List European Union Reference Dates Eurd Frequency Submission Periodic Safety Update Reports Psurs - en
List European Union Reference Dates Eurd Frequency Submission Periodic Safety Update Reports Psurs - en
The convention used to present the active substances and combinations of active substances has changed. From the 29th October 2015 the
following principles apply:
- A slash ('/') is used to separate the different active substances contained in a combination, this can be a fixed-dose combination or a combination pack.
- A comma (',') is used to indicate that a single PSUR assessment covering the different substances and/or combinations of active substances will be produced.
5 February 2025
EMA/630645/2012 Rev. 145
Procedure Management Department
List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Related Information:
Introductory cover note to the List of European Union reference dates
and frequency of submission of PSURs including requirements for PSURs https://www.ema.europa.eu/documents/other/introductory-cover-note-list-european-union-reference-dates-frequency-submission-periodic-safety_en.pdf
submission
Requests
The PSUR for amendments
assessment of the will
procedure EU start
reference datesto
according list
the Timetables https://www.ema.europa.eu/documents/template-form/template-request-amendments-addition-active-substances-combinations-active-substances-european-union_en-1.docx
published on EMA website following the Submission Dates indicated in https://www.ema.europa.eu/documents/other/timetable-periodic-safety-update-report-psur-psur-single-assessment-psusa_en.pdf
column
Single E and G below Reports of PSURs are shared among all Marketing Authorisation Holders involved in the concerned procedure.
Assessment
Next Submission
date
European Union
(According to the Are PSURs required
reference date Submission Next DLP
timelines defined in for products referred
(EURD) date (For active substances Publication Date (in (Lead) Member Centrally Nationally
PSUR GVP Module VII, to in Articles 10(1), Procedure number of the PSUR Procedure number of the PSUR
Active substances and combinations of (According to the or combination of accordance with Article State of the PSUR authorised authorised
ID Submission DLP Section A - For active 10a, 16a of Directive Notes single assessment single assessment PRAC representative of the PSUR single assessmentprocedure
active substances Not Available* = timelines defined active substances with 107c(7) of Directive single assessment product(s) product(s)
Frequency substances or 2001/83/EC as (DLP) procedure (Next DLP)
EURD not provided in GVP Module VII, a PSUR frequency of 2001/83/EC as amended) procedure (CAP) (NAP)
combination of active amended?
during the Section A) less than one year)
substances with a Yes/No
consultation phases
PSUR frequency of less
than one year)
9 5-aminolevulinic acid (glioma) 07/09/2007 3 years 07/03/2027 05/06/2027 No 20/11/2024 Next DLPamended
DLP was was updated on
on 20/11/2024 PSUSA/00000009/202703 Carla Torre Portugal CAP
04/02/2016
11 abacavir / lamivudine 14/11/2003 3 years 31/12/2025 31/03/2026 Yes 19/09/2024 PSUSA/00000011/202512 Zoubida Amimour France CAP NAP
13 abatacept 22/12/2005 3 years 22/12/2025 22/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000013/202512 Kimmo Jaakkola Finland CAP
PSURwas
DLP frequency
updatedamended and
on 01/03/2023
15 abiraterone 28/04/2011 5 years 28/04/2029 27/07/2029 No 05/02/2025 PSUSA/00000015/202904 Maria del Pilar Rayon Spain CAP NAP
DLP updated on 05/02/2025
Transferred from the List of
substances under PSUR Work
16 acamprosate 24/07/1987 8 years 01/07/2030 29/09/2030 No 01/03/2023 Sharing scheme and other PSUSA/00000016/203007 Rhea Fitzgerald Ireland NAP
substances contained in
Nationally Authorised Products
with DLP synchronised on
17 acarbose 31/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023
06/03/2015
PSUSA/00000017/202803 Maria del Pilar Rayon Spain NAP
26 acemetacin Not available* 6 years 01/05/2030 30/07/2030 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000026/203005 Melinda Palfi Hungary NAP
PSUR frequency and DLP were
updated on 02/03/2022
27 acenocoumarol 06/07/1955 3 years 01/07/2024 29/09/2024 No 02/03/2022 PSUSA/00000027/202407 Maria Popova-Kiradjieva Bulgaria NAP
PRAC representative and LMS
were added on 18/11/2020
29 acetazolamide 27/07/1953 16 years 26/10/2028 24/01/2029 Yes 28/03/2017 DLP was updated on 28/03/2017 PSUSA/00000029/202810 NAP
33 acetylcholine 09/06/1965 16 years 01/06/2028 30/08/2028 No 01/10/2012 PSUR frequency amended and PSUSA/00000033/202806 NAP
DLP updated on 28/06/2023
Next DLP
Active was amended
substance on
name was
40 acetylsalicylic acid / glycine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000040/203001 NAP
19/10/2016
amended on 06/03/2015
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 1 / 223
42 acetylsalicylic acid / caffeine / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000042/203001 NAP
43 acetylsalicylic acid / caffeine / etenzamide Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000043/203001 NAP
45 ublituximab 28/12/2022 6 months 27/12/2024 07/03/2025 27/06/2025 05/09/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000045/202412 PSUSA/00000045/202506 Liana Martirosyan Netherlands CAP
46 acetylsalicylic acid / codeine phosphate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000046/203001 NAP
49 mirikizumab 27/03/2023 6 months 27/09/2024 06/12/2024 27/03/2025 05/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000049/202409 PSUSA/00000049/202503 Sonja Hrabcik Austria CAP
77 miglustat (for treatment of Pompe disease) 20/03/2023 6 months 19/09/2024 28/11/2024 19/03/2025 28/05/2025 No 30/04/2024 DLP was amended
DLP was updated on
on22/09/2021
30/04/2024 PSUSA/00000077/202409 PSUSA/00000077/202503 Mari Thorn Sweden CAP
LMS and PRAC representative
were updated on 05/06/2019
PRAC Rapporteur name was
78 alendronate 10/11/2000 5 years 15/01/2026 15/04/2026 No 16/10/2023 PSUSA/00000078/202601 Karin Erneholm Denmark NAP
amended on 18/10/2023
Next DLP was updated on
22/09/2016
alendronic acid / colecalciferol, alendronic acid /
79 24/08/2005 5 years 15/01/2026 15/04/2026 No 22/09/2021 PSUSA/00000079/202601 Jan Neuhauser Austria CAP NAP
calcium / colecalciferol Are PSURs
DLP required
was updated onfor products
03/03/2021
referred to in Articles 10(1), 10a,
14, 16a
LMS andofPRAC
Directive 2001/83/EC
representative
80 alfacalcidol 31/01/1978 5 years 15/06/2025 13/09/2025 No 03/03/2021 as amended?
were added onYes/No" was
06/05/2020 PSUSA/00000080/202506 Terhi Lehtinen Finland NAP
amended on 16/07/2015
PSURwas
Lead
DLP frequency
MS and PRAC
updated and DLP were
onRapporteur
25/05/2022
Active added
updated
name substance name was
on 05/06/2019
on 15/11/2023
81 neomycin / triamcinolone 30/12/1991 6 years 01/08/2024 30/10/2024 No 26/07/2023 amended on 12/05/2015 PSUSA/00000081/202408 Eva Jirsová Czech Republic NAP
DLP was amended on 05/06/2019
New entry added on 26/07/2023
PRAC Rapporteur name was
82 alfentanil Not available* 3 years 14/09/2024 13/12/2024 No 25/05/2022 amended on 23/10/2018 PSUSA/00000082/202409 Eamon O'Murchu Ireland NAP
86 alglucosidase alfa 29/03/2006 3 years 28/09/2024 27/12/2024 No 19/09/2024 PRAC representative was PSUSA/00000086/202409 Zoubida Amimour France CAP
updated on 25/09/2019
PRAC representative was
DLP updated on 30/04/2019
88 alimemazine 05/06/1956 18 years 01/01/2030 01/04/2030 No 01/10/2012 updated on 19/10/2022 PSUSA/00000088/203001 NAP
PRAC Rapporteur name amended
PRAC Representative amended
on 04/07/2018
on 28/04/2022
89 aliskiren, aliskiren / hydrochlorothiazide 22/08/2007 3 years 30/09/2024 29/12/2024 No 29/06/2022 PSUSA/00000089/202409 Amelia Cupelli Italy CAP
Entry name and DLP were
DLP was updated on 22/09/2021
updated on 07/05/2018
PRAC Representative amended
91 alizapride 09/01/1979 5 years 09/01/2026 09/04/2026 No 28/04/2022 DLP was updated on 23/05/2017 PSUSA/00000091/202601 Jo Robays Belgium NAP
on 18/11/2016
Next DLP was amended on
Next DLP was updated on
03/05/2016
92 allantoin Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 22/09/2016 PSUSA/00000092/203001 NAP
"Are PSURs required for products
Lead MS was added on
referred to in Articles 10(1), 10a,
06/10/2015
14, 16a of Directive 2001/83/EC
as amended? Yes/No" was
DLP was amended on 16/06/2015
amended on 16/07/2015
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 2 / 223
93 ganaxolone 18/03/2022 6 months 17/09/2024 26/11/2024 17/03/2025 26/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000093/202409 PSUSA/00000093/202503 Adam Przybylkowski Poland CAP
95 allopurinol 01/01/1966 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000095/202612 Martin Huber Germany NAP
97 piflufolastat (18F) 26/05/2021 6 months 25/11/2024 03/02/2025 25/05/2025 03/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000097/202411 PSUSA/00000097/202505 Kimmo Jaakkola Finland CAP
99 talquetamab 09/08/2023 6 months 08/08/2024 17/10/2024 08/02/2025 19/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000099/202408 PSUSA/00000099/202502 Barbara Kovacic Bytyqi Croatia CAP
100 atogepant 28/09/2021 6 months 27/09/2024 06/12/2024 27/03/2025 05/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000100/202409 PSUSA/00000100/202503 Rugile Pilviniene Lithuania CAP
120 elacestrant 28/12/2022 6 months 27/12/2024 07/03/2025 27/06/2025 05/09/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000120/202412 PSUSA/00000120/202506 Sonja Hrabcik Austria CAP
125 alverine / simeticone 05/06/1990 10 years 01/02/2032 01/05/2032 No 19/09/2024 PSUSA/00000125/203202 Zoubida Amimour France NAP
136 tislelizumab 26/12/2019 6 months 25/12/2024 05/03/2025 25/06/2025 03/09/2025 No 05/02/2025 PRAC
New representative
CAP
DLP was authorised
amended was
onon added
05/02/2025 PSUSA/00000136/202412 PSUSA/00000136/202506 Bianca Mulder Netherlands CAP
on 06/05/2020
19/05/2022
LMS was
PSUR
DLP was added on
frequency
updated and25/09/2019
on DLP were
01/02/2023 Marie Louise Schougaard
138 amfepramone 01/06/1961 13 years 01/06/2033 30/08/2033 Yes 03/02/2021 updated on 31/07/2019 PSUSA/00000138/203306
Christiansen Denmark NAP
DLP and
Active Information
substance name included
was in
column
Lead
amended MS"Areon PSURs
and required for
PRAC Rapporteur
18/11/2020
products referred to
name amended on 06/02/2019 in Articles
141 amifampridine 23/12/2009 3 years 23/12/2024 23/03/2025 No 21/09/2022
10(1), 10a, 14, 16a
PSUSA/00000141/202412 Karin Bolin Sweden CAP
DLP was updated onof28/02/2018
Directive
2001/83/EC
DLP as amended?"
was updated was
on 31/07/2018
amended onincluded
Information 30/04/2019in column
143 amikacin (except for centrally authorised products) 06/06/1975 5 years 05/06/2027 03/09/2027 No 01/02/2023 DLP was
"Are PSURsupdated on for
required 21/07/2017
products PSUSA/00000143/202706 Maia Uusküla Estonia NAP
referred to in Articles 10(1), 10a,
Next16a
14, DLPofwas amended
Directive on
2001/83/EC
28/07/2016
as amended?" was amended on
30/01/2017
Next DLP was amended on
02/05/2014
PRAC
© European Medicines Agency, 2011. Reproduction is authorised provided the source representative and Lead
is acknowledged.
#Classified as internal/staff contractors by the EuropMember State were added on Page 3 / 223
18/11/2016
amiloride, amiloride / furosemide, amiloride /
Active substance name, PSUR
hydrochlorothiazide, amiloride / hydrochlorthiazide /
148 25/04/1969 8 years 03/06/2025 01/09/2025 No 05/01/2025 frequency and DLP were PSUSA/00000148/202506 Gudrun Thengilsdottir Iceland NAP
timolol, amiloride / bumetanide, amiloride /
amended on 20/12/2023
chlortalidone
152 aminaphtone 07/07/2005 13 years 06/07/2032 04/10/2032 Yes 28/02/2024 Entry re-activated on 28/02/2024 PSUSA/00000152/203207 none NAP
155 pirtobrutinib 27/01/2023 6 months 27/07/2024 05/10/2024 27/01/2025 07/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000155/202407 PSUSA/00000155/202501 Bianca Mulder Netherlands CAP
156 sodium hypochlorite (concentrated solution) 09/12/1991 8 years 09/12/2031 08/03/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000156/203112 none NAP
157 aminoacridine / lidocaine Not available* 12 years 06/09/2024 05/12/2024 No 01/10/2012 PSUSA/00000157/202409 Malta NAP
158 allantoin / aminoacridine / peru balsam / prednisolone Not available* 12 years 30/09/2024 29/12/2024 No 31/01/2024 Lead MS added on 31/01/2024 PSUSA/00000158/202409 Spain NAP
165 aminosalicylic acid Not available* 3 years 05/10/2025 03/01/2026 Yes 19/09/2024 PSUSA/00000165/202510 Zoubida Amimour France NAP
166 amiodarone 20/12/1966 3 years 20/12/2026 20/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000166/202612 Bianca Mulder Netherlands NAP
167 amisulpride 20/01/1986 3 years 20/01/2026 20/04/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000167/202601 Eamon O'Murchu Ireland NAP
168 magnesium gluconate 21/02/2005 9 years 21/02/2032 21/05/2032 No 20/12/2023 New entry added on 20/12/2023 PSUSA/00000168/203202 none NAP
169 zilucoplan 25/09/2023 6 months 24/09/2024 03/12/2024 24/03/2025 02/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000169/202409 PSUSA/00000169/202503 Karin Erneholm Denmark CAP
170 amitriptyline / perphenazine 31/07/1961 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000170/202701 Georgia Gkegka Greece NAP
173 palopegteriparatide 17/11/2023 6 months 16/11/2024 25/01/2025 16/05/2025 25/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000173/202411 PSUSA/00000173/202505 Lina Seibokiene Lithuania CAP
PRAC Rapporteur
DLP was amendedname was
on 18/12/2024
174 amlodipine 08/03/1989 5 years 07/03/2027 05/06/2027 No 16/10/2023 PSUSA/00000174/202703 Karin Erneholm Denmark NAP
amended on 18/10/2023
DLP was corrected on 27/03/2024
175 lebrikizumab 16/11/2023 6 months 16/11/2024 25/01/2025 16/05/2025 25/07/2025 No 18/12/2024 EURD, DLP and next DLP updated PSUSA/00000175/202411 PSUSA/00000175/202505 Liana Martirosyan Netherlands CAP
on 31/01/2024
Active substance name was
amended on 23/10/2024
New CAP authorised on
176 quizartinib 18/06/2019 6 months 17/12/2024 25/02/2025 17/06/2025 26/08/2025 No 05/02/2025 DLP was amended on 05/02/2025
16/11/2023
PSUSA/00000176/202412 PSUSA/00000176/202506 John Joseph Borg Malta CAP
PSUR frequency and DLP were
updated on 16/12/2020
177 amlodipine / atorvastatin 30/01/2004 3 years 31/01/2025 01/05/2025 No 19/09/2024 PSUSA/00000177/202501 Zoubida Amimour France NAP
PRAC Rapporteur name was
amended on 31/07/2018
PRAC Rapporteur name was
179 amlodipine / perindopril 23/04/2008 5 years 22/10/2026 20/01/2027 No 16/10/2023 DLP was updated on 19/12/2017 PSUSA/00000179/202610 Karin Erneholm Denmark NAP
amended on 18/10/2023
Reference to NAP products was
amlodipine / telmisartan, amlodipine / telmisartan / added on 23/05/2017
180 07/10/2010 5 years 31/03/2025 29/06/2025 No 23/10/2024 PSUSA/00000180/202503 Martin Huber Germany CAP NAP
hydrochlorothiazide
Next DLP was amended on
01/12/2014
182 ammonia solutions 19/09/1984 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000182/202801 NAP
Leadwas
PSUR
DLP MS and PRAC
frequency
amended
updated Rapporteur
amended
on
on and
15/11/2017
16/11/2022
186 amoxapine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00000186/202806 NAP
name
DLP was added
updated on 20/12/2016
on 28/08/2024
was PRAC
Lead MS and addedRapporteur
on
22/09/2016
name amended on 19/12/2018
187 amoxicillin 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022 PSUSA/00000187/202703 Jan Neuhauser Austria NAP
Information
DLP included
was amended onin15/11/2017
column
"Are PSURs required for products
referred
Lead MS to
wasin added
Articleson
10(1), 10a,
188 amoxicillin / clavulanate 07/03/1972 5 years 07/03/2027 05/06/2027 No 16/11/2022
14, 16a of Directive 2001/83/EC
PSUSA/00000188/202703 Martin Huber Germany NAP
22/09/2016
as amended?" was amended on
28/06/2016 included in column
Information
193 amphotericin b 19/03/1958 15 years 18/03/2027 16/06/2027 Yes 01/10/2012 "Are PSURs required for products PSUSA/00000193/202703 NAP
PRAC representative
referred to in Articleswas
10(1), 10a,
updated onDirective
14, 16a of 19/10/2022
2001/83/EC
as amended?"
PSUR frequency was
andamended
DLP on
194 amphotericin b / tetracycline 19/03/1958 11 years 02/04/2038 01/07/2038 No 23/10/2024 PRAC representative
28/06/2016 was PSUSA/00000194/203804 NAP
amended on 23/10/2024
updated on 27/07/2022
PSURcorrected
DLP frequencyonamended and
02/02/2022
195 ampicillin 01/03/1962 9 years 01/02/2028 01/05/2028 Yes 28/08/2024 PSUSA/00000195/202802 NAP
DLP updated on 28/08/2024
DLP was updated on 17/11/2021
Updated & published on
196 ampicillin / cloxacillin 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 PRAC representative was PSUSA/00000196/203405 NAP
23/10/2024
updated on 30/06/2021
202 latanoprost (eye drop emulsions containing CKC) 15/11/2023 6 months 14/11/2024 23/01/2025 14/05/2025 23/07/2025 No 18/12/2024 Next DLPamended
DLP was was amended on
on 18/12/2024 PSUSA/00000202/202411 PSUSA/00000202/202505 Jean-Michel Dogné Belgium CAP
29/10/2015
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 4 / 223
PSUR frequency amended and
DLP updated on 31/05/2023
222 pegzilarginase 14/12/2023 6 months 13/12/2024 21/02/2025 13/06/2025 22/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000222/202412 PSUSA/00000222/202506 Martin Huber Germany CAP
223 vamorolone 26/10/2023 6 months 25/10/2024 03/01/2025 25/04/2025 04/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000223/202410 PSUSA/00000223/202504 Rhea Fitzgerald Ireland CAP
225 elranatamab 14/08/2023 6 months 13/08/2024 22/10/2024 13/02/2025 24/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000225/202408 PSUSA/00000225/202502 Barbara Kovacic Bytyqi Croatia CAP
226 apixaban 18/05/2011 3 years 17/05/2027 15/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000226/202705 Bianca Mulder Netherlands CAP
PRACwas
DLP Rapporteur
updated name was
on 16/11/2022
227 apomorphine 28/05/2001 3 years 19/11/2025 17/02/2026 Yes 16/10/2023 PSUSA/00000227/202511 Karin Erneholm Denmark NAP
amended on 18/10/2023
PRAC Rapporteur name was
amended
PSUR on 28/04/2022
frequency and DLP
228 apraclonidine 16/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00000228/203408 NAP
amended on 23/10/2024
DLP was updated on 21/10/2020
234 aripiprazole 04/06/2004 3 years 16/07/2026 14/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000234/202607 Ana Sofia Diniz Martins Portugal CAP NAP
artemether / lumefantrin (apart from the dispersible Next DLP was updated on
236 14/10/1998 3 years 01/10/2025 30/12/2025 No 03/06/2020 PSUSA/00000236/202510 Mari Thorn Sweden NAP
tablet) 31/05/2023
239 articaine / epinephrine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000239/203201 NAP
240 triamcinolone / lidocaine (rectal use) 01/03/1974 9 years 28/02/2031 29/05/2031 No 28/02/2024 New entry added on 28/02/2024 PSUSA/00000240/203102 n/a none NAP
242 acetylsalicylic acid / ascorbic acid / bioflavonoids Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000242/203501 NAP
244 exagamglogene autotemcel 15/11/2023 6 months 14/11/2024 23/01/2025 14/05/2025 23/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000244/202411 PSUSA/00000244/202505 Bianca Mulder Netherlands CAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 5 / 223
New CAP authorised on
245 omaveloxolone 28/02/2023 6 months 27/08/2024 05/11/2024 27/02/2025 08/05/2025 No 28/02/2024 PSUSA/00000245/202408 PSUSA/00000245/202502 Amelia Cupelli Italy CAP
09/02/2024
alfatocopherol / ascorbic acid / biotin / calcium
pantothenate / colecalciferol / cyanocobalamin /
246 Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000246/203501 NAP
magnesium / manganese / pyridoxine / riboflavin /
thiamine / vitamin a / zinc
248 ascorbic acid / dichlorobenzyl alcohol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000248/203501 NAP
250 ascorbic acid / caffeine / glucuronamide Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000250/203501 NAP
251 ascorbic acid / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000251/203501 NAP
253 ascorbic acid / caffeine / paracetamol Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUR frequency and DLP were PSUSA/00000253/203501 NAP
DLP was updated on 03/03/2021
updated on 26/05/2021
PRAC representative was added
DLP was updated on 31/03/2021
ascorbic acid / paracetamol / phenylephrine on 06/05/2020
255 Not available* 5 years 15/06/2025 13/09/2025 No 03/03/2021 PSUSA/00000255/202506 Rugile Pilviniene Lithuania NAP
hydrochloride
DLP was updated on 01/04/2020
LMS was added on 01/04/2020
LMS and PRAC representative
256 asenapine 01/09/2010 3 years 12/08/2025 10/11/2025 No 05/04/2023 DLP was updated on 05/06/2019 PSUSA/00000256/202508 Ana Sofia Diniz Martins Portugal CAP
were updated on 05/06/2019
269 atropine / diphenoxylate 29/09/1960 14 years 01/01/2026 01/04/2026 No 01/10/2012 PSUSA/00000269/202601 NAP
294 baclofen (oral use, for muscle spasticity indication) 17/09/1970 3 years 30/09/2026 29/12/2026 No 05/06/2024 Lead MS amended
DLP was was added
onon
05/06/2024 PSUSA/00000294/202609 Eamon O'Murchu Ireland NAP
13/07/2015
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 6 / 223
PSUR frequency and DLP
296 bamifylline Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00000296/202905 NAP
amended on 31/07/2024
300 barnidipine 01/07/2000 7 years 03/03/2031 01/06/2031 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000300/203103 Bianca Mulder Netherlands NAP
304 BCG vaccine (freeze-dried) Not available* 5 years 02/03/2028 31/05/2028 No 15/01/2025 DLP was amended on 15/11/2023 PSUSA/00000304/202803 Mari Thorn Sweden NAP
DLP was updated on 21/09/2022
305 cefepime / enmetazobactam 29/06/1993 6 months 28/12/2024 08/03/2025 28/06/2025 06/09/2025 No 05/02/2025 Lead
PSUR MS
DLP was and PRAC
Frequency
amended Rapporteur
amended
on and
05/02/2025 PSUSA/00000305/202412 PSUSA/00000305/202506 Liana Martirosyan Netherlands CAP
name amended
next DLP onon
updated 19/12/2018
25/09/2017
Next DLP
Entrywas
DLP namewas amended
corrected
updated onon
on 01/03/2023
306 beclometasone 13/12/1966 5 years 31/12/2026 31/03/2027 No 21/09/2022 25/09/2017
23/05/2017 PSUSA/00000306/202612 Adam Przybylkowski Poland NAP
PRAC Representative amended
European
PRAC
on Union reference
Rapporteur
21/12/2022 date
name corrected
was28/02/2017
PSUR
on amended
frequency onand
21/07/2017
DLP
308 beclometasone dipropionate / neomycin sulfate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00000308/204003 NAP
amended
DLP on 23/10/2024
was updated on 05/02/2020
Lead MS
PRAC and PRACname
Rapporteur Rapporteur
was
name Frequency
amended
PSUR wasonadded on 28/07/2016
20/12/2016
and Next DLP
309 beclometasone / salbutamol Not available* 5 years 01/01/2027 01/04/2027 No 21/09/2022 were amended
PSUR frequencyon 30/01/2017
and DLP were PSUSA/00000309/202701 Ana Sofia Diniz Martins Portugal NAP
Lead MS on
updated and01/02/2023
PRAC Rapporteur
nameDLP
Next waswas
added on 28/07/2016
amended on
04/02/2016
PRAC Representative updated on
311 belatacept 17/06/2011 3 years 14/06/2025 12/09/2025 No 01/03/2023
Active substance name was
PSUSA/00000311/202506 Mari Thorn Sweden CAP
16/11/2022
amended
PSUR
DLP was on 03/06/2016
Frequency
updated and Next DLP
on 28/07/2021
amended
DLP on 31/07/2015
was updated on 05/02/2020
312 bemiparin 16/04/1998 5 years 30/04/2027 29/07/2027 No 01/02/2023 Transferred
PRAC from the
Rapporteur nameListupdated
of PSUSA/00000312/202704 Monica Martinez Redondo Spain NAP
substances
Next
on wasunder
DLP amended
23/10/2018 PSUR
amended Work
on
and PRAC
Sharing scheme
04/02/2015
Rapporteur nameand other on
updated
substances
30/01/2017
Next DLP wascontained
amended in on
313 benazepril 28/11/1989 5 years 20/11/2025 18/02/2026 No 15/01/2025 Nationally Authorised
Next DLP was amended on Products PSUSA/00000313/202511 Amelia Cupelli Italy NAP
28/07/2016
with
PRACDLP
08/08/2014synchronised
Rapporteur on
and Lead
06/03/2015
Member State on
DLP amended added on
31/07/2015
314 benazepril / hydrochlorothiazide 19/05/1992 5 years 31/05/2026 29/08/2026 No 19/09/2024 Next DLP was amended on
27/11/2015. PSUSA/00000314/202605 Zoubida Amimour France NAP
31/01/2014
Lead MS was added on
13/07/2015
PSUR frequency and DLP
315 bendazac 09/11/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00000315/203408 NAP
amended on 23/10/2024
DLP was updated on 03/04/2019
DLP was updated on 01/03/2023
329 benperidol 01/08/1967 6 years 31/07/2024 29/10/2024 No 03/04/2019 PSUSA/00000329/202407 Martin Huber Germany NAP
PRAC Representative and Lead
PRAC representative was
MS were added on 19/12/2017
updated on 06/05/2020
330 benserazide / levodopa 27/06/1973 5 years 26/06/2027 24/09/2027 No 01/03/2023 PSUSA/00000330/202706 Melinda Palfi Hungary NAP
DLP was updated on 28/02/2018
357 benzocaine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000357/203001 NAP
358 benzocaine / cetylpyridinium chloride 01/01/1996 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000358/203001 NAP
361 benzocaine / chloroxylenol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000361/203001 NAP
362 benzocaine / dequalinium hydrochloride 09/04/1991 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000362/203001 NAP
364 benzocaine / menthol / phenol, racemic / thymol Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000364/203001 NAP
365 benzocaine / phenazone Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000365/203001 NAP
366 benzocaine / triclosan Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000366/203001 NAP
PSUR frequency amended and
DLP updated on 28/02/2024
368 benzododecinium / boric acid Not available* 11 years 03/03/2040 01/06/2040 No 28/02/2024 PSUSA/00000368/204003 none NAP
Active substance name was
amended on 28/02/2024
371 benzoxonium chloride 01/02/1969 14 years 31/10/2025 29/01/2026 No 01/10/2012 PSUSA/00000371/202510 NAP
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PRAC representative was
updated on 27/07/2022
PRAC representative
Information included was added
385 besilesomab 11/01/2010 5 years 10/01/2029 10/04/2029 No 25/09/2024 DLP was amended onin column
25/09/2024 PSUSA/00000385/202901 Monica Martinez Redondo Spain CAP
on 06/05/2020
"Are PSURs required for products
referred to in Articles 10(1), 10a,
LMS16a
14, wasofadded on 01/04/2020
Directive 2001/83/EC
PSUR frequency amended and
387 beta-carotene Not available* 9 years 03/06/2029 01/09/2029 No 15/01/2025 as PSUSA/00000387/202906 Adam Przybylkowski Poland NAP
DLPamended?"
PSUR updated onwas
frequency
amended on
28/08/2024
and DLP were
15/11/2023
updated on 05/06/2019
408 biclotymol 11/06/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended
DLP was updated on
on17/10/2017
05/02/2025 PSUSA/00000408/203105 Zoubida Amimour France NAP
Next DLP was updated on
22/09/2016
PSUR frequency amended and
409 biclotymol / enoxolone / muramidase hydrochloride Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00000409/202512 Gudrun Thengilsdottir Iceland NAP
DLP updated on 31/07/2024
DLP updated on 06/10/2015
DLP and frequency were updated
on 17/11/2021
PSUR frequency amended and
411 bifonazole 01/12/1982 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00000411/202505 Martin Huber Germany NAP
DLP updated on 03/07/2024
413 bimatoprost 08/03/2002 5 years 07/03/2026 05/06/2026 No 17/11/2021 DLP was updated on 21/11/2018 PSUSA/00000413/202603 Karin Erneholm Denmark CAP NAP
DLP was updated on 25/09/2019
PRACwas
DLP Rapporteur
amendedname was
on 03/05/2023
amended on 06/06/2018
414 biotin Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 PRAC Representative and Lead PSUSA/00000414/202601 Jan Neuhauser Austria NAP
DLP was updated on 06/05/2020
Member state assigned on
PRAC Representative amended
04/07/2018
on 17/10/2017
DLP was updated on 23/05/2017
415 biperiden 16/08/1955 3 years 31/08/2025 29/11/2025 No 03/05/2023 PSUSA/00000415/202508 Jan Neuhauser Austria NAP
Next DLP
Lead updated
MS and PRAConRapporteur
27/11/2015.
name was added on 07/04/2016
Active substance name, PSUR
bisacodyl, bisacodyl / senna dry extract / senna pods / DLP was updated on 30/06/2021
416 01/06/1954 10 years 01/01/2034 01/04/2034 No 20/12/2023 frequency
PSUR and DLP
PSUSAfrequency andwere
number was DLP wereon
amended
PSUSA/00000416/203401 none NAP
sennae folium
amendedon
updated on26/05/2021
20/12/2023
06/10/2014
Next DLP was amended on
03/06/2016
419 bisoprolol 28/01/1986 5 years 30/09/2025 29/12/2025 No 30/06/2021 PRAC representative and LMS PSUSA/00000419/202509 Kimmo Jaakkola Finland NAP
were added
PRAC on 04/03/2020
Rapporteur name updated
on 06/10/2015
Information included in column
420 bisoprolol / hydrochlorothiazide 30/01/1992 3 years 30/11/2024 28/02/2025 No 19/09/2024 "Are PSURs
Lead required
MS added for products
on 12/05/2015
PSUSA/00000420/202411 Zoubida Amimour France NAP
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?", PSUR frequency
421 bivalirudin 20/09/2004 5 years 20/09/2025 19/12/2025 Yes 26/05/2021 PSUSA/00000421/202509 Jana Lukačišinová Czech Republic NAP
amended
DLP and DLPon
was updated updated and
21/12/2022
Reference to CAP removed
06/03/2019
PRAC Rapporteur name was
Marie Louise Schougaard
422 bleomycin 18/03/1970 10 years 31/03/2032 29/06/2032 No 21/12/2022 amended on 28/04/2022 PSUSA/00000422/203203
Christiansen Denmark NAP
DLP was updated on 07/05/2018
LMS and PRAC representative
Next DLP
were was
added onamended
20/10/2021on
423 borax / boric acid Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 26/04/2017 PSUSA/00000423/203501 NAP
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DLP was updated on 21/09/2022
436 bromfenac 18/05/2011 2 years 30/05/2025 28/08/2025 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000436/202505 Karin Erneholm Denmark CAP
PRAC frequency
PSUR Rapporteur
Information name
included updated
in column
amended and
480 cafedrine hydrochloride / theodrenaline hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 on 03/06/2016 PSUSA/00000480/202906 NAP
"Are
DLP PSURs required
updated for products
on 28/08/2024
referred to in Articles 10(1), 10a,
Next16a
14, DLPofwas amended
Directive on
2001/83/EC
481 caffeine 14/04/1969 28 years 01/01/2040 31/03/2040 No 01/10/2012 04/02/2016
as amended?" was amended on PSUSA/00000481/204001 NAP
17/10/2017
DLP was amended on 04/02/2015
PRAC Rapporteur name updated
482 caffeine (apnea) 02/07/2009 3 years 02/07/2026 30/09/2026 Yes 28/02/2024 DLP04/02/2016
Next
on was
DLPamended on 28/02/2024
was amended on PSUSA/00000482/202607 Sonja Hrabcik Austria CAP NAP
08/08/2014
Next DLP updated and PRAC
483 caffeine / dihydroergocryptine mesilate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 Next DLP was
Rapporteur amended
amended onon PSUSA/00000483/204001 NAP
31/01/2014
27/11/2015.
486 caffeine / isometheptene / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000486/204001 NAP
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488 caffeine / phenazone Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000488/204001 NAP
494 calcitonin salmon, synthetic analogue of eel calcitonin 13/05/1975 5 years 19/06/2026 17/09/2026 No 02/03/2022 PSUR frequency and DLP were PSUSA/00000494/202606 Monica Martinez Redondo Spain NAP
PRAC Representative updated on
updated on 22/09/2021
26/09/2018
PRAC representative was
PRAC Rapporteur name updated
495 calcitriol 01/01/1978 5 years 01/01/2026 01/04/2026 No 19/10/2022 updated on 25/09/2019
on 03/06/2016
PSUSA/00000495/202601 Amelia Cupelli Italy NAP
517 calcium folinate / cyanocobalamin Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PRAC representative was PSUSA/00000517/202701 NAP
updated on 01/03/2023
"Are
Next PSURs
DLP wasrequired
updated foron
products
548 carbidopa / levodopa 13/08/1973 3 years 01/10/2025 30/12/2025 No 03/06/2020
referred to in Articles 10(1), 10a,
PSUSA/00000548/202510 Barbara Kovacic Bytyqi Croatia NAP
31/05/2023
14, 16a of Directive 2001/83/EC
as amended? Yes/No" was
550 carbimazole 31/08/1988 7 years 02/12/2030 02/03/2031 No 31/07/2024 amended on 16/07/2015
DLP was amended on 31/07/2024 PSUSA/00000550/203012 Martin Huber Germany NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 10 / 223
DLP was updated on 19/10/2022
PSUR frequency amended and
554 carbocisteine 14/09/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00000554/202803 NAP
DLP
PRACupdated on 28/08/2024
representative was
updated on 28/07/2021
PSUR frequency amended and
555 carbocisteine / prenoxidiazine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PRAC representative was PSUSA/00000555/202907 NAP
DLP updated
PSUR on 28/08/2024
frequency and DLP were
updated on 28/04/2021
updated on 19/10/2022
DLP was updated on 17/10/2017
557 carbomers Not available* 5 years 31/01/2027 01/05/2027 No 19/10/2022 PRAC representative was PSUSA/00000557/202701 Polona Golmajer Slovenia NAP
updated
Lead MS on
was17/11/2021
amended on
22/09/2016
PSUR frequency
PRAC amended
representative was and
558 carbon dioxide Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00000558/202512 Melinda Pálfi Hungary NAP
DLP updated
updated on 31/07/2024
Lead MS on
and30/06/2021
PRAC Rapporteur
name was added on 28/07/2016
udpated on 22/09/2021
DLP was updated 25/09/2019
559 carboplatin 23/01/1986 5 years 23/01/2027 23/04/2027 Yes 19/10/2022 Active substance name was PSUSA/00000559/202701 Amelia Cupelli Italy NAP
Next
PRAC DLP was amended
Rapporteur
amended on
name updated
on 03/06/2016
19/10/2016
on 27/06/2017
560 carboprost 09/01/1979 5 years 08/01/2026 08/04/2026 No 22/09/2021
PRACDLP
Representative
PSUSA/00000560/202601 Eva Jirsová Czech Republic NAP
Next was updatedwas
on
DLP was updated
amended on 21/10/2020
on 27/11/2015.
22/09/2016
PSUR frequency
Correction amended
of PRAC and
Rapporteur
562 carmellose (eye preparation) 01/10/1990 8 years 03/06/2025 01/09/2025 No 30/10/2024 EURD
Lead andwas
MS DLP amended
added on on PSUSA/00000562/202506 Karin Bolin Sweden NAP
DLP
nameupdated on 03/07/2024
on 28/02/2017
06/10/2015
13/07/2015
PRAC Rapporteur
Lead MS added onname was
31/07/2015.
PSUR frequency and DLP
563 carbutamide 18/12/1997 8 years 03/11/2025 01/02/2026 No 31/07/2024 amended on 20/12/2016 PSUSA/00000563/202511 NAP
amended on 31/07/2024
PRAC Rapporteur name updated
on 04/02/2016
564 carglumic acid 24/01/2003 5 years 31/01/2025 01/05/2025 No 21/10/2020 PSUSA/00000564/202501 Ana Sofia Diniz Martins Portugal CAP
Next DLP and Are PSURs required
for products referred to in
PSUR frequency
PRAC and DLP
representative was
572 carnitine 01/09/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 Articles 10(1), 10a, 14, 16a of PSUSA/00000572/203408 NAP
amendedon
updated on19/10/2022
23/10/2024
Directive 2001/83/EC as
amended? Yes/No" was amended
DLP and Information included in
on 30/09/2015.
574 carteolol 07/03/1984 5 years 31/03/2029 29/06/2029 No 18/12/2024 DLP was"Are
column amended
PSURson 18/12/2024
required for PSUSA/00000574/202903 Anna Mareková Slovakia NAP
DLP
PRACwas
products updated
referred on
representative 21/12/2022
to in Articles
name was
10(1),
Lead MS
amended 10a,on14,
and 16a Rapporteur
PRAC of Directive
31/07/2015.
DLP was
2001/83/EC
name updated
added as on 19/12/2017
onamended?"
