LEBANON

587
 List of references cited in the regulatory text

LIYRL GENERAL PEOPLE'S HEALTH COMMITTEE

TRIPOLI, LIBYA

LJJ JOHNSON & JOHNSON

NEW BRUNSWICK, NJ 08902
UNITED STATES

LKADES MINISTRY OF HEALTH

COLOMBO, SRI LANKA

LKADIB UNIVERSITY OF PERADENIYA

MINISTRY OF HEALTH
COLOMBO, SRI LANKA

LKAGAZ THE GAZETTE OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA

(EXTRAORDINARY)
COLOMBO, SRI LANKA

LTHCW DECISION OF MEDICINE REGISTRATION CENTRE

MINISTRY OF HEALTH
VILNIUS 2600, LITHUANIA

LTHMCA STATE MEDICINES CONTROL AGENCY

GEDIMINO AVE. 27
VILNIUS 2600, LITHUANIA

LTHPHB STATE MEDICINES CONTROL AGENCY

GEDIMINO AVE. 27
VILNIUS 2600, LITHUANIA

MARDMP DIRECTORATE OF MEDICINES AND PHARMACY

MINISTRY OF HEALTH
RABAT, MOROCCO

MEXMH MINISTRY OF HEALTH

MEXICO CITY, MEXICO

MPPHD PHARMACY & POISONS (PROHIBITIONS OF HARMFUL DRUGS) REGULATIONS

MINISTRY OF HEALTH
PORT LOUIS, MAURITIUS

MUSCW MINISTRY OF HEALTH

PORT LOUIS, MAURITIUS

MUSMHQ MINISTRY OF HEALTH AND QUALITY OF LIFE

PORT LOUIS, MAURITIUS

MYSCW DRUG CONTROL AUTHORITY

MINISTRY OF HEALTH
KUALA LUMPUR, MAYLAYSIA

588
 List of references cited in the regulatory text
MYSDC MALAYSIAN DRUG CONTROL AUTHORITY
MINISTRY OF HEALTH
KUALA LUMPUR 5300
MALAYSIA

MYSDI DRUG CONTROL AUTHORITY

MINISTRY OF HEALTH
KUALA LUMPUR, MAYLAYSIA

MYSDN BERITA UBAT-UBATAN (DRUG NEWSLETTER)

DRUG CONTROL AUTHORITY
PETALING JAYA
MALAYSIA

MYSNL DRUG CONTROL AUTHORITY

MINISTRY OF HEALTH
KUALA LUMPUR, MAYLAYSIA

MYSPR MINISTRY OF HEALTH

PAHANG ROAD
KUALA LUMPUR 5300
MALAYSIA

NEJOM NEW ENGLAND JOURNAL OF MEDICINE

WALTHAM, MA 02451-1411
UNITED STATES

NETJAN NEDERLANDS TIJDSCHRIFT VOOR GENEESKUNDE

POSTBUS 13079
3507 LB UTRECHT, NETHERLANDS

NGAPN PHARMANEWS
LAGOS, NIGERIA

NLDMEB MEDICINES EVALUATION BOARD

MINISTRY OF HEALTH
AMSTERDAM, NETHERLANDS
www.cbg-meb.nl/uk/nieuws

NNSLM "NYTT FRA STATENS LEGEMIDDELKONTROLL"

(NEWS FROM THE NATIONAL CENTRE FOR
MEDICINAL PRODUCTS CONTROL")
STATENS LEGEMIDDELKONTROLL
SVEN OFTEDALS VEI 6
OSLO 9, NORWAY

NORMCA NORWEGIAN MEDICINES CONTROL AUTHORITY

OSLO, NORWAY

NORNL OSLO, NORWAY

NPHWB PHARMACEUTISCH WEEKBLAD

DE ERVEN BOHN B.V.
AMSTERDAM, POSTBUS 10697
NETHERLANDS

589
 List of references cited in the regulatory text

NPLDDA DEPARTMENT OF DRUG ADMINISTRATION

KATHMANDU, NEPAL

NPLGZ KATHMANDU, NEPAL

NZCSL "CLINICAL SERVICES LETTER"