31/01/2024 were
575 carvedilol 18/04/1990 5 years 17/04/2027 16/07/2027 No 21/12/2022 PSUSA/00000575/202704 Kimmo Jaakkola Finland NAP
amended on 21/09/2022
Lead
ActiveMS and PRAC
substance Rapporteur
name was
name
PRAC
amendedwason added
Representativeon 19/10/2016
31/01/2024amended
576 caspofungin 24/10/2001 3 years 13/12/2024 13/03/2025 No 21/09/2022 on 28/04/2022 PSUSA/00000576/202412 Jo Robays Belgium CAP NAP
DLP was updated on 06/05/2020
PSUR frequency amended and
DLP updated
LMS and PRAC onrepresentative
03/04/2019
582 estrogen / medroxyprogesterone 01/08/1987 5 years 31/08/2024 29/11/2024 No 31/01/2024 PSUSA/00000582/202408 Jana Lukačišinová Czech Republic NAP
added 03/07/2019
DLP was amended on 25/09/2017
Transferred from the List of
PSUR frequencyNAPamended and
583 cefaclor 19/08/1976 8 years 03/03/2025 01/06/2025 No 26/07/2024 Reference
substances tounder products
PSUR Work was PSUSA/00000583/202503 Melinda Palfi Hungary NAP
DLP updated
updated on on 03/07/2024
30/01/2017
Sharing
DLP wasscheme
updated and other
on 05/04/2023
substances contained in
PRACwas
DLP Representative
Nationally Authorised
updated amended
Products
on 27/03/2018
584 cefadroxil 12/07/1976 5 years 11/07/2027 09/10/2027 No 05/04/2023 on 18/11/2016
with DLP synchronised on PSUSA/00000584/202707 Jan Neuhauser Austria NAP
06/03/2015
Lead MS and PRAC Rapporteur
name was added on 20/12/2016
PSUR frequency and DLP
585 cefalexin 15/03/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUSA/00000585/202804 NAP
amended on 31/07/2024
Lead MS
PSUR was added
frequency on
amended and
600 cefotiam 26/10/1985 8 years 03/05/2025 01/08/2025 No 03/07/2024 PSUSA/00000600/202505 NAP
13/07/2015
DLP updated on 03/07/2024
604 cefpodoxim 02/08/1990 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000604/203012 Amelia Cupelli Italy NAP
605 cefprozil 23/12/1991 5 years 22/12/2027 21/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00000605/202712 Polona Golmajer Slovenia NAP
608 ceftazidime 17/10/1983 5 years 17/10/2028 15/01/2029 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00000608/202810 Mari Thorn Sweden NAP
613 ceftriaxone 27/05/1982 5 years 26/05/2028 24/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000613/202805 Zane Neikena Latvia NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 11 / 223
DLP was updated on 21/12/2022
645 charcoal activated 06/04/1949 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000645/204001 NAP
652 aminoacids / chloramphenicol / vitamin a Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000652/203001 NAP
654 chloramphenicol / dexamethasone 19/05/1964 18 years 31/05/2030 29/08/2030 No 01/10/2012 PSUSA/00000654/203005 NAP
655 chloramphenicol / hydrocortisone (ocular) 06/11/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000655/203001 NAP
Activefrequency
PSUR substanceamended
name wasand
715 chlorpromazine 29/05/1952 5 years 29/05/2028 27/08/2028 No 31/01/2024
amended on 30/04/2024
PSUSA/00000715/202805 Tiphaine Vaillant France NAP
DLP updated on 31/01/2024
730 cholera vaccine (inactivated, oral) 28/04/2004 3 years 28/04/2026 27/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000730/202604 Mari Thorn Sweden CAP
732 choline salicylate 10/12/1963 13 years 10/12/2025 10/03/2026 No 01/10/2012 PSUSA/00000732/202512 NAP
774 ciprofloxacin hydrochloride / hydrocortisone Not available* 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00000774/202611 Amelia Cupelli Italy NAP
775 ciprofloxacin (systemic use) 31/01/1987 5 years 02/04/2028 01/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00000775/202804 Karen Pernille Harg Norway NAP
DLP and 'Are PSURs required for
products referred to in Articles
Next DLP
10(1), was
10a, updated
16a on
of Directive
776 ciprofloxacin (topical use) 31/01/1987 5 years 31/01/2028 30/04/2028 No 18/10/2023 PSUSA/00000776/202801 Karen Pernille Harg Norway NAP
18/10/2023 as amended?' were
2001/83/EC
updated on 31/03/2021
783 citric acid / potassium salts, potassium citrate Not available* 6 years 03/11/2029 01/02/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00000783/202911 Polona Golmajer Slovenia NAP
DLP was updated on 20/10/2021
Entrywas
DLP name amended
updated on on
788 clarithromycin 17/07/1989 3 years 01/04/2026 30/06/2026 No 20/12/2023 DLP was amended on04/03/2020
20/12/2023 PSUSA/00000788/202604 Eamon O'Murchu Ireland NAP
19/12/2017
LMS and PRAC representatives
PRAC Representative
were added was
on 31/07/2019
789 clebopride 22/02/1979 5 years 30/06/2024 28/09/2024 No 04/03/2020 amended on 28/03/2017 PSUSA/00000789/202406 Monica Martinez Redondo Spain NAP
Transferred from the List of
next DLP was
substances amended
under PSUR on
Work
29/10/2015
Sharing
PSUR scheme and DLP
frequency other
790 clebopride hydrogen maleate / simeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUSA/00000790/202912 NAP
substances
amended oncontained in
28/08/2024.
Nationally Authorised Products
with DLP synchronised on
PSUR frequency amended and
06/03/2015
791 clemastine 11/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00000791/202803 NAP
DLP updated on 28/08/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
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PSUR frequency and DLP
821 cloprednol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUSA/00000821/202912 NAP
amended on 28/08/2024.
PSUR frequency
PRAC and DLP
representative was
824 clorazepate dipotassium Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUSA/00000824/202912 NAP
amendedon
updated on19/10/2022
28/08/2024.
Lead MS
PSUR was added
frequency on
amended and
829 clotrimazole 08/10/1975 8 years 03/03/2025 01/06/2025 No 26/07/2024 06/03/2015 PSUSA/00000829/202503 Melinda Palfi Hungary NAP
DLP updated on 03/07/2024
858 colchicine 30/07/1947 5 years 30/07/2028 28/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000858/202807 Maria del Pilar Rayon Spain NAP
864 colesevelam 10/03/2004 3 years 10/03/2027 08/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000864/202703 Bianca Mulder Netherlands CAP NAP
873 conestat alfa 28/10/2010 6 months 28/10/2024 06/01/2025 28/04/2025 07/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000873/202410 PSUSA/00000873/202504 Jan Neuhauser Austria CAP
883 cromoglicic acid 01/02/1969 5 years 01/02/2027 02/05/2027 No 19/10/2022 Correction of DLP on 31/01/2018 PSUSA/00000883/202702 Eamon O'Murchu Ireland NAP
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PSUR frequency amended and
886 cyamemazine 14/06/1971 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00000886/202503 Tiphaine Vaillant France NAP
DLP updated on 03/07/2024
905 cyproterone 22/11/2009 5 years 03/07/2028 01/10/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00000905/202807 Barbara Kovacic Bytyqi Croatia NAP
906 cyproterone / ethinylestradiol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00000906/202605 Bianca Mulder Netherlands NAP
PSUR frequency
Submission date amended
correctedand
on
928 dapoxetine 17/12/2008 5 years 17/12/2028 17/03/2029 No 25/09/2024 PSUSA/00000928/202812 Mari Thorn Sweden NAP
DLP updated on 25/09/2024
06/05/2020
DLP
PSURand PSUR frequency
frequency and DLP
929 dapsone Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 updated on PSUSA/00000929/202603 NAP
amended on30/04/2019
31/07/2024.
PRAC frequency
PSUR Rapporteurand
name
DLPupdated
were
PSUR
on frequency
03/04/2018
updated amended and
on 01/02/2023
930 dapsone / ferrous oxalate 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00000930/202806 NAP
DLP updated on 28/08/2024
Lead MS and
Reference PRACadded
to NAP Rapporteur
on
name updated on 23/10/2018
21/09/2022
931 daptomycin 19/01/2006 3 years 11/09/2024 10/12/2024 No 25/05/2022 PSUSA/00000931/202409 Pernille Harg Norway CAP
DLP
New was
CAP updated on on
authorised 07/05/2018
DLP was updated on 29/06/2022
24/03/2022
Next DLP was amended on
932 darbepoetin alfa 08/06/2001 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was
PRAC amended on name
Representative
26/04/2017
03/07/2024
was PSUSA/00000932/202610 Martin Huber Germany CAP
DLP was updated
corrected on 02/02/2022
on 29/07/2020
Next DLP
PRAC was amended
representative wason
DLP was updated on 03/07/2019
933 darifenacin 22/10/2004 3 years 31/10/2024 29/01/2025 No 29/06/2022 03/05/2016
updated on 31/03/2021 PSUSA/00000933/202410 Maria del Pilar Rayon Spain CAP
PRAC Representative
"Are was
PSURs required updated on
DLP
26/09/2018updated on for products
03/02/2021
referred
PSUR to in Articles
frequency 10(1),
amended 10a,
and
934 darunavir 12/02/2007 5 years 23/12/2028 23/03/2029 No 25/09/2024 14, 16a of Directive PSUSA/00000934/202812 Liana Martirosyan Netherlands CAP
DLP
Next
updated
was
DLPupdated on2001/83/EC
on 25/09/2024
was Yes/No"
updated05/02/2020
on
as amended? was
28/06/2016
amended on 16/07/2015
PRAC representative was
Marie Louise Schougaard
935 dasatinib 20/11/2006 3 years 27/06/2025 25/09/2025 No 01/02/2023 updated on 25/09/2019 PSUSA/00000935/202506
Christiansen Denmark CAP NAP
PSUR
PRAC frequency amended
representative was and
938 dectaflur / olaflur / sodium fluoride Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00000938/203003 NAP
DLP updated
updated on 28/08/2024
on 03/06/2020
Next DLP
PSUR was amended
frequency and DLPon
957 dermatan sulfate Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024
26/04/2017
PSUSA/00000957/202411 Amelia Cupelli Italy NAP
amended on 27/03/2024
PRAC representative was
Next DLPon
updated was amended on
19/10/2022
958 desflurane 18/09/1992 3 years 30/09/2026 29/12/2026 Yes 05/06/2024 03/05/2016
DLP was amended on 05/06/2024 PSUSA/00000958/202609 Melinda Palfi Hungary NAP
PRAC Representative
Information included inamended
column
Active
on Substance
28/04/2022
"Are PSURs wasfor
required amended
products
on 31/07/2015
referred to in Articles 10(1), 10a,
962 desloratadine 15/01/2001 5 years 15/07/2026 13/10/2026 Yes 28/04/2022 PSUSA/00000962/202607 Jo Robays Belgium CAP NAP
DLP16a
14, wasof
updated
Directiveon2001/83/EC
30/03/2022
Next
as DLP was amended
amended?" was amendedon on
02/05/2014
DLP was updated on 28/03/2017
27/07/2022
963 desloratadine / pseudoephedrine 30/07/2007 5 years 15/07/2026 13/10/2026 No 28/04/2022 PRAC Rapporteur name was PSUSA/00000963/202607 Jo Robays Belgium CAP
amended on 22/09/2022
PRAC Representative amended
18/11/2016
on 28/04/2022
DLP was updated on 02/03/2022
964 desmopressin 01/12/1972 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amendedon
DLP was updated
on 25/09/2024
updated on 30/06/2021
30/03/2022
PSUSA/00000964/202612 Jan Neuhauser Austria NAP
PRAC Rapporteur name updated
on 23/10/2018
Next
DLP DLPupdated
was was amended on
on 28/03/2017
966 desogestrel 01/07/1998 5 years 01/07/2026 29/09/2026 No 02/03/2022 03/06/2016 PSUSA/00000966/202607 Karin Bolin Sweden NAP
PSUR Frequency
PRAC amended
Representative and
amended
DLP18/11/2016
PRAC
on updated on 28/03/2017
Rapporteur name updated
on 30/09/2015
967 desogestrel / ethinylestradiol 01/10/1994 5 years 30/09/2025 29/12/2025 No 30/06/2021 Lead MS and PRAC Rapporteur PSUSA/00000967/202509 Kimmo Jaakkola Finland NAP
PRAC
"Are representative
was added
PSURs on wasproducts
04/02/2016
required for
updated onin
referred to 19/10/2022
Articles 10(1), 10a,
PSUSA
14,
PSUR16a number was
andamended
of Directive
frequency 2001/83/EC
DLP on
968 desonide 31/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PRAC representative PSUSA/00000968/202812 NAP
06/10/2014
as amended?
amended Yes/No"was
on 31/07/2024 was
updated on 27/07/2022
amended on 16/07/2015
PSUR
DLP frequency
Leadwas
MS updatedand
added onon DLP
20/10/2021
12/05/2015
969 desoximetasone 23/01/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00000969/203408 NAP
amended on 23/10/2024
PRAC representative was
updated on 30/06/2021
dexamethasone (apart from centrally authorised
973 01/01/1952 5 years 31/01/2026 01/05/2026 No 19/10/2022 PSUSA/00000973/202601 Amelia Cupelli Italy NAP
products)
Next DLP was amended on
19/10/2016
PSUR frequency and DLP
974 dexamethasone / framycetin / gramicidin 10/08/1954 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUSA/00000974/203612 NAP
Entry name
amended onamended on
23/10/2024
03/05/2016
dexamethasone / neomycin / polymyxin b, PSUR frequency andwas
DLPamended
977 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 Rapporteur's name PSUSA/00000977/203212 none NAP
dexamethasone / neomycin amended
PRAC on 23/10/2024
representative
on 27/11/2015. was
updated on 27/07/2022
Lead MS added on
PSUR frequency and DLP31/07/2015.
978 dexamethasone / polymyxin b / trimethoprim 01/01/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 DLP and active substance name PSUSA/00000978/204006 NAP
amended on 23/10/2024
updated on 22/12/2021
PSUR frequency amended and
DLP updated on 05/06/2024
dexamethasone / tobramycin (topical and ophtalmic PRAC representative was
979 Not available* 5 years 31/03/2026 29/06/2026 No 27/07/2022 PSUSA/00000979/202603 Amelia Cupelli Italy NAP
use, except systemic formulations) updated on 30/06/2021
Information included in column
"Are PSURs required for products
LMS and PRAC representative
referred to in Articles 10(1), 10a,
980 dexamethasone / lidocaine Not available* 8 years 11/05/2032 09/08/2032 Yes 05/06/2024 were added on 23/06/2020 PSUSA/00000980/203205 none NAP
14,
PSUR16a of Directive
frequency 2001/83/EC
amended and
as amended?"
DLP onwasonamended on
PSURupdated
was updated
Frequency 05/06/2024
19/10/2022
amended and
05/06/2024
dexamethasone isonicotinate / tramazoline next DLP
PSUR updated
frequency on DLP
and 25/09/2017
982 01/01/1963 11 years 03/07/2039 01/10/2039 No 23/10/2024 Informationofincluded
Correction in column PSUSA/00000982/203907 NAP
hydrochloride monohydrate amended on 23/10/2024 date on
submission
Active
"Are substance
PSURs
23/09/2020 name
required for was
products
amendedtoon
referred in05/06/2024
Articles 10(1), 10a,
dexamethasone / framycetin sulfate / polymyxin b 14, 16a
PSUR of Directive
frequency and2001/83/EC
DLP were
983 Not available* 10 years 01/12/2032 01/03/2033 Yes 05/06/2024 PSUSA/00000983/203212 none NAP
sulfate as amended?"
updated was amended on
on 25/09/2019
05/06/2024
DLP
LMS was
and updated on 02/03/2022
PRAC representative
PSUR frequency amended and
984 dexamethasone sodium phosphate / gentamicin sulfate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 Entry re-activated
updated on 05/06/2024
on 30/04/2019 PSUSA/00000984/203008 NAP
DLP updated
Next DLP wason 28/08/2024
updated on
06/03/2019
Name Frequency
PSUR of active substance
and DLP was
dexamethasone (centrally authorised product amendedon
updated on19/12/2018
28/02/2013
985 27/07/2010 3 years 27/01/2025 27/04/2025 No 19/10/2022 Correction of PRAC Rapporteur PSUSA/00000985/202501 Maria del Pilar Rayon Spain CAP
indicated in uveitis and macular oedema)
name on 28/02/2017
PSUR Frequency and DLP
updated on 26/09/2018
986 dexamfetamine Not available* 1 year 11/09/2024 20/11/2024 11/09/2025 20/11/2025 Yes 30/04/2024 PRAC Rapporteur
DLP was amendedname was
on 30/04/2024 PSUSA/00000986/202409 PSUSA/00000986/202509 Ana Sofia Diniz Martins Portugal NAP
amended on 20/12/2016
Next DLP was amended on
25/09/2017
Next DLP was updated on
989 dexchlorpheniramine 18/02/1962 3 years 30/06/2024 28/09/2024 No 02/03/2022 04/03/2016
Next PSUSA/00000989/202406 Ana Sofia Diniz Martins Portugal NAP
PRACDLP updated on 22/09/2016
Representative updated on
16/11/2022
Information included inoncolumn
Entry name amended
"Are PSURs required for products
996 dexibuprofen 25/07/2000 3 years 31/08/2026 29/11/2026 No 30/04/2024 03/05/2016
DLP was to
referred
amended
updated on29/06/2022
on
in Articles
30/04/2024
10(1), 10a,
PSUSA/00000996/202608 Jan Neuhauser Austria NAP
14, 16a
Next DLPof Directive
updated on2001/83/EC
30/09/2015
DLP was updated
as amended?" wasonamended
03/07/2019
on
997 dexketoprofen 07/07/2002 3 years 31/10/2024 29/01/2025 No 29/06/2022 04/03/2016 PSUSA/00000997/202410 Monica Martinez Redondo Spain NAP
PRAC Representative updated on
26/09/2018
PRAC representative was
updated on 04/03/2016
998 dexmedetomidine 16/09/2011 3 years 15/03/2027 13/06/2027 No 20/11/2024 Next DLPamended
DLP was was amended on
on 20/11/2024 PSUSA/00000998/202703 Karin Bolin Sweden CAP NAP
28/07/2016
Lead MS added on 01/04/2015
Lead MS
PSUR added on
frequency 16/06/2015
amended and
999 dexpanthenol 03/03/1999 10 years 02/01/2034 02/04/2034 No 25/09/2024 PSUSA/00000999/203401 Terhi Lehtinen Finland NAP
DLP updated on 25/09/2024
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PSUR frequency and DLP
1002 dextran Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 Information PSUSA/00001002/203506 NAP
amended onincluded in column
23/10/2024
"Are PSURs required for products
referred to in Articles 10(1), 10a,
PSUR
14, frequency
16a amended
of Directive and
2001/83/EC
1004 dextran 70 / hypromellose Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00001004/203008 NAP
DLPamended?"
as updated onwas28/08/2024
amended on
26/07/2023
PSUR frequency and DLP
1006 dextran 70 / sodium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUR frequency and DLP were PSUSA/00001006/204003 NAP
amended on 23/10/2024
updated on 28/06/2022
PSUR frequency
Information and DLP
included in column
1030 diazepam / pyridoxine 04/04/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUSA/00001030/203912 NAP
amended
"Are PSURsonrequired
23/10/2024
for products
referred to in Articles 10(1), 10a,
14, 16a
PSUR of Directive
frequency 2001/83/EC
amended and
1032 diazoxide 29/12/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 as amended?" PSUSA/00001032/202806 NAP
DLP updated onwas amended on
28/08/2024
28/05/2014
PSUR frequency, DLP and active
substance name were updated
1034 dibotermin alfa 09/09/2002 5 years 08/09/2025 07/12/2025 No 26/05/2021 on 26/05/2021
DLP was updated on 23/09/2020 PSUSA/00001034/202509 Bianca Mulder Netherlands CAP
DLP was
PRAC updated on 07/05/2018
representative was added
PSUR
on frequency and DLP
06/05/2020
1038 dichlorobenzyl alcohol Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00001038/202603 NAP
amended on 31/07/2024.
LMS was added 31/07/2019
PSUR frequency amended and
1040 diclofenac / misoprostol Not available* 2 years 17/07/2025 15/10/2025 No 28/02/2024 Information included in column PSUSA/00001040/202507 Karin Erneholm Denmark NAP
DLP updated on 28/02/2024
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
1041 cyanocobalamin / diclofenac / pyridoxine / thiamine Not available* 5 years 01/01/2025 01/04/2025 Yes 23/09/2020 PSUSA/00001041/202501 Adam Przybylkowski Poland NAP
as amended?" was amended on
06/02/2019
PSUR frequency and DLP
1045 diclofenac sodium / orphenadrine citrate Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 Next DLP was amended on PSUSA/00001045/202603 NAP
amended on 31/07/2024.
03/06/2016
"Are PSURs
PRAC required
Rapporteur for was
name products
1048 diclofenac (systemic formulations) 11/05/1977 3 years 30/09/2024 29/12/2024 No 16/10/2023 referred toon
in18/10/2023
Articles 10(1), 10a, PSUSA/00001048/202409 Karin Erneholm Denmark NAP
amended
14, 16a of Directive 2001/83/EC
as amended? Yes/No" was
PSUR frequency
amended and DLP
on 16/07/2015
1050 dicloxacillin 24/02/1961 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00001050/203404 NAP
amended on 23/10/2024
1057 dienogest / ethinylestradiol 14/02/1995 5 years 15/03/2028 13/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001057/202803 Martin Huber Germany NAP
1069 artenimol / piperaquine tetraphosphate 27/10/2011 3 years 27/10/2025 25/01/2026 No 28/06/2023 DLP was amended on 28/06/2023 PSUSA/00001069/202510 Martin Huber Germany CAP
Information included in column
"Are PSURs required for products
referred to in Articles 10(1), 10a,
1070 dihydrocodeine 11/11/1921 11 years 03/11/2036 01/02/2037 No 18/10/2023 14, 16a of Directive 2001/83/EC PSUSA/00001070/203611 none NAP
as amended?" , PSUR frequency
and DLP wereamended on
18/10/2023
1075 dihydroergotamine 01/07/1946 3 years 01/04/2027 30/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00001075/202704 Adam Przybylkowski Poland NAP
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PSUR frequency and DLP
1080 dihydrotachysterol 01/04/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00001080/203401 NAP
amended on 23/10/2024
1102 dimetindene / phenylephrine 29/09/1965 5 years 15/07/2025 13/10/2025 No 27/07/2022 PRAC representative was added PSUSA/00001102/202507 Anna Mareková Slovakia NAP
on 06/05/2020
LMS was
PSUR added amended
frequency on 01/04/2020
and
1103 dinoprost trometamol 08/05/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001103/202806 NAP
DLP updated on 28/08/2024
DLP was updated on 05/06/2019
Next DLP was updated on
1104 dinoprostone 26/09/1972 3 years 30/09/2025 29/12/2025 No 03/06/2020 PSUSA/00001104/202509 Karin Bolin Sweden NAP
31/05/2023
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
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PSUR frequency and DLP
1140 dirithromycin 26/04/1993 8 years 03/08/2025 01/11/2025 No 31/07/2024 PSUSA/00001140/202508 NAP
amended on 31/07/2024
PSUR frequency
PRAC amended
representative was and
1145 disulfiram 04/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001145/202806 NAP
DLP updated
updated on 28/08/2024
on 19/10/2022
PRAC Representative
PSUR frequency amended
and DLP
1150 dobesilate calcium 13/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 on 28/04/2022 PSUSA/00001150/202805 NAP
amended on 31/07/2024
Lead MS
PRAC and PRACname
Rapporteur Rapporteur
was
1166 dorzolamide / timolol 06/03/1998 5 years 18/02/2029 19/05/2029 No 16/10/2023
name wason
added on 28/02/2017
PSUSA/00001166/202902 Karin Erneholm Denmark NAP
amended 18/10/2023
DLP
PSURwas updatedamended
frequency on 05/04/2023
and
1174 doxylamine 07/04/1948 5 years 06/04/2028 05/07/2028 No 20/12/2023 PSUSA/00001174/202804 Ana Sofia Diniz Martins Portugal NAP
DLP updated on 20/12/2023
Reference to NAP removed on
05/04/2023
PSUR frequency and DLP
1176 doxylamine succinate / pyridoxine hydrochloride 07/04/1948 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00001176/203211 NAP
amended
DLP on 23/10/2024
was updated, Information
included in column "Are PSURs
required for products referred to
bemotrizinol / butyl methoxydibenzoylmethane / PSUR frequency and DLP
1178 Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 in Articles 10(1), 10a, 16a of PSUSA/00001178/202905 NAP
drometrizole amended on 31/07/2024
Directive 2001/83/EC as
amended?" and
Information reference
included to NAP
in column
was added
"Are PSURs on 01/04/2020
required for products
1180 dronedarone 26/11/2009 3 years 31/07/2025 29/10/2025 No 05/04/2023 PSUSA/00001180/202507 Bianca Mulder Netherlands CAP
referred to in Articles 10(1), 10a,
PSUR
14, 16aFrequency amended
of Directive and
2001/83/EC
DLPamended?"
as updated onwas 28/03/2017
amended on
1181 droperidol 20/04/1963 9 years 03/03/2028 01/06/2028 No 26/07/2023 26/07/2023 PSUSA/00001181/202803 none NAP
Next DLP was amended on
07/04/2016
Update of PSUR frequency & DLP
resulting
PSUR from PRAC
frequency and re-allocation
DLP
1182 droperidol / fentanyl 14/08/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 The DLP was amended PSUSA/00001182/203503 NAP
exercise
amended for
onentries withon
23/10/2024 DLPs in
06/03/2015
2025 on 26/07/2023
PSUR frequency
The DLP and DLP
was amended on
1183 dropropizine Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00001183/202603 NAP
amended on 31/07/2024.
01/04/2014
1202 eflornithine (topical use) 20/03/2001 5 years 26/07/2028 24/10/2028 No 27/03/2024 DLP was
PRAC amendedname
Rapporteur on 27/03/2024
updated PSUSA/00001202/202807 Rhea Fitzgerald Ireland CAP
DLP was updated on 25/05/2022
on 27/06/2017
PSUR frequency and DLP were
Next DLP was updated on
1204 eletriptan 20/01/2000 5 years 19/02/2026 20/05/2026 No 20/10/2021 updated on 30/04/2019 PSUSA/00001204/202602 Eva Jirsová Czech Republic NAP
18/11/2016
DLP was updated on 07/05/2018
The DLP amended on 30/09/2015
1205 eltrombopag 11/03/2010 3 years 30/09/2024 09/12/2024 No 25/05/2022 PSUSA/00001205/202409 Monica Martinez Redondo Spain CAP
DLP was updated on 23/05/2017
Lead MS was added on
13/07/2015
PRAC Representative amended
1207 emedastine 27/01/1999 3 years 31/05/2026 29/08/2026 No 19/09/2024 on 28/06/2016 PSUSA/00001207/202605 Zoubida Amimour France CAP
1210 emtricitabine / tenofovir disoproxil 21/02/2005 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001210/202604 Ana Sofia Diniz Martins Portugal CAP
1211 enalapril 01/11/2004 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001211/202803 Mari Thorn Sweden NAP
1215 enalapril maleate / lercanidipine 26/07/2006 7 years 03/06/2031 01/09/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001215/203106 Carla Torre Portugal NAP
The DLP
PSUR was
of amended
frequency
Correction amended
active on and
substance Marie Louise Schougaard
1234 epirubicin 28/06/1982 5 years 30/06/2028 28/09/2028 No 28/02/2024
03/03/2014
PSUSA/00001234/202806
Christiansen Denmark NAP
DLP
nameupdated on 28/02/2024
on 30/03/2022
PRAC representative
PSUR frequency was
and DLP
1235 epitizide / triamterene Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 updated on PSUSA/00001235/202603 NAP
amended on29/07/2020
31/07/2024.
PRAC representative was
PRAC representative
updated updated on
on 03/06/2020
1236 eplerenone 16/03/2004 7 years 15/03/2029 13/06/2029 No 31/01/2024 PSUSA/00001236/202903 Bianca Mulder Netherlands NAP
31/01/2024
DLP was updated on 05/06/2019
1237 epoetin alfa 04/08/1988 3 years 31/08/2024 29/11/2024 No 28/04/2022 PRAC Rapporteur name updated PSUSA/00001237/202408 Tiphaine Vaillant France CAP NAP
on 21/07/2017
PRAC Rapporteur
Next DLP nameon
was updated was
1239 epoetin beta 16/07/1997 3 years 13/02/2026 14/05/2026 No 18/10/2023 Reference
amended to 28/07/2016
on NAP removed on PSUSA/00001239/202602 Martin Huber Germany CAP
18/10/2023
25/09/2024
Next DLP was amended on
PSUR
Next frequency
DLP amended
was updated on and
1240 epoetin theta 23/10/2009 5 years 20/04/2029 19/07/2029 No 18/12/2024 03/05/2016 PSUSA/00001240/202904 Tiphaine Vaillant France CAP
DLP updated on 18/12/2024
25/09/2024
Rapporteur name amended on
DLP was updated and reference
04/11/2014
1241 epoetin zeta 18/12/2007 3 years 18/12/2026 18/03/2027 No 25/09/2024 DLP was updated on 21/12/2022 PSUSA/00001241/202612 Martin Huber Germany CAP
to NAP added on 22/09/2021
EURD Rapporteur
PRAC was amended on updated
name
PRAC Rapporteur name was
01/10/2013
on 23/10/2018
amended
DLP on 31/07/2018
was updated on 01/02/2023
1242 epoprostenol 18/03/1981 5 years 31/03/2027 29/06/2027 No 21/12/2022 PSUSA/00001242/202703 Eamon O'Murchu Ireland NAP
DLP was updated on 19/12/2017
DLP
PRACwas updated name
Rapporteur on 31/07/2018
was
amended
PSUR on 31/07/2018
frequency, DLP and active
Lead
DLP MS
was and PRAC Rapporteur
1243 eprosartan 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023 Next DLPupdated
substance
on
on01/02/2023
updatedwere 30/09/2015 PSUSA/00001243/202704 Martin Huber Germany NAP
name was name updated
added on 19/10/2016
DLP was amended
on 22/09/2021 on 31/01/2018
PRAC Rapporteur name was
amended on 31/07/2018
Lead MS
PRAC and PRAC Rapporteur
Representative updated on
1244 eprosartan / hydrochlorothiazide 30/04/1997 5 years 30/04/2027 29/07/2027 No 01/02/2023
name was added on 19/10/2016
PSUSA/00001244/202704 Martin Huber Germany NAP
26/09/2018
DLP was amended on 31/01/2018
DLP was updated on 31/07/2018
Lead MS and PRAC Rapporteur
1245 eptacog alfa 23/02/1996 5 years 31/12/2025 31/03/2026 No 22/09/2021
name was added on 19/10/2016
PSUSA/00001245/202512 Bianca Mulder Netherlands CAP
Reference to NAP products
removed on 19/12/2017
PRAC Rapporteur name was
1246 eptifibatide 01/07/1999 3 years 01/01/2026 01/04/2026 No 19/09/2024 amended on
Reference to 28/04/2022
NAP products added
PSUSA/00001246/202601 Zoubida Amimour France CAP
on 17/10/2017
PRAC Rapporteur name was
amended on 03/04/2019 Marie Louise Schougaard
1248 erdosteine Not available* 10 years 01/02/2026 02/05/2026 No 19/10/2016 PSUR Frequency amended on PSUSA/00001248/202602
Christiansen Denmark NAP
31/07/2015
PSUR Frequency amended and
DLP updated on 19/10/2016
PSUR frequency and DLP
1250 ergometrine Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PSUSA/00001250/202605 NAP
amended on 31/07/2024
Lead MS added on 31/07/2015.
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 21 / 223
PSUR frequency and DLP
1251 ergometrine / oxytocin 15/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00001251/203404 NAP
amended on 23/10/2024
doederlein bacillus selected strain (lactobacillus casei PSUR frequency and DLP
1285 22/09/1998 8 years 03/11/2025 01/02/2026 No 31/07/2024 PSUSA/00001285/202511 NAP
ssp rhamnosus) / estriol / progesterone amended on 31/07/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 22 / 223
PRAC Rapporteur name was
amended on 28/04/2022
ethyl nicotinate / hydroxyethyl salicylate / nonylic acid PSUR frequency amended and
1318 Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001318/203011 NAP
vanillylamide DLP updated on 28/08/2024
1321 etifoxine Not available* 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001321/202610 Maria Popova-Kiradjieva Bulgaria NAP
DLP was
PRAC updated name
Rapporteur on 21/11/2018
was
1344 technetium (99mTc) exametazime 01/02/1986 15 years 31/01/2031 01/05/2031 No 16/10/2023 PSUSA/00001344/203101 Karin Erneholm Denmark NAP
amended on 18/10/2023
PSUR submission frequency and
next DLP were amended on
PRAC
Next Rapporteur
DLP updated
was updated on on
1345 exemestane 16/12/1998 5 years 15/12/2025 15/03/2026 No 15/11/2023 29/10/2015 PSUSA/00001345/202512 Barbara Kovacic Bytyqi Croatia NAP
15/11/2023
28/06/2023
Correction of DLP was done on
PRAC Rapporteur name was
28/05/2014
1346 ezetimibe 17/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 amended on 31/07/2018 PSUSA/00001346/202710 Martin Huber Germany NAP
Conditional approval
DLP was
PSUR updatedand
frequency on DLP
04/07/2018
were
1347 ezetimibe / simvastatin 02/04/2004 5 years 10/03/2029 08/06/2029 No 20/11/2024 updated
DLP was on 22/09/2021
amended on 20/11/2024 PSUSA/00001347/202903 Martin Huber Germany NAP
Lead MS added on 16/06/2015
New
Lead CAP authorised
MS and on
PRAC Rapporteur
24/09/2020
name amended on 19/12/2018
1349 famciclovir 10/12/1993 5 years 31/12/2025 31/03/2026 No 22/09/2021 PSUSA/00001349/202512 Jana Lukačišinová Czech Republic NAP
DLP
DLP was
was updated
updated on
on 23/09/2020
26/09/2018
PRAC
Next Rapporteur
PRACDLP name
representative
was updatedandupdated
onLead
1350 famotidine 21/09/1984 5 years 30/09/2027 29/12/2027 No 27/07/2022 on 23/10/2018
Member State were added on
PSUSA/00001350/202709 Amelia Cupelli Italy NAP
31/05/2023
23/05/2017
PRAC Representative updated on
1351 calcium carbonate / famotidine / magnesium hydroxide Not available* 5 years 30/09/2028 29/12/2028 No 19/09/2024 26/09/2018 PSUSA/00001351/202809 Zoubida Amimour France NAP
PSUR Frequency amended and
next DLP updated on 25/09/2017
1352 fampridine 20/07/2011 5 years 21/01/2028 20/04/2028 No 23/09/2020 PSUSA/00001352/202801 Liana Martirosyan Netherlands CAP
Next DLP was updated on
22/09/2016
1353 febuxostat 21/04/2008 1 year 20/04/2025 29/06/2025 20/04/2026 29/06/2026 No 18/12/2024 DLP was amended on 18/12/2024
Next DLP was updated on
PSUSA/00001353/202504 PSUSA/00001353/202604 Jan Neuhauser Austria CAP
30/09/2105.
PSUR frequency
Next DLP and DLPon
was amended
1355 felbinac 25/09/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00001355/202812 NAP
amended on 31/07/2024
06/10/2014
Conditional approval
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 23 / 223
PRAC Rapporteur name was
1357 felodipine / metoprolol 31/12/1992 10 years 31/12/2027 30/03/2028 No 18/10/2023 PSUSA/00001357/202712 Karin Erneholm Denmark NAP
amended on 18/10/2023
1358 felodipine / ramipril 19/09/1997 5 years 19/09/2028 18/12/2028 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001358/202809 Martin Huber Germany NAP
1362 fenofibrate 04/11/1974 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00001362/202607 Jo Robays Belgium NAP
1363 fenofibrate / pravastatin 14/04/2011 3 years 14/04/2026 13/07/2026 No 19/09/2024 PSUSA/00001363/202604 Zoubida Amimour France CAP
fentanyl (transdermal patches, solution for injection - PSUR frequency amended and
1370 07/03/1995 3 years 30/04/2027 29/07/2027 No 18/12/2024 PSUSA/00001370/202704 Liana Martirosyan Netherlands NAP
nationally authorised product only) DLP updated on 18/12/2024
PSUR
PSUR frequency, DLP and and
frequency amended Marie Louise Schougaard
1371 fenticonazole 16/04/1986 8 years 03/06/2025 01/09/2025 No 30/10/2024 reference to NAP were updated PSUSA/00001371/202506
Christiansen Denmark NAP
DLP updated on 03/07/2024
on 16/12/2020
1382 ferucarbotran 01/07/2022 1 year 30/06/2025 08/09/2025 30/06/2026 08/09/2026 No 05/02/2025 PRAC Representative name was Mari Thorn Sweden
DLP was amended on16/11/2022
updated on 05/02/2025 PSUSA/00001382/202506 PSUSA/00001382/202606 NAP
corrected on 29/07/2020
PRAC Rapporteur name was
PRAC Representative updated on
1387 fesoterodine, desfesoterodine 20/04/2007 5 years 19/04/2025 18/07/2025 No 16/12/2020 amended on 28/04/2022 PSUSA/00001387/202504 Maria del Pilar Rayon Spain CAP NAP
26/09/2018
PRAC Rapporteur name was
Entry name was amended on
amended on 21/11/2018
06/06/2018 Marie Louise Schougaard
1388 fexofenadine 11/03/1996 5 years 11/03/2027 09/06/2027 No 16/11/2022 PSUSA/00001388/202703
Christiansen Denmark NAP
DLP was amended on 15/11/2017
DLP was updated on 19/12/2017
Leadwas
Next MS updated
was
wasaddedon on
1390 fidaxomicin 27/05/2011 3 years 26/05/2026 24/08/2026 No 31/01/2024 PRACDLP
DLP updated
Rapporteur name on
25/05/2022
updated PSUSA/00001390/202605 Mari Thorn Sweden CAP
22/09/2016
31/01/2024
on 03/06/2016
DLP was updated on 05/06/2019
PRAC Rapporteur name updated
1391 filgrastim 15/03/1991 3 years 15/09/2024 14/12/2024 No 25/05/2022 on 05/11/2018
Next DLP was amended on PSUSA/00001391/202409 Terhi Lehtinen Finland CAP NAP
03/06/2016
1393 fingolimod 17/03/2011 2 years 28/02/2025 29/05/2025 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001393/202502 Tiphaine Vaillant France CAP
DLP was updated on 01/03/2023
PSUR frequency and DLP
1395 flavoxate 04/08/1967 11 years 02/12/2039 01/03/2040 No 23/10/2024 PRAC Rapporteur name amended PSUSA/00001395/203912 NAP
amended on 23/10/2024
on 04/07/2018
Lead MS updated
DLP was and PRAConRapporteur
27/03/2018
1396 flecainide 25/06/1982 5 years 30/06/2027 28/09/2027 No 01/03/2023 name added on 26/07/2023 PSUSA/00001396/202706 Karen Pernille Harg Norway NAP
PRAC Representative name was
Entry re-activated
amended on 03/05/2023
on 17/10/2017
PSUR frequency amended and
1398 flopropione Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001398/203012 NAP
DLP updated
Entry on 28/08/2024
re-activated
Lead MS and PRACon 21/10/2022
Rapporteur
name was added on 20/12/2016
Information included in column
PSUR frequency and DLP
1399 fluanisone 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 "Are PSURs required
Information for products PSUSA/00001399/202812 NAP
amended onincluded
31/07/2024in column
referred
"Are to in
PSURs Articlesfor
required 10(1), 10a,
products
14, 16a of
referred toDirective
in Articles2001/83/EC
10(1), 10a,
as amended?"
14, was amended
16a of Directive 2001/83/ECon
1400 flubendazole 10/03/1980 5 years 04/02/2029 05/05/2029 Yes 03/05/2023 PSUSA/00001400/202902 Ana Sofia Diniz Martins Portugal NAP
21/10/2022
as amended" was amended on
16/12/2020
DLP was updated on 17/10/2017
1402 flucloxacillin 14/01/1971 8 years 03/03/2028 01/06/2028 No 16/12/2020 DLP was updated on 18/11/2020 PSUSA/00001402/202803 Ana Sofia Diniz Martins Portugal NAP
Correction of PRAC Rapporteur
name representative
PRAC on 28/02/2017 was added
on 06/05/2020 Marie Louise Schougaard
1404 fluconazole 08/03/1988 3 years 02/03/2026 31/05/2026 No 15/11/2023 PRACwas
DLP amended
updated name
Rapporteur on05/04/2023
on 15/11/2023
was PSUSA/00001404/202603
Christiansen Denmark NAP
amended
EURD on 20/12/2016
updated on 25/09/2019
Lead MS and PRAC Rapporteur
PSUR
name frequency
amended amended
on and
19/12/2018
1405 flucytosine 01/10/1975 8 years 03/03/2025 01/06/2025 No 26/07/2024 Leadwas
LMS MS and
addedPRAC
on Rapporteur
31/07/2019 PSUSA/00001405/202503 Tiphaine Vaillant France NAP
DLP updated
name on 03/07/2024
was added on 28/07/2016
DLP was updated on 07/05/2018
1406 fludarabine 11/08/1994 5 years 11/08/2027 09/11/2027 No 05/04/2023 PRAC Rapporteur name was PSUSA/00001406/202708 Terhi Lehtinen Finland NAP
amended on 27/03/2018
DLP
PSURwas corrected
frequency andonDLP
28/03/2017
1408 fludrocortisone 28/10/1954 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUSA/00001408/204006 NAP
amended on 23/10/2024
PRAC representative and Lead
Member State were added on
PSUR frequency and DLP
30/01/2017
1409 fludrocortisone / gramicidin / neomycin Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001409/202606 NAP
amended on 31/07/2024
1413 flumazenil 30/12/1986 3 years 29/12/2024 29/03/2025 No 21/09/2022 PRAC Representative updated on PSUSA/00001413/202412 Liana Martirosyan Netherlands NAP
26/09/2018
DLP
Nextwas
PSUR DLPupdated on DLP
was updated
frequency and 21/09/2022
on
1414 flumetasone 01/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025
22/09/2016
PSUSA/00001414/203907 Liana Martirosyan Netherlands NAP
amended on 23/10/2024
PRAC representative and LMS
were updated
Lead MS on 26/05/2021
was added on
PSUR frequency and DLP
13/07/2015
1415 clioquinol / flumetasone 15/02/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUSA/00001415/203407 NAP
amended
DLP on 23/10/2024
was updated on 25/09/2019
PRAC Representative
PSUR frequency updated
amended and on
1416 flunarizine 01/06/1977 5 years 31/05/2029 29/08/2029 No 05/02/2025 26/09/2018 PSUSA/00001416/202905 Ana Sofia Diniz Martins Portugal NAP
DLP updated on 05/02/2025
PRAC Rapporteur name amended
PSUR
on frequency amended and
04/07/2018
1417 flunisolide 25/08/1982 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00001417/202505 Martin Huber Germany NAP
DLP updated on 03/07/2024
PRAC Rapporteur name updated
on 21/07/2017
1418 flunitrazepam 01/01/2000 3 years 01/01/2025 01/04/2025 No 21/09/2022 PSUSA/00001418/202501 Jan Neuhauser Austria NAP
Next DLP was updated on
22/09/2016
MS added on 31/07/2015.