DEPARTMENT OF HEALTH
P.O. BOX 5013
WELLINGTON, NEW ZEALAND

NZLPU MINISTRY OF HEALTH

WELLINGTON, NEW ZEALAND

NZLTN MINISTRY OF HEALTH

WELLINGTON, NEW ZEALAND

OMNCR MINISTRY OF HEALTH

MUSCAT, OMAN

OMNDGP DIRECTORATE GENERAL OF PHAMACEUTICAL AFFAIRS

MINISTRY OF HEALTH
MUSCAT, OMAN

OMNDI DRUG INFORMATION

MINISTRY OF HEALTH
MUSCAT, OMAN

OMNMH OMAN MINISTRY OF HEALTH

P.O. BOX 393
MUSCAT, SULTANATE OF OMAN

OMNPN MINISTRY OF HEALTH

MUSCAT, OMAN

PAKDI MINISTRY OF HEALTH

ISLAMABAD, PAKISTAN

PAKMH MINISTRY OF HEALTH, SPECIAL EDUCATION AND SOCIAL WELFARE

ISLAMABAD, PAKISTAN

PANMR MINISTRY OF HEALTH

PANAMA

PERDGM DIRECCIÒN GENERAL DE MEDICAMENTOS, INSUMOS Y DROGAS

MINISTRY OF HEALTH
LIMA, PERU

PERMH MINISTRY OF HEALTH

LIMA, PERU

PHADO FOOD AND DRUG ADMINISTRATION

MINISTRY OF HEALTH
MANILA, PHILIPPINES

590
 List of references cited in the regulatory text

PHLCTW DEPARTMENT OF HEALTH AND BUREAU OF FOOD AND DRUGS

MANILA, PHILIPPINES

PRTIFM MINISTERIO DA SAUDE

INSTITUTO NACIONAL DA FARMACIA E DO MEDICAMENTO (INFARMED)
LISBON, PORTUGAL

PRTMH MINISTRY OF HEALTH

LISBON, PORTUGAL

PRTOC MINISTERIO DA SAUDE

INSTITUTO NACIONAL DA FARMACIA E DO MEDICAMENTO
LISBON, PORTUGAL

PRTRAC PURTUGUESE REGULATORY AGENCY (INRARMED)

LISBON, PORTUGAL

SANOFI LETTER TO REGULATORY AGENCIES

SANOFI-SYNTHELABO
PARIS, FRANCE

SAUCW MINISTRY OF HEALTH

SAUDI ARABIA

SGPCW NATIONAL PHARMACEUTICAL ADMINISTRATION

MINISTRY OF HEALTH
SINGAPORE

SGPHSA HEALTH SCIENCES AUTHORITY

SINGAPOR

SGPMA THE MEDICINES ACT (CHAPTER 176)

THE MEDICINES (LABELLING OF ASPIRIN PRODUCTS) REGULATIONS 1987
VOL.MH.(HQ) 36:26/1 VOL.3, AG/SL/31/84 PT.
SINGAPORE NATIONAL PRINTERS LTD (GOVERNMENT PRINTERS)
SINGAPORE

SGPPR HEALTH SCIENCES AUTHORITY

SINGAPORE

SGPRD THE SALE OF DRUGS (PROHIBITED DRUGS) REGULATIONS

SINGAPORE

SLVCW MINISTRY OF HEALTH

BRATISLAVA, SLOVAK REPUBLIC

SPCNR NEW RELEASE

SCHERING-PLOUGH CORPORATION
KENILWORTH, NJ 07033-0530
UNITED STATES

SSLMS INFORMATION FRAN SOCIALSTYRELSENS LAKEMEDELSAVDELNING

STOCKHOLM, SWEDEN

591
 List of references cited in the regulatory text
SWEFSL FARMACEUTISKA SPECIALITETER I SVERIGE. LKEMEDELSINFORMATION AB
STOCKHOLM, SWEDEN

SWEILS INFORMATION FRN LKEMEDELSVERKET

STOCKHOLM, SWEDEN

SWEMPA LÄKEMEDELSVERKET
(MEDICAL PRODUCTS AGENCY)
STOCKHOLM, SWEDEN

SYRAFD SUPRIM TECHNICAL COMMITTEE

MINISTRY OF HEALTH
DAMASCUS, SYRIA

THACW MINISTRY OF PUBLIC HEALTH

TIWANOND ROAD
NONTHAMBURI 11000, THAILAND

THAFDA FOOD AND DRUG ADMINISTRATION

MINISTRY OF HEALTH
TIWANOND ROAD
NONTHAMBURI 11000, THAILAND

THAMH MINISTRY OF PUBLIC HEALTH

TIWANOND ROAD
NONTHAMBURI 11000, THAILAND

TURCW GENERAL DIRECTORATE OF PHARMACEUTICALS AND PHARMACY

MINISTRY OF HEALTH
ANKARA, TURKEY

TURDPC DIVISION OF PAHARMACOVIGILANCE

MINISTRY OF HEALTH
ANKARA, TURKEY

TURMH MINISTRY OF HEALTH

ANKARA, TURKEY

UAECW MINISTRY OF HEALTH

ABU DHABI
UNITED ARAB EMIRATES

UAEDIB MINISTRY OF HEALTH

ABU DHABI
UNITED ARAB EMIRATES

UAEMD MINISTRY OF HEALTH

ABU DHABI
UNITED ARAB EMIRATES

UGLAAD UGESKRIFT FOR LAEGER

UDGIVET AF DEN ALMINDELIGE DANSKE LAEGEFORENING
KRISTIANIAGADE 12A
COPENHAGEN DK-2100, DENMARK

592
 List of references cited in the regulatory text
UNCPS UNITED NATIONS TREATY SERIES
UNITED NATIONS SECRETARIAT
NEW YORK, NY. 10017, USA

UNSND SINGLE CONVENTION ON NARCOTIC DRUGS 1961

(UNITED NATIONS TREATY SERIES VOL. 520, E/CONF.34/22)
AS AMENDED BY THE 1972 PROTOCOL (E/CONF.63/7-8, E.77.XI.3)
UNITED NATIONS SECRETARIAT
NEW YORK, NY 10017, USA

URTMH PHARMACY BOARD

MINISTRY OF HEALTH
DAR-ES-SALAM, TANZANIA

USADAC FOOD AND DRUG ADMINISTRATION

WASHINGTON D.C., USA

USADDL (www.fda.gov/medwatch/safety/1998)
FOOD AND DRUG ADMINISTRATION
WASHINGTON D.C., USA

USADHP BAYER PHARMACEUTICAL DIVISION

www.fda.gov/medwatch

USADIZ DRUG INFO ZONE

www.druginfozone.nhs.uk

USAMDR FOOD AND DRUG ADMINISTRATION

WASHINGTON D.C.
USA
www.fda.gov

USAMSA MEDWATCH SAFETY ALERT

www.fda.gov/medwatch

USAOPA OFFICE OF PUBLIC AFFAIRS

CALIFORNIA
DEPARTMENT OF HEALTH SERVICES
www.fda.gov

USAPHA FOOD AND DRUG ADMINISTRATION

WASHINGTON, D.C.
USA
www.fda.gov

USARLI ROXANE LABORATORIES INC.