PSUR frequency
PRAC amended
representative was and
1433 fluoride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001433/203012 NAP
DLP updated
updated on 28/08/2024
on 03/06/2020
PSUR
PSUR Frequency and DLP
frequency and DLP
1434 fluoride / malic acid Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 updated on PSUSA/00001434/203101 NAP
amended on19/12/2018
23/10/2024
DLP was updated on 31/07/2018
PSUR frequency and DLP
1435 fluoride / monofluorophosphate Not available* 9 years 31/01/2031 01/05/2031 No 23/10/2024 PSUSA/00001435/203101 NAP
amended
Active
DLP was on 23/10/2024
substance
amended name was
on 03/05/2023
amended on 06/06/2018
PRAC representative was
1437 fludeoxyglucose (18F) 14/11/1994 10 years 30/11/2027 28/02/2028 No 19/12/2018 Entry name
updated was corrected and
on 29/07/2020 PSUSA/00001437/202711 Tiphaine Vaillant France NAP
PRAC Rapporteur amended on
21/07/2017
PRAC representative was
PSUR frequency
updated amended and
on 03/06/2020
1438 fluorometholone 14/04/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001438/202806 NAP
PRACupdated
DLP Rapporteur name was
on 28/08/2024
amended
DLP on 28/07/2016
was updated on 06/06/2018
Information included in column
1442 fluoxetine 07/09/1986 5 years 07/09/2027 06/12/2027 No 03/05/2023 PRACPSURs
"Are Rapporteur name
required for updated
products PSUSA/00001442/202709 Tiphaine Vaillant France NAP
on 07/04/2016
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
PRAC
as
PSUR Rapporteur
amended?"
frequency was name
and DLPupdated
amended on
1443 fluoxetine / olanzapine Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 on 04/02/2016 PSUSA/00001443/203101 NAP
06/06/2018
amended on 23/10/2024
Lead
PRAC MS was added
Rapporteur on updated
name
1444 flupentixol 30/11/1965 13 years 30/11/2036 28/02/2037 No 31/07/2024 22/12/2014
on 21/07/2017
DLP was amended on 31/07/2024 PSUSA/00001444/203611 Jana Lukačišinová Czech Republic NAP
PRAC Rapporteur
Information name
included was
in column
Next DLP was updated on
1465 follitropin beta 03/05/1996 3 years 01/05/2026 30/07/2026 No 31/01/2024 amended
"Are PSURs onrequired
03/04/2019
for products PSUSA/00001465/202605 Rhea Fitzgerald Ireland CAP
31/01/2024
referred to in Articles 10(1), 10a,
PRAC
14, 16aRepresentative and LMS
of Directive 2001/83/EC
updated
as amended?"on 19/12/2018
was amended on
1466 fomepizole 21/09/2000 7 years 03/03/2025 01/06/2025 Yes 16/01/2025 PSUSA/00001466/202503 Zoubida Amimour France NAP
25/09/2024
Reference to NAP added on
31/01/2018
Lead MS and PRAC Rapporteur
name added on 28/02/2024
Next DLP was updated on
28/06/2016
PSUR frequency and DLP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
#Classified as internal/staff contractors by the Europamended on 15/11/2023 Page 25 / 223
PRAC Representative amended
on 21/12/2022
PRAC Rapporteur name was
amended on 22/09/2022
DLP was updated on 27/07/2022
PSUR frequency and DLP were
PSUR frequency and DLP were
updated on 03/02/2021
updated on 03/07/2019
PRAC Rapporteur name updated
PRAC Rapporteur name was
on 23/10/2018
amended on 31/07/2018
1467 fondaparinux 21/03/2002 3 years 06/12/2024 06/03/2025 No 27/07/2019 PSUSA/00001467/202412 Mari Thorn Sweden CAP
PRAC Rapporteur name was
DLP was updated on 04/07/2018
amended on 31/07/2018
1469 formoterol 29/06/1990 5 years 31/05/2025 29/08/2025 No 03/02/2021 DLP was updated on 21/07/2017 PSUSA/00001469/202505 Mari Thorn Sweden NAP
DLP was amended on 31/01/2018
Next DLP was amended on
Lead MS and PRAC Rapporteur
28/07/2016
1470 fosamprenavir 12/07/2004 5 years 20/10/2028 18/01/2029 No 19/09/2024 name was added on 19/10/2016 PSUSA/00001470/202810 Zoubida Amimour France CAP
Next DLP amended on
Transferred from the List of
13/07/2015
substances under PSUR Work
1471 fosaprepitant 11/01/2008 5 years 25/03/2029 23/06/2029 No 20/11/2024 DLP wasscheme
Sharing amended onother
and 20/11/2024 PSUSA/00001471/202903 Mari Thorn Sweden CAP
PSUR frequency and DLP were
substances
updated on contained
31/03/2021in
Nationally Authorised Products
PSUR frequency amended and
1472 foscarnet 31/03/1989 8 years 31/03/2031 29/06/2031 No 20/12/2023 with DLP synchronised
PRAC representative wason added PSUSA/00001472/203103 Liana Martirosyan Netherlands NAP
DLP updated on 20/12/2023
06/03/2015
on 06/05/2020
PSURwas
DLP frequency
updatedand
on DLP
16/11/2022
1482 framycetin sulfate / triamcinolone acetonide Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUSA/00001482/203101 NAP
amended on 23/10/2024
DLP was amended on 15/11/2017
1484 frovatriptan 31/10/2001 5 years 01/03/2027 30/05/2027 No 16/11/2022 PRAC Rapporteur name updated PSUSA/00001484/202703 Eva Jirsová Czech Republic NAP
on 27/06/2017
Lead MS
PSUR was added
frequency and on
DLP
1486 fructose / glucose / xylitol Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUSA/00001486/203101 NAP
22/09/2016
amended on 23/10/2024
1493 furosemide / spironolactone 11/01/1961 5 years 17/03/2028 15/06/2028 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00001493/202803 Karin Erneholm Denmark NAP
DLP
Leadwas
MS updated
added onon 03/02/2021
31/07/2015.
1502 gadobutrol 20/08/1998 2 years 30/04/2025 29/07/2025 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00001502/202504 Martin Huber Germany NAP
PRAC Rapporteur name was
amended on 23/10/2018
1503 gadodiamide 01/02/1993 5 years 30/04/2025 29/07/2025 No 03/02/2021 PSUSA/00001503/202504 Mari Thorn Sweden NAP
PRAC Rapporteur name was
amended on 31/07/2018
1504 gadopentetic acid Not available* 2 years 30/04/2025 29/07/2025 Yes 31/01/2024 Next DLPamended
DLP was was amended on
on 31/01/2024 PSUSA/00001504/202504 Martin Huber Germany NAP
04/02/2016
Lead MS
PRAC was added on
representative updated on
1505 gadoteric acid (intra articular formulation) 31/01/2002 5 years 30/04/2025 29/07/2025 Yes 31/01/2024 06/03/2015 PSUSA/00001505/202504 Bianca Mulder Netherlands NAP
31/01/2024
1506 gadoteric acid (IV and intravascular formulations) 08/03/1989 2 years 30/04/2025 29/07/2025 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00001506/202504 Bianca Mulder Netherlands NAP
1507 gadoteridol 29/10/1992 2 years 30/04/2025 29/07/2025 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00001507/202504 Karin Erneholm Denmark NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 26 / 223
Information included in column
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
1521 gemfibrozil 01/06/1981 8 years 03/05/2025 01/08/2025 No 30/10/2024 Information included in column PSUSA/00001521/202505 Karin Erneholm Denmark NAP
as amended?" was amended on
"Are PSURs required for products
28/06/2023
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
PSUR frequency amended and
1522 gentamicin (topical use) 28/02/1973 8 years 03/03/2025 01/06/2025 No 26/07/2024 as amended?" was amended on
DLP updated on 28/06/2023
PSUSA/00001522/202503 Amelia Cupelli Italy NAP
28/06/2023
PSURupdated
DLP frequency and DLP
on 17/11/2021
1525 gestrinone 21/01/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00001525/202812 NAP
amended on 31/07/2024
Correction to the PRAC
Information included
representative name in oncolumn
1529 glatiramer 23/12/1996 3 years 30/11/2026 28/02/2027 Yes 31/07/2024 DLP was
"Are amended
PSURs
05/02/2020 requiredonfor
31/07/2024
products PSUSA/00001529/202611 Karin Erneholm Denmark NAP
referred to in Articles 10(1), 10a,
14, 16a
Lead MSof Directive
and 2001/83/EC
PRAC Rapporteur
as amended?",
name amendedPSUR frequency
on 19/12/2018
1530 glibenclamide (for nationally authorised products only) 01/01/1969 9 years 03/05/2028 01/08/2028 No 18/10/2023 PSUSA/00001530/202805 none NAP
and DLP were amended on
18/10/2023
Next DLP was updated and
information included in column
1532 gliclazide 26/04/1971 5 years 28/02/2026 29/05/2026 No 17/11/2021 Active
"Are substance
PSURs name
required for updated
products PSUSA/00001532/202602 Guðrún Stefánsdóttir Iceland NAP
on 04/07/2018
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?"
PSUR frequency was amended
amended andon
1533 glicofosfopeptical 07/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUSA/00001533/202901 NAP
18/11/2016
DLP updated on 28/08/2024
Lead MS
PRAC was added
Rapporteur on
updated on
1535 glipizide 20/11/1971 3 years 31/01/2025 01/05/2025 Yes 15/11/2023 30/09/2015 PSUSA/00001535/202501 Petar Mas Croatia NAP
15/11/2023
DLP was
Active updated name
substance on 31/03/2021
amended
1552 glyceryl trinitrate 19/10/1981 5 years 15/07/2025 13/10/2025 No 31/03/2021 on 22/09/2021 PSUSA/00001552/202507 Polona Golmajer Slovenia NAP
PRAC representative was added
on 06/05/2020
PRAC Rapporteur name was
PSUR frequency and DLP
amended on 23/10/2018
1553 glycine Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUSA/00001553/202608 NAP
LMS was added
amended on 01/04/2020
on 23/10/2024
The name of the active
glycopyrronium (all indications except for the PSUR frequency
substance
Active and DLPwas
was amended
substance name were
on
1556 treatment of severe sialorhoea or for the treatment of Not available* 15 years 30/09/2030 29/12/2030 No 22/09/2021 updated on
22/09/2016
amended on05/06/2019
20/12/2023 PSUSA/00001556/203009 Eamon O'Murchu Ireland NAP
chronic obstructive pulmonary disease)
PSUR Frequency
PRAC Rapporteuramended
name wasand
DLP updated
amended on 03/06/2016
on 23/10/2018
1557 neostigmine, glycopyrronium / neostigmine 06/03/1992 15 years 30/09/2030 29/12/2030 No 20/12/2023 PSUSA/00001557/203009 Eamon O'Murchu Ireland NAP
Lead MS
PSUR added on
Frequency 12/05/2015
amended and
DLP updated on 03/06/2016
glycosaminoglycan polysulphate / salicylic acid / PSUR
Name frequency and DLP was
of active substance
1558 Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00001558/203103 NAP
suprarenal gland extract amended
amended on
on 23/10/2024
30/11/2012
Lead MS added on 12/05/2015
1560 golimumab 01/10/2009 3 years 06/04/2026 05/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001560/202604 Karin Bolin Sweden CAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 27 / 223
PSUR frequency and DLP
1574 guaifenesin 31/05/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00001574/203211 NAP
amended on 23/10/2024
1587 haloperidol 25/04/1960 14 years 24/01/2025 24/04/2025 No 01/10/2012 PSUSA/00001587/202501 Maia Uusküla Estonia NAP
1597 hepatitis B vaccine (rDNA) 14/11/1986 5 years 28/02/2025 29/05/2025 No 21/10/2020 DLP was updated
Reference to NAP on 21/11/2018
added on PSUSA/00001597/202502 Gabriele Maurer Germany CAP NAP
25/09/2019
Next DLP was updated on
18/11/2016
DLP was updated on 26/09/2018
1598 hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) 02/02/2005 3 years 01/02/2027 02/05/2027 No 19/10/2022 PSUSA/00001598/202702 Jean-Michel Dogné Belgium CAP
Name Representative
PRAC of active substance was
amended
amended
on on 31/05/2013
18/11/2016
deanol and all combinations with deanol except for PSUR frequency amended and
1601 Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00001601/203003 Ana Sofia Diniz Martins Portugal NAP
diclofenac deanol DLP updated on 28/08/2024
Next DLP was updated on
22/09/2016
PSUR frequency and DLP
1602 hexamidine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 DLP was corrected on 13/03/2015 PSUSA/00001602/203612 NAP
amended on 23/10/2024
1617 human coagulation factor IX 12/07/1985 5 years 12/07/2027 10/10/2027 No 19/10/2022 DLP was updated on 01/07/2020 PSUSA/00001617/202707 Gabriele Maurer Germany NAP
Reference to centrally authorised
products removed on 23/10/2019
PRAC Rapporteur name was
updated on 05/06/2019
PRAC Representative updated on
1619 human coagulation factor VII 01/11/1975 3 years 31/10/2025 29/01/2026 No 28/06/2023
26/09/2018
PSUSA/00001619/202510 Sonja Hrabcik Austria NAP
PRAC representative was
PRAC Representative name
updated
PRAC on 01/03/2023
representative was
updated on 17/10/2017
DLP was on
updated updated on 28/03/2017
01/03/2023
1620 human coagulation factor VIII (antihemophilic factor A) 30/11/1989 5 years 30/11/2024 28/02/2025 No 29/07/2020 DLP was updated on 29/07/2020
DLP was updated on 21/07/2017
PSUSA/00001620/202411 Gabriele Maurer Germany NAP
The DLP
PSUR was amended
frequency and DLP onwere
01/04/2014
Lead MS was28/06/2022
updated added on
Lead MS on
and PRAC Rapporteur
human coagulation factor viii / human von willebrand 22/12/2014
DLP was amended on03/06/2016
03/05/2023
1621 07/06/1982 5 years 07/10/2026 05/01/2027 No 29/06/2022 name was added on PSUSA/00001621/202610 Gabriele Maurer Germany NAP
factor DLP was updated on 03/07/2019
PRAC representative was
Next DLPon
updated was updated on
01/03/2023
1622 human coagulation factor XIII Not available* 5 years 30/06/2027 28/09/2027 No 03/05/2023 28/06/2016 PSUSA/00001622/202706 Gabriele Maurer Germany NAP
DLP was updated on 27/03/2018
02/03/2022
Lead MS added on 16/06/2015
Lead DLP
Next MS and
wasPRAC Rapporteur
updated on
1624 human fibrinogen 04/01/1966 3 years 30/06/2024 28/09/2024 No 02/03/2022
name was added on 20/12/2016
PSUSA/00001624/202406 Gabriele Maurer Germany NAP
06/03/2019
PRAC representative was
PSUR Frequency
updated and Next DLP
on 01/03/2023
1629 human hemin 05/05/1995 3 years 31/05/2027 29/08/2027 No 05/02/2025 Information
were
DLP amended
was included
amended onin column
on 04/03/2016
05/02/2025 PSUSA/00001629/202705 Tiphaine Vaillant France NAP
"Are PSURs required for products
PSUR frequency
referred and DLP were
Lead MS to
updated
in Articles
added
on
10(1),
on 01/04/2015.
03/02/2021
10a,
14, 16a of Directive 2001/83/EC
1631 human hepatitis B immunoglobulin 02/06/1979 5 years 30/11/2028 28/02/2029 Yes 23/10/2024 as amended?" was amended on PSUSA/00001631/202811 Gabriele Maurer Germany CAP NAP
Submission
23/10/2024 date was corrected
on 28/02/2018
PSUR frequency amended and
1632 human leucocyte interferon-alfa 26/11/1987 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUR frequency 31/07/2024
amended and PSUSA/00001632/202506 Liana Martirosyan Netherlands NAP
DLP updated on 03/07/2024
DLP updated on 31/01/2018
1657 hydrochlorothiazide / metoprolol 11/05/1978 8 years 11/05/2025 09/08/2025 No 05/01/2025 PSUSA/00001657/202505 Martin Huber Germany NAP
1658 hydrochlorothiazide / nebivolol 20/09/2009 6 years 03/11/2029 01/02/2030 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00001658/202911 Amelia Cupelli Italy NAP
1704 ibritumomab tiuxetan 16/01/2004 3 years 28/02/2026 29/05/2026 No 15/11/2023 Reference to NAP added
DLP was amended on
on 15/11/2023 PSUSA/00001704/202602 Karin Erneholm Denmark CAP
25/09/2017
DLP was updated on 31/03/2021
Next DLPPRAC
LMS and was updated and NAP
representative
1708 ibuprofen / levomenthol Not available* 8 years 15/07/2028 13/10/2028 No 31/03/2021 products removed on 04/03/2016 PSUSA/00001708/202807 Jana Lukačišinová Czech Republic NAP
were added on 18/12/2019
Name
DLP of updated
was active substance was
on 05/06/2019
1711 ibuprofen / pseudoephedrine Not available* 3 years 18/07/2026 16/10/2026 Yes 19/09/2024 amended on 31/01/2013 PSUSA/00001711/202607 Zoubida Amimour France NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 29 / 223
PRAC Representative amended
on 21/12/2022
1712 ibuprofen (indicated in ductus arteriosus) 29/07/2004 3 years 29/07/2026 27/10/2026 No 27/03/2024 DLP was amended
DLP was updated on
on30/03/2022
27/03/2024 PSUSA/00001712/202607 Rhea Fitzgerald Ireland CAP
New CAP authorised on
16/07/2021
1713 ibutilide 28/12/1995 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001713/202712 Georgia Gkegka Greece NAP
PSUR frequency amended and
DLP updated on 06/02/2019
1714 icatibant 11/07/2008 3 years 11/07/2024 09/10/2024 No 30/03/2022 PSUSA/00001714/202407 Mari Thorn Sweden CAP
PRAC frequency
PSUR Rapporteurand
name
DLPwas
were
amendedon
updated on02/03/2022
31/07/2018
calcium oxide / ichthammol / potassium aluminium PSUR frequency amended and
1718 Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 DLP was
DLP was updatedand
updated on DLP
on
were
28/02/2018
03/03/2021 PSUSA/00001718/202906 NAP
sulfate / sodium perborate DLP updated
updated on 28/08/2024
on 30/06/2021
Next DLP
PRAC was amended
representative andon
DLP
DLP was updated on 06/06/2018
28/02/2017
Next
were DLP was updated
updated on
on 04/03/2020
1720 idarubicin 29/11/1989 3 years 30/11/2025 28/02/2026 No 26/07/2023 PSUSA/00001720/202511 Jan Neuhauser Austria NAP
26/07/2023
PRAC Rapporteur amended
DLP was on
Next DLP,amended
Lead MS on
and04/03/2016
PRAC
07/05/2018
Rapporteur name were amended
1721 idebenone (non centrally authorised products) 30/09/1986 5 years 30/09/2025 29/12/2025 No 30/06/2021 DLP06/03/2019
on was amended on 04/02/2015 PSUSA/00001721/202509 John Joseph Borg Malta NAP
Scope of Active Substance was
amended
PRAC on 27/11/2015.
Rapporteur name was
DLP was updated on 28/02/2018
amended on 22/09/2022
1722 idursulfase 08/01/2007 3 years 23/07/2024 21/10/2024 No 02/03/2022 Next DLP amended on PSUSA/00001722/202407 Liana Martirosyan Netherlands CAP
PRAC Representative amended
13/07/2015
DLP was updated on 31/03/2021
on 28/03/2017
Rapporteur name
PRAC representative wasand
1723 ifosfamide 13/07/1976 8 years 31/07/2028 29/10/2028 No 31/03/2021 Next DLP was amended on
country updated on 01/12/2014 PSUSA/00001723/202807 Mari Thorn Sweden NAP
updated on 16/12/2020
28/02/2017
PRAC representative was added
Next DLP was amended on
1724 iloprost (nebuliser solution only) 27/04/1994 5 years 15/09/2028 14/12/2028 No 19/09/2024 on 06/05/2020
04/03/2016 PSUSA/00001724/202809 Zoubida Amimour France CAP NAP
Reference
PRAC to NAP products
representative updated on
1751 insulin glargine 21/04/2000 3 years 21/04/2025 20/07/2025 No 31/01/2024
removed on 28/02/2018
PSUSA/00001751/202504 Bianca Mulder Netherlands CAP
31/01/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 30 / 223
DLP was updated on 23/09/2020
1771 iopamidol 18/05/1981 8 years 31/12/2027 30/03/2028 No 23/09/2020 PSUSA/00001771/202712 Eamon O'Murchu Ireland NAP
LMS and PRAC representatives
DLP was updated on 03/03/2021
were added on 31/07/2019
PRAC representative was added
1773 iopromide 28/02/1985 8 years 30/06/2028 28/09/2028 No 03/03/2021 PSUSA/00001773/202806 Karen Pernille Harg Norway NAP
on 06/05/2020
1792 isoniazid / rifampicin 01/05/1968 5 years 01/05/2029 30/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001792/202905 Amelia Cupelli Italy NAP
1804 ketamine 10/12/1968 3 years 09/12/2024 09/03/2025 No 27/07/2022 PRAC Representative amended PSUSA/00001804/202412 Jean-Michel Dogné Belgium NAP
on 18/11/2016
DLP and Name of active
Next DLP
PSUR was updated
frequency
substance were onon
and DLP
updated
1806 ketazolam Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUSA/00001806/203107 NAP
22/09/2016
amended on 23/10/2024
03/02/2021
ketobemidone, Lead MS
PSUR was added
Frequency wason
amended
1807 ketobemidone/dimethylaminodiphenylbutene 07/05/1993 9 years 31/05/2029 29/08/2029 No 03/02/2021 13/07/2015
on 03/06/2020 PSUSA/00001807/202905 Karen Pernille Harg Norway NAP
hydrochloride
PRAC representative was added
on 06/05/2020
1808 ketoconazole 01/06/1980 7 years 31/05/2031 29/08/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001808/203105 Guðrún Stefánsdóttir Iceland NAP
DLP was updated on 19/10/2022
LMS was added on 25/09/2019
DLP was updated on 07/05/2018
1809 ketoprofen (all formulations except topical) 27/07/1972 5 years 23/01/2027 23/04/2027 No 19/10/2022 PSUSA/00001809/202701 Karin Bolin Sweden NAP
PRAC representative and Lead
Member State were added on
30/01/2017
PRAC Rapporteur name was
1810 ketorolac (ophtalmic formulations) 20/07/1989 5 years 31/07/2027 29/10/2027 No 16/10/2023 PSUSA/00001810/202707 Karin Erneholm Denmark NAP
amended on 18/10/2023
1812 ketotifen (ophtalmic formulations) 15/10/1977 10 years 30/06/2032 28/09/2032 No 01/03/2023 DLP was updated on 27/03/2018 PSUSA/00001812/203206 Karin Bolin Sweden NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 31 / 223
PRAC representative was
updated on 27/07/2022
1821 lactulose 21/05/1964 5 years 31/05/2026 29/08/2026 No 27/07/2022 Next DLP was updated on PSUSA/00001821/202605 Amelia Cupelli Italy NAP
30/01/2017
1824 lamivudine (chronic hepatitis B) 29/07/1999 5 years 31/07/2025 29/10/2025 No 19/09/2024 DLP was updated on 21/09/2022 PSUSA/00001824/202507 Zoubida Amimour France CAP NAP
DLP was updated on 16/11/2022
Next DLP was amended on
PRAC representative was
25/09/2017
Next DLPonwas updated on
1825 lamotrigine 05/11/1990 5 years 30/11/2027 28/02/2028 No 26/07/2023 updated 19/10/2022 PSUSA/00001825/202711 Liana Martirosyan Netherlands NAP
26/07/2023
Correction of PRAC Rapporteur
PSUR frequency and DLP were
name on 28/02/2017
updated
PSUR on 23/10/2019
frequency amended and
1826 lanreotide 16/05/1994 3 years 31/05/2026 29/08/2026 No 31/01/2024 PSUSA/00001826/202605 Zane Neikena Latvia NAP
DLP updated
PRAC on 31/01/2024
Rapporteur name was
DLP was updated on 23/10/2018
amended on 20/12/2016
1827 dexlansoprazole, lansoprazole 31/12/1990 5 years 31/12/2026 31/03/2027 No 21/09/2022 PRAC Representative updated on PSUSA/00001827/202612 Ana Sofia Diniz Martins Portugal NAP
Lead MS and PRAC Rapporteur
26/09/2018
name was added on 28/07/2016
DLP was updated on 17/10/2017
Name Representative
PRAC of active substance was
amended
1829 lapatinib 10/06/2008 3 years 12/03/2025 10/06/2025 No 16/11/2022
amended on 08/01/2014
PSUSA/00001829/202503 Mari Thorn Sweden CAP
on 28/04/2022
Next DLP was amended on
19/10/2016
Information
DLP included
was updated in column
on 22/12/2021
1830 laronidase 10/06/2003 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was
"Are
DLP was
PSURsupdated
amended on
required 01/02/2023
onfor products
05/02/2025 PSUSA/00001830/202704 Zoubida Amimour France CAP
DLP was corrected on 04/03/2016
referred
Next DLPtoand
in Articles 10(1),
typo in the 10a,
name
PSUR Frequency
14, 16a ofon amended
Directive and
2001/83/EC
amended
Correction of 30/01/2017
entry
DLP updated
as amended?" on 28/02/2018
was amended on
latanoprost (except for products with paediatric
1832 05/06/1996 5 years 30/04/2026 29/07/2026 No 28/04/2022 30/11/2012 PSUSA/00001832/202604 Jean-Michel Dogné Belgium NAP
indication) PRAC
PSUR Representative
submission amended
frequency and
PRAC representative and Lead
on 18/11/2016
DLP amended
Member State on
were29/10/2015
added on
18/11/2016
1833 latanoprost / timolol 05/06/1996 5 years 04/06/2027 02/09/2027 No 01/02/2023 Lead Member
Next DLP State on
amended was added PSUSA/00001833/202706 Karin Bolin Sweden NAP
on 21/12/2015.
04/11/2014
Transferred from the List of
substances under PSUR Work
Name of entry
Conditional amended on
approval
1834 latanoprost (products with paediatric indication) 05/06/1996 5 years 30/04/2028 29/07/2028 No 31/01/2024 Sharing
DLP wasscheme
03/03/2014amended andonother
31/01/2024 PSUSA/00001834/202804 Adam Przybylkowski Poland NAP
substances contained in
Nationally Authorised Products
with DLP synchronised on
1835 lauromacrogol 400 25/05/1966 18 years 25/05/2030 23/08/2030 No 01/10/2012 06/03/2015 PSUSA/00001835/203005 NAP
PSUR frequency amended and
updated
DLP was on 28/06/2023
updated on 29/06/2022
1836 lauromacrogols combinations Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PRAC representative was PSUSA/00001836/203001 NAP
updated on 29/07/2020
PRAC
PSUSARapporteur name was on
1867 lidocaine / prilocaine (not centrally authorised product) 01/04/1985 5 years 31/03/2027 29/06/2027 No 16/10/2023 number was amended PSUSA/00001867/202703 Karin Erneholm Denmark NAP
amended
DLP on 18/10/2023
was updated
06/10/2014 on 03/03/2021
DLP was updated on 03/03/2021
PRAC representative was added
PRAC representative was added
1868 lidocaine / tetracaine 29/06/2006 8 years 30/06/2028 28/09/2028 No 03/03/2021 on 06/05/2020 PSUSA/00001868/202806 Jean-Michel Dogné Belgium NAP
on 06/05/2020
LMS was added on 01/04/2020
carrageenin / titanium dioxide / zinc oxide, carrageenin LMS was added on 01/04/2020
1869 / lidocaine / titanium dioxide / zinc oxide, titanium Not available* 8 years 15/06/2028 13/09/2028 No 03/03/2021 PSUSA/00001869/202806 NAP
DLP was updated on 05/06/2019
dioxide / zinc oxide / tetracaine hydrochloride
The active substance name was
allantoin / aminoacridine / hydrocortisone
1873 Not available* 12 years 30/09/2024 29/12/2024 No 31/01/2024 amended on 01/04/2015
Lead MS added on 31/01/2024 PSUSA/00001873/202409 Spain NAP
hemisuccinate / lidocaine hydrochloride
DLP was updated on 31/03/2021
The active substance name was
amended
PRAC
PSUR on 01/12/2014
representative
frequency and were
and DLP LMS
1879 lidocaine hydrochloride / methylprednisolone acetate Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 PSUSA/00001879/202808 Zane Neikena Latvia NAP
were added
updated on 04/03/2020
on 21/12/2022
DLP was
PRAC updated on 05/06/2019
representative was
PSUR frequency and DLP
1887 lincomycin 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 updated on 27/07/2022 PSUSA/00001887/203403 NAP
amended on 23/10/2024
PRAC representative was
updated on 06/05/2020
1888 linezolid 18/04/2000 3 years 17/04/2025 16/07/2025 Yes 21/12/2022 PSUSA/00001888/202504 Anna Mareková Slovakia NAP
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
1890 liothyronine 16/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001890/203101 Martin Huber Germany NAP
DLP was updated on 19/12/2017
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# Classified as internal/staff contractors by the Europ Page 32 / 223
PSUR frequency and DLP
1891 levothyroxine sodium / liothyronine sodium Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUSA/00001891/203109 NAP
amended on 23/10/2024
1892 liraglutide 30/06/2009 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001892/202612 Bianca Mulder Netherlands CAP
1897 lithium 20/02/1967 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00001897/202908 Martin Huber Germany NAP
1905 lopinavir / ritonavir 20/03/2001 3 years 30/09/2024 29/12/2024 No 19/09/2024 PSUSA/00001905/202409 Zoubida Amimour France CAP
DLP was updated on 19/10/2022
PSUR frequency and DLP
1906 loprazolam 10/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PRAC Representative amended PSUSA/00001906/202811 NAP
amended on 31/07/2024
on 28/04/2022
DLP was updated on 19/10/2022
DLP was updated on 17/10/2017
1907 loratadine 01/10/1991 5 years 02/02/2027 03/05/2027 No 19/10/2022 PRAC Representative amended PSUSA/00001907/202702 Jean-Michel Dogné Belgium NAP
on 28/04/2022
PRAC Representative amended
on 18/11/2016
DLP was updated on 17/10/2017
1908 loratadine / pseudoephedrine 01/10/1991 5 years 02/02/2027 03/05/2027 No 19/10/2022 PSUSA/00001908/202702 Jean-Michel Dogné Belgium NAP
Lead MS and PRAC Rapporteur
PRAC Representative amended
name was added on 28/07/2016
on 18/11/2016
PRAC Rapporteur name was
1909 lorazepam 31/12/1963 3 years 31/01/2025 01/05/2025 No 16/10/2023 PSUSA/00001909/202501 Karin Erneholm Denmark NAP
amended on 18/10/2023
Lead MS and PRAC Rapporteur
name was added on 28/07/2016
1910 lormetazepam 07/12/1980 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001910/202612 Sonja Hrabcik Austria NAP
1913 loteprednol 31/03/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001913/203105 Amelia Cupelli Italy NAP
PSUR
PSUR frequency
frequency amended and
and DLP were Marie Louise Schougaard
1918 lutropin alfa 29/11/2000 5 years 28/11/2027 26/02/2028 No 26/07/2023 PSUSA/00001918/202711
Christiansen Denmark CAP
DLP updated
updated on 26/07/2023
on 01/02/2023
PRAC representative
PSUR frequency was and
amended
1919 lymecycline 31/01/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 updated on 27/07/2022 PSUSA/00001919/202802 NAP
DLP updated on 28/08/2024
DLP was updated on 05/02/2020
PSUR frequency amended and
1920 lynestrenol 20/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001920/202806 NAP
DLP updated
PRAC on 28/08/2024
representative was
updated on 25/09/2019
1924 macrogol 3350 15/04/1991 5 years 31/05/2027 29/08/2027 No 01/02/2023 Lead MS and PRAC Rapporteur PSUSA/00001924/202705 Amelia Cupelli Italy NAP
name
DLP amended
was updatedonon19/12/2018
29/06/2022
Nextwas
DLP DLPupdated
amendedonon21/07/2017
1926 magnesium hydroxide 09/11/1970 5 years 31/10/2026 29/01/2027 No 15/01/2025
30/01/2017
PSUSA/00001926/202610 Karin Bolin Sweden NAP
Lead MS and PRAC Rapporteur
PRAC Rappoerteur
name was added onand Lead
03/06/2016
PSUR frequency and DLP
1928 magnesium orotate, magnesium lactate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 Member State added on PSUSA/00001928/202611 none NAP
amended on 23/10/2024
27/11/2015.
DLP was
Active updated name
substance on 02/03/2022
was
amended
PSUSA on 18/12/2024
number was amended on
1929 ascorbic acid / magnesium oxide, magnesium oxide Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 PRAC representative was PSUSA/00001929/203106 Adam Przybylkowski Poland NAP
06/10/2014
updated on 17/11/2021
PSUR frequency and DLP
amended on 28/02/2024
PRAC representative was
1930 malathion 04/03/1992 18 years 04/03/2030 02/06/2030 No 01/10/2012 updated on 25/09/2019 PSUSA/00001930/203003 NAP
1939 mebendazole 03/05/1971 15 years 03/05/2025 01/08/2025 No 05/01/2025 PSUSA/00001939/202505 Amelia Cupelli Italy NAP
1942 mecasermin 03/08/2007 1 year 31/08/2024 09/11/2024 31/08/2025 09/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00001942/202408 PSUSA/00001942/202508 Terhi Lehtinen Finland CAP
1945 meclozine 08/05/1953 15 years 31/08/2025 29/11/2025 No 05/01/2025 PSUSA/00001945/202508 Jo Robays Belgium NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 33 / 223
PSUR frequency and DLP
1949 medrogestone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00001949/202611 NAP
amended on 23/10/2024
1963 melatonin 29/06/2007 3 years 28/09/2026 27/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00001963/202609 Ana Sofia Diniz Martins Portugal CAP NAP
1985 mepyramine 31/12/1969 9 years 31/12/2031 30/03/2032 No 18/12/2024 PSUSA/00001985/203112 none NAP
1986 mequitazine 31/01/1970 5 years 31/01/2025 01/05/2025 No 19/09/2024 DLP was updated on 19/10/2022 PSUSA/00001986/202501 Zoubida Amimour France NAP
DLP was updated on 28/04/2022
PRAC Rapporteur name was
DLP was updated
amended on 05/06/2019
on 28/04/2022
PSUR frequency amended and
1988 mercaptopurine 11/09/1953 3 years 01/09/2026 30/11/2026 No 30/04/2024 PSUSA/00001988/202609 Mari Thorn Sweden CAP NAP
DLP updated on 30/04/2024
Next and
LMS DLPPRAC
was amended on
representative
03/05/2016
and 'Are PSURs required for
1989 meropenem 31/08/1994 3 years 31/08/2024 29/11/2024 No 28/04/2022 products referred to in Articles PSUSA/00001989/202408 Jan Neuhauser Austria NAP
"Are PSURs
10(1), required
10a, 16a for products
of Directive
referred to inasArticles
2001/83/EC amended'10(1), 10a,
were
14, 16a of
updated onDirective
28/07/20212001/83/EC
Marie Louise Schougaard
1990 mesalazine 20/02/1984 2 years 19/02/2026 20/05/2026 Yes 19/10/2022 as amended? Yes/No" was PSUSA/00001990/202602
Christiansen Denmark NAP
amended
PSUR on 16/07/2015
frequency and DLP were
updated on 21/10/2020
Lead MS
PSUR added on
frequency and12/05/2015
DLP
1991 mesna Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00001991/202611 NAP
Lead MS and
amended PRAC Rapporteur
on 23/10/2024
name amended on 19/12/2018
PSUR frequency
The Next and
DLP was DLP
amended on
1994 metacycline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00001994/203608 NAP
amended on 23/10/2024
29/10/2015
Lead MS
PSUR was added
frequency and on
DLP
1995 metadoxine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 04/02/2015 PSUSA/00001995/203112 NAP
amended on 23/10/2024
1997 metamizole 24/03/1923 3 years 24/03/2027 22/06/2027 No 20/11/2024 DLP was amended
DLP was updated on
on23/09/2020
20/11/2024 PSUSA/00001997/202703 Melinda Palfi Hungary NAP
Active substance name was
amended on 29/07/2020
PSUR frequency and DLP
1998 hyoscine butylbromide / metamizole 03/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00001998/203406 NAP
amended on 23/10/2024
PRAC representative was added
on 06/05/2020
1999 metamizole sodium / triacetonamine tosilate Not available* 5 years 01/01/2025 01/04/2025 Yes 23/09/2020 PSUSA/00001999/202501 Maria Popova-Kiradjieva Bulgaria NAP
LMS was added on 31/07/2019
PSUR frequency
Information and DLP
included in column
2011 methocarbamol Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002011/202412 Martin Huber Germany NAP
amended
"Are PSURsonrequired
27/03/2024
for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
2013 methocarbamol / paracetamol Not available* 6 years 02/12/2024 02/03/2025 Yes 26/07/2024 as amended?" was amended on PSUSA/00002013/202412 Monica Martinez Redondo Spain NAP
05/06/2024
2017 methoxy polyethylene glycol-epoetin beta 20/07/2007 3 years 19/07/2026 17/10/2026 No 27/03/2024 DLP was
PRAC amendedname
Rapporteur on 27/03/2024
was PSUSA/00002017/202607 Monica Martinez Redondo Spain CAP
amended on 22/09/2022
2026 methylprednisolone (systemic use) 18/12/1957 3 years 30/11/2028 28/02/2029 No 25/09/2024 DLP
Entrywas
For advice
nameupdated
on on 27/07/2022
submission
updated on for PSUSA/00002026/202811 Jan Neuhauser Austria NAP
DLPs falling before 31/10/2015
25/09/2024
DLP was
please updated
consult theon 31/07/2018
List of
substance
DLP under Work
was amended sharing
on 31/07/2024
2029 methylthioninium chloride 03/11/1987 3 years 05/05/2026 03/08/2026 No 31/01/2024 DLP was
PRAC
scheme amended
Rapporteur
and on 31/01/2024
othername was
substance PSUSA/00002029/202605 Mari Thorn Sweden CAP
updated
containedonin04/07/2018
Nationally
Authorised Products with DLPs
PRAC Rapporteur amended on
synchronised.
2036 metoclopramide 17/11/1964 3 years 17/11/2024 15/02/2025 No 27/07/2022 PSUSA/00002036/202411 Karen Pernille Harg Norway NAP
28/02/2018
2046 metyrapone 14/06/1961 6 years 14/06/2030 12/09/2030 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002046/203006 Kimmo Jaakkola Finland NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
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2068 mirtazapine 01/09/1994 5 years 31/08/2028 29/11/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002068/202808 Liana Martirosyan Netherlands NAP
PRAC frequency
PSUR Rapporteuramended
name wasand
2076 mitoxantrone 15/06/1981 3 years 30/06/2025 28/09/2025 Yes 16/10/2023 PSUSA/00002076/202506 Karin Erneholm Denmark NAP
amended
DLP on 18/10/2023
updated on 23/10/2018
LeadDLP
The
PSUR MS was amended
was added
frequency on on and
amended
2107 naftazone 18/12/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 06/03/2015 PSUSA/00002107/202901 NAP
29/10/2015
DLP updated on 28/08/2024
2110 nalbuphine 15/05/1979 5 years 01/05/2028 30/07/2028 Yes 31/01/2024 DLP was amended
updated on
on05/06/2019
31/01/2024 PSUSA/00002110/202805 Eva Jirsová Czech Republic NAP
2113 buprenorphine / naloxone 26/09/2006 4 years 26/09/2027 25/12/2027 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002113/202709 Martin Huber Germany CAP NAP
2125 naproxen 04/08/1961 3 years 03/08/2026 01/11/2026 No 30/04/2024 DLP was amended
DLP was updated on
on16/11/2022
30/04/2024 PSUSA/00002125/202608 Amelia Cupelli Italy NAP
PRAC Rapporteur name was
amended on 31/07/2018
2126 naratriptan 10/03/1997 5 years 28/02/2027 29/05/2027 No 16/11/2022 PSUSA/00002126/202702 Karin Bolin Sweden NAP
DLP was amended on 15/11/2017
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 36 / 223
New CAP authorised on
22/09/2023
2140 neomycin sulfate / nystatin / triamcinolone acetonide Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was
DLP amended
updated
and PSUR on05/02/2020
on
frequency31/07/2024
were PSUSA/00002140/202912 Adam Przybylkowski Poland NAP
updated on 02/02/2022
Next DLP updated on 30/01/2017
2143 nepafenac 11/12/2007 5 years 30/05/2027 28/08/2027 No 01/02/2023 DLP was updated on 06/02/2019 PSUSA/00002143/202705 Maria del Pilar Rayon Spain CAP NAP
DLP
PRACwas updated on 01/02/2023
Representative amended
on 28/06/2016
Reference to NAP removed on
PRAC representative was
15/11/2017
PSUR frequency
updated and DLP
on 17/11/2021
2146 netilmicin 01/01/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR Frequency amended and PSUSA/00002146/202811 NAP
amended on 31/07/2024
DLP updated
Correction of on 04/02/2016
PRAC Rapporteur
PRAC representative was
name on 28/02/2017
updated
DLP was on 30/06/2021
amended on 04/02/2015
2147 nevirapine 05/02/1998 5 years 06/05/2026 04/08/2026 No 02/02/2022 PSUSA/00002147/202605 Ana Sofia Diniz Martins Portugal CAP
PRAC Rapporteur name was
DLP
Nextwas
DLPupdated
was on 05/02/2020
amended on
amended on 20/12/2016
31/01/2014
DLP was updated on 03/02/2021
PRAC Rapporteur name amended
2149 nicardipine 31/05/1981 3 years 31/05/2025 29/08/2025 No 01/02/2023 Next DLP was amended on PSUSA/00002149/202505 Amelia Cupelli Italy NAP
on 04/07/2018
Next DLP was
was amended
amended on on
04/02/2016
Next DLP
31/01/2014
04/02/2016
Next DLP was updated on
"Are PSURs required for products
2150 nicergoline 26/05/1972 5 years 25/05/2025 23/08/2025 No 03/02/2021 30/01/2017
referred to in Articles 10(1), 10a, PSUSA/00002150/202505 Zane Neikena Latvia NAP
'PRAC Rapporteur name
14, 16a ofon
amended Directive 2001/83/EC
16/06/2015
PRAC Rapporteur and Lead
as amended?Yes/No" was
Member
PSUR
DLP State added
frequency
was on and
amended
2151 niclosamide 23/03/1964 5 years 01/08/2028 30/10/2028 No 27/03/2024 MS updated
amended
Lead on on
on 06/03/2015
was added 16/11/2022 PSUSA/00002151/202808 Amelia Cupelli Italy NAP
27/11/2015.
DLP updated on 27/03/2024
06/03/2015
DLP was updated on 20/11/2019
PSUSA number was amended on
2152 nicorandil 09/02/1990 3 years 28/02/2025 29/05/2025 No 16/11/2022 06/10/2014
Next DLP was updated on PSUSA/00002152/202502 Jan Neuhauser Austria NAP
18/11/2016
Lead Member
PSUR State
frequency andwas
DLPadded
2153 nicotine Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024
on 30/09/2015
PSUSA/00002153/202412 Karin Erneholm Denmark NAP
amended on 27/03/2024
DLP was updated on 21/09/2022
PRAC representative updated on
2156 nifedipine 31/08/1993 5 years 31/08/2025 29/11/2025 No 31/01/2024 PRAC representative was PSUSA/00002156/202508 Bianca Mulder Netherlands NAP
31/01/2024
updated on 06/05/2020
2181 nomegestrol Not available* 3 years 31/01/2027 01/05/2027 No 20/10/2021 The next DLP was amended on PSUSA/00002181/202701 Adam Przybylkowski Poland NAP
Next DLP was amended on
29/10/2015.
29/10/2015
08/08/2014.
Lead
PSUR MS was added
frequency on
amended and
2182 estradiol / nomegestrol acetate 27/07/2011 5 years 26/01/2029 26/04/2029 No 25/09/2024 The procedure PSUSA/00002182/202901 Zoubida Amimour France CAP NAP
updated onnumber
04/02/2015
DLP for the
25/09/2024
DLP was corrected on
27/08/2014.
Name of active substance was
PSUR frequency
amended amended and
on 03/07/2013
2183 nonacog alfa 27/08/1997 5 years 10/08/2028 08/11/2028 No 30/04/2024 PSUSA/00002183/202808 Gabriele Maurer Germany CAP
DLP updated on 30/04/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 37 / 223
Information included in column
PSUR frequency
"Are PSURs and DLP
required for products
2186 nordazepam Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUSA/00002186/203112 NAP
amended
referred toon
in23/10/2024
Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?" was amended on
2187 norepinephrine 30/10/1962 9 years 03/03/2028 01/06/2028 No 26/07/2023 26/07/2023 PSUSA/00002187/202803 none NAP
DLP was updated on 05/04/2023
Update of PSUR frequency & DLP
DLP was updated on 07/05/2018
resulting from PRAC re-allocation
2188 norethisterone 29/04/1971 5 years 06/08/2027 04/11/2027 No 05/04/2023
exercise for entries with DLPs in
PSUSA/00002188/202708 Kimmo Jaakkola Finland NAP
PRAC representative and Lead
2025 on 26/07/2023
Member State were added on
30/01/2017
2190 norfloxacin 04/11/1982 13 years 04/06/2036 02/09/2036 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002190/203606 Maria del Pilar Rayon Spain NAP
2192 nortriptyline 31/03/1963 5 years 31/03/2028 29/06/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002192/202803 Maia Uusküla Estonia NAP
PSURwas
DLP Frequency
updatedand DLP was
on 23/05/2017
amended on 27/11/2015
2201 octreotide (for nationally authorised products) 23/06/1995 3 years 30/06/2026 28/09/2026 No 28/02/2024 DLP was amended on 28/02/2024
Nextwas
DLPupdated
was amended on
PSUSA/00002201/202606 Eamon O'Murchu Ireland NAP
DLP on 29/06/2022
23/05/2016
PRAC Rapporteur name was
2203 ofloxacin (systemic use) 16/04/1985 2 years 16/04/2025 15/07/2025 Yes 20/12/2023 DLP was amended
amended on 20/12/2023
on 31/07/2018 PSUSA/00002203/202504 Petar Mas Croatia NAP
2220 orlistat 08/08/1997 3 years 07/02/2025 08/05/2025 No 19/09/2024 Information included in column PSUSA/00002220/202502 Zoubida Amimour France CAP NAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14,
PSUR16a of Directive
frequency and2001/83/EC
DLP
2221 ornidazole 19/06/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 as amended?" was amended on PSUSA/00002221/202811 NAP
amended on 31/07/2024
30/11/2012
Active substance
Reference to NAP name wason
removed
amended
23/10/2024 on 23/10/2024
2224 orphenadrine / paracetamol, orphenadrine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00002224/203608 none NAP
PSURwas
DLP frequency
updatedamended and
on 25/05/2022
DLP updated on 25/09/2024
DLP was updated on 05/06/2019
2225 oseltamivir 20/06/2002 3 years 20/09/2024 19/12/2024 No 23/10/2024 PSUSA/00002225/202409 Terhi Lehtinen Finland CAP
Reference to NAP added on
31/01/2018
PSUR frequency amended and
2226 otilonium bromide 08/09/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PSUSA/00002226/202809 NAP
DLP updated on 28/08/2024
Next DLP was amended on
03/06/2016
PSUR frequency and DLP
2227 oxaceprol 15/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002227/202811 NAP
amended on 31/07/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 38 / 223
PSUR frequency and DLP
2237 oxeladin 06/06/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUSA/00002237/203407 NAP
amended on 23/10/2024
2258 oxymetazoline 31/05/1962 6 years 01/08/2026 30/10/2026 No 31/03/2021 PSUR frequency, DLP and PRAC PSUSA/00002258/202608 Maia Uusküla Estonia NAP
rapporteur were updated on
Reference
05/06/2019to CAP removed on
28/02/2024
PSUR frequency and DLP
2261 oxymorphone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 New CAP authorised on PSUSA/00002261/203203 NAP
amended on 23/10/2024
PSUR frequency and DLP were
21/03/2024
PSUR frequency amended and
updated
PRAC on 21/09/2022
Rapporteur name was
oxytetracycline, hydrocortisone / oxytetracycline, DLP updated on 25/09/2024
2262 hydrocortisone / oxytetracycline / polymyxin b, 31/05/1950 11 years 03/06/2040 01/09/2040 No 25/09/2024 DLP and active
amended substance name
on 28/04/2022 PSUSA/00002262/204006 none NAP
DLP was
was updated
updated on 31/07/2019
on 02/03/2022
oxytetracycline / polymyxin b Entry name updated on
DLP and PSUR frequence were
25/09/2024
New CAPon
updated authorised on
02/02/2022
2264 paclitaxel 29/12/1992 5 years 28/12/2026 28/03/2027 No 28/02/2024 20/11/2018
18/06/2020 PSUSA/00002264/202612 Carla Torre Portugal NAP
PRAC representative was
PRACDLP
Next Representative
updated was
on updatedupdated
31/03/2021 on on
26/09/2018
06/03/2019
2266 paliperidone 25/06/2007 3 years 30/06/2024 28/09/2024 No 02/03/2022 PSUSA/00002266/202406 Karin Bolin Sweden CAP
PSURwas
DLP frequency
updatedand
on DLP were
05/04/2023
Next
PRAC DLP was updated
Rapporteur
updated on nameon
03/03/2021 was
22/09/2016
amended on 31/07/2018
DLP was updated on 01/04/2020 Marie Louise Schougaard
2267 palivizumab 13/08/1999 3 years 18/06/2024 16/09/2024 No 02/02/2022 PRAC representative was PSUSA/00002267/202406
Christiansen Denmark CAP
Lead MS
PSUR
updated
PRAC was25/09/2019
on added
Frequency
Rapporteur on wasand
amended
name
13/07/2015
DLP updated
amended on 04/02/2016
on 23/10/2018
PRAC Rapporteur name was
2268 palonosetron 22/03/2005 3 years 24/07/2025 22/10/2025 No 05/04/2023
correctedamended on28/03/2017
on 03/04/201904/02/2015 PSUSA/00002268/202507 Rhea Fitzgerald Ireland CAP NAP
DLP was updated on
Name
PRAC
NAP of active
Rapporteur
products substance
name
added on was was
PRAC
DLP representative
was updated updated on
on 29/07/2020
2269 pamidronate 02/05/1989 5 years 31/05/2026 29/08/2026 No 31/01/2024 amended
22/09/2016 01/08/2013
on 06/06/2018 PSUSA/00002269/202605 Bianca Mulder Netherlands NAP
31/01/2024
PSUR frequency amended and
PRAC
DLP
The Rapporteur
updated
was
DLP updated
was name updated
on 03/05/2023
on 28/02/2018
amended on
amylase / bromelain / chymotrypsin / lipase / on 23/10/2018
03/03/2014
PSUR frequency amended and
2273 pancreatin / papain / rutoside / trypsin, trypsin/ Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 DLP was updated
PRACupdated on 25/05/2022
Representative amended PSUSA/00002273/202903 Jana Lukačišinová Czech Republic NAP
DLP on 28/08/2024
bromelain/ rutoside trihydrate PRAC Representative and Lead
on 17/10/2017
Member
DLP was state assigned
updated on
on 26/05/2021
04/07/2018
2275 pancuronium 01/01/1991 6 years 01/12/2025 01/03/2026 Yes 15/01/2025 PSUSA/00002275/202512 Martin Huber Germany NAP
DLP was updated on 06/05/2020
Transferred from the List of
substances
DLP under on
was updated PSUR Work
30/04/2019
pandemic influenza vaccine (H5N1) (split virion,
2281 19/10/2009 3 years 19/05/2027 17/08/2027 No 05/02/2025 Sharing
DLP wasscheme
amended and
onother
05/02/2025 PSUSA/00002281/202705 Liana Martirosyan Netherlands CAP
inactivated, adjuvanted)
substances
Lead MS andcontained in
PRAC Rapporteur
Nationally
name Authorised
updated Products
on 23/10/2018
with DLP synchronised on
2283 panitumumab 03/12/2007 3 years 30/09/2025 29/12/2025 No 03/05/2023 06/03/2015 PSUSA/00002283/202509 David Olsen Norway CAP
DLP was updated on 07/05/2018
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 39 / 223
dextromethorphan hydrobromide / paracetamol / PSUR frequency and DLP
2300 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00002300/202411 John Joseph Borg Malta NAP
promethazine hydrochloride amended on 27/03/2024
DLP was updated on 03/03/2021
DLP
PRACwas amended onwas
representative 16/06/2015
pelargonium sidoides dc and/or pelargonium reniforme updated on 03/06/2020
2329 Not available* 5 years 01/06/2028 30/08/2028 Yes 31/01/2024 DLP
Nextwas
DLPamended on 31/01/2024
was amended on PSUSA/00002329/202806 Melinda Palfi Hungary NAP
curt. / radix
31/01/2014
DLP was updated on 23/10/2018
2330 pemetrexed 20/09/2004 5 years 04/02/2029 05/05/2029 No 05/06/2024 DLP was updated on 28/04/2022 PSUSA/00002330/202902 Tiphaine Vaillant France CAP NAP
Reference to NAP added on
25/09/2017
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
PRAC Rapporteur name updated
2333 penciclovir 28/02/1996 5 years 28/08/2026 26/11/2026 No 28/04/2022
on 21/07/2017
PSUSA/00002333/202608 Jan Neuhauser Austria NAP
DLP was updated on 23/05/2017
PRAC Rapporteur name was
Lead MS
PSUR and PRAC
frequency Rapporteur
amended and
2335 penicillamine 04/04/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 amended on 28/07/2016 PSUSA/00002335/202803 NAP
name
DLP was added
updated on 07/04/2016
on 28/08/2024
PRAC Rapporteur name updated
on 03/06/2016
PSUR frequency and DLP
2336 pentaerithrityl tetranitrate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUSA/00002336/203203 NAP
amended on 23/10/2024
DLP
Nextwas
DLPupdated on 01/03/2023
was updated on
30/09/2015
PSUR frequency
PRAC and DLP
representative was
2337 pentagastrin 09/11/1981 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUSA/00002337/203505 NAP
amendedon
updated on19/10/2022
23/10/2024
pentosan polysulfate sodium (apart from centrally PSUR frequency and DLP
2341 13/06/1961 10 years 02/04/2034 01/07/2034 No 05/01/2025 PSUSA/00002341/203404 Melinda Palfi Hungary NAP
authorised product) amended on 23/10/2024
Correction of DLP on 20/11/2024
Marie Louise Schougaard
2343 pentostatin Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 PSUSA/00002343/202611
Christiansen Denmark NAP
PSUR frequency and DLP
amended on 23/10/2024
PSUR frequency and DLP
2344 pentoxifylline 14/05/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUSA/00002344/202804 NAP
amended on 31/07/2024
PSURwas
DLP frequency
updatedand
on DLP
21/09/2022
2347 peptidic preparation from porcine brain (cerebrolysin) Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00002347/203608 NAP
amended on 23/10/2024
DLP was updated on 25/09/2019
2350 perflutren 18/05/1998 3 years 27/12/2024 27/03/2025 No 21/09/2022 PRAC Representative updated on PSUSA/00002350/202412 Mari Thorn Sweden CAP
26/09/2018
Next
© European Medicines Agency, 2011. Reproduction is authorised provided the source DLP was updated
is acknowledged. on
# Classified as internal/staff contractors by the Europ22/09/2016 Page 40 / 223
Updated & published on
2352 periciazine 09/05/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00002352/203405 NAP
23/10/2024
2355 permethrin Not available* 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002355/202608 Martin Huber Germany NAP
PSURwas
DLP frequency
updatedand
on DLP
31/03/2021
2356 perphenazine 15/10/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00002356/203401 NAP
amended on 23/10/2024
PRAC representative was added
on 06/05/2020
2357 pethidine 28/03/1941 5 years 01/08/2025 30/10/2025 No 31/03/2021 PSUSA/00002357/202508 Melinda Palfi Hungary NAP
LMS was added on 01/04/2020
2368 ascorbic acid / paracetamol / pheniramine maleate Not available* 8 years 07/03/2028 05/06/2028 No 18/11/2020 PRAC representative was added PSUSA/00002368/202803 Maia Uusküla Estonia NAP
on 06/05/2020
31/07/2019
LMS was added on 01/04/2020
2370 phenobarbital 27/01/1943 8 years 27/01/2028 26/04/2028 No 21/10/2020 PSUSA/00002370/202801 Maia Uusküla Estonia NAP
PSUR frequency, "Are PSURs
required for products referred to
in Articles
PSUR 10(1), and
frequency 10a,DLP
14, 16a of
2373 phenoxymethylpenicillin 01/06/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00002373/202712 NAP
Directive
amended 2001/83/EC as
on 31/07/2024
amended?Yes/No" and DLP were
updated on 25/09/2019
PSUR frequency and DLP
2374 phenprocoumon 16/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00002374/202712 NAP
amended on 31/07/2024
2392 phenytoin 12/08/1960 3 years 12/08/2026 10/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002392/202608 Eamon O'Murchu Ireland NAP
Information included in column
"Are PSURs required for products
referred to in Articles 10(1), 10a,
2393 metylphenobarbital / phenytoin sodium 20/04/1950 10 years 01/12/2032 01/03/2033 No 18/10/2023 14, 16a of Directive 2001/83/EC PSUSA/00002393/203212 none NAP
as amended?", PSUR frequency
and DLP were amended on
18/10/2023
PSUR frequency and DLP
2398 phosphocreatine Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 PSUSA/00002398/202411 Amelia Cupelli Italy NAP
amended on 23/10/2024
Active substance name was
amended on 23/10/2024
2400 phytomenadione, menadiol 01/01/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00002400/203401 none NAP
PSUR frequency and DLP
amended on 23/10/2024
PSUR frequency and DLP
2402 phytosterol Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00002402/203608 NAP
amended on 23/10/2024
2413 pimozide 15/02/1971 12 years 15/02/2025 16/05/2025 No 05/01/2025 Reference to NAP removed on PSUSA/00002413/202502 Jo Robays Belgium NAP
17/11/2021
01/10/2013
DLP was amended on 03/05/2023
PSURand
DLP frequency amendedwere
PSUR frequency and
2431 pirenoxine Not available* 7 years 01/01/2025 01/04/2025 No 19/07/2024 PSUSA/00002431/202501 Amelia Cupelli Italy NAP
DLP updated
updated on 30/04/2024
on 20/10/2021
2451 plerixafor 31/07/2009 3 years 15/12/2025 15/03/2026 No 20/09/2023 Lead Member State
DLP amended wa+L2036s
on 20/09/2023 PSUSA/00002451/202512 Bianca Mulder Netherlands CAP
added on 27/11/2015.
2456 polidocanol / urea Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002456/202612 NAP
PSUR frequency amended and
DLP updated on 31/01/2024
poliovirus type 1 / poliovirus type 2 / poliovirus type 3
2459 02/07/1982 5 years 01/07/2030 29/09/2030 No 31/01/2024 PSUSA/00002459/203007 none NAP
vaccine (inactivated)
Entry re-introduced and entry
name changed on 04/03/2020
PSUR frequency and DLP
2468 polygeline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUR frequency amended and PSUSA/00002468/203611 NAP
amended on 23/10/2024
DLP updated on 31/05/2023
PSURand
DLP frequency and DLP
Information included in
2469 polymyxin b 01/01/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUSA/00002469/203612 NAP
amended
column on PSURs
"Are 23/10/2024
required for
products referred to in Articles
10(1), 10a, 14, 16a of Directive
PSUR frequency and DLP
2470 polymyxin b / trimethoprim Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 2001/83/EC as amended?" was PSUSA/00002470/203205 NAP
amended on 23/10/2024
updated on 29/06/2022
2480 posaconazole 25/10/2005 3 years 25/10/2026 23/01/2027 No 19/09/2024 PSUR frequency amended and PSUSA/00002480/202610 Zoubida Amimour France CAP NAP
DLP updated on 07/04/2016
2481 potassium / sodium Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002481/202612 NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 42 / 223
PSUR frequency amended and
2488 allantoine / povidone iodinated Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00002488/202903 NAP
DLP updated on 28/08/2024
2506 prednisolone 13/07/1956 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002506/202908 Polona Golmajer Slovenia NAP
2507 prednisolone / salicylic acid Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002507/202612 NAP
2525 primidone 30/06/1953 8 years 30/06/2028 28/09/2028 No 03/03/2021 PSUR frequency, "Are PSURs PSUSA/00002525/202806 Martin Huber Germany NAP
required for products referred to
in Articles 10(1), 10a, 14, 16a of
Directive
PSUR 2001/83/EC
frequency as
and DLP
2527 probenecid 01/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00002527/203404 NAP
amended?Yes/No"
amended and DLP were
on 23/10/2024
updated on 25/09/2019
PSUR frequency and DLP
2528 procainamide Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUSA/00002528/204005 NAP
amended on 23/10/2024
2545 promethazine 26/10/1948 9 years 26/04/2033 25/07/2033 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002545/203304 Eva Jirsová Czech Republic NAP
2547 carbocisteine / promethazine hydrochloride Not available* 13 years 03/11/2024 01/02/2025 No 19/10/2023 DLP was amended on 19/10/2023 PSUSA/00002547/202411 Amelia Cupelli Italy NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 43 / 223
DLP was updated on 20/10/2021
2568 prucalopride 15/10/2009 2 years 14/10/2025 12/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002568/202510 Mari Thorn Sweden CAP
2569 prulifloxacin 21/06/2004 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002569/202609 Amelia Cupelli Italy NAP
2609 ranibizumab 22/01/2007 3 years 05/10/2025 03/01/2026 No 31/05/2023 PSUR frequency and DLP were PSUSA/00002609/202510 Karin Bolin Sweden CAP
updated on 26/05/2021
PSUR frequency
Next DLP amended
was amended onand
2613 rasburicase 23/02/2001 5 years 23/02/2028 23/05/2028 No 18/10/2023 PSUSA/00002613/202802 Bianca Mulder Netherlands CAP
DLP updated on 18/10/2023
08/08/2014
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 44 / 223
DLP was updated on 16/12/2020
NextDLP
PRAC DLP wasamended
updated
representative on
was
2667 rotigotine 15/02/2006 3 years 15/02/2026 16/05/2026 No 18/10/2023 The was on PSUSA/00002667/202602 Ana Sofia Diniz Martins Portugal CAP
18/10/2023
updated on 30/06/2021
06/03/2015
PSUR frequency
The DLP and DLP
was amended onwere
2669 roxithromycin 04/08/1986 3 years 31/12/2024 31/03/2025 No 19/10/2022 updated on 25/09/2019
03/03/2014 PSUSA/00002669/202412 Amelia Cupelli Italy NAP
2679 salicylamide Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002679/202612 NAP
2680 salicylic acid (topical use) Not available* 6 years 02/12/2029 02/03/2030 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002680/202912 Martin Huber Germany NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 45 / 223
PRAC Rapporteur name was
amended on 22/09/2022
2745 sodium glycerophosphate pentahydrate Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002745/202612 NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 46 / 223
DLP was updated on 21/09/2022
PSUR frequency amended and
2756 sodium nitroprusside 30/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 DLP was updated on 25/09/2019 PSUSA/00002756/202809 NAP
DLP updated on 28/08/2024
PRAC Rapporteur name updated
on 19/12/2018
2758 sodium phenylbutyrate 08/12/1999 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00002758/202412 Rhea Fitzgerald Ireland CAP
PRAC Rapporteur name was
amended on 23/10/2018
PSUR frequency and DLP
2759 sodium picosulfate 01/10/1967 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUSA/00002759/202804 NAP
amended on 31/07/2024
Next DLP was updated on
22/09/2016
2760 liquid paraffin / sodium picosulfate Not available* 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002760/204006 NAP
2807 sodium hyaluronate / sulfadiazine silver Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002807/202612 NAP
2822 sulfur hexafluoride 26/03/2001 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00002822/202609 Tiphaine Vaillant France CAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 47 / 223
PSUR frequency and DLP
2823 sulindac 30/06/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00002823/202808 NAP
amended on 31/07/2024
Correction of DLP on 20/11/2024
2824 sulodexide 09/10/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 PSUSA/00002824/203412 Amelia Cupelli Italy NAP
PSUR frequency and DLP
amended on 23/10/2024
2828 sulprostone 17/12/1980 3 years 21/04/2025 20/07/2025 No 19/09/2024 DLP was updated on 28/07/2021 PSUSA/00002828/202504 Zoubida Amimour France NAP
Next DLP was amended on
28/07/2016
2829 sultamicillin 01/11/1983 5 years 20/11/2025 18/02/2026 No 28/07/2021 Active substance name changed PSUSA/00002829/202511 Maia Uusküla Estonia NAP
Information
on 21/12/2022included in column
DLP amended on 13/07/2015
"Are PSURs required for products
referred
DLP was to in Articles 10(1), 10a,
Lead MS updated
was added on on
03/06/2020
2830 sultiame Not available* 10 years 03/11/2036 01/02/2037 No 18/10/2023 14, 16a of Directive 2001/83/EC
13/07/2015
PSUSA/00002830/203611 none NAP
as amended?"
PRAC Rapporteur , PSUR
namefrequency
updated
and23/10/2018
on DLP were amended on
18/10/2023
PSUR frequency and DLP
2831 sultopride 01/10/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00002831/202812 NAP
amended
PRAC on 31/07/2024
Representative updated on
26/09/2018
2832 sumatriptan, naproxen / sumatriptan 11/04/1991 5 years 30/09/2024 29/12/2024 No 21/12/2022 Next DLP amended on PSUSA/00002832/202409 Liana Martirosyan Netherlands NAP
13/07/2015
2839 tacrolimus (systemic formulations) 02/04/1993 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00002839/202703 Eamon O'Murchu Ireland CAP NAP
2840 tacrolimus (topical formulations) 28/02/2002 2 years 31/03/2025 29/06/2025 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002840/202503 Rhea Fitzgerald Ireland CAP NAP
2841 tadalafil 12/11/2002 3 years 15/10/2025 13/01/2026 No 28/06/2023 DLP was amended on 28/06/2023 PSUSA/00002841/202510 Maria del Pilar Rayon Spain CAP NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 48 / 223
DLP was updated on 21/12/2022
New CAPs
PRAC authorisedwas
representative on added
27/08/2020
on 06/05/2020
2904 terizidone Not available* 5 years 15/09/2025 14/12/2025 No 26/05/2021 PSUSA/00002904/202509 Rugile Pilviniene Lithuania NAP
DLP updated
LMS on on
was added 05/06/2019
01/04/2020
DLP was updated on 21/09/2022
2905 terlipressin 01/05/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 Leadwas
DLP MS amended
and PRACon
updated Rapporteur
on05/06/2019
05/02/2025 PSUSA/00002905/202704 Karin Erneholm Denmark NAP
DLP
namewas updatedonon06/02/2019
amended 25/09/2019
Next
Lead DLP
MS wasPRAC
and updated on
PSUR frequency andRapporteur
DLP
2906 tertatolol 25/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 22/09/2016
name amended on 21/11/2018 PSUSA/00002906/202812 NAP
amended on 31/07/2024
Active substance
Reference to NAP name
addedwas
on
DLP was amended on 03/05/2023
amended
31/01/2018on 03/06/2016
2908 testosterone (topical use) 28/07/2006 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00002908/202412 Maia Uusküla Estonia NAP
PRAC representative was
Lead
PSUR MS added on
Frequency 31/07/2015.
amended and
updated on 01/03/2023
DLP updated on 03/05/2016
2909 human tetanus immunoglobulin 30/08/1999 5 years 29/08/2027 27/11/2027 No 03/05/2023 Conditions to the marketing PSUSA/00002909/202708 Gabriele Maurer Germany NAP
DLP was updated on 07/05/2018
authorisation following referral
Art 31
PRAC representative and Lead
2910 tetanus vaccines 01/01/1978 5 years 01/01/2028 31/03/2028 No 20/09/2023 Member State on
DLP amended
Name
were added on
20/09/2023
of the active substance PSUSA/00002910/202801 Gabriele Maurer Germany NAP
30/01/2017
was amended on 31/10/2013
DLP
PSURwas updatedand
frequency on DLP
26/05/2021
2915 tetracycline 19/11/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00002915/203401 NAP
amended on 23/10/2024
PRAC representative was
updated on 29/07/2020
PSUR frequency and DLP
2918 tetryzoline Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002918/203611 NAP
amended
PRAC on 23/10/2024
representative was
updated on 03/06/2020
Active substance name, DLP and
2919 thalidomide 16/04/2008 2 years 09/10/2024 07/01/2025 Yes 31/05/2023 DLP was updated
"Information and in
included reference
column PSUSA/00002919/202410 Tiphaine Vaillant France CAP NAP
to NAP was added on
"Are PSURs required for 06/05/2020
products
referred to in Articles 10(1), 10a,
14, 16a
DLP wasof Directive
updated 05/06/2019
on2001/83/EC
01/03/2023
2920 thallium [201TL] 31/08/1980 10 years 31/08/2024 29/11/2024 Yes 03/05/2023 PSUSA/00002920/202408 Jean-Michel Dogné Belgium NAP
as amended?" were amended on
DLP was updated
03/05/2023
European on 06/06/2018
Union reference date
and DLP amended on 0405/2018
2921 theophylline 14/06/1947 5 years 14/06/2027 12/09/2027 No 01/03/2023 PRAC MS
Lead Rapporteur
and PRACname updated
Rapporteur PSUSA/00002921/202706 Maria Popova-Kiradjieva Bulgaria NAP
on 21/07/2017
name
DLP added
was on 29/06/2022
updated on 27/03/2018
DLP was
Lead
PSUR MS updated
and PRAC
frequency onRapporteur
23/05/2017
amended and
2922 thiamazole 30/06/1978 8 years 03/03/2025 01/06/2025 No 26/07/2024
name was added on 20/12/2016
PSUSA/00002922/202503 Martin Huber Germany NAP
DLP updated on 03/07/2024
Next DLP and PRAC Rapporteur
name was amended on
PSUR frequency and DLP
03/06/2016
2924 cyanocobalamin / pyridoxine / thiamine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00002924/203506 NAP
amended on 23/10/2024
DLP was amended on 16/06/2015
2925 thiamphenicol 14/07/1960 5 years 31/05/2028 29/08/2028 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002925/202805 Amelia Cupelli Italy NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 49 / 223
PSUR
PRAC frequency
Rapporteurand DLPupdated
name
2928 thioctic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUSA/00002928/202708 NAP
amended on 23/10/2024
on 23/10/2018
2932 thiotepa 09/03/1959 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on27/07/2022
updated on 18/12/2024 PSUSA/00002932/202703 Tiphaine Vaillant France CAP NAP
PSUR frequency
PRAC Rapporteurand DLPwas
name
2958 tilbroquinol / tiliquinol 15/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00002958/203406 NAP
amended on 23/10/2024
corrected 03/04/2019
2967 tinzaparin 28/02/1991 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002967/203012 Jo Robays Belgium NAP
New
PRACCAP authorised on
representative updated on
2972 tiotropium 09/10/2001 5 years 09/10/2026 07/01/2027 No 31/01/2024 20/06/2024 PSUSA/00002972/202610 Bianca Mulder Netherlands NAP
31/01/2024
PSUR frequency and DLP were
updated
New CAPon 01/02/2023
authorised on
2973 tipranavir 25/10/2005 5 years 31/12/2027 30/03/2028 No 19/09/2024 15/09/2023 PSUSA/00002973/202712 Zoubida Amimour France CAP
DLP was updated on 05/02/2020
PRAC representative was
Next DLPon
updated updated on 30/01/2017
01/03/2023
2974 tirofiban 14/05/2003 5 years 31/05/2027 29/08/2027 No 01/02/2023 PSUSA/00002974/202705 Martin Huber Germany NAP
PRACwas
DLP Rapporteur
updated and Lead
on 21/12/2022
Member State was added on
27/11/2015.
PSUR frequency and DLP were
2975 tiropramide 30/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002975/202811 NAP
amended
DLP on20/11/2019
was on
updated 31/07/2024
updated on 23/09/2020
PSUSA number was amended on
06/10/2014
Next
DLP DLPupdated
was was updated on
on 21/11/2018
2977 tizanidine 15/12/1983 5 years 31/12/2024 31/03/2025 No 23/09/2020 30/09/2015 PSUSA/00002977/202412 Terhi Lehtinen Finland NAP
DLP was amended on 15/11/2017
Lead MS was added on
22/12/2014
PSUR Frequency amended and
2980 tocilizumab 11/04/2005 3 years 10/04/2025 09/07/2025 No 21/12/2022 PSUSA/00002980/202504 Gabriele Maurer Germany CAP
DLP updated on 23/05/2017
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 50 / 223
PSUR frequency and DLP
2989 nystatine / tolnaftate Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUSA/00002989/203203 NAP
amended on 23/10/2024
3002 tramadol 18/04/1973 3 years 22/06/2026 20/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00003002/202606 Tiphaine Vaillant France NAP
New
PRACCAP authorised on
representative updated on
3005 trandolapril / verapamil 16/03/1995 5 years 15/03/2025 13/06/2025 No 31/01/2024 15/11/2023 PSUSA/00003005/202503 Bianca Mulder Netherlands NAP
31/01/2024
PRAC
DLP representative
Nextwas
DLPamended onwas
was amended 03/05/2023
on
3015 tretinoin (oral formulations) 31/03/1994 5 years 30/03/2027 28/06/2027 No 21/12/2022 PSUSA/00003015/202703 Tiphaine Vaillant France NAP
updated on 28/07/2021
04/11/2014
Lead MS and PRAC Rapporteur
Lead
name MS and
wasPRAC
amended
Next DLP Rapporteur
on 19/12/2018
amended on
3016 tretinoin (topical formulations) 25/01/1973 5 years 31/08/2027 29/11/2027 Yes 03/05/2023 name amended
02/05/2014 on 19/12/2018 PSUSA/00003016/202708 Adam Przybylkowski Poland NAP
DLP was updated on 06/06/2018
DLP was updated on 19/12/2017
Lead MS
PRAC and PRAC Rapporteur
representative updated on
3017 triamcinolone (topical and nasal formulations) 14/12/1953 5 years 13/07/2027 11/10/2027 No 31/01/2024 Lead MS
name and
was PRAC
added onRapporteur
28/02/2017
PSUSA/00003017/202707 Carla Torre Portugal NAP
31/01/2024
name was added on 19/10/2016
3021 salicylic acid / triamcinolone acetonide Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00003021/202612 NAP
benzalkonium / chloride solution / light liquid paraffin / PSUR frequency amended and
3029 Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00003029/202906 NAP
triclosan DLP updated on 28/08/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 51 / 223
Correction of DLP on 05/02/2025
3034 trifluridine Not available* 8 years 03/11/2027 01/02/2028 No 05/02/2025 PSUSA/00003034/202711 Amelia Cupelli Italy NAP
PSUR frequency and DLP
amended on 28/08/2024
PSUR frequency and DLP
3035 triflusal 19/01/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00003035/202811 NAP
amended on 31/07/2024
3043 trimetazidine 06/08/2001 3 years 06/08/2026 04/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003043/202608 Amelia Cupelli Italy NAP
3047 pseudoephedrine / triprolidine Not available* 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00003047/202612 Martin Huber Germany NAP
DLP was updated on 21/12/2022
3056 troxerutin, troxerutin / heptaminol / ginkgo leaf 09/10/1970 8 years 03/11/2027 01/02/2028 No 05/01/2025 Active substance name, PSUR PSUSA/00003056/202711 Martin Huber Germany NAP
frequency and DLP were
amended on 20/12/2023
amylase / cortex granati / gentiana lutea / lipase /
PSUR frequency amended and
3059 quercus cortex / radix ratanhiae / rhizoma tormentillae Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00003059/202903 NAP
DLP updated on 28/08/2024
/ salicylic acid / tannic acid / trypsin
3074 ulipristal (female emergency contraceptive) 15/05/2009 3 years 14/05/2027 12/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003074/202705 Bianca Mulder Netherlands CAP NAP
DLP and PSUR frequency were
updated on 02/03/2022
PSUR frequency and DLP
3075 ulobetasol Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00003075/203211 NAP
amended on 23/10/2024
Next DLP was updated on
06/03/2019
PSUR frequency and DLP
3076 undecylenic acid Not available* 8 years 03/11/2024 01/02/2025 Yes 05/01/2025 Correction of Lead MS and PRAC PSUSA/00003076/202411 Polona Golmajer Slovenia NAP
amended on 28/08/2024
Rapporteur on 28/02/2017
Next DLP
PSUR was updated
frequency on
and DLP
3081 cytidine / uridine triphosphate sodium Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 04/03/2016 PSUSA/00003081/202603 NAP
amended on 31/07/2024.
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 52 / 223
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
Reference to NAP on
DLP was updated added on
28/03/2017
3109 vernakalant hydrochloride 01/09/2010 3 years 31/08/2025 29/11/2025 No 03/05/2023 23/10/2024 PSUSA/00003109/202508 Bianca Mulder Netherlands CAP
Next DLP was amended on
PRAC representative was
07/04/2016
3110 verteporfin 27/07/2000 3 years 31/12/2024 31/03/2025 No 19/09/2024 updated on 19/10/2022 PSUSA/00003110/202412 Zoubida Amimour France CAP
"Are PSURs required for products
New CAPto
referred authorised
in Articleson
10(1), 10a,
24/03/2022
14, 16a of Directive 2001/83/EC
3112 vigabatrin 22/09/1989 3 years 22/09/2026 21/12/2026 No 05/06/2024 DLPamended?Yes/No"
as was amended on was05/06/2024 PSUSA/00003112/202609 Terhi Lehtinen Finland CAP NAP
DLP was updated
amended on 17/11/2021
on 04/02/2015
PSUR frequency
The active and DLP
substance name was
3119 vincamine 26/06/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00003119/202812 NAP
amended on
amended on 31/07/2024
01/12/2014
Information included
PSUR frequency in column
amended and
3134 xylometazoline 29/08/1959 5 years 31/05/2028 29/08/2028 No 31/01/2024 "Are PSURs required for products PSUSA/00003134/202805 Zane Neikena Latvia NAP
DLP updated on 31/01/2024
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
Next DLP was updated
as amended?" on
was amended on
3135 yellow fever vaccine (live) 27/01/1986 3 years 02/12/2025 02/03/2026 No 26/07/2023 PSUSA/00003135/202512 Gabriele Maurer Germany NAP
26/07/2023
04/11/2014
3148 hydrochlorothiazide / zofenopril 03/03/2004 7 years 03/05/2031 01/08/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00003148/203105 Amelia Cupelli Italy NAP
3168 dorzolamide 11/11/1994 3 years 18/02/2025 19/05/2025 No 19/09/2024 DLP was updated on 28/04/2021 PSUSA/00003168/202502 Zoubida Amimour France NAP
PRAC representative was
updated on 31/03/2021
3170 hexoprenaline sulfate 13/08/1970 5 years 13/08/2025 11/11/2025 No 28/04/2021 PSUSA/00003170/202508 Roxana Dondera Romania NAP
Next DLP was amended on
03/05/2016
PSUR frequency and DLP
3171 hypromellose 30/11/1955 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00003171/203401 NAP
Lead MS added
amended on 12/05/2015
on 23/10/2024
3175 lanthanum Not available* 3 years 18/03/2027 16/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00003175/202703 Mari Thorn Sweden NAP
PRAC representative was
updated on 31/05/2023
PSUR frequency and DLP
3177 methandienone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PRAC representative was PSUSA/00003177/202611 NAP
amended on 23/10/2024
updated on 31/03/2021
3184 sorbitol Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 PRAC Rapporteur
DLP amended amended on
on 23/10/2024 PSUSA/00003184/202612 NAP
06/02/2019
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 54 / 223
9005 aclidinium bromide 20/07/2012 1 year 20/07/2024 28/09/2024 20/07/2025 28/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00009005/202407 PSUSA/00009005/202507 Adam Przybylkowski Poland CAP
Lead MS
PSUR added on
frequency 04/02/2015
and DLP
9062 ascorbic acid / biotin / calcium pantotenate Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00009062/202905 NAP
amended on 31/07/2024
9074 balsalazide 18/12/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009074/203101 Amelia Cupelli Italy NAP
botulinum neurotoxin type a (150 kd) free from DLP was updated on 25/09/2019
9084 31/05/2005 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00009084/202412 Rhea Fitzgerald Ireland NAP
complexing proteins
Next DLP was updated on
22/09/2016
PSUR frequency amended and
9085 bromelain Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00009085/202512 Martin Huber Germany NAP
DLP updated on 31/07/2024
Lead MS was added on
13/07/2015
PSUR frequency amended and
9088 caffeine / dextropropoxyphene / paracetamol Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUSA/00009088/202512 NAP
DLP updated on 31/07/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 55 / 223
9142 emtricitabine / rilpivirine / tenofovir disoproxil 28/11/2011 3 years 10/08/2026 08/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009142/202608 Liana Martirosyan Netherlands CAP
9147 exenatide 20/11/2006 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00009147/202703 Mari Thorn Sweden CAP
9153 fluorescein (systemic use) 30/11/1971 3 years 30/04/2026 29/07/2026 No 31/01/2024 Active
DLP wassubstance
amendedname was
on 31/01/2024 PSUSA/00009153/202604 Martin Huber Germany NAP
amended on 22/12/2021
9154 fluticasone furoate 11/01/2008 3 years 26/04/2027 25/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00009154/202704 Adam Przybylkowski Poland CAP NAP
9159 gentamicin (systemic use) 28/02/1973 3 years 31/03/2026 29/06/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00009159/202603 Amelia Cupelli Italy NAP
PRACwas
DLP Rapporteur
amendedname was
on 28/06/2023
PSUR frequency
updated and DLP
on 05/06/2019
9171 hydroxyethyl salicylate / heparin / menthol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUSA/00009171/203106 Jan Neuhauser Austria NAP
amended on 23/10/2024
PRAC representative was
DLP was on
updated updated on 23/10/2018
19/10/2022
PSUR frequency amended and
9172 benzyl nicotinate / heparin sodium Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 DLP was
Active updated name
substance and PRAC
was PSUSA/00009172/202512 NAP
DLP updated on 31/07/2024
Representative
amended name amended
on 30/06/2021
on 17/10/2017
human coagulation factor VIII (inhibitor bypassing New CAP authorised on
9174 04/02/1977 3 years 28/02/2027 29/05/2027 No 20/10/2021 PSUSA/00009174/202702 Sonja Hrabcik Austria NAP
fraction) Next DLP was amended on
27/05/2021
19/10/2016
DLP was updated on 01/07/2020
Next DLP was updated on
9175 human papillomavirus vaccine (rDNA) - 2-valent 20/09/2007 3 years 17/11/2025 15/02/2026 No 26/07/2023 DLP was amended on PSUSA/00009175/202511 Jean-Michel Dogné Belgium CAP
26/07/2023
30/09/2015.