www.fda.gov

VTNMHD MINISTRY OF HEALTH

DRUG ADMINISTRATION
VIET NAM

WHOCON WORLD HEALTH ORGANIZATION

1211 GENEVA 27, SWITZERLAND

593
 List of references cited in the regulatory text
WHODI WORLD HEALTH ORGANIZATION
1211 GENEVA 27, SWITZERLAND

WHODIB WORLD HEALTH ORGANIZATION

1211, GENEVA 27, SWITZERLAND

WHORUD THE RATIONAL USE OF DRUGS

WORLD HEALTH ORGANIZATION
1211 GENEVA 27, SWITZERLAND

WHTAC TECHNICAL REPORT SERIES

WORLD HEALTH ORGANIZATION
1211 GENEVA 27, SWITZERLAND

WIMAM WICHTIGE MITTEILUNG UBER ARZNEIMITTEL 1984

BUNDESMINISTERIUM FUR GESUNDHEIT
UND UMWELTSCHUTZ
GRUPPE PHARMAZIE
LANDSTRASSE HAUPTSTRASSE 55-57
1030 WIEN, AUSTRIA

YEMCW MINISTRY OF PUBLIC HEALTH

SANA’A, REPUBLIC OF YEMEN

ZAFMCC MEDICINES CONTROL COUNCIL

MINISTRY OF HEALTH
PRETORIA 0001, SOUTH AFRICA

ZAFPS MINISTRY OF HEALTH

PRETORIA 0001, SOUTH AFRICA

ZMBSI STATUTORY INSTRUMENT

MINISTRY OF HEALTH
LUSAKA, ZAMBIA

ZWDCC NEWS BULLETIN

DRUGS CONTROL COUNCIL
HARARE, ZIMBABWE

ZWEDIB MINISTRY OF HEALTH

HARARE, ZIMBABWE

ZWESI STATUTORY INSTRUMENT

MINISTRY OF HEALTH
HARARE, ZIMBABWE

594
 Annex IV
Questionnaire
Dear Reader,

Both the Economic and Social Council and the General Assembly of the United Nations have expressed interest in
ascertaining the use which is being made of the Consolidated List. They have also requested that the Secretariat keep the
format of the List under continuing review. The present questionnaire has been prepared with a view to obtaining this
information, which will be reported to the Economic and Social Council and the General Assembly; comments regarding
the format of the List will be taken into account in the preparation of future editions.

Please mail the questionnaire as soon as possible to: United Nations Secretariat, DESA/DESC/EICB, One United
Nations Plaza, Room DC1-1438, New York, NY 10017, United States of America.

Name and address of ministry/organization/institution/company/university:

A. In what capacity do you use the Consolidated List?

Government:
___ Regulator ___ Customs enforcement ___ Policy maker

Other:
___ Academic ___ Media
___ International organization ___ NGO/public intersecretariat group
___ Manufacturer ___ Other: _________________________
B. For which category of products have you used the List?
___ Agricultural chemicals ___ Industrial chemicals
___ Consumer products
C. 1. Has the information provided in the List prompted any action on your part?
___ Yes ___ No

If “yes” please describe the nature of this action either in general terms or in relation to specific products.
____________________________________________________________________________________
____________________________________________________________________________________

_______________________________________________________________________________________________________
595
 2. What is the nature of this action? (Information on the following points is particularly requested from national regulatory
authorities)
___ Review of licensing provisions for chemical products
___ Review of regulations for already regulated products
___ Review of enforcement of laws and regulations
___ Regulation of previously unregulated products
___ Meeting with manufacturers/distributors
___ Other actions (please describe)

____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
___________________________________________________________________________________________

D. Are you aware of any additional products or restrictive regulatory actions that should be included
in the List?
___ Yes ___ No
If “yes” please specify or attach a copy of any such regulation.
____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
E. Are you aware of any additional trade and manufacturing data that should be included in the List?
___ Yes ___ No
If “yes” please specify.
____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________

_______________________________________________________________________________________________________
596
F. Do you find the following items of information useful?
Yes No
Product category listing ___ ___
CAS numbers ___ ___
Synonyms ___ ___
Date of decision ___ ___
Citation of national regulations/decisions ___ ___
Trade names/manufacturer information ___ ___
WHO comment ___ ___
Bibliographic references ___ ___

G. Which other sources do you use to obtain information on banned and severely restricted products?
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

H. Would you be interested in and have the facilities to obtain on-line access to the List?
___ Yes ___ No

I. What are your suggestions regarding the use of the List?

___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

J. What are your suggestions regarding the preparation of the List?

___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

K. Do you have any other comments?

___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

_______________________________________________________________________________________________________
597