PRAC Representative updated on
26/09/2018
hydrocortisone (for centrally authorised products for Lead MS was added on
9176 adrenal insufficiency, congenital adrenal hyperplasia, 03/11/2011 3 years 03/11/2025 01/02/2026 No 28/06/2023 13/07/2015 PSUSA/00009176/202511 Karin Bolin Sweden CAP
PRAC Rapporteur name was
modified-release formulations)
amended on 31/07/2018
Transferred from the List of
PSUR frequency
substances amended
under and
PSUR Work
9177 dexpanthenol / hydrocortisone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 Next DLP was amended on PSUSA/00009177/203008 NAP
DLP updated
Sharing on 28/08/2024
scheme and other
27/06/2017
substances contained in
Nationally
Next DLP Authorised
was amended
PSUR frequency and DLP Products
on
9178 hydrogen peroxide Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 with DLP synchronised
03/06/2016 on PSUSA/00009178/203106 NAP
amended on 23/10/2024
06/03/2015
DLP was amended on 16/06/2015
PSUR frequency and DLP
9179 hydrotalcite Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00009179/202611 NAP
amended
Next on 23/10/2024
DLP was amended
08/01/2014 and 08/08/2014
PSUR frequency and DLP
9180 hydrotalcite / simeticone Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 Name of active substance was PSUSA/00009180/203106 NAP
amended on 23/10/2024
amended on 01/08/2013
9190 iloprost (intravenous (IV)use only) 27/04/1994 5 years 31/01/2029 01/05/2029 No 19/09/2024 PRAC Representative was PSUSA/00009190/202901 Zoubida Amimour France NAP
amended on 28/04/2022
PRAC representative was
DLP was updated on 31/03/2021
9191 indium (111In) pentetate 06/03/1992 8 years 15/07/2028 13/10/2028 Yes 28/04/2022 updated on 19/10/2022 PSUSA/00009191/202807 Jo Robays Belgium NAP
LMS and PRAC representative
DLP was updated on 31/03/2021
were added on 18/12/2019
9192 indium (111In) pentetreotide 16/02/1994 8 years 15/07/2028 13/10/2028 No 31/03/2021 PRAC representative was added
DLP was updated on 05/06/2019
PSUSA/00009192/202807 Jo Robays Belgium NAP
on 06/05/2020
Active substance name was
LMS was added on 01/04/2020
amended on 19/10/2016
DLP was updated on 05/06/2019
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 56 / 223
PSUR frequency and DLP
9194 gentamicin sulfate / indometacin 25/05/1999 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00009194/202511 Zoubida Amimour France NAP
amended on 31/07/2024
DLP
PSURwas updatedand
frequency on DLP
04/03/2020
9251 paraffin liquid Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUSA/00009251/204006 Jo Robays Belgium NAP
amended on 23/10/2024
Next DLP, Lead MS and PRAC
Rapporteur name were amended
9253 pasireotide 24/04/2012 3 years 24/10/2026 22/01/2027 No 03/07/2024 on
DLP06/03/2019
was amended on 03/07/2024 PSUSA/00009253/202610 Mari Thorn Sweden CAP
DLP was updated on 28/02/2018
Correction of PSUR frequency
9254 peginterferon alfa-2a 05/07/2001 3 years 04/07/2026 02/10/2026 No 28/02/2024 and DLP
DLP was on 29/06/2022 Mari Thorn Sweden
Next DLPamended on 28/02/2024
was amended on PSUSA/00009254/202607 CAP
28/02/2017
DLP was updated on 16/12/2020
PSUR Frequency amended and
9255 perampanel 23/07/2012 3 years 22/07/2025 20/10/2025 No 01/03/2023 PRAC Representative amended PSUSA/00009255/202507 Tiphaine Vaillant France CAP
next DLP updated on 25/09/2017
on 07/05/2018
Next DLP was updated on
DLP was updated and
9256 phenol Not available* 10 years 16/04/2030 15/07/2030 Yes 16/12/2020 22/09/2016 PSUSA/00009256/203004 John Joseph Borg Malta NAP
information included in column
"Are PSURs required for products
DLP and Next DLP were updated
referred to in Articles 10(1), 10a,
on 04/03/2016
PSUR frequency amended and
9257 esculoside / phenylephrine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 14, 16a of Directive 2001/83/EC PSUSA/00009257/203011 NAP
DLP updated on 28/08/2024
as amended?" was amended on
Next DLP was updated on
28/03/2017
30/09/2015
PSUR frequency and DLP
9258 piketoprofen 08/08/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 Lead MS was added on PSUSA/00009258/202812 NAP
amended
Next on 31/07/2024
DLP was amended on
06/03/2015
06/03/2015
PSURwas
DLP frequency
updatedand
on DLP
17/11/2021
9275 pyridoxine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUSA/00009275/203205 NAP
amended on 23/10/2024
PRAC representative was
updated on 17/11/2021
l(+)biaspartate / glutamic acid / glycin / magnesium / PSUR frequency and DLP
9276 01/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00009276/203503 NAP
potassium / pyridoxine amended on 23/10/2024
PRAC representative was
updated on 25/09/2019
9277 rabies vaccine 16/05/1975 5 years 11/03/2026 09/06/2026 No 17/11/2021 PSUSA/00009277/202603 Amelia Cupelli Italy NAP
Next DLP was updated on
18/11/2016
PSUR frequency and DLP
9278 ephedrine hydrochloride / resorcinol 10/05/1994 8 years 03/08/2025 01/11/2025 No 31/07/2024 PRAC Representative was PSUSA/00009278/202508 NAP
amended on 31/07/2024
amended on 27/11/2015.
Lead Member
PSUR State
frequency andwas
DLPadded
9279 ascorbic acid / colecalciferol / retinol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 on 30/09/2015 PSUSA/00009279/202905 NAP
amended on 31/07/2024
9282 rilpivirine (for oral use) 28/11/2011 3 years 19/05/2027 17/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00009282/202705 Liana Martirosyan Netherlands CAP
PSUR frequency
PRAC Rapporteurand DLPwas
name
9312 thiamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00009312/203211 NAP
23/10/2024
amended on 25/09/2017
Next DLP
PSUR was amended
frequency and DLPon
9331 zinc orotate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 06/10/2014 PSUSA/00009331/203211 NAP
amended on 23/10/2024
10002 fluorodopa (18F) Not available* 3 years 10/03/2027 08/06/2027 Yes 20/11/2024 DLP
PRACwas amended on amended
Representative 20/11/2024 PSUSA/00010002/202703 John Joseph Borg Malta NAP
on 18/11/2016
Transferred
PSUR from the DLP
List of
PSUR frequency
frequency and
amendedwereand
10006 5-aminolevulinic acid (keratosis) 07/09/2007 5 years 14/06/2029 12/09/2029 No 05/02/2025 substances
updated on under PSUR Work
29/06/2022 PSUSA/00010006/202906 Martin Huber Germany CAP NAP
DLP updated on 05/02/2025
Sharing scheme and other
substances
DLP contained
was updated in
on 30/06/2021
Nationally Authorised Products
10007 ribavirin (oral formulations) 07/05/1999 3 years 24/07/2026 22/10/2026 Yes 19/09/2024 with was
DLP updated
synchronised on PSUSA/00010007/202607 Zoubida Amimour France NAP
DLP on 03/06/2020
Active substance name was
06/03/2015
pandemic influenza vaccine (H5N1) (surface antigen, PRAC representative
amended was
on 27/03/2024
inactivated, adjuvanted), prepandemic influenza DLP was on
updated updated on 05/06/2019
19/10/2022
10008 19/10/2009 1 year 19/10/2024 28/12/2024 19/10/2025 28/12/2025 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010008/202410 PSUSA/00010008/202510 Amelia Cupelli Italy CAP
vaccine (H5N1) (surface antigen, inactivated, DLP was updated on 03/02/2021
adjuvanted) Lead MS
PSUR and PRAC
Frequency Rapporteur
updated on
name amended on 21/11/2018
28/04/2022
PSUR Frequency amended and
10012 ciprofloxacin / dexamethasone (ear drops, suspension) 31/05/2012 5 years 30/04/2025 29/07/2025 No 27/03/2024 DLP updated on 04/02/2016 PSUSA/00010012/202504 Martin Huber Germany NAP
DLP was
DLP was updated
updated onon 30/03/2022
06/06/2018
Next DLP was updated on
Nextwas
DLP DLPupdated
was amended on
on 31/03/2021
21/12/2015.
10013 ceftaroline fosamil 29/10/2010 3 years 28/10/2024 26/01/2025 No 29/06/2022 27/06/2017 PSUSA/00010013/202410 Maia Uusküla Estonia CAP
DLP was
Lead MS updated
was addedon on
04/03/2020
Next DLP was amended on
06/03/2015
03/06/2016
Next DLP was updated on
10015 ruxolitinib 23/08/2012 1 year 22/02/2025 03/05/2025 22/02/2026 03/05/2026 No 18/10/2023 PSUSA/00010015/202502 PSUSA/00010015/202602 Mari Thorn Sweden CAP
18/10/2023
06/03/2019
Next DLP was updated on
27/11/2015.
PRAC Rapporteur name updated
10017 lixisenatide 07/01/2013 3 years 07/01/2026 07/04/2026 No 20/09/2023 DLP
DLP
on was updated
amended
23/10/2018 on 30/03/2022
on 20/09/2023 PSUSA/00010017/202601 Mari Thorn Sweden CAP
DLP was updated on 19/10/2022
Next DLP was amended on
PRAC Rapporteur
01/12/2014
DLP was updated name was
on 27/03/2018
Submission date was corrected
updated on 05/06/2019
10019 aflibercept (oncological indication(s)) 03/08/2012 3 years 03/08/2024 01/11/2024 No 28/04/2022 on 28/07/2021 PSUSA/00010019/202408 Mari Thorn Sweden CAP
Next DLP
Next DLP was
was amended
amended onon
DLP was updated on 03/04/2019
28/05/2014
28/02/2017
New
PSUR CAP authorised
frequency and on
DLP were
13/01/2025
updated on 25/09/2019
10020 aflibercept (ophthalmological indication(s)) 22/11/2012 3 years 30/11/2025 28/02/2026 No 19/09/2024 PRAC
Next Rapporteur
Next DLP
DLP amended name
on updated
was amended on PSUSA/00010020/202511 Zoubida Amimour France CAP
on 27/03/2018
30/11/2013
04/03/2016
New
DLP CAP updated
was authorised
on on
26/09/2018
13/11/2024
PRAC representative
PSURDLP
Frequency and was
Next
10021 alprostadil (patency of the ductus arteriosus) 23/07/1981 3 years 22/07/2024 20/10/2024 No 30/03/2022 Next was amended onDLP PSUSA/00010021/202407 Sonja Hrabcik Austria NAP
amended
amended onon 19/12/2017
06/10/2015
25/09/2017
PRAC representative
Next DLP and Lead MSwas
were
PRAC Rapporteur name was
amended
amended on
on 17/10/2017
10022 axitinib 27/01/2012 3 years 26/01/2025 26/04/2025 No 19/10/2022 amended on 06/03/2015
27/06/2017 PSUSA/00010022/202501 David Olsen Norway CAP
Next
ActiveDLP was amended
substance name on
PRAC Rapporteur name was
was
07/04/2016
amended onon 20/12/2016
04/02/2015
amended
10025 linaclotide 30/08/2012 1 year 29/08/2024 07/11/2024 29/08/2025 07/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010025/202408 PSUSA/00010025/202508 Martin Huber Germany CAP
PRAC
The Rapporteur name updated
Next DLP was updated on on
next DLP was amended
on 06/10/2015
06/10/2014
22/09/2016
PSUR frequency and DLP
10026 dectaflur / olaflur Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 Lead MS added onamended
01/04/2015 PSUSA/00010026/202603 NAP
amended
The next
DLP on 31/07/2024.
DLP was
was updated on
on 06/10/2015
DLP was updated on 21/12/2022
01/04/2014
PSUR frequency amended and
concentrate of proteolytic enzymes enriched in Next DLP wason
DLP updated amended on
10028 18/12/2012 1 year 17/12/2024 17/03/2025 17/12/2025 25/02/2026 No 31/01/2024 PSUR frequency 31/01/2024
and DLP were PSUSA/00010028/202412 PSUSA/00010028/202512 Martin Huber Germany CAP
bromelain 06/10/2014
updated on 20/11/2019
DLP amended on 20/09/2023
Next DLP was amended on
DLP was updated on 21/11/2018
10029 dapagliflozin 05/10/2012 1 year 04/10/2024 13/12/2024 04/10/2025 13/12/2025 No 05/06/2024 01/04/2014
DLP was amended on 05/06/2024 PSUSA/00010029/202410 PSUSA/00010029/202510 Mari Thorn Sweden CAP
PRAC Rapporteur name was
amended on 31/07/2018
PRAC Rapporteur updated on
10030 dexpanthenol / xylometazoline Not available* 8 years 31/05/2028 29/08/2028 No 15/11/2023 PSUSA/00010030/202805 Barbara Kovacic Bytyqi Croatia NAP
15/11/2023
DLP was amended
Correction of DLP onon03/05/2023
15/11/2017
Next DLP
PSUR was updated
frequency on and
amended
10031 mirabegron 01/07/2011 1 year 30/06/2025 08/09/2025 30/06/2026 08/09/2026 No 05/02/2025 DLP was amended
18/11/2016
DLP updated on 05/02/2025
on 05/04/2023 PSUSA/00010031/202506 PSUSA/00010031/202606 Maria del Pilar Rayon Spain CAP
DLP was
PSUR amended
frequency on 15/11/2017
corrected on
10032 florbetapir (18f) 06/04/2012 3 years 06/04/2025 05/07/2025 No 21/12/2022 28/04/2022 PSUSA/00010032/202504 Martin Huber Germany CAP
Next DLP was amended on
21/12/2015.
DLP was updated on 17/11/2021
Next DLPPRAC
DLP and was amended on
Representative
10039 brentuximab vedotin 19/08/2011 3 years 18/08/2025 16/11/2025 No 03/05/2023 04/11/2014
were updated on 26/09/2018 PSUSA/00010039/202508 Bianca Mulder Netherlands CAP
Next DLPupdated
DLP was was amended on
on 17/10/2017
28/05/2014
PSUR frequency amended and
10041 magnesium pidolate 01/04/1992 8 years 03/06/2025 01/09/2025 No 30/10/2024
Correction of on
DLP03/07/2024
on 20/12/2016
PSUSA/00010041/202506 Jana Lukačišinová Czech Republic NAP
DLP updated
Next DLP was amended
30/11/2013
Next DLP was updated on
10042 crizotinib 26/08/2011 2 years 25/08/2025 23/11/2025 No 30/04/2024 22/09/2016
DLP was amended on 30/04/2024 PSUSA/00010042/202508 Tiphaine Vaillant France CAP
Conditional Approval
Theisnext
© European Medicines Agency, 2011. Reproduction is authorised provided the source DLP was
acknowledged. amended on
# Classified as internal/staff contractors by the Europ06/10/2014 Page 59 / 223
10071 betamethasone / chloramphenicol 24/03/1964 18 years 31/08/2030 29/11/2030 No 29/11/2013 Lead MS and PRAC Rapporteur PSUSA/00010071/203008 NAP
name was added on 03/06/2016
10073 bosutinib 04/09/2012 3 years 03/03/2027 01/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010073/202703 Martin Huber Germany CAP
10074 bedaquiline 05/03/2014 1 year 05/09/2024 14/11/2024 05/09/2025 14/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010074/202409 PSUSA/00010074/202509 Mari Thorn Sweden CAP
Rapporteur updated
PRAC representative was on
10078 chloroprocaine hydrochloride 19/03/2012 5 years 19/03/2027 17/06/2027 No 15/11/2023 PSUSA/00010078/202703 Petar Mas Croatia NAP
15/11/2023
updated on 22/12/2021
10084 dabrafenib 26/08/2013 1 year 29/05/2025 07/08/2025 29/05/2026 07/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010084/202505 PSUSA/00010084/202605 Mari Thorn Sweden CAP
10086 defibrotide 18/10/2013 3 years 18/10/2026 16/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010086/202610 Mari Thorn Sweden CAP
PRACand
DLP representative was were
PSUR frequency
01/03/2023
updated on 20/10/2021
10087 dexpanthenol / retinol palmitate 16/07/1975 20 years 31/08/2032 29/11/2032 No 29/11/2013 PSUSA/00010087/203208 NAP
21/12/2022
DLP was updated on 21/10/2020
dextran 40 / sodium chloride / potassium chloride /
magnesium sulphate heptahydrate / disodium PSURwas
DLP frequency
updatedand
on DLP were
25/09/2019
10088 22/05/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00010088/203409 NAP
phosphate dodecahydrate / monopotassium phosphate amendedon
updated on20/11/2019
23/10/2024
/ dextrose monohydrate
diphtheria / tetanus / pertussis antigens (pertussis Lead MS and PRAC Rapporteur
DLP was updated on 22/12/2021
toxoid, filamentous haemagglutinin) (acellular, DLP was
name updated
updated on on 21/11/2018
30/04/2019
10091 component) / hepatitis b (rdna) / poliomyelitis 17/04/2013 3 years 17/04/2025 16/07/2025 No 21/12/2022 PSUSA/00010091/202504 Gabriele Maurer Germany CAP
Next DLP was updated on
(inactivated) / haemophilus type b conjugate vaccines amendedon
DLP was updated on26/09/2018
15/11/2017
30/01/2017
(adsorbed)
DLP was
PSUR updatedamended
frequency on 18/11/2016
and
10092 docosanol 14/11/2003 5 years 30/04/2026 29/07/2026 No 22/12/2021 PRAC Representative amended PSUSA/00010092/202604 Petar Mas Croatia NAP
DLP updated on 27/03/2018
on 18/11/2016
DLP was updated on 27/11/2015
Next DLP was amended on
Lead Member State and PRAC
10093 brimonidine (centrally authorised product only) 21/02/2014 3 years 21/02/2027 22/05/2027 No 20/10/2021 DLP was amended
25/09/2017 on 01/12/2014
Representative was added on
PSUSA/00010093/202702 Rhea Fitzgerald Ireland CAP
27/11/2015.
amendedand
DLP was updated on 28/05/2014
PRAC
DLP was
DLPupdated
Representative
Next on 19/10/2022
amended
was updated on on
10094 florbetaben (18f) 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023
28/03/2017
PSUSA/00010094/202602 Martin Huber Germany CAP
18/10/2023
PSUR frequency and DLP were
updated
Next DLPon 25/09/2019
was updated on
10095 enzalutamide 31/08/2012 3 years 30/08/2026 28/11/2026 No 30/04/2024 22/09/2016
DLP was amended on 30/04/2024 PSUSA/00010095/202608 Maria del Pilar Rayon Spain CAP
Lead MS and PRAC Rapporteur
nameDLP
Next updated on 30/04/2019
was amended on
07/04/2016
10096 fenofibrate / simvastatin 26/08/2013 3 years 25/02/2025 26/05/2025 No 19/10/2022 DLP was updated on 26/09/2018 PSUSA/00010096/202502 Maia Uusküla Estonia CAP
DLP and Next DLP was updated
DLP was updated on 17/10/2017
on 06/10/2015
10097 fluprednidene Not available* 10 years 11/03/2034 09/06/2034 No 20/11/2024 DLP was amended on 20/11/2024
Next
PSUSA/00010097/203403 Jana Lukačišinová Czech Republic NAP
Next DLP
DLP was
was updated
amendedon
on
22/09/2016
01/04/2015
10098 fluprednidene / gentamicin Not available* 10 years 11/03/2034 09/06/2034 No 20/11/2024 The
DLP Next DLP was amended
was amended on
on 20/11/2024 PSUSA/00010098/203403 Jana Lukačišinová Czech Republic NAP
29/10/2015.
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 60 / 223
PSUR frequency amended and
DLP updated on 28/04/2022
Conditional approval
Next DLP was amended on
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
#
06/10/2014
Classified as internal/staff contractors by the Europ Page 61 / 223
10171 para-aminosalicylic acid (centrally authorised product) 07/04/2014 3 years 07/10/2024 05/01/2025 Yes 29/06/2022 DLP was updated on 07/05/2018 PSUSA/00010171/202410 Mari Thorn Sweden CAP
Next DLP was updated and typo
in the entry name was corrected
Next DLP was amended on
on 18/11/2016
26/04/2017
10174 riociguat 19/03/2013 3 years 19/09/2024 18/12/2024 No 25/05/2022
Next DLP was amended on
PSUSA/00010174/202409 Kimmo Jaakkola Finland CAP
PSUR frequency and following
03/06/2016
DLP updated
Entry on 18/11/2016
re-activated due to splitting
PSUR frequency
of entries amended
andupdated
active on and
substance Marie Louise Schougaard
10178 aztreonam (parenteral use) 04/08/1984 7 years 03/08/2030 01/11/2030 No 30/04/2024 Next DLP
Nextupdated
DLP
was
wason amended on
PSUSA/00010178/203008
Christiansen Denmark NAP
DLP
name amended
27/11/2015. 30/04/2024
on 02/03/2022
19/10/2016
Next DLP
Next DLP was
was amended
amended on on
PRAC representative updated on
10180 cabozantinib 29/11/2012 3 years 28/11/2024 26/02/2025 No 31/01/2024 DLP and next DLP were amended
27/06/2017
12/05/2015of DLP on 21/12/2022
Correction PSUSA/00010180/202411 Bianca Mulder Netherlands CAP
31/01/2024
on 03/05/2016
Active
Active
DLP wassubstance
substance name
updated name was "Are
and
on 21/09/2022
The Next DLP
amended was amended on
on 07/04/2016
10184 rabbit anti-human thymocyte immunoglobulin 16/04/1984 3 years 30/06/2024 28/09/2024 No 02/03/2022 PSURs required for products PSUSA/00010184/202406 Maia Uusküla Estonia NAP
29/10/2015.
referred to to
Correction in Submission
Articles 10(1), 10a,
date on
PSUR
14, 16afrequency
22/12/2021 and2001/83/EC
of Directive DLP were
Next DLPon
updated was amended on
04/03/2016'
as amended?Yes/No" were
10186 vedolizumab 20/05/2014 3 years 19/05/2027 17/08/2027 No 05/02/2025 12/05/2015
DLP was amended onDLP
05/02/2025 PSUSA/00010186/202705 Adam Przybylkowski Poland CAP
amended
PSUR on 06/03/2015
frequency and were
PSUR Frequency
updated on 31/07/2019and Next DLP
DLP
EURD was
amendedwas updated
amended
on on on
25/09/2019
31/07/2015
Name of entry was amended on
amino acid combinations (only combinations of pure 04/11/2014
06/10/2014
DLP was updated on 31/07/2018 Martin Huber Germany
10187 amino acids or combination of amino acids with Not available* 7 years 01/01/2026 01/04/2026 No 25/09/2019 PRAC
Lead Representative and Lead PSUSA/00010187/202601 NAP
mineral compounds/electrolytes, i.v. application) ActiveMS
Member
was added
substance
state assigned
on
name was
on
22/12/2014
Next
amended on 23/10/2024on
DLP was amended
amino acid combinations / glucose / triglyceride 04/07/2018
25/09/2017
combinations (e.g. olive oil, soya bean oil, fish oil)/
10190 20/01/2011 3 years 31/12/2024 31/03/2025 No 21/09/2022 Active substance name was PSUSA/00010190/202412 Karin Bolin Sweden NAP
with or without electrolytes/ mineral compounds (i.v.
Active substance
amended name was
on 20/12/2023
application) - only for the drug Numeta
amended on 28/02/2017 (scope
amlodipine / candesartan, amlodipine / candesartan /
remains
DLP was unchanged)
updated on 21/12/2022
10191 hydrochlorothiazide, candesartan / amlodipine / 20/03/2014 5 years 28/04/2027 27/07/2027 No 23/10/2024 PSUSA/00010191/202704 Eva Jirsová Czech Republic NAP
DLP was updated on 21/09/2022
atorvastatin
Nextwas
DLP DLPupdated
was updated on
on 21/11/2018
22/09/2016
Next DLP was amended on
10192 amlodipine / lisinopril 30/04/2004 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP
DLP was
was amended
amended on on 15/11/2023
31/01/2018 PSUSA/00010192/202612 Zane Neikena Latvia NAP
25/09/2017
PSUR Frequency amended and
Lead MS and on
DLP updated PRAC Rapporteur
04/03/2016
Lead MS and PRAC Rapporteur
name added on 26/07/2023 19/10/2016
name was added on 28/07/2016
10196 benfotiamine 21/08/2013 5 years 03/07/2028 01/10/2028 Yes 15/11/2023 Lead MS was added on PSUSA/00010196/202807 Maia Uusküla Estonia NAP
Update of PSUR frequency & DLP
13/07/2015
resulting from PRAC re-allocation
bismuth salts and combinations (except for fixed dose
exercise
Name of for entries
entry was with DLPson
amended
Lead MS added on 01/04/2015 in
10198 combination bismuth subcitrate potassium / Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00010198/203501 NAP
2025 on 05/04/2023
02/07/2014
metronidazole / tetracycline)
10213 delamanid 28/04/2014 6 months 27/10/2024 05/01/2025 27/04/2025 06/07/2025 No 18/12/2024 DLP was amended on26/09/2018
updated on 18/12/2024 PSUSA/00010213/202410 PSUSA/00010213/202504 Jo Robays Belgium CAP
10221 ethyl esters of iodised fatty acids from poppyseed oil 31/03/1978 15 years 31/01/2028 30/04/2028 No 02/07/2014 DLP
PSURwas updatedamended
Frequency on 01/02/2023
and PSUSA/00010221/202801 NAP
DLP updated on 22/09/2016
PRAC representative was
updated
Next DLPon 23/09/2020
was amended on
fluocinolone acetonide (intravitreal implant in
10224 04/05/2012 2 years 26/08/2025 24/11/2025 No 30/04/2024 DLP was amended on 30/04/2024
07/04/2016 PSUSA/00010224/202508 Carla Torre Portugal NAP
applicator)
DLP was updated on 05/02/2020
Next DLP updated on 30/09/2015
Next DLP was amended on
10226 fusidic acid (systemic use) 31/05/1962 3 years 30/05/2025 28/08/2025 No 30/10/2024 PSUSA/00010226/202505 Zoubida Amimour France NAP
30/01/2017
The next DLP was amended on
01/04/2015
PRAC Rapporteur and Lead
PSUR frequency amended and
10227 fusidic acid (topical use) 31/05/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 Member
The DLP Statecorrected
was was addedon on PSUSA/00010227/202803 Zoubida Amimour France NAP
DLP updated on 28/08/2024
27/11/2015.
08/08/2014
hydroxocobalamin (only for products for chemical Name of entry was amended on
10228 23/11/2007 3 years 23/11/2025 21/02/2026 No 19/09/2024 08/08/2014 PSUSA/00010228/202511 Zoubida Amimour France CAP
poisoning) DLP was updated on 30/03/2022
PSURDLP,
Next Frequency
Lead MSamended and
and PRAC
10274 ataluren 31/07/2014 6 months 31/07/2024 09/10/2024 31/01/2025 11/04/2025 No 25/09/2024 DLP was
updated on 04/02/2016
amended
Rapporteur name on 25/09/2024
were amended PSUSA/00010274/202407 PSUSA/00010274/202501 Liana Martirosyan Netherlands CAP
on 06/03/2019
PSUR Frequency and Next DLP
amended
DLP on 31/07/2015
was updated on 28/02/2018
10275 peginterferon beta-1A 18/07/2014 5 years 18/07/2029 16/10/2029 No 05/02/2025 Entry re-activated and DLP PSUSA/00010275/202907 Karin Bolin Sweden CAP
updated
The Next
PSUR on 05/06/2024
DLP
Frequencywasamended
amendedand
on
01/12/2014
next DLP updated on 25/09/2017
Next DLP
PRAC was updatedname
Representative on was
10276 simoctocog alfa 22/07/2014 2 years 22/01/2025 22/04/2025 No 18/10/2023 PSUSA/00010276/202501 Mari Thorn Sweden CAP
18/10/2023
corrected
New on 29/07/2020
Next CAP
DLP authorised
was amendedon on
18/07/2014
28/02/2017
DLP
PRACwas updated on 29/06/2022
Representative updated on
10279 obinutuzumab 01/11/2013 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was
DLPamended
26/09/2018
Next on 03/07/2024
was updated on PSUSA/00010279/202610 Mari Thorn Sweden CAP
PRAC representative was
22/09/2016
updated
PSUR on 22/12/2021
Frequency amended and
Next
next DLPNext
DLP was DLP
updated
updated on on
25/09/2017
10280 acetylsalicylic acid / atorvastatin / ramipril 20/02/2014 3 years 20/02/2026 21/05/2026 No 18/10/2023 DLP and
PRAC
were updated
representative was PSUSA/00010280/202602 Jan Neuhauser Austria NAP
18/10/2023
on 04/03/2016
updated
Next DLPon 06/05/2020
was updated on
22/09/2016
Next DLP was updated on
10283 gaxilose 10/11/2011 9 years 09/11/2032 07/02/2033 No 05/06/2024 DLP was updated on 31/07/2019 PSUSA/00010283/203211 Maria del Pilar Rayon Spain NAP
30/09/2015
PRAC Rapporteur name updated
Lead MS and PRAC Rapporteur
on 03/06/2016
name amended on 19/12/2018
PRAC representative updated on
10285 solifenacin / tamsulosin 06/05/2013 5 years 01/07/2026 29/09/2026 No 31/01/2024
PSUR Frequency amended and
PSUSA/00010285/202607 Bianca Mulder Netherlands NAP
31/01/2024
Next DLP wason
DLP updated updated and PSUR
07/04/2016
Frequency amended on
28/06/2016
10287 acetylsalicylic acid / bisoprolol 05/11/2010 3 years 05/11/2024 03/02/2025 No 29/06/2022 Active Substance corrected on PSUSA/00010287/202411 Anna Mareková Slovakia NAP
21/12/2015.
Next DLP was updated and PSUR
Frequency
Next DLP amended
was updated onon
PSUR frequency
updatedamended and
10288 clevidipine 23/11/2011 3 years 23/11/2026 21/02/2027 No 03/07/2024 DLP was
21/12/2015
30/09/2015
on 29/06/2022 PSUSA/00010288/202611 Jan Neuhauser Austria NAP
DLP updated on 03/07/2024
DLP was updated on 27/07/2022
PSUR frequency
Lead MS
MS and on
was added
added DLP updated
Lead was on
on 05/06/2019
06/03/2015
Active
Next substance
DLP nameon
was updated was
10289 lisdexamfetamine 23/02/2007 1 year 22/02/2025 03/05/2025 22/02/2026 03/05/2026 No 18/10/2023 22/12/2014 PSUSA/00010289/202502 PSUSA/00010289/202602 Karin Bolin Sweden NAP
amended
18/10/2023 on 03/03/2021
Lead MS and
For advice onPRAC Rapporteur
submission for
name amended
DLPs falling
PRAC on 05/05/2015
before
representative 21/11/2018
updated,
Marie Louise Schougaard
10291 misoprostol (gastrointestinal indication) 28/06/1984 2 years 30/06/2025 28/09/2025 Yes 28/02/2024 please
PSUR consult
frequency the List of
amdended
DLP was amended on 28/02/2024 and PSUSA/00010291/202506
Christiansen Denmark NAP
DLP was updated
substance
updatedunder on 06/06/2018
Work sharing
on 03/07/2019
scheme and other substance
Next DLP
contained
PSUR was
in amended
Nationally
frequency amended onand
PRAC representative updated on
10292 triamcinolone (intraocular formulations) 31/03/2011 2 years 31/03/2025 29/06/2025 No 31/01/2024 27/06/2017
Authorised
DLP updatedProducts with DLPs
on 06/02/2019 PSUSA/00010292/202503 Carla Torre Portugal NAP
31/01/2024
synchronised.
PRAC Representative and amended
LMS
on 28/03/2017
updated on 19/12/2018
10293 flutemetamol (18f) 22/08/2014 3 years 31/10/2024 29/01/2025 No 29/06/2022 PSUSA/00010293/202410 Martin Huber Germany CAP
PSURwas
DLP Frequency
updatedamended and
on 04/07/2018
DLP updated on 20/12/2016
10294 dapagliflozin / metformin 16/01/2014 3 years 15/01/2027 15/04/2027 No 25/09/2024 DLP was amended onon 25/09/2024
31/01/2018 PSUSA/00010294/202701 Bianca Mulder Netherlands CAP
Next DLP was amended on
03/06/2016
Next DLP was amended on
27/06/2017
10296 sucroferric oxyhydroxide 27/11/2013 3 years 26/11/2024 24/02/2025 No 27/07/2022 Next DLP was updated on PSUSA/00010296/202411 Kimmo Jaakkola Finland CAP
27/11/2015.
Europena Union reference date
amended on 28/03/2017
10297 human fibrinogen / human thrombin 08/06/2004 3 years 08/06/2026 06/09/2026 No 31/01/2024 Next DLPamended
DLP was amendedonon31/01/2024 PSUSA/00010297/202606 Gabriele Maurer Germany CAP
13/07/2015
Next DLP amended on
30/01/2017
influenza vaccine (split virion, inactivated) (non New CAP
Next DLP authorised onon
was updated
10298 08/08/1996 1 year 15/03/2025 24/05/2025 15/03/2026 24/05/2026 No 18/10/2023 18/07/2014
Next DLP was updated on PSUSA/00010298/202503 PSUSA/00010298/202603 Gabriele Maurer Germany NAP
centrally authorised products) 18/10/2023
DLP was updated on 30/03/2022
28/06/2016
New CAP authorised on
15/11/2024
Next DLP, PSUR frequency, Lead
influenza vaccine (surface antigen, inactivated,
10300 20/09/2010 1 year 15/03/2025 24/05/2025 15/03/2026 24/05/2026 No 18/10/2023 Next DLP was amended on
MS and PRAC Rapporteur name PSUSA/00010300/202503 PSUSA/00010300/202603 Jean-Michel Dogné Belgium CAP NAP
adjuvanted) 04/02/2016
Next
were DLP was updated
amended on
on 06/03/2019
18/10/2023
Next DLP
PSUR was updated on and
frequency
10301 ibrutinib 13/11/2013 2 years 12/11/2025 10/02/2026 No 03/07/2024 DLP was updatedamended
on 28/02/2018 PSUSA/00010301/202511 Barbara Kovacic Bytyqi Croatia CAP
30/09/2015
DLP updated on 03/07/2024
PSUR Frequency amended and
Next DLP was amended on
next DLP updated on 25/09/2017
PSUR frequency and DLP
06/03/2015
10302 ibuprofen / paracetamol Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00010302/202611 Lina Šeibokienė Lithuania NAP
amended on 23/10/2024
PRAC Representative amended
New CAP authorised on
on 28/03/2017
26/08/2014
10303 idelalisib 23/07/2014 3 years 22/07/2024 20/10/2024 No 30/03/2022 PSUSA/00010303/202407 Martin Huber Germany CAP
Next DLP was amended on
28/02/2017
10332 porfimer 19/04/1993 3 years 19/04/2026 18/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010332/202604 Petar Mas Croatia NAP
10333 tixocortol, chlorhexidine gluconate / tixocortol pivalate 18/11/1976 5 years 01/11/2027 30/01/2028 No 19/09/2024 PSUR frequency and DLP were PSUSA/00010333/202711 Zoubida Amimour France NAP
updated on 23/10/2019
10335 bupivacaine, bupivacaine / epinephrine 27/04/1966 5 years 26/04/2029 25/07/2029 No 18/12/2024 DLP was amended
DLP was updated on
on23/10/2018
18/12/2024 PSUSA/00010335/202904 Zane Neikena Latvia NAP
PSUR frequency
DLP was updatedand
on DLP were
17/10/2017
PSUR frequency
updated and DLP were
on 20/10/2021
10336 fosfomycin (IV formulation) 13/07/1983 5 years 31/07/2027 29/10/2027 No 19/09/2024 updated on 30/03/2022 PSUSA/00010336/202707 Zoubida Amimour France NAP
PSUR Frequency amended and
DLP updated
DLP was updated on 21/10/2020
on 26/04/2017
PSUR frequency amended and
DLP updated on 03/04/2019
Nextwas
DLPupdated on 25/09/2019
was amended on
10338 apremilast 21/03/2014 3 years 20/03/2025 18/06/2025 No 16/11/2022 PSUSA/00010338/202503 Monica Martinez Redondo Spain CAP
19/10/2016
Lead MS and PRAC Rapporteur
name amendedon
updated on30/04/2019
19/12/2018
PRAC Representative amended
10339 fluticasone propionate / formoterol fumarate dihydrate 23/08/2012 5 years 31/07/2026 29/10/2026 No 30/03/2022 on 28/06/2016 PSUSA/00010339/202607 Mari Thorn Sweden NAP
27/03/2018
DLP was updated on 26/09/2018
Next DLP was amended on
DLP was
PSUR updatedamended
frequency on 28/03/2017
and
03/05/2016
10340 ospemifene 26/02/2013 3 years 26/02/2027 27/05/2027 No 20/10/2021 DLP updated on 27/03/2018 PSUSA/00010340/202702 Terhi Lehtinen Finland CAP
Next DLP was amended on
The Next DLP was amended on
07/04/2016
DLP was updated on 17/10/2017
29/10/2015.
10341 secukinumab 26/12/2014 3 years 25/12/2026 25/03/2027 No 25/09/2024 DLP
Leadwas
DLP MS amended
updated
was added on02/03/2022
on 25/09/2024
on on
PSUSA/00010341/202612 Monica Martinez Redondo Spain CAP
New was
CAP updated
authorised 28/03/2017
on
aprotinin / calcium chloride / human factor xiii / human 13/07/2015
Active substance name was
15/01/2015.
Correction of Reference to NAP
fibrinogen / human thrombin, aprotinin / fibrinogen / Next DLP was
amended amended on
on 03/07/2024
10342 fibronectin / humanformulations),
diclofenac (topical coagulation factor XIII / /plasma
diclofenac heparin 11/05/1977 6 years 30/09/2029 29/12/2029 No 03/07/2024 added on
19/10/201620/10/2021 PSUSA/00010342/202909 Karin Erneholm Denmark NAP
protein fraction / plasminogen / thrombin, aprotinin / PRAC representative
PSUR frequency was and
amended
human fibrinogen / thrombin / calcium chloride, PRAC
DLP Rapporteur
updated
was on
updated
Nextupdated
DLP wason name
01/03/2023
on
amended was
25/05/2022
on
DLP 05/06/2024
aprotinin / calcium chloride / factor xiii / human corrected
07/04/2016on 03/04/2019
amlodipine / valsartan, amlodipine /
10344 thrombin / human clottable protein containing mainly 16/01/2007 5 years 30/06/2026 28/09/2026 No 02/03/2022 DLP was
PRAC updated on 27/07/2022
representative was PSUSA/00010344/202606 Karin Erneholm Denmark CAP NAP
hydrochlorothiazide / valsartan
fibrinogen and fibronectin, calcium chloride / human PRAC Rapporteur
updated
New CAP on name
29/07/2020
authorised on was
fibrinogen / factor xiii / fibronectin / plasminogen / amended
Next on 06/06/2018
DLP was
15/01/2015. amended on
human thrombin / bovine aprotinin, calcium chloride / 25/09/2017
PRAC representative was
10346 Not available* 5 years 30/11/2026 28/02/2027 No 27/07/2022
PRAC Representative amended
PSUSA/00010346/202611 Gabriele Maurer Germany NAP
human fibrinogen / factor xiii / fibronectin / human updated on 03/06/2020
thrombin / bovine aprotinin, human fibrinogen / on 17/10/2017
Lead MS and PRAC Rapporteur
calcium chloride dihydrate / plasma fibronectin / name
DLP was
was added on
updated 28/07/2016
05/06/2019
10347 thrombin / bovine aprotinin / human coagulation factor
atorvastatin 07/11/1996 6 years 31/10/2029 29/01/2030 No 03/07/2024 DLP was amended
updated on on28/03/2017
03/07/2024 PSUSA/00010347/202910 Martin Huber Germany NAP
xiii, human fibrinogen / calcium chloride dihydrate / The name
PRAC
DLP was of the active
Rapporteur
amended name updated
on 03/05/2023
plasma protein fraction / fibronectin / thrombin / substance
on was amended on
21/07/2017
bovine aprotinin / human coagulation factor xiii, 06/10/2015
PSUR frequency and DLP were
10348 carmustine (implant)
human fibrinogen / plasminogen / human thrombin / 23/09/1996 3 years 23/09/2024 22/12/2024 No 25/05/2022 PSUSA/00010348/202409 Tiphaine Vaillant France NAP
PRAC Rapporteur
updated name was
on 31/03/2021
bovine aprotinin / human coagulation factor xiii / amended on 28/07/2016
human fibronectin DLP was updatedamended
on 01/04/2020
carmustine (powder and solvent for solution for PSUR frequency and
10349 23/04/1974 5 years 22/04/2029 21/07/2029 No 18/12/2024 Next DLP was amended on PSUSA/00010349/202904 Tiphaine Vaillant France NAP
infusion) DLP updated on 18/12/2024
03/06/2016
DLP was updated on 03/04/2019
PRAC
PRAC Rapporteur name updated
Representative
10350 dalbavancin 23/05/2014 3 years 22/11/2026 20/02/2027 No 31/07/2024 amended on updated
DLP07/04/2016
on was on
31/07/2024 PSUSA/00010350/202611 Rugile Pilviniene Lithuania CAP
26/09/2018
PRACwas
DLP Rapporteur
updated name updated
on 27/03/2018
10351 eliglustat 19/01/2015 2 years 19/08/2024 17/11/2024 No 03/05/2023 on 04/02/2016 PSUSA/00010351/202408 Maria del Pilar Rayon Spain CAP
PSUR Frequency amended and
DLP updated
DLP was amended on 16/06/2015
on 17/10/2017
Next
© European Medicines Agency, 2011. Reproduction is authorised provided the source DLP was updated
is acknowledged. on
# Classified as internal/staff contractors by the Europ22/09/2016 Page 64 / 223
Next DLP
PRAC was amended
representative wason
amitriptyline, amitriptyline / amitriptylinoxide,
10374 31/07/1961 3 years 10/01/2027 10/04/2027 No 25/09/2024 19/10/2016
updated
DLP
PRACwas
on 01/03/2023
amended onupdated
representative 25/09/2024
on PSUSA/00010374/202701 Georgia Gkegka Greece NAP
amitriptylinoxide
23/02/2024
DLP and next DLP were
PSUR frequency and DLPamended
were
on 03/052016
updated on 02/03/2022
10376 ivermectin (topical use) 22/03/2015 3 years 22/04/2027 21/07/2027 No 18/12/2024 PRAC representative
DLP was amended onwas18/12/2024 PSUSA/00010376/202704 Zoubida Amimour France NAP
updated
CAPon
New was 19/10/2022
authorised
DLP updated on on
03/03/2021
18/03/2015
PSUR frequency and DLP were
10377 ivermectin (systemic use) 15/10/1987 3 years 14/04/2025 13/07/2025 No 19/09/2024 DLP was updated on 05/02/2020 PSUSA/00010377/202504 Zoubida Amimour France NAP
amended on 20/10/2021
PSUR frequency and DLP were
DLP was updated on 23/09/2020
updated on 31/07/2019
10378 mifepristone / misoprostol Not available* 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010378/202605 Bianca Mulder Netherlands NAP
DLP was updated on 25/09/2019
DLP was updated on 06/02/2019
DLP and PRAC Representative
DLP was updated on 31/07/2018
10379 nivolumab 04/09/2014 3 years 03/07/2024 01/10/2024 No 02/03/2022 were updated on 26/09/2018 PSUSA/00010379/202407 Martin Huber Germany CAP
DLP was amended on 31/01/2018
PSUR frequency amended and
DLP updated on 27/03/2018
10380 lenvatinib 13/02/2015 3 years 12/02/2027 13/05/2027 No 20/10/2021 DLP was updated on 21/07/2017 PSUSA/00010380/202702 Mari Thorn Sweden CAP
Next DLP was amended on
Next DLP was updated on
25/09/2017
30/01/2017
PRAC representative updated on
10381 ivabradine / metoprolol 29/05/2015 3 years 25/04/2026 24/07/2026 No 31/01/2024 PSUSA/00010381/202604 Bianca Mulder Netherlands NAP
31/01/2024
PSUR Frequency amended and
Next DLP was updated on
next DLP updated on 26/04/2017
22/09/2016
PRAC representative updated on
10382 tioconazole, tioconazole / hydrocortisone 13/04/1981 13 years 01/04/2030 30/06/2030 No 31/01/2024 PSUR Frequency amended and PSUSA/00010382/203004 Carla Torre Portugal NAP
31/01/2024
Next DLP
PSUR was amended
frequency and DLPon
were
DLP updated
Active on 28/03/2017
substance name was
04/02/2016
updated on 01/02/2023
amended on 20/12/2023
PSURDLP
frequency amended
on and
10385 atorvastatin / ezetimibe 13/11/2014 7 years 15/07/2030 13/10/2030 No 27/03/2024 Next
New
DLP
was updated
CAP updated
authorised
on on PSUSA/00010385/203007 Martin Huber Germany NAP
DLP was
updated
22/09/2016
02/02/2022
on 27/03/2024
PSUR frequency and DLP were
19/06/2015
updated
DLP was on 26/05/2021
updated on 03/02/2021
colecalciferol, colecalciferol / calcium, ergocalciferol, Next DLP was amended on
10386 Not available* 5 years 31/10/2024 29/01/2025 No 20/12/2023 07/04/2016 PSUSA/00010386/202410 Jan Neuhauser Austria NAP
ergocalciferol / calcium DLP was
DLP was updated
updated on
on 05/02/2020
01/07/2020
New was
DLP CAP updated
authorised
on on
21/07/2017
PSUR frequency and DLP were
10387 edoxaban 22/04/2011 3 years 21/10/2026 19/01/2027 No 19/09/2024 28/05/2015. PSUSA/00010387/202610 Zoubida Amimour France CAP
updated on 31/07/2019
Lead MS and PRAC Rapporteur
name was added
Correction of DLPson
on03/06/2016
06/03/2019
10388 empagliflozin, empagliflozin / metformin 17/04/2014 2 years 17/04/2026 16/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010388/202604 Maria del Pilar Rayon Spain CAP
DLP, Lead
PRAC MS and PRAC
representative was
Rapporteur
updated on name amended on
27/07/2022
06/02/2019
human papillomavirus 9-valent vaccine (recombinant,
10389 10/12/2014 3 years 09/06/2025 07/09/2025 No 01/02/2023 PSUR frequency and DLP were PSUSA/00010389/202506 Jean-Michel Dogné Belgium CAP
adsorbed)
DLP was on
updated updated on 31/07/2018
25/05/2022
PRAC Rapporteur
Next DLP nameand
was updated updated
EURD
10396 valsartan, hydrochlorothiazide / valsartan 13/05/1996 3 years 30/04/2025 29/07/2025 No 01/02/2023 on 23/10/2018
date corrected on 18/11/2016 PSUSA/00010396/202504 Mari Thorn Sweden NAP
PRAC Rapporteur
Next DLP name was
was amended on
amended on 31/07/2018
03/06/2016
DLP
New was
CAP amended onon
authorised 31/01/2018
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
27/05/2015
Classified as internal/staff contractors by the EuropLead Page 65 / 223
#
10401 phenylephrine (IV, nasal or oral formulations ) 01/01/1940 13 years 01/01/2028 31/03/2028 No 29/10/2015 PSUSA/00010401/202801 NAP
DLP was updated on 23/09/2020
10404 atazanavir / cobicistat 29/01/2015 5 years 28/01/2029 28/04/2029 No 19/09/2024 PSUR frequency and DLP were PSUSA/00010404/202901 Tiphaine Vaillant France CAP
updated on 01/07/2020
Entry name
PSUR changed
frequency and Are
amended and
PSURs requiredon for products
10406 1-propanol / 2-propanol / orthophenylphenol 23/10/1980 10 years 23/10/2029 21/01/2030 No 01/07/2020 DLP updated 03/05/2023 PSUSA/00010406/202910 Adam Przybylkowski Poland NAP
referred to in Articles 10(1), 10a,
14,
PRAC16a of Directive 2001/83/EC
Representative name was
as amended?
corrected on 29/07/2020
PSUR frequency and DLP
10407 dibrompropamidine , propamidine 16/01/1959 11 years 02/04/2038 01/07/2038 No 23/10/2024 Yes/No was updated on PSUSA/00010407/203804 Rhea Fitzgerald Ireland NAP
amended on 23/10/2024
07/05/2018
PSUR frequency and DLP were
updated on 01/04/2020
New substance
PSUR frequencyadded on and
amended
10408 sonidegib 30/06/2015 2 years 29/06/2026 27/09/2026 No 05/02/2025 27/11/2015 PSUSA/00010408/202606 Petar Mas Croatia CAP
DLP updated
was on 05/02/2025
updated on 03/04/2019
10411 ceftolozane / tazobactam 19/12/2014 3 years 19/12/2026 19/03/2027 No 25/09/2024 DLP was amended
updated on
on28/03/2017
25/09/2024 PSUSA/00010411/202612 Adam Przybylkowski Poland CAP
10443 dienogest / estradiol (HRT indication) 13/12/2000 5 years 13/06/2029 11/09/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010443/202906 Bianca Mulder Netherlands NAP
10444 dienogest / estradiol (contraception indication) 03/11/2008 5 years 08/09/2028 07/12/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010444/202809 Bianca Mulder Netherlands NAP
10445 asparaginase (centrally authorised product) 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010445/202701 Jan Neuhauser Austria CAP
10446 birch bark extract (centrally authorised products) 14/01/2016 6 months 14/07/2024 22/09/2024 14/01/2025 25/03/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010446/202407 PSUSA/00010446/202501 Zane Neikena Latvia CAP
10447 brivaracetam 14/01/2016 3 years 14/01/2027 14/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010447/202701 Adam Przybylkowski Poland CAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 67 / 223
PSUR frequency and DLP were
updated on 21/12/2022
10481 human coagulation factor X 16/03/2016 3 years 16/03/2027 14/06/2027 No 20/11/2024 DLP was amended
DLP was updated on
on28/04/2022
20/11/2024 PSUSA/00010481/202703 Bianca Mulder Netherlands CAP
10482 rhubarb extract / salicylic acid Not available* 15 years 30/09/2030 29/12/2030 No 03/05/2016 New entry
PSUR addedamended
frequency on 03/05/2016
on PSUSA/00010482/203009 NAP
01/04/2020
PSURwas
DLP frequency
updatedamended and
on 05/02/2020
10483 phenylpropanolamine 29/11/2005 5 years 10/06/2029 08/09/2029 No 05/02/2025 PSUSA/00010483/202906 Eva Jirsová Czech Republic NAP
DLP updated on 05/02/2025
DLP was updated on 03/07/2019
10484 methoxyflurane 18/05/2015 3 years 17/05/2025 15/08/2025 No 21/12/2022 DLP was updated on 06/02/2019 PSUSA/00010484/202505 Karin Bolin Sweden NAP
10488 isotretinoin (oral formulations) 07/05/1982 1 year 06/05/2025 15/07/2025 06/05/2026 15/07/2026 Yes 18/12/2024 DLP was amended on
on 18/12/2024
31/01/2018 PSUSA/00010488/202505 PSUSA/00010488/202605 Maia Uusküla Estonia NAP
10490 pitolisant 31/03/2016 1 year 30/09/2024 09/12/2024 30/09/2025 09/12/2025 No 05/06/2024 New entry
DLP was added on
amended on03/05/2016
05/06/2024 PSUSA/00010490/202409 PSUSA/00010490/202509 Terhi Lehtinen Finland CAP
10491 azithromycin (systemic use formulations) 04/04/1991 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010491/202604 Kimmo Jaakkola Finland NAP
10493 ixekizumab
calcium chloride / glucose / magnesium chloride / 22/03/2016 3 years 22/03/2027 20/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010493/202703 Gabriele Maurer Germany CAP
sodium chloride / sodium lactate, calcium chloride / DLP was updated on 01/03/2023
glucose / magnesium chloride / sodium chloride /
sodium lactate/ sodium bicarbonate, calcium chloride / PRAC representative was
10494 Not available* 15 years 01/01/2027 01/04/2027 No 03/06/2016 New entry added on 03/06/2016 PSUSA/00010494/202701 NAP
amino acids blend / magnesium chloride / sodium updated on 17/11/2021
chloride / sodium lactate, calcium chloride /
icodextrin / magnesium chloride / sodium chloride / PRAC representative was
New active substance added on
10495 sodium lactate (peritoneal dialysis solutions)
immunocyanine 25/03/1997 15 years 30/06/2030 28/09/2030 No 03/06/2016 updated on 30/06/2021 PSUSA/00010495/203006 NAP
03/06/2016
PRAC Rapporteur name amended
on 04/07/2018
10496 delapril / manidipine, delapril / indapamide 17/01/1989 5 years 30/06/2027 28/09/2027 No 01/03/2023 PRAC representative was PSUSA/00010496/202706 Amelia Cupelli Italy NAP
updated
DLP was on 01/03/2023
updated on 27/03/2018
DLP
Entrywas
PSUR updated
'delapril
frequency on 28/07/2021
/ manidipine'
amended and
10498 daratumumab 16/11/2015 2 years 15/11/2024 13/02/2025 No 28/06/2023 replaced withon'delapril / PSUSA/00010498/202411 Carla Torre Portugal CAP
DLP updated 28/06/2023
DLP was updated
manidipine, on /29/07/2020
delapril
indapamide' on 03/06/2016
10499 eftrenonacog alfa 20/03/2014 3 years 19/03/2026 17/06/2026 No 15/11/2023 PSUR frequency
DLP was amended and
onDLP were
15/11/2023 PSUSA/00010499/202603 Gabriele Maurer Germany CAP
updated on 05/02/2020
pandemic influenza vaccine (H5N1) (live attenuated, DLP was updated on 04/07/2018
10501 20/05/2016 6 months 20/11/2024 29/01/2025 20/05/2025 29/07/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010501/202411 PSUSA/00010501/202505 Sonja Hrabcik Austria CAP
nasal)
DLP was amended on 31/01/2018
PRAC representative updated on
10502 pitavastatin 17/07/2003 3 years 16/07/2025 14/10/2025 No 31/01/2024 Next DLP was amended on PSUSA/00010502/202507 Bianca Mulder Netherlands NAP
31/01/2024
27/06/2017
10512 amlodipine / losartan 06/01/2014 5 years 05/01/2029 05/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010512/202901 Melinda Palfi Hungary NAP
New CAP authorised on
21/02/2022
PSUR frequency amended and
10513 ceftazidime / avibactam 25/02/2015 3 years 24/02/2026 25/05/2026 No 18/10/2023 PSUSA/00010513/202602 Rugile Pilviniene Lithuania CAP
DLP and
DLP updated
PSURon 18/10/2023
frequency were
updated on 02/02/2022
PRAC representative was
10514 emtricitabine / rilpivirine / tenofovir alafenamide 01/03/2016 3 years 28/02/2026 29/05/2026 No 15/11/2023 updated
DLP was on 27/07/2022
amended
updated on03/02/2021
on 15/11/2023 PSUSA/00010514/202602 Ana Sofia Diniz Martins Portugal CAP
PSUR frequency and DLP were
DLP
PRACand PSUR frequency
Representative were
name was
updated on 21/09/2022
updated on
corrected on02/03/2022
29/07/2020
10515 emtricitabine / tenofovir alafenamide 04/04/2016 3 years 03/04/2026 02/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010515/202604 Ana Sofia Diniz Martins Portugal CAP
DLP was updated on 22/09/2021
DLP
DLP was
was updated
updated on
on 03/03/2021
05/02/2020
DLP was updated on 23/09/2020
10516 opicapone 24/06/2016 3 years 24/06/2024 22/09/2024 No 02/02/2022 Entry name
DLP was updated
updated on
on 06/02/2019 PSUSA/00010516/202406 Maria del Pilar Rayon Spain CAP
23/09/2020
DLP was updated on 25/09/2019
PRAC Representative updated on
DLP was updated on 04/03/2020
26/09/2018
10517 trifluridine / tipiracil 24/03/2014 3 years 24/03/2026 22/06/2026 No 15/11/2023 PSUR frequency amended and
DLP was amended on 15/11/2023 PSUSA/00010517/202603 Mari Thorn Sweden CAP
DLP updated on 06/03/2019
New
PSURactive substance
frequency amended and
combination
updated added on
on 31/07/2018
DLP was updated on 31/07/2018
10519 elbasvir / grazoprevir 19/01/2016 3 years 18/01/2025 18/04/2025 No 21/09/2022 05/02/2019 PSUSA/00010519/202501 Ana Sofia Diniz Martins Portugal CAP
amendedon
DLP was updated on28/02/2018
31/01/2018
PRAC representative was
updated
DLP was on 25/09/2019
Next DLPupdated on 21/07/2017
was amended on
10520 saxagliptin / dapagliflozin 15/07/2016 3 years 14/07/2024 12/10/2024 No 27/07/2022
25/09/2017
PSUSA/00010520/202407 Amelia Cupelli Italy CAP
PSUR
New CAP authorised on were
frequency and DLP
updated
24/06/2016 on 31/07/2019
Correction of PRAC Rapporteur
name on 28/02/2017
Next DLP, Lead MS and PRAC
Rapporteur name were amended
PRAC Rapporteur name was
on 06/03/2019
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europamended on 20/12/2016 Page 68 / 223
DLP was updated on 31/07/2018
New CAP authorised on
22/09/2016
DLP was updated on 28/02/2018
10525 deoxycholic acid 29/04/2015 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended
updated on 17/10/2017
on21/07/2017
05/02/2025 PSUSA/00010525/202704 Karin Bolin Sweden NAP
New was
DLP CAP updated
authorised
on on
21/07/2017
dequalinium, dequalinium / cinchocaine, dequalinium / 22/09/2016
PSUR frequency and DLP
10526 lidocaine, dequalinium / enoxolone / tyrothricin/ 01/06/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 Correctionon
of 23/10/2024
PRAC Rapporteur PSUSA/00010526/203907 Amelia Cupelli Italy NAP
amended
hydrocortisone / lidocaine PRAC
name representative
on 28/02/2017 was
diphenhydramine, ammonium chloride / updated on 19/10/2022
diphenhydramine hydrochloride, diphenhydramine PSUR
PSUR frequency amended and
10527 05/03/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PRAC frequency
Rapporteurand DLPwas
name PSUSA/00010527/203503 Rhea Fitzgerald Ireland NAP
hydrochloride / levomenthol, ammonium chloride / DLP updated
amended on on 31/05/2023
PRAC
amended on 23/10/2024
representative was
20/12/2016
diphenhydramine hydrochloride / levomenthol updated on 27/07/2022
DLP was updated on 29/06/2022
glycopyrronium (indicated for the treatment of severe New CAP authorised on
10529 15/09/2016 1 year 14/09/2024 23/11/2024 14/09/2025 23/11/2025 Yes 30/04/2024 DLP was
PSUR amended
frequency
22/09/2016 onDLP
and 30/04/2024
were PSUSA/00010529/202409 PSUSA/00010529/202509 Zane Neikena Latvia CAP NAP
sialorhoea) DLP was updated on 30/06/2021
updated on 29/06/2022
PSUR frequency
PRACwas and DLP
representative wereon
updated
10532 lisinopril, lisinopril / hydrochlorothiazide 24/09/1987 5 years 23/09/2025 22/12/2025 No 31/01/2024 DLP updated on 30/06/2021 PSUSA/00010532/202509 Carla Torre Portugal NAP
updated on 16/12/2020
31/01/2024
DLP was updated on 01/07/2020
DLP was updated on 03/06/2020
10533 etelcalcetide 11/11/2016 3 years 10/11/2024 08/02/2025 No 19/10/2022 PRAC representative was PSUSA/00010533/202411 Amelia Cupelli Italy CAP
DLP was updated on 20/11/2019
updated on 25/09/2019
DLP was updated on 05/06/2019
DLP was updated on 03/07/2019
10534 irinotecan (liposomal formulations) 22/10/2015 3 years 22/10/2025 20/01/2026 No 31/05/2023 PSUSA/00010534/202510 David Olsen Norway CAP
DLP updated on 21/11/2018
PSUR frequency amended and
DLP updated on 19/12/2018
DLP was updated on 06/06/2018
10535 ixazomib 20/11/2015 2 years 19/11/2025 17/02/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010535/202511 Mari Thorn Sweden CAP
DLP was updated on 04/07/2018
DLP was amended on 15/11/2017
DLP
PSURwas updatedand
on DLP
19/12/2017
10536 lactic acid / urea, urea 21/11/1969 10 years 02/09/2034 01/12/2034 No 30/10/2024 PRAC frequency
Rapporteur name was PSUSA/00010536/203409 Polona Golmajer Slovenia NAP
amended on
amended on 23/10/2024
27/06/2017
New CAP authorised on 11
November 2016
European
PSUR Union reference
frequency and DLP date
10537 mesoglycan 22/12/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 and Next DLP were amended on PSUSA/00010537/202811 NAP
amended on 31/07/2024
28/03/2017
10539 empagliflozin / linagliptin 11/11/2016 3 years 10/11/2026 08/02/2027 No 03/07/2024 New CAPamended
DLP was authorised
onon
03/07/2024 PSUSA/00010539/202611 Maria del Pilar Rayon Spain CAP
14/10/2016
DLP was updated on 21/12/2022
10540 olanzapine 27/09/1996 3 years 31/03/2025 29/06/2025 No 21/12/2022 DLP was updated on 18/12/2019 PSUSA/00010540/202503 Kimmo Jaakkola Finland CAP NAP
Active substance name was
New entry created on 20/12/2016
sulfogaiacol, sodium benzoate / sulfogaiacol, codeine / amended on 27/03/2024
10542 sodium benzoate, codeine sulfogaiacol, codeine / 12/08/1996 5 years 31/12/2027 30/03/2028 No 27/03/2024 PSUSA/00010542/202712 Petar Mas Croatia NAP
sulfogaiacol / grindelia soft extract PRAC Rapporteur updated on
15/11/2023
10543 sodium benzoate / grindelia tincture / polygala syrup 06/09/1996 3 years 31/12/2025 31/03/2026 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010543/202512 Adam Przybylkowski Poland NAP
PSUR frequency
Information and DLP
included in column
10545 ascorbic acid / calcium, ascorbic acid / calcium / lysine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00010545/202905 Roxana Dondera Romania NAP
amended
"Are PSURsonrequired
31/07/2024
for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
benzalkonium chloride / cetrimide, cetrimide /
10546 Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 as amended?" was amended on PSUSA/00010546/202906 Rhea Fitzgerald Ireland NAP
dimeticone
23/10/2024
10550 mycophenolate mofetil, mycophenolic acid 03/05/1995 2 years 02/05/2025 31/07/2025 Yes 31/01/2024 DLP was
PRAC amended onwas
representative 31/01/2024 PSUSA/00010550/202505 Karin Erneholm Denmark CAP NAP
updated on 23/09/2020
PSUR frequency and DLP were
updated
DLP was on 27/07/2022
updated on 23/10/2019
10551 mesterolone 25/05/1967 3 years 31/01/2025 01/05/2025 No 19/10/2022 PSUSA/00010551/202501 Petar Mas Croatia NAP
DLP
Leadwas
MS updated
and PRAConRapporteur
28/07/2021
name added on 31/07/2018
PSUR frequency
DLP was updatedamended and
on 29/07/2020
10552 edotreotide 08/12/2016 3 years 07/12/2025 07/03/2026 Yes 26/07/2023 PSUSA/00010552/202512 Rhea Fitzgerald Ireland CAP NAP
DLP updated on 26/07/2023
New active substance added on
PSUR frequency
20/12/2016 and DLP were
updated on 05/02/2020
10554 follitropin delta 12/12/2016 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010554/202611 Bianca Mulder Netherlands CAP
DLP was updated on 03/07/2019
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 69 / 223
PSUR frequency and DLP were
updated on 01/03/2023
PRACwas
DLP Rapporteur
updated name updated
on 03/03/2021
on 31/01/2024
PSUR frequency amended and
Leadupdated
DLP
PRAC MS and on PRAC Rapporteur
06/02/2019
representative was
10571 naphazoline, naphazoline / zinc sulphate 16/10/1946 12 years 31/07/2024 29/10/2024 No 28/02/2017 name added
updated on 15/11/2023
on 19/10/2022 PSUSA/00010571/202407 Karin Erneholm Denmark NAP
PRAC Representative amended
New
on active
07/05/2018
PRAC substancewas
representative added on
28/02/2017
updated on following merge of
27/07/2022
10572 nitrous oxide, nitrous oxide / oxygen Not available* 3 years 23/06/2025 21/09/2025 Yes 01/03/2023 DLP was
entries updated on 30/06/2021 PSUSA/00010572/202506 John Joseph Borg Malta NAP
DLP was updated and
PSUR frequency
information amended
included and
in column
PSUR
PRAC frequency and DLP
Representative were on
updated
DLP
"Are updated
PSURs on 31/05/2023
updated on required
26/09/2018 28/06/2022for products
10573 mercaptamine (treatment of nephropathic cystinosis) 23/06/1997 5 years 23/10/2025 21/01/2026 No 30/06/2021 referred to in Articles 10(1), 10a, PSUSA/00010573/202510 Monica Martinez Redondo Spain CAP
DLP wasof
14, 16a updated
Directiveon2001/83/EC
29/06/2022
DLP
New was updated
active on 30/06/2021
substance added on
as amended?" was amended on
28/02/2017
DLP following
was updated split of
on 30/06/2021
mercaptamine (Indicated for the treatment of corneal 28/02/2018
DLP was
was amended
updated on
10574 19/01/2017 3 years 18/01/2027 18/04/2027 No 25/09/2024 previous
DLP entry on01/07/2020
25/09/2024 PSUSA/00010574/202701 Maria del Pilar Rayon Spain CAP
cystine crystal deposit only)
DLP
New was updated on 16/12/2020
PRACactive substance
representative added on
was
28/02/2017 following merge of
updated on 25/09/2019
10575 tenofovir alafenamide 10/11/2016 3 years 09/11/2024 07/02/2025 No 19/10/2022 PSUR
entriesfrequency and DLP were PSUSA/00010575/202411 Amelia Cupelli Italy CAP
updated on 03/06/2020
DLP was updated on 03/07/2019
DLP was updated on DLP
20/11/2019
PSUR frequency and
amendedwere
and
10576 bezlotoxumab 21/10/2016 3 years 20/10/2025 18/01/2026 No 31/05/2023 updated on 01/03/2023
DLP updated on 19/12/2018
PSUSA/00010576/202510 Adam Przybylkowski Poland CAP
DLP was updated on 05/06/2019
DLP was updated on 02/03/2022
04/07/2018
DLP was
PSUR updatedamended
frequency on 21/11/2018
amended and
10577 insulin glargine / lixisenatide 11/01/2017 3 years 21/11/2026 19/02/2027 No 03/07/2024 PSUR frequency and PSUSA/00010577/202611 Bianca Mulder Netherlands CAP
DLP updated
PRAC
DLP updated
was on 03/05/2023
Rapporteur
on
updated 03/07/2024
name was
on 19/12/2017
DLP was updated
Correction
amended onfrequency
06/06/2018
to 02/02/2022
on PSUR
and DLP
PRAC on 02/02/2022
representative
European Union was date
reference
10578 baricitinib 13/02/2017 1 year 13/02/2025 24/04/2025 13/02/2026 24/04/2026 No 25/09/2024 DLP
DLP was
updated
and DLP
updated
amended
was date
updated
on on
on
wereon
01/03/2023 19/12/2017
25/09/2024
03/03/2021
amended on PSUSA/00010578/202502 PSUSA/00010578/202602 Adam Przybylkowski Poland CAP
DLP was updated on 17/11/2021
28/03/2017
EURD and
DLP was DLP amended
updated on
05/02/2020
on 28/04/2022
26/04/2017
DLP
10579 citrulline malate 31/10/1991 13 years 12/03/2034 10/06/2034 No 02/02/2022 New was
CAP updated on on
authorised 21/11/2018
PSUSA/00010579/203403 Eva Jirsová Czech Republic NAP
PSUR
DLP frequency and next DLP
was updated on 28/04/2021
09/01/2017
New updated
PRAC
was CAP authorised
representative on
and Lead
on 20/11/2019
18/01/2017
Member
DLP was State
DLP was were
updated
amended on
onadded on
06/05/2020
03/05/2023
10581 alectinib 04/07/2014 3 years 03/07/2025 01/10/2025 No 01/03/2023 21/07/2017
DLP was updated on 31/07/2019 PSUSA/00010581/202507 Jana Lukacisinova Czech Republic CAP
PSUR frequency and DLP
PRAC Rapporteur name was were
allergen for therapy: dermatophagoides New entry
Lead MS on
updated
amended added
and
on PRAConRapporteur
20/11/2019 28/03/2017
28/04/2022
pteronyssinus / dermatophagoides farina (oromucosal PSUR
name frequency and DLP
added on 06/03/2019
10582 23/09/2015 3 years 22/09/2025 21/12/2025 No 03/05/2023 corrected on 28/04/2022 PSUSA/00010582/202509 Gabriele Maurer Germany NAP
use, products authorised via mutually recognition Next DLP
PRAC was updated
representative on
was
procedure and decentralised procedure) DLP was on
updated
05/06/2019
updated on 06/02/2019
31/03/2021
DLP was updated on 30/03/2022
bendroflumethiazide, bendroflumethiazide / potassium
10583 28/02/1960 6 years 01/01/2030 01/04/2030 No 25/09/2024 DLP was amended
DLP updated on
updated on 31/07/2018
21/11/2018
on06/05/2020
25/09/2024 PSUSA/00010583/203001 Eva Jirsová Czech Republic NAP
chloride DLP was updated on 31/03/2021
DLP was
New amended
CAP updated onon
on
authorised 31/01/2018
06/06/2018
benzyl nicotinate / camphor / dimethyl sulfoxide / PSUR
PSUR frequency
frequency and DLP were
amended and
10584 01/01/1994 5 years 31/03/2028 29/06/2028 No 20/12/2023 04/04/2020 PSUSA/00010584/202803 Zane Neikena Latvia NAP
nonivamide / turpentine oil, Nicoboxil/ Nonivamide updated
Entry
DLP on 21/10/2020
PRACupdated
Rapporteur
name name
amended onupdated
on 20/12/2023
on 27/06/2017
17/10/2017
PRAC representative was
PRAC representative was
updated on 25/09/2019
updated
New CAP on 29/07/2020
authorised on Marie Louise Schougaard
10585 budesonide / formoterol 25/08/2000 3 years 24/08/2025 22/11/2025 No 03/05/2023 Lead MS and PRAC Rapporteur PSUSA/00010585/202508
Christiansen Denmark CAP NAP
16/02/2017
name Rapporteur
PRAC was added on name27/06/2017
was
PRAC representative was
corrected on 03/04/2019
updated on substance
New active 03/06/2020 added on
10587 chlormethine 23/08/2013 3 years 22/08/2024 20/11/2024 No 28/04/2022 26/04/2017
PRAC Rapporteur name was
PSUSA/00010587/202408 Tiphaine Vaillant France CAP
DLP was updated on 01/04/2020
amended on 06/06/2018
DLP was updated on 25/09/2019
10588 tofacitinib 06/11/2012 1 year 05/11/2024 14/01/2025 05/11/2025 14/01/2026 No 03/07/2024 PRAC Representative
DLP was amended on amended
03/07/2024 PSUSA/00010588/202411 PSUSA/00010588/202511 Liana Martirosyan Netherlands CAP
on 17/10/2017
DLP was updated on 03/04/2019
chenodeoxycholic acid (inborn error in primary bile PRAC representative and Lead
10590 acid synthesis, xanthomatosi - centrally authorised 10/04/2017 1 year 09/10/2024 18/12/2024 09/10/2025 18/12/2025 No 05/06/2024 DLP was amended
updated on 26/09/2018
Member State wereon 05/06/2024
added on PSUSA/00010590/202410 PSUSA/00010590/202510 Adam Przybylkowski Poland CAP
products only) 21/07/2017
DLP was updated on 27/03/2018
10591 parathyroid hormone 24/04/2017 6 months 23/10/2024 01/01/2025 23/04/2025 02/07/2025 No 18/12/2024 New
DLP entry added on
on26/04/2017 Rhea Fitzgerald Ireland
PRACwas amended
Rapporteur name18/12/2024
updated PSUSA/00010591/202410 PSUSA/00010591/202504 CAP
following merge of entries
on 21/07/2017
sulfametrole / trimethoprim, sulfadiazine /
PRAC Rapporteur
New CAP updated
authorised on on
10593 trimethoprim, sulfamethoxazole / trimethoprim (co- 01/04/1969 8 years 31/03/2027 29/06/2027 No 15/11/2023 PSUSA/00010593/202703 Barbara Kovacic Bytyqi Croatia NAP
15/11/2023
03/03/2017
trimoxazole)
10594 fluciclovine (18F) 27/05/2016 3 years 27/05/2026 25/08/2026 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010594/202605 Rugile Pilviniene Lithuania CAP
10596 cerliponase alfa 27/04/2017 3 years 26/04/2027 25/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010596/202704 Mari Thorn Sweden CAP
10597 dinutuximab beta 08/05/2017 1 year 08/11/2024 17/01/2025 08/11/2025 17/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010597/202411 PSUSA/00010597/202511 Gabriele Maurer Germany CAP
10601 irbesartan, irbesartan / hydrochlorothiazide 12/08/1997 5 years 12/08/2026 10/11/2026 No 28/04/2022 European Union reference date, PSUSA/00010601/202608 Maria del Pilar Rayon Spain CAP NAP
PRAC
DLP andrepresentative
Submission datewas were
updated
updated on on 01/03/2023
28/02/2018
PSUR frequency amended and
benzocaine / chlorhexidine, benzocaine /
10603 Not available* 18 years 01/01/2030 01/04/2030 No 21/07/2017 New updated
DLP
Activeentry added on 21/07/2017
on 23/10/2024
substance name was PSUSA/00010603/203001 NAP
chlorhexidine / tyrothricin New combination of active
amended onadded
substances 01/04/2020
following
Activefrequency
PSUR
merge substance name
and
on 27/06/2017 DLPwas
were
amended
Information
updated on29/06/2022
on 23/10/2024
included in column
10604 chlorhexidine / tetracaine 22/12/1969 8 years 22/12/2033 22/03/2034 No 23/10/2024 *for irbesartan containing PSUSA/00010604/203312 Anna Mareková Slovakia NAP
"Are PSURs
products the next PSUR
Active
required
DLP was substance
updated amended
for products on
referred
willto
on 30/06/2021
(PSUSA/00010601/202109)
19/12/2017
in Articles
cover 10(1),
period of 6 10a,
years,14,form
16a of
10605 human plasma proteins with no less than 95% albumin 01/07/1950 5 years 01/07/2024 29/09/2024 Yes 01/04/2020 Directive
DLP 2001/83/EC
was updated
12/08/2015 as
01/03/2023
on 16/12/2020
to 30/09/2021 PSUSA/00010605/202407 Gabriele Maurer Germany NAP
New entry added
amended?" and DLPon 21/07/2017
were
updated
DLP
PSUR was on 04/03/2020
updated
frequency on 04/03/2020
was updated on
10606 itopride 30/06/1995 3 years 30/06/2025 28/09/2025 Yes 01/03/2023 23/09/2020 PSUSA/00010606/202506 Rugile Pilviniene Lithuania NAP
Active
LMS andsubstance name was
PRAC representative
amended
werewas
DLP addedonon05/02/2020
updated 31/07/2019
on 03/06/2020
meningococcal group B vaccine (recombinant,
10607 29/10/2014 3 years 28/10/2024 26/01/2025 No 29/06/2022 LMS
New and
DLP was PRAC
entry representative
added
updated on 21/07/2017
18/12/2019 PSUSA/00010607/202410 Jean-Michel Dogné Belgium CAP
adsorbed) were added on 31/07/2019
DLP was updated on 05/06/2019
New entry
PSUR addedamended
frequency on 21/07/2017
and
10608 nonacog beta pegol 31/05/2017 3 years 31/05/2026 29/08/2026 No 31/01/2024
was updated on 19/12/2018
PSUSA/00010608/202605 Gabriele Maurer Germany CAP
DLP updated on 31/01/2024
10610 shark liver oil / yeast extract 01/01/1957 15 years 31/12/2031 30/03/2032 No 21/07/2017 New entry
New added on 21/07/2017
CAP authorised on PSUSA/00010610/203112 NAP
24/05/2017
10611 tripelennamine 04/04/1984 10 years 31/10/2026 29/01/2027 No 21/07/2017 New entry added on 21/07/2017 PSUSA/00010611/202610 NAP
10612 sodium oxybate (oral use) 13/06/1961 1 year 12/10/2024 21/12/2024 12/10/2025 21/12/2025 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010612/202410 PSUSA/00010612/202510 Ana Sofia Diniz Martins Portugal CAP NAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 70 / 223
DLP was updated on 25/05/2022
PRACwas
DLP representative added on
updated on 03/03/2021
pentosan polysulfate sodium (for centrally authorised 17/10/2017
10614 02/06/2017 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010614/202706 Ana Sofia Diniz Martins Portugal CAP
product) DLP was updated on 04/03/2020
New entry added on 21/07/2017
PSUR frequency and DLP were
10616 brodalumab 17/07/2017 3 years 16/07/2024 14/10/2024 No 02/03/2022 updated on 31/07/2019 PSUSA/00010616/202407 Monica Martinez Redondo Spain CAP
PSUR frequency
Next DLP and DLP
was updated onwere
updated on 01/03/2023
06/03/2019
10617 beclometasone / formoterol / glycopyrronium bromide 17/07/2017 1 year 16/07/2024 24/09/2024 16/07/2025 24/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010617/202407 PSUSA/00010617/202507 Jan Neuhauser Austria CAP
DLP was
DLP was updated
updated on
on 31/07/2018
02/03/2022
PSUR frequency and DLP were
updated on 01/03/2023
10618 patiromer 21/10/2015 3 years 20/10/2026 18/01/2027 No 03/07/2024 DLP
New was
DLP was updated
CAPamended on
authorised 03/03/2021
onon
03/07/2024 PSUSA/00010618/202610 Terhi Lehtinen Finland CAP
17/07/2017
DLP was updated on 02/03/2022
DLP was updated on 04/03/2020
10619 sofosbuvir / velpatasvir / voxilaprevir 18/07/2017 3 years 17/07/2025 15/10/2025 No 01/03/2023 DLP was updated on 03/03/2021 PSUSA/00010619/202507 Ana Sofia Diniz Martins Portugal CAP
PSUR frequency and DLP were
DLP was on
updated updated on 23/09/2020
31/07/2019
DLP was updated on 04/03/2020
LMS
Next and
DLPPRAC representative
was updated on
10620 glecaprevir / pibrentasvir 26/07/2017 3 years 25/07/2025 23/10/2025 No 01/03/2023 PSUR added
were frequency
06/03/2019 on and DLP were
31/07/2019 PSUSA/00010620/202507 Ana Sofia Diniz Martins Portugal CAP
updated on 25/09/2019
Information
DLP included
was updated in column
on 31/07/2018
Next PSURs
"Are DLP was updated
required foron
products
10621 bismuth / lidocaine / zinc oxide, lidocaine / zinc oxide Not available* 8 years 01/01/2028 31/03/2028 Yes 23/09/2020
06/03/2019
PSUSA/00010621/202801 Rugile Pilviniene Lithuania NAP
referred
New CAPto in Articleson
authorised 10(1), 10a,
calcium chloride dihydrate / magnesium chloride
14, 16a of Directive 2001/83/EC
18/07/2017
hexahydrate / malic acid / sodium acetate trihydrate / DLPamended?"
was updated
as wasonamended
26/09/2018
on
sodium chloride / potassium chloride, calcium chloride
10622 Not available* 13 years 01/01/2036 31/03/2036 No 20/09/2023 06/02/2019
DLP amended on 20/09/2023 PSUSA/00010622/203601 Polona Golmajer Slovenia NAP
dihydrate / sodium chloride / sodium lactate / New CAP authorised on
potassium chloride, calcium chloride / sodium chloride 26/07/2017
New entry introduced on
/ potassium chloride
25/09/2017
Next DLP was updated on
10623 cariprazine 13/07/2017 2 years 05/10/2024 03/01/2025 No 26/05/2021 PSUSA/00010623/202410 Ana Sofia Diniz Martins Portugal CAP
31/05/2023
10624 cenegermin 06/07/2017 1 year 05/07/2024 13/09/2024 05/07/2025 13/09/2025 No 28/02/2024 PSUR frequency
DLP was amendedamended and
on 28/02/2024 PSUSA/00010624/202407 PSUSA/00010624/202507 Jan Neuhauser Austria CAP
mucopolysaccharide polysulfuric acid ester DLP updated on 23/10/2024
(chondroitin), mucopolysaccharide polysulfuric acid
ester (chondroitin)/salicylic acid, mucopolysaccharide Active substance name was
10625 polysulfuric acid ester (chondroitin)/salicylic Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 amended on 23/10/2024 PSUSA/00010625/203112 none NAP
acid/flufenamic acid, mucopolysaccharide polysulfuric
acid ester (chondroitin)/salicylic
mucopolysaccharide polysulfuricacid/suprarenal
acid ester New active sustance combination
extract [cutaneous
(chondroitin), use]
mucopolysaccharide polysulfuric acid addedfrequency
PSUR following merge on
and DLP
10626 Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUSA/00010626/203112 NAP
ester (chondroitin)/ glucosamine [oral and 25/09/2017
amended on 23/10/2024
intramuscular use] DLP was updated on 21/12/2022
PSUR frequency
PRAC and DLP
representative was
10627 benzyl benzoate / disulfiram 22/10/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00010627/202812 Sweden NAP
amendedon
updated on19/10/2022
31/07/2024
10634 cladribine (multiple sclerosis) 08/07/2010 1 year 07/07/2024 15/09/2024 07/07/2025 15/09/2025 No 28/02/2024 DLP was amended on20/10/2021
updated on 28/02/2024 PSUSA/00010634/202407 PSUSA/00010634/202507 Carla Torre Portugal CAP
10644 atezolizumab 18/05/2016 1 year 17/05/2025 26/07/2025 17/05/2026 26/07/2026 No 05/02/2025 DLP was amended on28/04/2021
updated on 05/02/2025 PSUSA/00010644/202505 PSUSA/00010644/202605 Carla Torre Portugal CAP
10653 fluticasone furoate / umeclidinium / vilanterol 18/09/2017 3 years 17/03/2027 15/06/2027 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010653/202703 Mari Thorn Sweden CAP
10655 niraparib 27/03/2017 1 year 26/03/2025 04/06/2025 26/03/2026 04/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010655/202503 PSUSA/00010655/202603 Jan Neuhauser Austria CAP
DLP was updated on 21/09/2022
10660 letermovir 01/11/2017 3 years 01/11/2024 30/01/2025 No 29/06/2022 DLP was updated on 18/12/2019 PSUSA/00010660/202411 Terhi Lehtinen Finland CAP
DLP
PSURwas updatedamended
frequency on 05/04/2023
and
10665 loperamide, loperamide / simeticone 31/05/1973 5 years 31/05/2029 29/08/2029 No 05/02/2025 PSUSA/00010665/202905 Adam Przybylkowski Poland NAP
DLP updated on 05/02/2025
PRAC representative was
updated on 01/03/2023
pseudoephedrine, acetylsalicylic acid / PSUR frequency amended and
10667 01/02/1986 3 years 28/06/2026 26/09/2026 No 28/02/2024 PSUSA/00010667/202606 Maia Uusküla Estonia NAP
pseudoephedrine DLP updated
PSUR on 28/02/2024
frequency and DLP were
updated on 19/10/2022
10668 emicizumab 16/11/2017 1 year 15/11/2024 24/01/2025 15/11/2025 24/01/2026 No 03/07/2024 DLP was
PSUR amended
frequency on 03/07/2024
corrected on PSUSA/00010668/202411 PSUSA/00010668/202511 Amelia Cupelli Italy CAP
28/04/2022
10672 prasterone (vaginal use/Pessary) 16/11/2016 2 years 15/11/2025 13/02/2026 No 31/07/2024 DLP was amended
DLP was updated on
on03/04/2019
31/07/2024 PSUSA/00010672/202511 Bianca Mulder Netherlands CAP
10679 atorvastatin / perindopril 16/01/2018 5 years 22/10/2025 20/01/2026 No 30/06/2021 PRAC represenative and LMS PSUSA/00010679/202510 Amelia Cupelli Italy NAP
were added on 01/04/2020
DLP was
New
PSUR updated
active
frequency on 21/11/2018
substance added
amended andon
10683 Krypton (81 mKr) 31/01/1995 10 years 30/01/2026 30/04/2026 No 06/06/2018 PSUSA/00010683/202601 NAP
06/06/2018
DLP updated on 23/10/2024
New entry added on 07/05/2018
coal tar, distilled coal tar, coconut oil / distilled coal tar Active substance name was
10684 / salicylic acid, coal tar solution / salicylic acid / sulfur, 16/02/1989 8 years 16/02/2033 17/05/2033 No 23/10/2024 amended on 23/10/2024 PSUSA/00010684/203302 Liana Martirosyan Netherlands NAP
coal tar / salicylic acid, coal tar / menthol
EURD added on 23/10/2024
10685 lisinopril / torasemide 12/12/2017 5 years 11/12/2028 11/03/2029 Yes 31/07/2024 DLP was amended on 31/07/2024
New entry added on 06/06/2018
PSUSA/00010685/202812 Jana Lukačišinová Czech Republic NAP
amended
PSUR frequency and and
DLP were
10688 gemtuzumab ozogamicin 17/05/2000 3 years 16/05/2026 14/08/2026 No 31/01/2024 PSUSA/00010688/202605 Carla Torre Portugal CAP
DLP updated
updated on 31/01/2024
on 01/02/2023
10696 iron dextran Not available* 3 years 01/01/2027 01/04/2027 Yes 25/09/2024 DLP was
PRAC amended onwas
representative 25/09/2024 PSUSA/00010696/202701 Zane Neikena Latvia NAP
updated on 22/12/2021
10697 inotersen 06/07/2018 1 year 05/07/2024 13/09/2024 05/07/2025 13/09/2025 No 28/02/2024 PSUR frequency
DLP was amendedwas
onupdated on
28/02/2024 PSUSA/00010697/202407 PSUSA/00010697/202507 Rhea Fitzgerald Ireland CAP
25/08/2021
PSUR frequency
DLP was updatedamended and
on 23/09/2020
DLP
PSURupdated on 05/04/2023
frequency amended and
10699 erenumab 17/05/2018 3 years 16/05/2027 14/08/2027 No 18/12/2024
PRAC representative was
PSUSA/00010699/202705 Terhi Lehtinen Finland CAP
DLP updated on 18/12/2024
PRAC representative
updated updated on
on 06/05/2020
21/12/2022
10700 metreleptin 25/03/2013 1 year 24/01/2025 04/04/2025 24/01/2026 04/04/2026 No 25/09/2024 DLP was amended
updated on
on05/02/2020
25/09/2024 PSUSA/00010700/202501 PSUSA/00010700/202601 Adam Przybylkowski Poland CAP
DLP was updated on 30/03/2022
DLP was updated on 25/09/2019
DLP was updated on 31/03/2021
10701 daunorubicin / cytarabine 03/08/2017 3 years 02/08/2025 31/10/2025 No 05/04/2023 Lead MS and PRAC Rapporteur PSUSA/00010701/202508 Carla Torre Portugal CAP
PSUR
name frequency and DLP were
added on 21/11/2018
updated on 23/09/2020
10702 tisagenlecleucel 30/08/2017 1 year 12/08/2024 21/10/2024 12/08/2025 21/10/2025 No 27/03/2024 New CAPamended
DLP was authorised
onon
27/03/2024 PSUSA/00010702/202408 PSUSA/00010702/202508 Gabriele Maurer Germany CAP
DLP was updated on 04/03/2020
26/07/2018
10710 alitretinoin (oral use) Not available* 1 year 18/01/2025 29/03/2025 18/01/2026 29/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010710/202501 PSUSA/00010710/202601 Jan Neuhauser Austria NAP
10713 caplacizumab 31/08/2018 1 year 30/08/2024 08/11/2024 30/08/2025 08/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010713/202408 PSUSA/00010713/202508 Jan Neuhauser Austria CAP
10715 patisiran 10/08/2018 1 year 09/08/2024 18/10/2024 09/08/2025 18/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010715/202408 PSUSA/00010715/202508 Rhea Fitzgerald Ireland CAP
10717 binimetinib 27/06/2018 1 year 26/06/2025 04/09/2025 26/06/2026 04/09/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010717/202506 PSUSA/00010717/202606 Carla Torre Portugal CAP
10718 eravacycline 27/08/2018 1 year 26/08/2024 04/11/2024 26/08/2025 04/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010718/202408 PSUSA/00010718/202508 Adam Przybylkowski Poland CAP
10719 encorafenib 27/06/2018 1 year 26/06/2025 04/09/2025 26/06/2026 04/09/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010719/202506 PSUSA/00010719/202606 Rugile Pilviniene Lithuania CAP
DLP was updated on 01/03/2023
10720 tildrakizumab 20/03/2018 1 year 19/03/2025 28/05/2025 19/03/2026 28/05/2026 No 15/11/2023 DLP was
PRAC amendedname
Rapporteur on 15/11/2023
was PSUSA/00010720/202503 PSUSA/00010720/202603 Adam Przybylkowski Poland CAP
amended on 22/09/2022
DLP was updated on 01/03/2023
allergen for diagnostic and/or therapy: Vespula SPP. DLP was updated on 31/03/2021
10721 03/07/1980 5 years 02/07/2027 30/09/2027 No 01/03/2023 PRAC Rapporteur name was PSUSA/00010721/202707 Mari Thorn Sweden NAP
(802) (with or without adjuvant), Wasp venom
amended on 22/09/2022
PRAC representative and LMS
were added on 18/11/2020
allergen for diagnostic and/or therapy: Apis mellifera DLP was updated on 31/03/2021
10722 03/07/1980 5 years 02/07/2027 30/09/2027 No 01/03/2023 PSUSA/00010722/202707 Mari Thorn Sweden NAP
(801) (with or without adjuvant), Apis mellifera venom
New active substance added on
PRAC representative and LMS
21/11/2018
were added on 18/11/2020
10723 durvalumab 01/05/2017 1 year 30/04/2025 09/07/2025 30/04/2026 09/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010723/202504 PSUSA/00010723/202604 David Olsen Norway CAP
New active substance added on
21/11/2018
10724 abemaciclib 28/09/2017 1 year 28/09/2024 07/12/2024 28/09/2025 07/12/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010724/202409 PSUSA/00010724/202509 Carla Torre Portugal CAP
10727 meropenem / vaborbactam 29/08/2017 3 years 28/08/2026 26/11/2026 No 30/04/2024 PSUR frequency amended and PSUSA/00010727/202608 Maria del Pilar Rayon Spain CAP
30/04/2024
DLP updated on 05/04/2023
10742 voretigene neparvovec 19/12/2017 1 year 23/07/2024 01/10/2024 23/07/2025 01/10/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010742/202407 PSUSA/00010742/202507 Gabriele Maurer Germany CAP
10749 argipressin 01/04/1979 3 years 31/03/2027 29/06/2027 Yes 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010749/202703 Terhi Lehtinen Finland NAP
10752 rosuvastatin/ perindopril /indapamide 09/08/2018 5 years 09/08/2028 07/11/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010752/202808 Polona Golmajer Slovenia NAP
10753 naldemedine 23/03/2017 2 years 22/03/2026 20/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010753/202603 Eamon O Murchu Ireland CAP
10755 lusutrombopag 28/09/2015 3 years 27/09/2026 26/12/2026 No 30/04/2024 PSUR frequency amended and PSUSA/00010755/202609 Mari Thorn Sweden CAP
30/04/2024
DLP updated on 03/05/2023
DLP was
PSUR updatedand
frequency on DLP
01/07/2020
were
10762 volanesorsen 03/05/2019 6 months 02/11/2024 11/01/2025 02/05/2025 11/07/2025 No 18/12/2024 DLP was on
updated amended on 18/12/2024
22/09/2021 PSUSA/00010762/202411 PSUSA/00010762/202505 Martin Huber Germany CAP
DLP was updated on 05/02/2020
DLP was updated on 31/03/2021
New CAP authorisation
10763 zanamivir (centrally authorised products only) 09/02/1999 3 years 31/01/2027 01/05/2027 No 22/09/2021 03/05/2019 PSUSA/00010763/202701 Mari Thorn Sweden CAP
PSUR frequency and DLP were
updated on 23/09/2020
10764 andexanet alfa 26/04/2019 6 months 25/10/2024 03/01/2025 25/04/2025 04/07/2025 No 18/12/2024 New CAPamended
DLP was authorisation
on 18/12/2024 PSUSA/00010764/202410 PSUSA/00010764/202504 Bianca Mulder Netherlands CAP
26/04/2019
10765 risankizumab 26/03/2019 1 year 25/03/2025 03/06/2025 25/03/2026 03/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010765/202503 PSUSA/00010765/202603 Liana Martirosyan Netherlands CAP
10768 levofloxacin (ocular use) 01/10/1993 5 years 01/10/2028 30/12/2028 No 05/06/2024 DLP was
PSUR amended
frequency onDLP
and 05/06/2024
were PSUSA/00010768/202810 Martin Huber Germany NAP
uodated on 21/09/2022
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PSUR frequency amended and
DLP updated on 03/05/2023
10778 buprenorphine (implant) 26/05/2016 1 year 25/11/2024 03/02/2025 25/11/2025 03/02/2026 No 03/07/2024 PSUR frequency
DLP was amendedcorrected on
on 03/07/2024 PSUSA/00010778/202411 PSUSA/00010778/202511 Adam Przybylkowski Poland CAP
21/12/2022
10787 ravulizumab 01/01/2019 1 year 31/12/2024 11/03/2025 31/12/2025 11/03/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010787/202412 PSUSA/00010787/202512 Kimmo Jaakkola Finland CAP
10788 technetium (99mtc) N,N'-ethylene-(L,L)-dicysteine 28/09/2010 15 years 27/09/2033 26/12/2033 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010788/203309 NAP
10790 aniracetam 20/08/1993 10 years 19/08/2031 17/11/2031 No 24/08/2022 PRAC representative and LMS PSUSA/00010790/203108 Jana Lukačišinová Czech Republic NAP
PSUR frequency and DLP were
were added on 03/02/2021
updated on 02/03/2022
New entry added on 25/09/2019
10791 bovine lung phospholipid 22/12/1989 5 years 30/06/2026 28/09/2026 Yes 02/03/2022 PRAC representative and LMS PSUSA/00010791/202606 Terhi Lehtinen Finland NAP
were added on 18/11/2020
10793 cod-liver oil (topical use), cod-liver oil/zinc oxide Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010793/203401 NAP
botulinum toxin type A (for centrally authorised PSUR frequency amended and
10796 01/02/2019 3 years 31/01/2027 01/05/2027 No 25/09/2024 PSUSA/00010796/202701 Adam Przybylkowski Poland CAP
products only) DLP updated on 25/09/2024
10799 larotrectinib 26/11/2018 6 months 25/11/2024 03/02/2025 25/05/2025 03/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010799/202411 PSUSA/00010799/202505 Rugile Pilviniene Lithuania CAP
ethanol extracts of: Iberis amara L., planta tota
recens / Angelica archangelica L., radix / Matricaria
recutita L., flos / Carum carvi L., fructus / Silybum DLP was amended
updated on
10800 23/01/1968 3 years 30/11/2026 28/02/2027 No 31/07/2024 DLP was on05/04/2023
31/07/2024 PSUSA/00010800/202611 Martin Huber Germany NAP
marianum type
poliovirus (L.) Gaertn., fructus
1 / poliovirus / Melissa
type officinalis
2 / poliovirus typeL.,3
folium / Mentha
vaccine piperita
(oral, live, L., folium
attenuated), / Chelidonium
poliovirus type 1 majus
/ LMS and PRAC representative
L., herba / type
poliovirus Glycyrrhiza glabra
3 vaccine L.,live,
(oral, radix were added on 06/05/2020
10801 attenuated),poliovirus type 1 (oral, live, attenuated) 01/01/1964 3 years 26/07/2025 24/10/2025 Yes 05/04/2023 PSUSA/00010801/202507 Jean-Michel Dogné Belgium NAP
vaccine, poliovirus type 2 (oral, live, attenuated) EURD ID corrected on 05/02/2020
vaccine,poliovirus type 3 (oral, live, attenuated)
vaccinerefined fish oil / glycerol / purified egg
highly New entry following merge on
10802 30/03/1998 5 years 29/03/2029 27/06/2029 No 20/11/2024 DLP was amended on 20/11/2024
20/11/2019
PSUSA/00010802/202903 Polona Golmajer Slovenia NAP
phosphatide
10810 lavender oil 26/06/2009 5 years 27/04/2028 26/07/2028 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010810/202804 Guðrún Stefánsdóttir Iceland NAP
10813 inactivated leptospire vaccine 04/04/1979 5 years 30/11/2027 28/02/2028 No 19/09/2024 DLP was updated on 16/11/2022 PSUSA/00010813/202711 Zoubida Amimour France NAP
PRAC Rapporteur name was
amended on 28/04/2022
Marie Louise Schougaard
10814 aviptadil / phentolamine mesilate 10/07/1998 5 years 28/02/2027 29/05/2027 No 16/11/2022 PSUSA/00010814/202702
Christiansen Denmark NAP
LMS and PRAC representative
were added on 28/07/2021
PSUR frequency amended and
10815 allergen for therapy: betula verrucosa (sublingual use) 02/07/2019 3 years 02/07/2026 30/09/2026 No 28/02/2024
New updated
entry added on 05/02/2020
PSUSA/00010815/202607 Terhi Lehtinen Finland NAP
DLP on 28/02/2024
10817 polatuzumab vedotin 10/06/2019 1 year 09/06/2025 18/08/2025 09/06/2026 18/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010817/202506 PSUSA/00010817/202606 Mari Thorn Sweden CAP
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PSUR frequency amended and
10818 siponimod 26/03/2019 3 years 25/03/2027 23/06/2027 No 20/11/2024 PSUSA/00010818/202703 Maria del Pilar Rayon Spain CAP
DLP updated on 20/11/2024
10819 fostamatinib 17/04/2018 1 year 16/04/2025 25/06/2025 16/04/2026 25/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010819/202504 PSUSA/00010819/202604 Bianca Mulder Netherlands CAP
10824 romosozumab 08/01/2019 1 year 07/01/2025 18/03/2025 07/01/2026 18/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010824/202501 PSUSA/00010824/202601 Tiphaine Vaillant France CAP
10826 glucagon (for centrally authorised product only) 24/07/2019 1 year 24/07/2024 02/10/2024 24/07/2025 02/10/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010826/202407 PSUSA/00010826/202507 Rhea Fitzgerald Ireland CAP
10829 brolucizumab 07/10/2019 1 year 06/10/2024 15/12/2024 06/10/2025 15/12/2025 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010829/202410 PSUSA/00010829/202510 Gabriele Maurer Germany CAP
10830 imipenem / cilastatin / relebactam 16/07/2019 1 year 15/07/2024 23/09/2024 15/07/2025 23/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010830/202407 PSUSA/00010830/202507 Adam Przybylkowski Poland CAP
10831 solriamfetol 20/03/2019 1 year 19/03/2025 28/05/2025 19/03/2026 28/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010831/202503 PSUSA/00010831/202603 Julia Pallos Hungary CAP
10832 gilteritinib 21/09/2018 1 year 20/09/2024 29/11/2024 20/09/2025 29/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010832/202409 PSUSA/00010832/202509 Martin Huber Germany CAP
10833 enoxaparin 15/09/2016 3 years 03/04/2027 02/07/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010833/202704 Bianca Mulder Netherlands CAP NAP
calcium carbonate/
10837 magnesium carbonate/ 28/01/1988 10 years 01/01/2029 01/04/2029 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010837/202901 NAP
simeticone
10839 givosiran 20/11/2019 1 year 19/05/2025 28/07/2025 19/05/2026 28/07/2026 No 05/02/2025 DLP was amended
corrected on 05/02/2025
on 26/07/2023 PSUSA/00010839/202505 PSUSA/00010839/202605 Martin Huber Germany CAP
10841 bempedoic acid, bempedoic acid / ezetimibe 21/02/2020 1 year 20/02/2025 01/05/2025 20/02/2026 01/05/2026 No 05/04/2023 DLP was updated on 30/03/2022 PSUSA/00010841/202502 PSUSA/00010841/202602 Kimmo Jaakkola Finland CAP
10846 13C-methacetin 28/03/2018 3 years 15/10/2025 13/01/2026 No 31/05/2023 DLP was updated on 30/06/2021 PSUSA/00010846/202510 Adam Przybylkowski Poland NAP
10848 onasemnogene abeparvovec 24/05/2019 1 year 23/05/2025 01/08/2025 23/05/2026 01/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010848/202505 PSUSA/00010848/202605 Karin Bolin Sweden CAP
10849 cefiderocol 14/11/2019 1 year 13/11/2024 22/01/2025 13/11/2025 22/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010849/202411 PSUSA/00010849/202511 Martin Huber Germany CAP
10850 indacaterol / mometasone furoate 30/05/2020 1 year 29/05/2025 07/08/2025 29/05/2026 07/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010850/202505 PSUSA/00010850/202605 Jan Neuhauser Austria CAP
10852 ozanimod 20/05/2020 1 year 19/05/2025 28/07/2025 19/05/2026 28/07/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010852/202505 PSUSA/00010852/202605 Maria del Pilar Rayon Spain CAP
10853 drospirenone 12/11/2019 1 year 12/11/2024 21/01/2025 12/11/2025 21/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010853/202411 PSUSA/00010853/202511 Karin Bolin Sweden NAP
DLP was updated on 22/12/2021
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10859 glasdegib 21/11/2018 1 year 20/11/2024 29/01/2025 20/11/2025 29/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010859/202411 PSUSA/00010859/202511 Bianca Mulder Netherlands CAP
10860 luspatercept 25/06/2020 1 year 24/06/2025 02/09/2025 24/06/2026 02/09/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010860/202506 PSUSA/00010860/202606 Jo Robays Belgium CAP
10861 indacaterol / glycopyrronium / mometasone 03/07/2020 1 year 02/07/2025 10/09/2025 02/07/2026 10/09/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010861/202507 PSUSA/00010861/202607 Jan Neuhauser Austria CAP
10862 cholera vaccine, oral, live 10/06/2016 1 year 09/06/2025 18/08/2025 09/06/2026 18/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010862/202506 PSUSA/00010862/202606 Jean-Michel Dogné Belgium CAP
10863 pretomanid 14/08/2019 1 year 13/08/2024 22/10/2024 13/08/2025 22/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010863/202408 PSUSA/00010863/202508 Liana Martirosyan Netherlands CAP
10864 iron sucrose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010864/202701 Zane Neikena Latvia NAP
10865 ferric carboxymaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010865/202701 Zane Neikena Latvia NAP
10866 ferric derisomaltose (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010866/202701 Zane Neikena Latvia NAP
10867 sodium iron gluconate (parenteral use) 06/12/1949 3 years 01/01/2027 01/04/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010867/202701 Zane Neikena Latvia NAP
10868 ivacaftor / tezacaftor / elexacaftor 21/10/2019 6 months 20/10/2024 29/12/2024 20/04/2025 29/06/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010868/202410 PSUSA/00010868/202504 Martin Huber Germany CAP
10870 imlifidase 25/08/2020 6 months 25/08/2024 03/11/2024 25/02/2025 06/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010870/202408 PSUSA/00010870/202502 Bianca Mulder Netherlands CAP
10871 alpelisib 24/05/2019 1 year 23/05/2025 01/08/2025 23/05/2026 01/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010871/202505 PSUSA/00010871/202605 Bianca Mulder Netherlands CAP
10872 lefamulin 19/08/2019 1 year 18/08/2024 27/10/2024 18/08/2025 27/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010872/202408 PSUSA/00010872/202508 Eva Jirsová Czech Republic CAP
10874 entrectinib 18/06/2019 6 months 17/12/2024 25/02/2025 17/06/2025 26/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010874/202412 PSUSA/00010874/202506 Bianca Mulder Netherlands CAP
10875 sodium oleate 06/09/1956 13 years 01/01/2033 01/04/2033 No 21/10/2020 New entry added on 21/10/2020 PSUSA/00010875/203301 NAP
10876 amlodipine/irbesartan 14/06/2020 5 years 14/06/2025 12/09/2025 No 30/10/2024 New entry added on 21/10/2020 PSUSA/00010876/202506 Maia Uusküla Estonia NAP
10877 leuprorelin (depot formulations) 31/07/1984 2 years 31/07/2025 29/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010877/202507 Amelia Cupelli Italy CAP NAP
10878 avapritinib 09/01/2020 6 months 08/07/2024 16/09/2024 08/01/2025 19/03/2025 No 25/09/2024 DLP was
PSUR amended
frequency onDLP
and 25/09/2024
were PSUSA/00010878/202407 PSUSA/00010878/202501 Bianca Mulder Netherlands CAP
updated on 01/02/2023
PSUR frequency
PRAC amended
representative was and
10879 filgotinib 24/09/2020 1 year 23/09/2024 02/12/2024 23/09/2025 02/12/2025 No 20/11/2024 PSUSA/00010879/202409 PSUSA/00010879/202509 Petar Mas Croatia CAP
DLP updated
updated on 20/11/2024
on 27/07/2022
10884 lumasiran 19/11/2020 1 year 18/11/2024 27/01/2025 18/11/2025 27/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010884/202411 PSUSA/00010884/202511 Mari Thorn Sweden CAP
10887 acalabrutinib 31/10/2017 1 year 30/10/2024 08/01/2025 30/10/2025 08/01/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010887/202410 PSUSA/00010887/202510 Barbara Kovacic Bytyqi Croatia CAP
10889 bupivacaine (liposomal formulations) 28/10/2011 1 year 27/10/2024 05/01/2025 27/10/2025 05/01/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010889/202410 PSUSA/00010889/202510 Eamon O Murchu Ireland CAP
10890 serenoa repens 26/06/1981 5 years 26/06/2026 24/09/2026 No 03/02/2021 New entry added on 03/02/2021 PSUSA/00010890/202606 NAP
10891 methacholine 31/10/1986 5 years 31/10/2028 29/01/2029 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010891/202810 Jana Lukačišinová Czech Republic NAP
ascorbic acid / acid folic / alfa-tocopherol / biotin / Active substance and DLP
cholecalciferol / cyanocobalamin / nicotinamide / amended on 28/04/2022
10892 22/01/2001 8 years 22/01/2029 22/04/2029 No 28/04/2022 PSUSA/00010892/202901 NAP
pantothenic acid / pyridoxine hydrochloride / retinol /
riboflavin / thiamine New entry added on 03/02/2021
10893 acetylsalicylic acid/rosuvastatin 26/06/2020 5 years 26/06/2028 24/09/2028 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010893/202806 Polona Golmajer Slovenia NAP
10894 trastuzumab deruxtecan 20/12/2019 6 months 19/12/2024 27/02/2025 19/06/2025 28/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010894/202412 PSUSA/00010894/202506 Carla Torre Portugal CAP
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# Classified as internal/staff contractors by the Europ Page 77 / 223
cabotegravir (for treatment of human
10900 18/03/2020 1 year 17/03/2025 26/05/2025 17/03/2026 26/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010900/202503 PSUSA/00010900/202603 Martin Huber Germany CAP
immunodeficiency virus type 1 (HIV-1)
10901 rilpivirine (for intramuscular use) 18/03/2020 1 year 17/03/2025 26/05/2025 17/03/2026 26/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010901/202503 PSUSA/00010901/202603 Liana Martirosyan Netherlands CAP
10903 brexucabtagene autoleucel 24/07/2020 6 months 23/07/2024 01/10/2024 23/01/2025 03/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010903/202407 PSUSA/00010903/202501 Bianca Mulder Netherlands CAP
10904 inclisiran 09/12/2020 1 year 31/12/2024 11/03/2025 31/12/2025 11/03/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010904/202412 PSUSA/00010904/202512 Kimmo Jaakkola Finland CAP
10905 latanoprost / netarsudil 07/01/2021 1 year 17/06/2025 26/08/2025 17/06/2026 26/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010905/202506 PSUSA/00010905/202606 Adam Przybylkowski Poland CAP
10906 pertuzumab / trastuzumab 29/06/2020 1 year 28/06/2025 06/09/2025 28/06/2026 06/09/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010906/202506 PSUSA/00010906/202606 Gabriele Maurer Germany CAP
10907 fenfluramine 25/06/2020 1 year 24/06/2025 02/09/2025 24/06/2026 02/09/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010907/202506 PSUSA/00010907/202606 Martin Huber Germany CAP
10909 fedratinib 16/08/2019 6 months 15/08/2024 24/10/2024 15/02/2025 26/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010909/202408 PSUSA/00010909/202502 Sonja Hrabcik Austria CAP
10913 oxytocin (systemic use) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010913/202606 Karen Pernille Harg Norway NAP
10914 oxytocin (nasal spray) 02/06/1955 3 years 30/06/2026 28/09/2026 Yes 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010914/202606 Karen Pernille Harg Norway NAP
10915 Rosuvastatin/ Omega-3-acid ethyl esters 15/01/2020 5 years 14/01/2025 14/04/2025 No 31/03/2021 New entry added on 31/03/2021 PSUSA/00010915/202501 Bianca Mulder Netherlands NAP
10917 selpercatinib 08/05/2020 6 months 08/11/2024 17/01/2025 08/05/2025 17/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010917/202411 PSUSA/00010917/202505 Bianca Mulder Netherlands CAP
10918 tucatinib 17/04/2020 1 year 16/04/2025 25/06/2025 16/04/2026 25/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010918/202504 PSUSA/00010918/202604 Jean-Michel Dogné Belgium CAP
10919 hepatitis B surface antigen, CpG 1018 adjuvant 09/11/2017 1 year 08/11/2024 17/01/2025 08/11/2025 17/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010919/202411 PSUSA/00010919/202511 Gabriele Maurer Germany CAP
10920 somapacitan 28/08/2020 1 year 31/08/2024 09/11/2024 31/08/2025 09/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010920/202408 PSUSA/00010920/202508 Martin Huber Germany CAP
10921 cenobamate 21/11/2019 1 year 26/09/2024 05/12/2024 26/09/2025 05/12/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010921/202409 PSUSA/00010921/202509 Jo Robays Belgium CAP
10922 icosapent ethyl 26/07/2012 1 year 25/07/2024 03/10/2024 25/07/2025 03/10/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010922/202407 PSUSA/00010922/202507 Bianca Mulder Netherlands CAP
10923 pemigatinib 17/04/2020 6 months 16/10/2024 25/12/2024 16/04/2025 25/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010923/202410 PSUSA/00010923/202504 Bianca Mulder Netherlands CAP
10925 risdiplam 07/08/2020 6 months 06/08/2024 15/10/2024 06/02/2025 17/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010925/202408 PSUSA/00010925/202502 Jan Neuhauser Austria CAP
10926 selinexor 26/03/2021 1 year 25/03/2025 03/06/2025 25/03/2026 03/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010926/202503 PSUSA/00010926/202603 Bianca Mulder Netherlands CAP
10927 ofatumumab 26/03/2021 1 year 25/09/2024 04/12/2024 25/09/2025 04/12/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010927/202409 PSUSA/00010927/202509 Amelia Cupelli Italy CAP
10930 berotralstat 03/12/2020 1 year 02/12/2024 10/02/2025 02/12/2025 10/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010930/202412 PSUSA/00010930/202512 Julia Pallos Hungary CAP
10931 dostarlimab 21/04/2021 1 year 20/04/2025 29/06/2025 20/04/2026 29/06/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010931/202504 PSUSA/00010931/202604 Carla Torre Portugal CAP
10932 potassium citrate / potassium hydrogen carbonate 30/04/2021 1 year 29/04/2025 08/07/2025 29/04/2026 08/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010932/202504 PSUSA/00010932/202604 Adam Przybylkowski Poland CAP
10936 selumetinib 10/04/2020 6 months 09/10/2024 18/12/2024 09/04/2025 18/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010936/202410 PSUSA/00010936/202504 Mari Thorn Sweden CAP
10938 drospirenone / estetrol 19/05/2021 1 year 19/05/2025 28/07/2025 19/05/2026 28/07/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010938/202505 PSUSA/00010938/202605 Martin Huber Germany CAP
10939 duvelisib 24/09/2018 6 months 23/09/2024 02/12/2024 23/03/2025 01/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010939/202409 PSUSA/00010939/202503 Petar Mas Croatia CAP
10940 ponesimod 18/03/2021 1 year 17/03/2025 26/05/2025 17/03/2026 26/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00010940/202503 PSUSA/00010940/202603 Karin Erneholm Denmark CAP
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PSUR frequency amended and
10941 setmelanotide 25/11/2020 1 year 24/11/2024 02/02/2025 24/11/2025 02/02/2026 No 05/02/2025 PSUSA/00010941/202411 PSUSA/00010941/202511 Anna Mareková Slovakia CAP
DLP updated on 05/02/2025
10942 relugolix / estradiol / norethisterone acetate 26/05/2021 1 year 25/05/2025 03/08/2025 25/05/2026 03/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010942/202505 PSUSA/00010942/202605 Martin Huber Germany CAP
10943 tirbanibulin 14/12/2020 1 year 13/12/2024 21/02/2025 13/12/2025 21/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010943/202412 PSUSA/00010943/202512 Anna Mareková Slovakia CAP
10944 satralizumab (for centrally authorised products) 01/06/2020 1 year 31/05/2025 09/08/2025 31/05/2026 09/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010944/202505 PSUSA/00010944/202605 Jan Neuhauser Austria CAP
10945 evinacumab 11/02/2021 1 year 11/02/2025 22/04/2025 11/02/2026 22/04/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010945/202502 PSUSA/00010945/202602 Mari Thorn Sweden CAP
10946 glycerol / urea 18/03/2021 13 years 17/03/2034 15/06/2034 No 28/07/2021 New entry added on 28/07/2021 PSUSA/00010946/203403 NAP
10947 telmisartan / indapamide 08/02/2021 5 years 07/02/2026 08/05/2026 No 28/07/2021 New entry added on 28/07/2021 PSUSA/00010947/202602 NAP
10951 tafasitamab 31/07/2020 6 months 30/07/2024 08/10/2024 30/01/2025 10/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010951/202407 PSUSA/00010951/202501 Mari Thorn Sweden CAP
10952 vosoritide 26/08/2021 1 year 25/08/2024 03/11/2024 25/08/2025 03/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010952/202408 PSUSA/00010952/202508 Zane Neikena Latvia CAP
10953 bimekizumab 20/08/2021 1 year 19/08/2024 28/10/2024 19/08/2025 28/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010953/202408 PSUSA/00010953/202508 Liana Martirosyan Netherlands CAP
10954 idecabtagene vicleucel 26/03/2021 1 year 25/03/2025 03/06/2025 25/03/2026 03/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010954/202503 PSUSA/00010954/202603 Mari Thorn Sweden CAP
10956 phentermine/ topiramate 17/07/2012 1 year 17/07/2024 25/09/2024 17/07/2025 25/09/2025 No 18/11/2024 DLP was amended on 28/02/2024 PSUSA/00010956/202407 PSUSA/00010956/202507 Karin Bolin Sweden NAP
10958 artesunate 23/06/2020 1 year 22/06/2025 31/08/2025 22/06/2026 31/08/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010958/202506 PSUSA/00010958/202606 Martin Huber Germany CAP
10960 zanubrutinib 14/11/2019 6 months 13/11/2024 22/01/2025 13/05/2025 22/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010960/202411 PSUSA/00010960/202505 Bianca Mulder Netherlands CAP
10961 pralsetinib 04/09/2020 6 months 03/09/2024 12/11/2024 03/03/2025 12/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010961/202409 PSUSA/00010961/202503 Mari Thorn Sweden CAP
10962 ripretinib 15/05/2020 1 year 14/05/2025 23/07/2025 14/05/2026 23/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010962/202505 PSUSA/00010962/202605 Barbara Kovacic Bytyqi Croatia CAP
10963 casirivimab / imdevimab (Ronapreve) 19/07/2021 1 year 18/07/2024 26/09/2024 18/07/2025 26/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010963/202407 PSUSA/00010963/202507 Mari Thorn Sweden CAP
10967 avacopan 27/09/2021 1 year 26/03/2025 04/06/2025 26/11/2025 04/02/2026 No 05/02/2025 DLP was amended on 20/11/2024 PSUSA/00010967/202503 PSUSA/00010967/202511 Liana Martirosyan Netherlands CAP
10971 tecovirimat 13/07/2018 1 year 12/01/2025 23/03/2025 12/01/2026 23/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010971/202501 PSUSA/00010971/202601 Martin Huber Germany CAP
10973 sotrovimab 20/08/2021 1 year 19/08/2024 28/10/2024 19/08/2025 28/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00010973/202408 PSUSA/00010973/202508 Liana Martirosyan Netherlands CAP
10974 pegcetacoplan 14/05/2021 1 year 13/11/2024 22/01/2025 13/11/2025 22/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010974/202411 PSUSA/00010974/202511 Kimmo Jaakkola Finland CAP
10976 abrocitinib 08/09/2021 1 year 07/09/2024 16/11/2024 07/09/2025 16/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010976/202409 PSUSA/00010976/202509 Petar Mas Croatia CAP
10978 finerenone 09/07/2021 1 year 08/07/2024 16/09/2024 08/07/2025 16/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010978/202407 PSUSA/00010978/202507 Bianca Mulder Netherlands CAP
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10979 tepotinib 25/03/2020 1 year 24/03/2025 02/06/2025 24/03/2026 02/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010979/202503 PSUSA/00010979/202603 Bianca Mulder Netherlands CAP
10980 anifrolumab 30/07/2021 1 year 29/07/2024 07/10/2024 29/07/2025 07/10/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010980/202407 PSUSA/00010980/202507 Liana Martirosyan Netherlands CAP
10983 voxelotor 14/02/2022 6 months 13/08/2024 22/10/2024 13/02/2025 24/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010983/202408 PSUSA/00010983/202502 Jo Robays Belgium CAP
10984 nirmatrelvir / ritonavir 31/12/2021 1 year 30/12/2024 10/03/2025 30/12/2025 10/03/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010984/202412 PSUSA/00010984/202512 Martin Huber Germany CAP
10987 myristalkonium, benzalkonium (vaginal use only) 17/02/1986 13 years 01/01/2025 01/04/2025 No 28/04/2022 New entry added on 28/04/2022 PSUSA/00010987/202501 Lina Šeibokienė Lithuania NAP
10989 enfortumab vedotin 18/12/2019 1 year 17/12/2024 25/02/2025 17/12/2025 25/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010989/202412 PSUSA/00010989/202512 Eva Jirsová Czech Republic CAP
10990 lisocabtagene maraleucel / lisocabtagene maraleucel 05/02/2021 6 months 04/08/2024 13/10/2024 04/02/2025 15/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010990/202408 PSUSA/00010990/202502 Gabriele Maurer Germany CAP
10993 daridorexant 07/01/2022 1 year 06/01/2025 17/03/2025 06/01/2026 17/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010993/202501 PSUSA/00010993/202601 Ana Sofia Diniz Martins Portugal CAP
10994 relugolix 08/01/2019 1 year 07/01/2025 18/03/2025 07/01/2026 18/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010994/202501 PSUSA/00010994/202601 Karin Erneholm Denmark CAP
10998 linzagolix choline 14/06/2022 6 months 05/11/2024 14/01/2025 05/05/2025 14/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010998/202411 PSUSA/00010998/202505 Martin Huber Germany CAP
10999 mosunetuzumab 03/06/2022 6 months 02/12/2024 10/02/2025 02/06/2025 11/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010999/202412 PSUSA/00010999/202506 Mari Thorn Sweden CAP
11000 ciltacabtagene autoleucel 28/02/2022 6 months 27/08/2024 05/11/2024 27/02/2025 08/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011000/202408 PSUSA/00011000/202502 Jo Robays Belgium CAP
11002 avalglucosidase alfa 06/08/2021 1 year 06/08/2024 15/10/2024 06/08/2025 15/10/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00011002/202408 PSUSA/00011002/202508 Liana Martirosyan Netherlands CAP
11003 olipudase alfa 28/03/2022 6 months 28/09/2024 07/12/2024 28/03/2025 06/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00011003/202409 PSUSA/00011003/202503 Martin Huber Germany CAP
11005 lonafarnib 20/11/2020 6 months 19/11/2024 28/01/2025 19/05/2025 28/07/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011005/202411 PSUSA/00011005/202505 Adam Przybylkowski Poland CAP
11006 eptacog beta (activated) 15/07/2022 1 year 14/07/2024 22/09/2024 14/07/2025 22/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00011006/202407 PSUSA/00011006/202507 Bianca Mulder Netherlands CAP
11008 asciminib 29/10/2021 1 year 28/04/2025 07/07/2025 28/04/2026 07/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011008/202504 PSUSA/00011008/202604 Eva Jirsová Czech Republic CAP
11009 valoctocogene roxaparvovec 24/08/2022 6 months 23/08/2024 01/11/2024 23/02/2025 04/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011009/202408 PSUSA/00011009/202502 Bianca Mulder Netherlands CAP
11010 teclistamab 23/08/2022 6 months 22/08/2024 31/10/2024 22/02/2025 03/05/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00011010/202408 PSUSA/00011010/202502 Jana Lukacisinova Czech Republic CAP
11012 lenacapavir 17/08/2022 1 year 16/08/2024 25/10/2024 16/08/2025 25/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00011012/202408 PSUSA/00011012/202508 Ana Sofia Diniz Martins Portugal CAP
11013 melphalan flufenamide 06/02/2022 6 months 06/08/2024 15/10/2024 06/02/2025 17/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00011013/202408 PSUSA/00011013/202502 Martin Huber Germany CAP
11016 faricimab 28/01/2022 6 months 27/07/2024 05/10/2024 27/01/2025 07/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00011016/202407 PSUSA/00011016/202501 Carla Torre Portugal CAP
11017 fosdenopterin 26/02/2021 6 months 25/08/2024 03/11/2024 25/02/2025 06/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011017/202408 PSUSA/00011017/202502 Martin Huber Germany CAP
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11018 nivolumab / relatlimab 18/03/2022 6 months 17/09/2024 26/11/2024 17/03/2025 26/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011018/202409 PSUSA/00011018/202503 Gabriele Maurer Germany CAP
11019 tirzepatide 13/05/2022 6 months 13/11/2024 22/01/2025 13/05/2025 22/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011019/202411 PSUSA/00011019/202505 Bianca Mulder Netherlands CAP
11020 voclosporin 22/01/2021 6 months 21/07/2024 29/09/2024 21/01/2025 01/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00011020/202407 PSUSA/00011020/202501 Adam Przybylkowski Poland CAP
11021 vutrisiran 13/06/2022 1 year 12/06/2025 21/08/2025 12/06/2026 21/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011021/202506 PSUSA/00011021/202606 Liana Martirosyan Netherlands CAP
11022 capmatinib 06/05/2020 1 year 05/05/2025 14/07/2025 05/05/2026 14/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011022/202505 PSUSA/00011022/202605 Carla Torre Portugal CAP
11023 sutimlimab 04/02/2022 6 months 04/08/2024 13/10/2024 04/02/2025 15/04/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00011023/202408 PSUSA/00011023/202502 Jan Neuhauser Austria CAP
11024 maribavir 23/11/2021 6 months 22/11/2024 31/01/2025 22/05/2025 31/07/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011024/202411 PSUSA/00011024/202505 Adam Przybylkowski Poland CAP
11025 mitapivat 17/02/2022 6 months 16/08/2024 25/10/2024 16/02/2025 27/04/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00011025/202408 PSUSA/00011025/202502 Adam Przybylkowski Poland CAP
11026 nirsevimab 31/10/2022 6 months 30/10/2024 08/01/2025 30/04/2025 09/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011026/202410 PSUSA/00011026/202504 Kimmo Jaakkola Finland CAP
11027 loncastuximab tesirine 23/04/2021 6 months 22/10/2024 31/12/2024 22/04/2025 01/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011027/202410 PSUSA/00011027/202504 Eva Jirsová Czech Republic CAP
11029 abaloparatide 28/04/2017 6 months 27/10/2024 05/01/2025 27/04/2025 06/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011029/202410 PSUSA/00011029/202504 Karin Erneholm Denmark CAP
11030 gozetotide 23/03/2022 6 months 22/09/2024 01/12/2024 22/03/2025 31/05/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00011030/202409 PSUSA/00011030/202503 John Joseph Borg Malta CAP NAP
11031 lutetium (177LU) vipivotide tetraxetan 23/03/2022 6 months 22/09/2024 01/12/2024 22/03/2025 31/05/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00011031/202409 PSUSA/00011031/202503 John Joseph Borg Malta CAP
11032 maralixibat 29/09/2021 6 months 28/09/2024 07/12/2024 28/03/2025 06/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00011032/202409 PSUSA/00011032/202503 Adam Przybylkowski Poland CAP
11033 spesolimab
dengue tetravalent vaccine (live, attenuated) [Dengue 01/09/2022 6 months 01/09/2024 10/11/2024 01/03/2025 10/05/2025 No 19/09/2024 PSUSA/00011033/202409 PSUSA/00011033/202503 Zoubida Amimour France CAP
virus, serotype 2, expressing Dengue virus, serotype 1,
surface proteins, live, attenuated / Dengue virus,
serotype 2, expressing Dengue virus, serotype 3,
11034 19/08/2022 6 months 18/08/2024 27/10/2024 18/02/2025 29/04/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00011034/202408 PSUSA/00011034/202502 Liana Martirosyan Netherlands CAP
surface proteins, live, attenuated / Dengue virus,
serotype 2, expressing Dengue virus, serotype 4,
surface proteins, live, attenuated / Dengue virus,
11036 serotype
octreotide2,(for
live, attenuated.]
centrally authorised products) 02/12/2022 6 months 01/12/2024 09/02/2025 01/06/2025 10/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011036/202412 PSUSA/00011036/202506 Eamon O Murchu Ireland CAP
11037 etranacogene dezaparvovec 22/11/2022 6 months 21/11/2024 30/01/2025 21/05/2025 30/07/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011037/202411 PSUSA/00011037/202505 Bianca Mulder Netherlands CAP
11038 tremelimumab 21/10/2022 6 months 20/10/2024 29/12/2024 20/04/2025 29/06/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011038/202410 PSUSA/00011038/202504 David Olsen Norway CAP
11039 donepezil / memantine 27/07/2020 5 years 26/07/2028 24/10/2028 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00011039/202807 Jana Lukačišinová Czech Republic NAP
11040 rosuvastatin / ramipril 19/06/2021 5 years 18/06/2026 16/09/2026 No 05/04/2023 New entry added on 05/04/2023 PSUSA/00011040/202606 NAP
11041 ramipril / bisoprolol 11/05/2022 5 years 22/10/2025 20/01/2026 No 03/05/2023 New entry added on 03/05/2023 PSUSA/00011041/202510 Slovakia NAP
11042 meldonium 14/04/2003 8 years 13/04/2031 12/07/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011042/203104 none NAP
11043 nifedipine / lidocaine 01/02/2004 10 years 03/03/2035 01/06/2035 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011043/203503 none NAP
11044 ipidacrine 12/05/2008 8 years 11/05/2031 09/08/2031 Yes 03/05/2023 New entry added on 03/05/2023 PSUSA/00011044/203105 none NAP
11046 deucravacitinib 09/09/2022 6 months 08/09/2024 17/11/2024 08/03/2025 17/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011046/202409 PSUSA/00011046/202503 Liana Martirosyan Netherlands CAP
11047 cipaglucosidase alfa 20/03/2023 6 months 19/09/2024 28/11/2024 19/03/2025 28/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011047/202409 PSUSA/00011047/202503 Mari Thorn Sweden CAP
11049 pegunigalsidase alfa 04/05/2023 6 months 03/11/2024 12/01/2025 03/05/2025 12/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011049/202411 PSUSA/00011049/202505 Liana Martirosyan Netherlands CAP
11050 vadadustat 29/06/2020 6 months 28/12/2024 08/03/2025 28/06/2025 06/09/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011050/202412 PSUSA/00011050/202506 Eva Jirsová Czech Republic CAP
11051 niraparib / abiraterone acetate 19/04/2023 6 months 19/10/2024 28/12/2024 19/04/2025 28/06/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00011051/202410 PSUSA/00011051/202504 Jan Neuhauser Austria CAP
11052 ruxolitinib (for non-segmental vitiligo) 21/09/2021 6 months 20/09/2024 29/11/2024 20/03/2025 29/05/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00011052/202409 PSUSA/00011052/202503 Adam Przybylkowski Poland CAP
11054 iptacopan 05/12/2023 6 months 04/12/2024 12/02/2025 04/06/2025 13/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011054/202412 PSUSA/00011054/202506 Lina Seibokiene Lithuania CAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 81 / 223
Correction of DLP on 03/07/2024
11056 danicopan 18/01/2024 6 months 17/07/2024 25/09/2024 17/01/2025 28/03/2025 No 05/06/2024 Correction of DLP and Next DLP PSUSA/00011056/202407 PSUSA/00011056/202501 Martin Huber Germany CAP
New CAP authorised on
on 28/08/2024
pandemic influenza vaccine (H5N1) (surface antigen, 19/04/2024
inactivated, adjuvanted, prepared in cell cultures), EURD updated on 31/07/2024
11057 prepandemic influenza vaccine (H5N1) (surface 31/01/2020 6 months 31/07/2024 09/10/2024 31/01/2025 11/04/2025 No 31/07/2024 PSUSA/00011057/202407 PSUSA/00011057/202501 Mari Thorn Sweden CAP
antigen, inactivated, adjuvanted, prepared in cell Correction of DLP on 03/07/2024
cultures)
New CAP authorised on
11058 chikungunya vaccine (live) 09/11/2023 6 months 08/11/2024 17/01/2025 08/05/2025 17/07/2025 No 31/07/2024
19/04/2024
PSUSA/00011058/202411 PSUSA/00011058/202505 Gabriele Maurer Germany CAP
28/06/2024
11070 hydroxyprogesterone caproate 01/05/2010 3 years 30/04/2026 29/07/2026 No 31/07/2024 New entry added on 31/07/2024 PSUSA/00011070/202604 not yet assigned none NAP
Single-stranded 5' capped mRNA encoding the EURD and DLP amended on
11075 Respiratory syncytial virus glycoprotein F stabilized in 31/05/2024 6 months 29/11/2024 07/02/2025 29/05/2025 07/08/2025 No 20/11/2024 23/10/2024 PSUSA/00011075/202411 PSUSA/00011075/202505 Jean-Michel Dogné Belgium CAP
the prefusion conformation
New CAP authorised on
22/08/2024
11076 sotatercept 26/03/2024 6 months 25/09/2024 04/12/2024 25/03/2025 03/06/2025 No 19/09/2024 PSUSA/00011076/202409 PSUSA/00011076/202503 Zoubida Amimour France CAP
11083 fluoroethyltyrosine (18F) 23/12/2015 3 years 23/12/2027 22/03/2028 Yes 25/09/2024 New entry added on 25/09/2024 PSUSA/00011083/202712 not yet assigned none NAP
11084 dienogest / ethinylestradiol (prolonged-release tablet) 13/03/2024 1 year 15/03/2025 24/05/2025 15/03/2026 24/05/2026 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011084/202503 PSUSA/00011084/202603 Karin Bolin Sweden NAP
11085 valsartan / indapamide 10/05/2024 5 years 10/05/2029 08/08/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011085/202905 not yet assigned none NAP
11086 isothipendyl 12/08/2011 10 years 12/08/2034 10/11/2034 No 25/09/2024 PSUSA/00011086/203408 not yet assigned none NAP
11087 methylprednisolone
allergen for therapy:(topical
Dactylisuse)
Glomerata L., Phleum 18/12/1957 5 years 30/11/2028 28/02/2029 No 25/09/2024 New entry added on 25/09/2024 PSUSA/00011087/202811 not yet assigned none NAP
Pratense L., Anthoxanthum Odoratum L., Lolium
Perenne L., Poa Pratensis L. Salsola Kali L., Blomia
11088 Tropicalis,
ifurtimox Zea Mays L., Fraxinus Excelsior L., 08/01/1970 3 years 08/01/2026 08/04/2026 No 23/10/2024 New entry added on 23/10/2024 PSUSA/00011088/202601 not yet assigned none NAP
Arrhenatherum Elatius, Cynodon Dactylon (L.) pers.,
latex, Festuca Pratensis Hudson, Parietaria Officinalis
L., Cat Epithelia, Dog Epithelia, Triticum Aestivum,
11089 Dermatophagoides Farinae, Juniperus Ashei Buchholz, 10/08/2004 8 years 10/08/2033 08/11/2033 No 23/10/2024 New entry added on 23/10/2024 PSUSA/00011089/203308 not yet assigned none NAP
Hordeum Vulgare L., Alnus Glutinosa L., Agrostis
Capillaris L., Corylus Avellana L., Secale Cereale L.,
Avena Fatua whole., Holcus Lanatus, Artemisia New CAP authorised on
11090 macitentan / tadalafil
Vulgaris L., Olea Europaea L., Ambrosia Artemisiifolia,
14/10/2024 6 months 14/10/2024 23/12/2024 14/04/2025 23/06/2025 No 09/10/2024 PSUSA/00011090/202410 PSUSA/00011090/202504 Maria del Pilar Rayon Spain CAP
27/09/2024
Dermatophagoides Pteronyssinus, Carpinus Betulus L.,
Avena Sativa L., Bromus Inermis whole, Parietaria
New CAP authorised on
11091 Judaica L., Betula single or mixes (Staloral)
delgocitinib 23/01/2020 6 months 22/01/2025 02/04/2025 22/07/2025 30/09/2025 No 23/10/2024 PSUSA/00011091/202501 PSUSA/00011091/202507 Liana Martirosyan Netherlands CAP
19/09/2024
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 82 / 223
New CAP authorised on
11094 toripalimab 17/12/2018 6 months 16/12/2024 24/02/2025 16/06/2025 25/08/2025 No 23/10/2024 PSUSA/00011094/202412 PSUSA/00011094/202506 Karin Erneholm Denmark CAP
19/09/2024
Correction of DLP on 20/11/2024
11095 zolbetuximab 26/03/2024 6 months 25/09/2024 04/12/2024 25/03/2025 03/06/2025 No 23/10/2024 PSUSA/00011095/202409 PSUSA/00011095/202503 Bianca Mulder Netherlands CAP
New CAP authorised on
19/09/2024
DLP corrected on 18/12/2024
11096 meningococcal group A, B, C, W and Y vaccine 20/10/2023 6 months 19/04/2025 28/06/2025 19/10/2025 28/12/2025 No 18/12/2024 PSUSA/00011096/202504 PSUSA/00011096/202510 Jean-Michel Dogné Belgium CAP
New CAP authorised on
14/11/2024
Correction of DLP on 18/12/2024
11097 mirvetuximab soravtansine 14/11/2022 6 months 13/05/2025 22/07/2025 13/11/2025 22/01/2026 No 18/12/2024 PSUSA/00011097/202505 PSUSA/00011097/202511 Maria del Pilar Rayon Spain CAP
New CAP authorised on
14/11/2024
11098 furazidine 24/10/2025 5 years 28/02/2026 29/05/2026 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011098/202602 not yet assigned none NAP
11099 magnesium chloride Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011099/204409 not yet assigned none NAP
11100 sodium acetate Not available* 20 years 02/09/2044 01/12/2044 Yes 18/12/2024 New entry added on 18/12/2024 PSUSA/00011100/204409 not yet assigned none NAP
Correction of EURD and DLP on
05/02/2025
Marie Louise Schougaard
11101 marstacimab 11/10/2024 6 months 10/04/2025 19/06/2025 10/10/2025 19/12/2025 No 05/02/2025 PSUSA/00011101/202504 PSUSA/00011101/202510
Christiansen Denmark CAP
New CAP authorised on
18/11/2024
New CAP authorised on
11102 repotrectinib 15/11/2023 6 months 14/05/2025 23/07/2025 14/11/2025 23/01/2026 No 05/02/2025 PSUSA/00011102/202505 PSUSA/00011102/202511 Barbara Kovacic Bytyqi Croatia CAP
13/01/2025
107800 levodopa 21/12/2018 1 year 20/12/2024 28/02/2025 20/12/2025 28/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00107800/202412 PSUSA/00107800/202512 Barbara Kovacic Bytyqi Croatia CAP
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 83 / 223
Active substances and combinations of active substances
removed from the EURD list
quinidine
obeticholic acid
darvadstrocel
chlortalidone / metoprolol
magnesium oxide
pixantrone
pralsetinib
chlorhexidine / neomycin
chlorocresol combinations
clopamide / pindolol
clopamide / reserpine
dextromethorphan / paracetamol
guaifenesin / pseudoephedrine
menadiol
miglitol
orphenadrine
ketoprofen / sucralfate
zaleplon
dihydrocodeine / paracetamol
ferrimanitol ovoalbumin
dibromotyrosine
hydrocortisone / oxytetracycline
dibromotyrosine / thiamazole
obiltoxaximab
amifostine
clemastine / dexamethasone
azidamfenicol
beractant
eberconazole
fluocortolone
lofexidine
talinolol
tiopronin
dexamethasone / neomycin
piretanide
proguanil
tazarotene
mephenesin
naloxone / tilidine
chlorphenamine / phenylephrine
pirenzepine
propantheline
belantamab mafodotin
cetylpyridinium / menthol
homatropine
mezlocillin
orciprenaline
procaine benzylpenicillin
sulfogaiacol
demoxytocin
dextropropoxyphene hydrochloride
benzododecinium bromide
chorionic gonadotrophin
dihydralazine
dimethoxanate
reteplase
ornithine
perazine
trifluoperazine
abciximab
acrivastine / pseudoephedrine
altretamine
amiloride
amiloride / bumetanide
amiloride / chlortalidone
amiloride / hydrochlorthiazide
bacitracin / neomycin
bisacodyl combinations
chloroxine
colecalciferol
cyanamide
dimemorfan
ergocalciferol
lomefloxacin
neostigmine
nilvadipine
quazepam
saquinavir
bacitracin / polymyxine
calcium / ergocalciferol
bupivacaine/meloxicam
dimenhydrinate
metildigoxin
pancreatin / simeticone
dimethicone / pancreatin
selenite sodium
xipamide
crizanlizumab
elivaldogene autotemcel
neridronic acid
chlorphenoxamine
acrivastine / pseudoephedrine
pholcodine
rufloxacin
ioxaglic acid
lysine acetylsalicylate
lidocaine / norepinephrine
piretanide
peppermint oil
nilvadipine
sulbactam
xenon
indinavir
telbivudine
telithromycin
ibalizumab
adefovir
peginterferon alpha-2b
aminotridecane adipate
atenolol / nifedipine
hydrochlorothiazide / moexipril
halofantrine
ertugliflozin
ceftibuten
interferon alpha-2a
sotagliflozin
nateglinide
moxetumomab pasudotox
cefodizime
sodium aurothiomalate
dicobalt edetate
betibeglogene autotemcel
flubendazole
oxatomide
pergolide
lesinurad
naltrexone
crisaborole
didanosine
cinoxacin
enoxacin
interferon alpha-2b
nalidixic acid
pipemidic acid
dihydroergocryptine
dihydroergotoxine
eluxadoline
necitumumab
lidocaine
furosemide / ramipril
alendronate / alfacalcidol
peramivir
oxytocin
indoramin
quizartinib
ivabradine
carvedilol / ivabradine
strontium ranelate
stavudine
rolapitant
rimexolone
chlorpropamide
lidocaine / paraformaldehyde
sulfanilamide
acetyldigoxin combinations
alpha chymotrypsin
sacarose / trioxymethylene
pyrimethamine / sulfalene
aminopropylone / sulodexide
sulphur / triclosan
cibenzoline
formaldehyde
pristinamycin
levonorgestrel
phentermine
androstanolone
acetyldigoxin
allobarbital / aminophenazone
allopurinol / benzbromarone
ambucetamide
aminaftone
amlodipine / benazepril
amoxicillin / metronidazole
amphetamine
amphetamine / dextroamfetamine
ascorbic acid / biotin / cyanocobalamin / folic acid / niacinamide /
pantothenic acid / pyridoxine hydrochloride / riboflavin / thiamine
mononitrate, biotine / cyanocobalamin / nicotinamide /
pantothenic acid / pyridoxine / riboflavin / thiamine
auranofin
benfotiamine / cyanocobalamin
benfotiamine / pyridoxine
benidipine
benzatropine
benzonatate
bupranolol
butalbital / paracetamol
butenafine
butriptyline
cafedrine
carbenicillin
carbimide
cefcapene
cefpiramide
cefsulodin
cefteram
ceftezole
cefapirin
cerivastatin
chlormadinone / estradiol
chlornitrofenol
chlorproethazine
chlorxylenol / cinchocaine
chlorzoxazone / paracetamol
cilastatin
clofibrate
clorazepate / pyridoxine
codeine / creosote
codeine / diphenhydramine
dantrone / poloxamer
delavirdine
dexbudesonide
dexetimide
dextranomer
dibenzepine
diclofenac / gentamicin
diclofenac / tobramycin
dipivefrine
docusate
doxercalciferol
ethambutol / isoniazid
etoperidone
etynodiol / mestranol
fenbufen
fendiline
flurithromycin
guaifenesin / hydrocodone
guaifenesin / pentoxyverine
hyaluronate zinc
hydrochlorothiazide / methyldopa
hydrocodone
atropine / hydromorphone
iodamide
acidum malicum levogirum / calcium chloride dihydrate / glucose
monohydrate / glycine / l proline / l-alanine / l-arginine / l-
histidine / l-isoleucine / l-leucine / l-lysine hydrochloride / l-
methionine / l-phenylalanine / l-threonine / l-tryptophane / l-
valine / magnesium chloride hexahydrate / potassium chloride /
sodium chloride / sodium glycerophosphate pentahydrate / zinc
chloride
lovastatin / nicotinic acid
lumiracoxib
meclofenamate
mepenzolate
mesuximide
methenamine / phenazopyridine
methyl diethylacetylsalicylate
metipamide
metizoline
mitiglinide
nafcillin
norfenefrine
nystatin / triamcinolone
oxiglutatione
parethoxycaine
phenazone / tetracaine
phendimetrazine
phenylsalicylate
betaxolol / pilocarpine
pranlukast
prenoxdiazine
progabide
quinaprilat
rebamipide
reserpine
rofecoxib
rokitamycin
rosoxacin
sermorelin
streptodornase
tegaserod
teprenone
terconazole
terguride
thyroglobulin
tiotixene
tolazamide
tolmetin
vidarabine
boceprevir
olaratumab
enoxaparin (biosimilars)
fenspiride
benzathine phenoxymethylpenicillin
daclatasvir
ertugliflozin / metformin
ertugliflozin / sitagliptin
etanercept (biosimilars)
zafirlukast
adalimumab (biosimilars)
ursodeoxycholic acid
pramocaine
dasabuvir
hydrochlorothiazide / ramipril
tauroursodeoxycholic acid
antithrombin alpha
ofatumumab
acetylcysteine / tuaminoheptane
colchicine / probenecid
fluorometholone / tetryzoline
fluorometholone / urea
retapamulin
infliximab (biosimilars)
lubiprostone
amidotrizoic acid
pegaptanib
metaxalone
metoxybutropate
pipobroman
polycarbophil
albiglutide
amrinone
chloramphenicol / methyluracil
dienestrol
estradiol / gestodene
estrogen / methyltestosterone
ethinylestradiol / etynodiol
ethinylestradiol / lynestrenol
ethinylestradiol / norgestrel
fluorometholone / gentamicin
heptaminol
magnesium peroxide
mebhydroline
metipranolol
oxandrolone
oxymetholone
pegademase
pimethixene
polyestradiol
polythiazide
polythiazide / reserpine
sodium bromide
cobamamide / cyproheptadine
olpadronic acid
amyl nitrite
chloramphenicol / collagenase
cilnidipine
co-danthrusate
desipramine
eptotermin alpha
fructose
ibacitabine
acebutolol / mefruside
acebutolol / nifedipine
amineptine
azintamide / hyoscine
bile-dispert / pancreatin
bretylium
broxaterol
buformin
butorphanol
calcium pidolate
camostat
carisoprodol
carisoprodol / paracetamol
carmofur
carmoisine
cevimeline
chymopapain
corticotropin
cyanocobalamin / hydroxocobalamin
cyclandelate
dalfopristin / quinupristin
denileukin diftitox
deslanoside
dextromoramide
dimefline
diphemanil
disodium inosinate
dixyrazine
domiphen
drofenine / propyphenazone
dronabinol
eledoisin
embramine
emetine
epervudine
estropipate
eszopiclone
etofylline / hexobendine
etretinate
fluocortin
fursultiamine / riboflavin
glibornuride
gramicidin / neomycin
ibudilast
iopanoic acid
edrophonium
prenoxdiazine
propacetamol
proscillaridin
quinfamide
resorcinol / sulphur
sibutramine
sivelestat
sodium aurothiosulfate
sodium bromebrate
sodium pidolate
stannous fluoride
tedisamil
tinidazole / tioconazole
retigabine
sodium fluoride
catalase
catalase / neomycin
cellulase
cetalkonium / lidocaine
cicletanine
clofoctol
desoxycortone acetate
dimecrotate magnesium
ethionamide
fenoldopam
halcinonide
ibopamine
metixene
procaterol
rociverine
takadiastase
alitretinoin
acetylaminonitropropoxybenzene
acetylleucine
alibendole
altizide
amezinium
amilomer
aminoglutethimide
aminohippurate
aminotridecane undecylenate
ampicillin / flucloxacillin
azulenolum
barbexaclone
benexate
benorilate
bopindolol
buclizine
cadralazine
cortivazol
ditazole
flavodate
idrocilamide
iotrolan
lidoflazine
limaprost
linsidomine
mabuprofen
mitoguazone
nimorazole
nitrogen
nonivamide
oxilofrine
oxitropium
pemoline
pipotiazine
pitofenone
ramelteon
stanozolol
thioproperazine
triclabendazole
trimethobenzamide
tropatepine
troxipide
tulobuterol
unoprostone
valethamate
vasopressin
viloxazine
viminol
voglibose
vorinostat
xantinol nicotinate
simeprevir
flupirtine
indometacin / methocarbamol
pheniramine
acediasulfone
alfoscerate olamine
aloxiprin
benzethonium chloride
coconut oil / distilled coal tar / salicylic acid, coal tar solution /
salicylic acid / sulfur
delapril
mebutizide
reviparin
trilostane
abarelix
peramivir
prasterone
tiemonium
telavancin
nesiritide
benzocaine / chlorobutanol
caffeine / propyphenazone
cineole / thymol
daclizumab
lactobacillus acidophilus
sitagliptin
triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/
with or without mineral compounds/electrolytes (i.v. application)
brompheniramine / pseudoephedrine
cefdinir
estradiol / norgestimate
insulin porcine
iotalamic acid
lisuride
loperamide
chlorphenesin
adenosine / allopurinol / glutathione / lactobionic acid / magnesium
sulphate / poly (0-2-hydroxyethyl) starch (pentafraction) /
potassium dihydrogen phosphate / potassium hydroxide / raffinose
/ sodium hydroxide
brompheniramine
dolasetron
ketanserin
catumaxomab
desirudin
alipogene tiparvovec
gadoversetamide
mestranol / norethisterone
dihydroergocristine
bemetizide / triamterene
ebastine / pseudoephedrine
clodronic acid
vorapaxar
roxatidine
tiludronic acid
eucalyptol
tropisetron
buflomedil
cefminox
chondroitin
chondroitin / glucosamine
fructose / glycerin
hexamidine / tetravacaine
icodextrin
methysergide
tetrazepam
zinc oxide
sodium oxybate
benzocaine / chlorhexidine
fexofenadine combinations
glucosamine / lidocaine
mangafodipir
lactobacillus rhamnosus
lactobacillus acidophilus
hydrochlorothiazide / irbesartan
irbesartan
propiomazine
palifermin
elvitegravir
co-trimoxazole
amyleine / chlorhexidine
bacitracin / chlorhexidine
bendroflumethiazide
collagen
dinutuximab
chlorhexidine / hydrocortisone
chlorhexidine / tolnaftate
mycobacterium bovis
ferucarbotran
fusafungine
rimantadine
nicotinic acid
oxedrine
penamecillin
phenolphthalein
sulfamethoxazole
meprobamate
mercaptamine
oxetacaine
nitrous oxide
naphazoline
enoxaparin
sulfametrole / trimethoprim
sulpiride
mycophenolate mofetil
morphine
itopride
olanzapine
olanzapine pamoate
diazepam / sulpiride
urea
lisinopril
pegloticase
telaprevir
ajmaline
hypericin
tegafur / uracil
dequalinium
diphenhydramine
levobunolol
pyridoxin / thiamine
dutasteride
delapril / manidipine
azithromycin
ambroxol / doxycycline
bromhexine / oxymetazoline
histrelin
selenomethionine (75Se)
thrombin
almagate
erythromycin / isotretinoin
isotretinoin
fosinopril
fosinopril / hydrochlorothiazide
thiocolchicoside
paracetamol / thiocolchicoside
metopimazine
estradiol
terfenadine
dienogest / estradiol
alfatradiol
almitrine
chlortalidone / spironolactone
'dexbrompheniramine / pseudoephedrine
dexchlorpheniramine / pseudoephedrine
galactose
glucose
linagliptin
linagliptin / metformin
dibrompropamidine
trapidil
empagliflozin
tocopherol / tretinoin
tioconazole
phenylephrine
nystatin / tinidazole
tinidazole
macrogol 4000
rosiglitazone
valsartan
hydrochlorothiazide / valsartan
budipine
cidofovir
ferumoxytol
floctafenine
raltegravir
amitriptyline
amitriptylinoxide
amitriptyline / amitriptylinoxide
colestilan
bacterial lysate
amlodipine / indapamide
budipine
adrafinil
phloroglucinol / trimethylphloroglucinol
phloroglucinol
niaprazine
mazindol
ferumoxides
carmustine
codergocrine mesilate
ibuprofen lysine
ibuprofen
sodium bicarbonate
amlodipine / valsartan
pegaspargase
cilazapril / hydrochlorothiazide
bromhexine / ephedrine
canagliflozin / metformin
acethylthyrosine / acetylcysteine / alanine / arginine / asparagine
monohydrate / aspartic acid / glutamic acid / glycine / histidine /
isoleucine / leucine / lysine acetate / methionine / ornithine
hydrochloride / phenylalanine / proline / serine / threonine /
tryptophane / valine
metformin / vildagliptin
hydroxyzine
doripenem
camphor / menthol
camphor / ichtamol
bendroflumethiazide / spironolactone
nelfinavir
chlorazepate
benztropine mesylate
ferrous sulfate
ferrous lactate
ferrous gluconate
ferrous fumarate
ferrous aspartate
dextriferron
divalproex sodium
valproic acid
methotrimeprazine
diacethyl-midecamycin
desvenlafaxine
iobitridol
rilonacept
alogliptin / metformin
porfimer
flupirtine
clarithromycin
cilostazol
quinine combinations
defibrotide
alemtuzumab
symphytum officinale L.
radix
xysmalobium undulatum L.
Aiton f. var. undulatatum, radix
cyproterone / ethinylestradiol
gentamicin / zyrconium
amcinonide / neomycin
deltamethrin
doxylamine
grepafloxacin hydrochloride
Entry (EURD ID: 10935) deleted due to merge with EURD ID: 274 Jan-25
Entry 2477 deleted due to merge with EURD ID: 2475 Feb-24
Jan-24
Entry deleted due to merge with EURD ID: 582
Jan-24
Entry deleted due to merge with EURD ID: 2426 & 2536
Jan-24
Entry deleted due to merge with EURD ID: 2426 & 2536
Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151
Dec-23
with entry EURD ID: 148
Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151
Dec-23
with entry EURD ID: 148
Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151
Dec-23
with entry EURD ID: 148
Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151
Dec-23
with entry EURD ID: 148
Deletion due to merge entries EURD ID: 145, 146, 147, 149 and 151
Dec-23
with entry EURD ID: 148
Entry deleted due to merge entries EURD ID: 862, 1249 and 9089
Dec-23
with entry EURD ID: 10386
Dec-23
Entry removed as Atripla (CAP) surrendered
Entry deleted due to merge entries EURD ID: 862, 1249 and 9089
Dec-23
with entry EURD ID: 10386
Dec-23
Entry removed as Prevenar (CAP) surrendered
Dec-23
Entry removed as Invirase (CAP) surrendered
Entry deleted due to merge all the bacitracin containing entries
(EURD ID: 288, 289, 291, 292 and 9072) in a single one (EURD ID: Dec-23
285)
Entry deleted due to merge entries EURD ID: 862, 1249 and 9089
Dec-23
with entry EURD ID: 10386
Oct-23
Entry for deletion as Adakveo (CAP) is revoked
Sep-23
Entry for deletion as Skysona (CAP) is withdrawn
Entry removed due to merge with EURD ID: 39 (acetylsalicylic acid) Jun-23
Entry removed due to split (see entry ID: 10933 and 10934) Jun-21
Entry removed due to split (see entry ID: 10913 and 10914) Feb-21
Entry removed as Protelos and Osseor were withdrawn in April 2020 Nov-20
Entry removed due to split (see entry ID: 10864, 10865, 10866 and
Sep-20
10867)
Entry removed due to split (See entries ID: 10855, 10856) Jul-20
Entry removed due to split (See entry ID: 107831 and 107832) Jan-20
Entry removed from the EURD list since product containing this active
Feb-19
substance is authorised only in one MS
Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS
Entry to be removed: no products authorised in Art.57.
The last product which was authorised, Virazole in Spain, was Dec-18
withdrawn on 19/10/2018.
Entry to be removed: no products authorised , as the CAP Ionsys
Dec-18
belonging to the procedure has now been withdrawn.
Entry removed from the EURD list since products containing this
Nov-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Nov-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Nov-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Oct-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Oct-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Oct-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Oct-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Oct-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list since products containing this
Sep-18
active substance are authorised only in one MS
Entry removed from the EURD list due to splitting existing entry into
two separate entries: alitretinoin (cutaneous use) and alitretinoin Sep-18
(oral use)
Entry removed from the EURD list due to procedure scope change
and merging with "rabbit anti-humanT-lymphocyte immunoglobulin
Sep-18
(concentrate for solution for infusion)" entry. New entry: "rabbit anti-
humanT-lymphocyte immunoglobulin".
Entry to be removed since no products have been identified
Jul-18
containing this active substance
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only products in one MS
Jul-18
identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only products in one MS
Jul-18
identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only products in one MS
Jul-18
identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only products in one MS
Jul-18
identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.
Entry to be removed from the EURD list since only products in one MS
Jul-18
identified containing this combination of active substances.
Entry to be removed from the EURD list since only products in one MS
Jul-18
identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
May-18
MS identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
May-18
Removal fromMS identified
EURD listcontaining this active
following merge. substance.
Entry: "coal tar, distilled
coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar /
salicylic acid, coal tar solution / salicylic acid / sulfur, coal tar /
May-18
salicylic acid, coal tar / menthol, coal tar solution / salicylic acid /
benzalkonium chloride solution / polyoxyethylene 4 lauryl ether /
polyoxyethylene 23 lauryl
Entry to be removed ether"
since no to be followed
products have (PSUSA/00010684)
been identified
May-18
containing this active substance
Entry to be removed from the EURD list since only one product in one
Jan-18
MS identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Jan-18
MS identified containing this active substances.
Entry to be removed from the EURD list since only one product in one
Jan-18
MS identified containing this active substances.
Entry to be removed from the EURD list since only one product in one
Jan-18
MS identified containing this active substances.
Removal from EURD list following merge: Entry: "menthol / methyl
salicylate / camphor, menthol / methyl salicylate" to be followed Jan-18
(PSUSA/00010658)
Removal from EURD list following merge: Entry: "menthol / methyl
salicylate / camphor, menthol / methyl salicylate" to be followed Jan-18
(PSUSA/00010658)
Entry should be removed as the Marketing Authorisation has been
Dec-17
withdrawn on 2nd June 2017.
Entry to be removed from the EURD list since only one product in one
Dec-17
MS identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Nov-17
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Nov-17
MS identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Nov-17
MS identified containing this combination of active substances.
Removal from EURD list following merge: Entry: "triglyceride
combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without
Nov-17
mineral compounds/electrolytes (i.v. application)" to be followed
(PSUSA/00010648)
Removal from EURD list following merge: Entry: "clodronic acid,
Nov-17
clodronic acid / lidocaine" to be followed (PSUSA/00010650)
Entry to be removed from the EURD list since only one product in one
Oct-17
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Oct-17
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Sep-17
MS identified containing this active substance.
Entry to be removed from the EURD list since only one product in one
Sep-17
MS identified containing this active substance.
Removal from EURD list following merge: Entry: "zinc oxide, zinc
Sep-17
oxide/calamine" to be followed (PSUSA/00010632)
Entry to be removed from the EURD list since only one product in one
Jul-17
MS identified containing this combination of active substances.
Entry to be removed. The products of this entry will fall into the scope
of the newly introduced entry "human plasma proteins with not less Jul-17
than 95% albumin".
Entry to be removed. The products of this entry will fall into the scope
of the newly introduced entry "human plasma proteins with not less Jul-17
than 95% albumin".
Product withdrawn on 21 June 2012, therefore entry should be
Jul-17
removed.
Entry to be removed from the EURD list since only one product in one
Jun-17
MS identified containing this combination of active substances.
Entry to be removed from the EURD list since only one product in one
Jun-17
MS identified containing this combination of active substances.
New entry was created by merging 'sulfametrole / trimethoprim,
sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim
May-17
(co-trimoxazole), therefore entry for “'sulfametrole / trimethoprim,
sulfadiazine / trimethoprim” should be deleted.
Product withdrawn on 24.02.2016, therefore entry is removed. May-17
The entry removed from the list as a duplicate (to 1694 'hydroxyethyl
May-17
starch').
Entry to be removed from the EURD list since only one product in one
Mar-17
MS identified containing this combination of active substances.
Entry to be removed from the EURD list since this fixed dose
Mar-17
combination is authorised only in one Member State.
Entry to be removed from the EURD list since this fixed dose
Mar-17
combination is authorised only in one Member State.
Entry to be removed from the EURD list since products with this
Mar-17
active substance are authorised only in one Member State.
Entry to be removed from the EURD list since products with this
Mar-17
active substance are authorised only in one Member State.
Entry to be removed from the EURD list since only one WEU product
Mar-17
is authorised in only one Member State.
Entry to be removed from the EURD list since products with this
Mar-17
active substance are authorised only in one Member State.
Entry to be removed from the EURD list since products with this
Mar-17
active substance are authorised only in one Member State.
Entry removed from the list due to withdrawal of the product. Feb-17
Entry to be removed from the EURD list since only one product
Dec-16
authorised in 1 MS has been identified.
Removal from EURD list: olanzapine and olanzapine pamoate entries
were merged. New entry to be followed: "olanzapine" Dec-16
(PSUSA/0010540)
Removal from EURD list: olanzapine and olanzapine pamoate entries
Dec-16
were merged. Entry to be followed: "olanzapine" (PSUSA/0010540)
Removal from EURD list: New entry: coconut oil / distilled coal tar /
salicylic acid, coal tar solution / salicylic acid / sulfur to be followed Dec-16
(PSUSA/00010548)
Entry to be removed from the EURD list since only one product
Dec-16
authorised in 1 MS has been identified.
Removal from the EURD List: New entry "'lactic acid / urea, urea" to
Dec-16
be followed (PSUSA/00010536)
Entry to be removed from the EURD list since only one product
Oct-16
authorised in 1 MS has been identified.
Entry removed and merged with diphenhydramine, diphenhydramine
hydrochloride / levomenthol. Entry to be followed: "diphenhydramine,
ammonium chloride / diphenhydramine hydrochloride, Oct-16
diphenhydramine hydrochloride / levomenthol, ammonium chloride /
diphenhydramine hydrochloride / levomenthol"
Entry to be removed since no products have been identified
Oct-16
containing this active substance combination.
Entry removed from the EURD List following the merging with another
Jun-16
combination of active substances
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in any combination including one or more of the following:
multivitamins, minerals, aminoacids, herbal extracts, lecithine Jul-14
(except for combinations with folic acid)to be followed
Entry iron in any combination including one or more of the following:
multivitamins, minerals, aminoacids, herbal extracts, lecithine Jul-14
(except for combinations with folic acid)to be followed
Entry iron in any combination including one or more of the following:
multivitamins, minerals, aminoacids, herbal extracts, lecithine Jul-14
(except for combinations with folic acid)to be followed
Entry calcium folinate, iron succinyl-protein complex in the EURD list
Jul-14
to be followed
Entry iron in any combination including one or more of the following:
multivitamins, minerals, aminoacids, herbal extracts, lecithine Jul-14
(except for combinations with folic acid)to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed
Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed