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List European Union Reference Dates Eurd Frequency Submission Periodic Safety Update Reports Psurs - en

The document outlines changes to the presentation of active substances and combinations in the European Union, effective from October 29, 2015. It specifies the use of slashes and commas to denote different active substances and the assessment of periodic safety update reports (PSURs). Additionally, it includes a list of Union reference dates and submission frequencies for PSURs, detailing various active substances and their respective timelines.

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0% found this document useful (0 votes)
322 views223 pages

List European Union Reference Dates Eurd Frequency Submission Periodic Safety Update Reports Psurs - en

The document outlines changes to the presentation of active substances and combinations in the European Union, effective from October 29, 2015. It specifies the use of slashes and commas to denote different active substances and the assessment of periodic safety update reports (PSURs). Additionally, it includes a list of Union reference dates and submission frequencies for PSURs, detailing various active substances and their respective timelines.

Uploaded by

heba.emco
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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An agency of the European Union

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)

Lead MS and PRAC Rapporteur name added on 18/10/2023


2 calcium chloride / histidine / magnesium chloride / manni 24/11/1989 6 years 31/01/2030 01/05/2030 No 28/06/2023 PSUSA/00000002/203001 Jean-Michel Dogné Belgium NAP
New entry added on 28/06/2023

PSUR frequency amended and


4 131i-6-iodo-norcholesterol 21/06/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00000004/202901 NAP
DLP updated on 28/08/2024
(3s,10s,14s)-1-[4-[[(2s)-4-carboxy-2-[(2s)-4-carboxy-2-
(6-[18f] fluoropyridin-3-amido) butanamido]
5 butanamido]methyl]phenyl]-3-[(naphthalen-2- 09/12/2021 3 years 08/12/2027 07/03/2028 No 28/06/2023 New entry added on 28/06/2023 PSUSA/00000005/202712 not yet assigned none NAP
YL)methyl]-1,4,12-trioxo-2,5,11,13-
tetraazahexadecane-10,14,16-tricarboxylic acid
6 ¹³C-urea, ¹4C-urea 14/08/1997 5 years 15/01/2028 14/04/2028 No 20/09/2023 DLP and PSUR on
DLP amended frequency were
20/09/2023 PSUSA/00000006/202801 Jan Neuhauser Austria CAP NAP
updated on 02/02/2022

PRAC representative was


7 5 fluorouracil (IV use) 16/12/1977 3 years 16/12/2026 16/03/2027 Yes 25/09/2024 DLP was on
updated amended on 25/09/2024
22/12/2021 PSUSA/00000007/202612 Martin Huber Germany NAP

PRAC representative was


updated on 06/05/2020
8 5 fluorouracil / salicylic acid 25/05/1994 5 years 25/05/2026 23/08/2026 No 02/02/2022 PSUSA/00000008/202605 Anna Mareková Slovakia NAP
DLP was updated on 06/02/2019

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

Lead MS was added on


10 abacavir 29/06/1998 3 years 31/12/2025 31/03/2026 Yes 19/09/2024 06/03/2015 PSUSA/00000010/202512 Zoubida Amimour France CAP NAP

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

PRAC Rapporteur name was


18 acebutolol 16/12/1974 8 years 16/12/2030 16/03/2031 No 15/01/2025 PSUSA/00000018/203012 Eva Jirsova Czech Republic NAP
amended on 18/10/2023

PSUR frequency amended and


22 aceclofenac 19/03/1990 5 years 31/03/2028 29/06/2028 No 20/12/2023 PSUSA/00000022/202803 Melinda Palfi Hungary NAP
DLP updated on 20/12/2023
PSUR frequency amended and
sirolimus (indicated for treatment of angiofibroma DLP updated on 18/12/2024
25 15/05/2023 1 year 14/11/2024 23/01/2025 14/05/2025 23/07/2025 No 18/12/2024 PSUSA/00000025/202411 PSUSA/00000025/202505 Mari Thorn Sweden CAP NAP
associated with tuberous sclerosis complex)
DLP was amended on 03/07/2024

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

PSUR frequency and DLP


30 acetic acid Not available* 8 years 03/11/2025 01/02/2026 No 16/01/2025 PSUSA/00000030/202511 Georgia Gkegka Greece NAP
amended on 31/07/2024

respiratory syncytial virus, glycoprotein f,


31 recombinant, stabilised in the pre-fusion conformation, 03/05/2023 6 months 02/11/2024 11/01/2025 02/05/2025 11/07/2025 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000031/202411 PSUSA/00000031/202505 Maria del Pilar Rayon Spain CAP
adjuvanted with as01e

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

34 acetylcysteine 14/09/1963 5 years 13/09/2028 12/12/2028 No 05/06/2024 DLP was amended


DLP was updated on
on19/10/2022
05/06/2024 PSUSA/00000034/202809 Adam Przybylkowski Poland NAP
PRAC representative was
updated on 06/05/2020
39 acetylsalicylic acid 17/10/1942 8 years 01/02/2030 02/05/2030 No 28/06/2023 PSUSA/00000039/203002 Melinda Palfi Hungary NAP
DLP was updated on 23/10/2019

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

Lead MS was added on


41 acetylsalicylic acid / caffeine Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 31/07/2015 PSUSA/00000041/203001 NAP

© 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

PSUR frequency amended and Marie Louise Schougaard


48 aciclovir 10/06/1981 3 years 09/06/2027 07/09/2027 No 05/02/2025 PSUSA/00000048/202706
Christiansen Denmark NAP
DLP updated on 05/02/2025

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

PRAC Rapporteur name was


50 acipimox 05/05/1984 5 years 05/05/2026 03/08/2026 No 16/10/2023 PSUSA/00000050/202605 Karin Erneholm Denmark NAP
amended on 18/10/2023

Marie Louise Schougaard


51 acitretin 01/12/1987 1 year 30/10/2024 08/01/2025 30/10/2025 08/01/2026 Yes 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000051/202410 PSUSA/00000051/202510
Christiansen Denmark NAP

Active substance name, PSUR


54 acrivastine, acrivastine / pseudoephedrine 31/12/1990 7 years 02/12/2024 02/03/2025 No 26/07/2023 frequency and DLP were PSUSA/00000054/202412 Terhi Lehtinen Finland NAP
DLP was updated on 03/04/2019
amended on 26/07/2023
PRAC Rapporteur name updated
58 adapalene 03/07/1992 8 years 31/07/2026 29/10/2026 No 03/04/2019 on 23/10/2018 PSUSA/00000058/202607 Eamon O'Murchu Ireland NAP

PRAC Representative and Lead


MS were added on 19/12/2017
59 adapalene / benzoyl peroxide 30/09/2007 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00000059/202609 Karin Bolin Sweden NAP

DLP was amended on 03/05/2023


PSUR frequency and DLP
61 ademetionine 28/04/1993 8 years 03/08/2025 01/11/2025 No 30/10/2024 PSUSA/00000061/202508 Amelia Cupelli Italy NAP
amended on 31/07/2024
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
62 adenosine 14/08/1991 5 years 14/08/2027 12/11/2027 No 03/05/2023 PSUSA/00000062/202708 Adam Przybylkowski Poland NAP
DLP was updated on 07/05/2018

PRAC representative and Lead


66 sodium thiosulfate 20/09/2022 6 months 19/09/2024 28/11/2024 19/03/2025 28/05/2025 No 30/04/2024 Member
DLP was State wereon
amended added on
30/04/2024 PSUSA/00000066/202409 PSUSA/00000066/202503 Karin Erneholm Denmark CAP
DLP was updated on 30/03/2022
30/01/2017

Active substance name updated


67 glofitamab 24/03/2023 6 months 23/09/2024 02/12/2024 23/03/2025 01/06/2025 No 20/11/2024 DLP02/03/2022
on was amended on 20/11/2024 PSUSA/00000067/202409 PSUSA/00000067/202503 Jana Lukacisinova Czech Republic CAP

PRAC representative was


68 futibatinib 30/09/2022 6 months 29/09/2024 08/12/2024 29/03/2025 07/06/2025 No 20/11/2024 updated
DLP was on 04/03/2020
amended on 20/11/2024 PSUSA/00000068/202409 PSUSA/00000068/202503 Mari Thorn Sweden CAP
DLP was updated on 05/04/2023
DLP was updated on 03/04/2019
DLP was updated on 20/10/2021
DLP was updated on 01/04/2020
69 agalsidase alfa 03/08/2001 3 years 03/08/2024 01/11/2024 No 30/03/2022 PRAC Rapporteur name was PSUSA/00000069/202408 Liana Martirosyan Netherlands CAP
PSUR Frequency
amended and DLP
on 25/09/2017
PRAC representative was
updated on 26/09/2018
updated on 04/03/2020
PSUR Frequency amended and
70 agalsidase beta 03/08/2001 3 years 31/07/2025 29/10/2025 No 05/04/2023 PRAC Rapporteur
DLP updated name amended
on 04/03/2016
PSUSA/00000070/202507 Liana Martirosyan Netherlands CAP
PRAC Rapporteur name was
on 04/07/2018
amended on 25/09/2017
The DLP was amended on
Next DLP was amended on
71 agomelatine 19/02/2009 5 years 19/02/2029 20/05/2029 No 20/10/2021 06/03/2015
DLP was updated on 28/03/2017 PSUSA/00000071/202902 Pernille Harg Norway CAP
25/09/2017
PSURDLP
The Frequency amended
was amended on and
PRACupdated
DLP Rapporteur
03/03/2014 name was
on 26/04/2017
01/04/2014
72 ajmaline 09/11/1962 10 years 22/08/2026 20/11/2026 No 26/04/2017 amended on 20/12/2016 PSUSA/00000072/202608 Martin Huber Germany NAP
Entrywas
DLP restored to the
updated list on
on 03/03/2021
Next DLP was updated on
20/12/2016
22/09/2016
Next DLP was amended on
73 albendazole 10/07/1981 5 years 10/07/2025 08/10/2025 No 03/03/2021 PSUSA/00000073/202507 Adam Przybylkowski Poland NAP
07/04/2016
DLP updated on 06/10/2015
Lead MS added on 01/04/2015
74 mavacamten 28/04/2022 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/00000074/202410 PSUSA/00000074/202504 Kimmo Jaakkola Finland CAP

75 alclometasone 03/06/1987 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000075/203001 NAP

PRAC representative updated on


76 aldesleukin 03/07/1989 7 years 31/12/2029 31/03/2030 No 31/01/2024 PSUSA/00000076/202912 Bianca Mulder Netherlands NAP
31/01/2024

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

Next DLP was amended on


03/06/2016
Next DLP was updated on
84 alfuzosin 12/11/1987 5 years 12/11/2027 10/02/2028 No 26/07/2023 PSUSA/00000084/202711 Karin Bolin Sweden NAP
26/07/2023
Lead MS updated
DLP was added onon12/05/2015
29/06/2022
Active substance name was
potassium chloride / sodium chloride / magnesium
amended on 26/07/2023
85 chloride / sodium acetate / sodium gluconate and/or 22/03/1971 20 years 02/09/2044 01/12/2044 Yes 26/07/2023 PRAC representative was PSUSA/00000085/204409 not yet assigned none NAP
glucose updated onadded
17/11/2021
New entry on 26/07/2023

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

PSUR frequency and DLP


98 alminoprofen Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUSA/00000098/203505 NAP
amended on 23/10/2024

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

PSUR frequency amended and


101 almotriptan 23/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 PSUSA/00000101/202806 Maria del Pilar Rayon Spain NAP
DLP updated on 28/02/2024

respiratory syncytial virus vaccine (bivalent,


102 31/05/2023 6 months 30/11/2024 08/02/2025 30/05/2025 08/08/2025 No 05/02/2025 DLP was
DLP was amended on16/11/2022
updated on 05/02/2025 PSUSA/00000102/202411 PSUSA/00000102/202505 Liana Martirosyan Netherlands CAP
recombinant)

PRAC representative was


104 alfa amylase 06/06/1967 10 years 01/01/2032 31/03/2032 No 19/09/2024 updated on 29/07/2020 PSUSA/00000104/203201 Zoubida Amimour France NAP
PRAC Rapporteur name was
amended on 28/04/2022
DLP was updated on 20/11/2019
New was
DLP CAP updated
authorised
on on
23/09/2020
107 epcoritamab 22/09/2023 6 months 21/09/2024 30/11/2024 21/03/2025 30/05/2025 No 18/10/2023 PRAC Representative updated on PSUSA/00000107/202409 PSUSA/00000107/202503 Monica Martinez Redondo Spain CAP
22/09/2023
26/09/2018
PRAC Rapporteur name was
amended on 03/04/2019
human alfa1-proteinase inhibitor (apart from the PRAC Rapporteur name updated Marie Louise Schougaard
108 21/03/2006 5 years 31/12/2024 31/03/2025 No 23/09/2020 PSUSA/00000108/202412
Christiansen Denmark NAP
centrally authorised product) on 21/07/2017
Entry name amended on
03/05/2016
Next DLP was updated on
109 alprazolam 12/03/1980 3 years 11/03/2025 09/06/2025 No 16/11/2022 18/11/2016
DLP updated on 06/10/2015
PSUSA/00000109/202503 Tiphaine Vaillant France NAP
DLP was
PSUR updatedamended
frequency on 20/10/2021
and
PRACupdated
DLP Rapporteur05/04/2023
name updated
Lead MS was onadded on
on 21/07/2017
Next DLP was amended on
110 alprostadil (erectile dysfunction) 23/07/1981 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 22/12/2014 PSUSA/00000110/202601 Eva Jirsová Czech Republic NAP
19/10/2016
DLP and information included in
PRAC Rapporteur
column "Are PSURs name was for
required
amended
Lead
products on 28/07/2016
MS added onto
referred 31/07/2015.
in Articles
alprostadil (indicated in peripheral arterial occlusive
111 28/11/1984 8 years 31/07/2030 29/10/2030 No 05/04/2023 10(1), 10a, 14, 16a of Directive PSUSA/00000111/203007 Eva Jirsová Czech Republic NAP
diseases) Leadwas
MS updated
wasasadded
2001/83/EC
DLP on on
amended?" were
01/02/2023
06/10/2015
updated on 07/05/2018
DLP was amended on 31/01/2018
112 alteplase 06/06/1987 5 years 31/05/2027 29/08/2027 No 01/02/2023 "Are
PRACPSURs required for
representative andproducts
Lead
PSUSA/00000112/202705 Martin Huber Germany NAP
referred
Member
Lead to in
MS State Articles 10(1),
wereRapporteur
and PRAC added on 10a,
14, 16a of Directive
30/01/2017
name was added on 2001/83/EC"
19/10/2016
PSUR frequency
was amended onamended
06/03/2015 and
115 aluminium Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00000115/202903 NAP
DLP updated on 28/08/2024

cabotegravir (for pre-exposure prophylaxis of HIV-1 New CAP authorised on


116 18/03/2020 6 months 17/09/2024 26/11/2024 17/03/2025 26/05/2025 No 18/10/2023 PSUSA/00000116/202409 PSUSA/00000116/202503 Martin Huber Germany CAP
infection) 22/09/2023

Marie Louise Schougaard


118 decitabine / cedazuridine 06/07/2020 6 months 06/07/2024 14/09/2024 06/01/2025 17/03/2025 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000118/202407 PSUSA/00000118/202501
Christiansen Denmark CAP

PSUR frequency and DLP


119 aluminium chlorhydroxide-complex Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUSA/00000119/203505 none NAP
amended on 23/10/2024

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

aluminium oxide hydrated / magnesium hydroxide / PSUR frequency amended and


122 Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00000122/202903 NAP
monmectite DLP updated on 28/08/2024

alginic acid / aluminium oxide hydrated / sodium


123 hydrogen carbonate, alginic acid / aluminium Not available* 7 years 03/06/2031 01/09/2031 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000123/203106 Terhi Lehtinen Finland NAP
hydroxide / calcium carbonate / sodium carbonate

PRAC Rapporteur updated on


124 alverine 10/02/1950 10 years 01/02/2032 01/05/2032 No 15/11/2023 PSUSA/00000124/203202 Petar Mas Croatia NAP
15/11/2023

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

126 amantadine 14/12/1965 6 years 01/01/2030 01/04/2030 No 25/09/2024 Information included


DLP was amended onin column
25/09/2024 PSUSA/00000126/203001 Martin Huber Germany NAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
127 ambazone Not available* 7 years 03/06/2031 01/09/2031 Yes 18/12/2024 as amended?" was amended on PSUSA/00000127/203106 Roxana Dondera Romania NAP
18/12/2024
PSUR frequency amended and
DLP updated on 31/05/2023
PSUR frequency and DLP
128 ambenonium 14/12/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUSA/00000128/203710 NAP
amended
DLP 28/02/2024
on 23/10/2024
was updated on 03/06/2020

Next DLP was amended on


129 ambrisentan 21/04/2008 3 years 14/06/2026 12/09/2026 No 28/02/2024 DLP was amended on 28/02/2024
27/06/2017 PSUSA/00000129/202606 Maria del Pilar Rayon Spain CAP
PSUR frequency amended and
DLP updated on 31/05/2023
Correction of PRAC Rapporteur
name on 28/02/2017
130 ambroxol 23/08/1978 5 years 30/09/2027 29/12/2027 No 31/05/2023 DLP was updated on 03/06/2020 PSUSA/00000130/202709 Ana Sofia Diniz Martins Portugal NAP
PRAC Rapporteur name updated
Next DLP was amended on
on 30/01/2017
27/06/2017
131 ambroxol / clenbuterol 27/06/1984 5 years 30/09/2027 29/12/2027 No 31/05/2023 PSUSA/00000131/202709 Ana Sofia Diniz Martins Portugal NAP
PRAC Rapporteur name was
Correction of PRAC Rapporteur
amended on 20/12/2016
name on 28/02/2017
132 gefapixant 20/01/2022 6 months 19/07/2024 27/09/2024 19/01/2025 30/03/2025 No 25/09/2024 DLP was
PRAC amended onand
representative 25/09/2024
Lead PSUSA/00000132/202407 PSUSA/00000132/202501 Jan Neuhauser Austria CAP
PRAC representative and Lead
Member State were added on
Member State were added on
03/05/2016
03/05/2016
133 ritlecitinib 23/06/2023 6 months 22/12/2024 02/03/2025 22/06/2025 31/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000133/202412 PSUSA/00000133/202506 Adam Przybylkowski Poland CAP

PSUR frequency and DLP


135 amcinonide Not available* 10 years 03/05/2035 01/08/2035 No 23/10/2024 PSUSA/00000135/203505 NAP
amended on 23/10/2024
03/02/2021
DLP was updated on 21/09/2022

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

PSUR frequency amended and


159 aminocaproic acid Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00000159/202903 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


163 aminomethylbenzoic acid 17/09/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00000163/203409 NAP
amended on 23/10/2024

164 aminophylline 24/02/1963 14 years 01/01/2026 01/04/2026 No 01/10/2012 PSUSA/00000164/202601 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

Next DLP was amended on


02/07/2014
183 ichthammol Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 PSUSA/00000183/202801 NAP
Correction of the DLP was done
on the 01/04/2014
184 ammonium chloride, ammonium chloride combinations Not available* 16 years 01/01/2028 31/03/2028 No 01/10/2012 DLP was updated on 01/03/2023 PSUSA/00000184/202801 NAP
Next DLP was amended on
PRAC representative was
29/11/2013
updated on 06/05/2020
185 amorolfine 10/06/1991 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUSA/00000185/202706 Melinda Palfi Hungary NAP
27/03/2018
DLP was updated on 16/11/2022

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

DLP was updated


Information on 21/11/2018
included in column
197 ampicillin / sulbactam 24/02/1987 3 years 28/02/2027 29/05/2027 No 19/10/2022 PSUSA/00000197/202702 Amelia Cupelli Italy NAP
"Are PSURs required for products
PRAC Rapporteur
referred name
to in Articles amended
10(1), 10a,
on 04/07/2018
14, 16a of Directive 2001/83/EC
199 amsacrine 23/04/1982 5 years 01/06/2029 30/08/2029 Yes 23/10/2024 as amended?" was amended on PSUSA/00000199/202906 Bianca Mulder Netherlands NAP
PRAC Rapporteur name
23/10/2024
amended.
enalapril maleate (centrally authorised product for use PRAC representative updated on
201 15/11/2023 1 year 31/03/2025 09/06/2025 31/03/2026 09/06/2026 No 20/11/2024 DLP was
PRAC amendedname
Rapporteur
31/01/2024
on 20/11/2024 PSUSA/00000201/202503 PSUSA/00000201/202603 Mari Thorn Sweden CAP
in children below the age of 18)
amended.

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

Lead MS added on 04/02/2015

© 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

Correction: Information included


in column "Are PSURs required
for products referred to in
Articles 10(1), 10a, 14, 16a of
Directive 2001/83/EC as
amended?" was amended on
21/10/2022

PSUR frequency and DLP were


updated on 28/04/2021
203 amylmetacresol / dichlorobenzyl alcohol 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000203/203001 NAP
PRAC representative was
updated on 29/07/2020
PSUR frequency amended and
204 amylmetacresol / ascorbic acid / dichlorobenzyl alcohol Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00000204/202903 NAP
DLP updated
PRAC on 28/08/2024
representative was
updated on 03/06/2020
DLP was updated on 01/02/2023
205 amylmetacresol / dichlorobenzyl alcohol / levomenthol 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 DLP was updated on 06/05/2020 PSUSA/00000205/203001 NAP
PRAC representative was
DLP was on
updated updated on 30/04/2019
31/03/2021
206 amylmetacresol / dichlorobenzyl alcohol / lidocaine 01/09/1958 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000206/203001 NAP
DLP was updated on and18/12/2019
information included in column
"Are PSURs
PRAC required for
representative wasproducts
208 anagrelide 16/11/2004 5 years 13/09/2027 12/12/2027 No 31/05/2023 referred
updated to
onin Articles 10(1), 10a,
25/09/2019 PSUSA/00000208/202709 Tiphaine Vaillant France CAP NAP
14, 16a of Directive 2001/83/EC
as amended?"
PRAC wasname
Rapporteur updated
was on
07/05/2018
corrected on 03/04/2019
209 anakinra 08/03/2002 3 years 01/05/2025 30/07/2025 No 01/02/2023 PSUSA/00000209/202505 Karin Erneholm Denmark CAP
updated
PRAC Rapporteur name was
on 21/07/2017
amended on 06/06/2018
210 anastrozole 11/08/1995 1 year 11/08/2024 20/10/2024 11/08/2025 20/10/2025 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000210/202408 PSUSA/00000210/202508 Zane Neikena Latvia NAP
Next DLP
PRAC was amended
Representative on
amended
26/04/2017
on 17/10/2017
213 anethole trithione Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 DLP
PRACand
Next DLP Information
Rapporteur included
name
was amended was
on in PSUSA/00000213/204001 NAP
column
amended "Are
20/12/2016 on PSURs required for
28/07/2016
products referred to in Articles
214 adagrasib 12/12/2022 6 months 11/12/2024 19/02/2025 11/06/2025 20/08/2025 No 05/02/2025 10(1),
PRAC
The
DLP DLP10a,
was was14,
Rapporteur
amended16a of 05/02/2025
name
amended
on Directive
updated
on PSUSA/00000214/202412 PSUSA/00000214/202506 Kimmo Jaakkola Finland CAP
2001/83/EC
on 03/06/2016
08/01/2014 as amended?" were
updated on 19/10/2022
Next DLP was amended on
215 anidulafungin 20/09/2007 5 years 31/01/2027 01/05/2027 No 19/10/2022 PRAC Rapporteur name was
03/05/2016 PSUSA/00000215/202701 Liana Martirosyan Netherlands CAP NAP
amended on 23/10/2018
"Are PSURs required for products
PSUR Frequency
referred amended
to in Articles 10(1),and
10a,
216 rozanolixizumab 26/06/2023 6 months 25/12/2024 05/03/2025 25/06/2025 03/09/2025 No 05/02/2025 DLP was amended on 05/02/2025
DLP updated on 17/10/2017
PSUSA/00000216/202412 PSUSA/00000216/202506 Maria del Pilar Rayon Spain CAP
14, 16a of Directive 2001/83/EC
as amended? Yes/No" was
PRAC Rapporteur
amended name was
on 16/07/2015
217 antazoline Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 amended on 25/09/2017 PSUSA/00000217/203501 NAP
Rapporteur name amended on
04/11/2014
PSUR frequency and DLP
218 antazoline / naphazoline 01/06/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00000218/203906 NAP
amended on 23/10/2024

PSUR frequency and DLP


219 antazoline / tetryzoline 03/10/1972 10 years 01/12/2024 01/03/2025 No 05/01/2025 PSUSA/00000219/202412 John Joseph Borg Malta NAP
amended on 23/10/2024

PSUR frequency and DLP


220 antazoline / xylometazoline 01/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUSA/00000220/203912 NAP
amended on 23/10/2024

New CAP authorised on


221 rezafungin 22/03/2023 6 months 21/09/2024 30/11/2024 21/03/2025 30/05/2025 No 31/01/2024 PSUSA/00000221/202409 PSUSA/00000221/202503 Adam Przybylkowski Poland CAP
22/12/2024

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

229 aprepitant 25/03/2003 5 years 25/03/2029 23/06/2029 No 20/11/2024 PRAC Rapporteur


DLP was amendedname was
on 20/11/2024 PSUSA/00000229/202903 Mari Thorn Sweden CAP NAP
amended on 03/04/2019

DLP was updated on 21/11/2018


Marie Louise Schougaard
230 aprotinin Not available* 2 years 28/02/2026 29/05/2026 No 16/11/2022 PSUSA/00000230/202602
Christiansen Denmark NAP
PSUR Frequency amended and
DLP updated on 18/11/2016
231 fezolinetant 12/05/2023 6 months 11/11/2024 20/01/2025 11/05/2025 20/07/2025 No 18/12/2024 DLP was amended on 18/12/2024
Lead MS and PRAC Rapporteur
PSUSA/00000231/202411 PSUSA/00000231/202505 Martin Huber Germany CAP
name was added on 07/04/2016
Correction of DLP on 18/12/2024
232 gadopiclenol 21/09/2022 2 years 30/04/2025 29/07/2025 No 18/12/2024 The DLP was amended on PSUSA/00000232/202504 Martin Huber Germany CAP
New CAP authorised on
27/11/2015.
07/12/2023
arginine hydrochloride / cyanocobalamin / The DLP
PSUR was amended
frequency on and
amended
233 Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 02/07/2014 PSUSA/00000233/202903 NAP
cyproheptadine hydrochloride / levocarnitine DLP updated on 28/08/2024

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

PSUR frequency amended and


235 arsenic trioxide 05/03/2002 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUSA/00000235/202809 Tiphaine Vaillant France CAP
DLP updated on 05/06/2024

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

238 articaine 29/04/1975 20 years 01/01/2032 31/03/2032 No 01/10/2012 PSUSA/00000238/203201 NAP

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

acetylsalicylic acid / ascorbic acid, acetylsalicylic acid /


241 28/07/1972 23 years 04/02/2035 05/05/2035 No 23/10/2024 PSUSA/00000241/203502 none NAP
citric acid / sodium hydrogen carbonate

242 acetylsalicylic acid / ascorbic acid / bioflavonoids Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000242/203501 NAP

acetylsalicylic acid / ascorbic acid / codeine phosphate


243 Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000243/203501 NAP
hemihydrate

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

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# 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

alfatocopherol acetate / ascorbic acid / ergocalciferol /


249 Not available* 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000249/203501 NAP
retinol

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

PSUR frequency and DLP was


updated on 03/05/2023
252 acetylsalicylic acid / ascorbic acid / paracetamol 13/12/1985 23 years 01/01/2035 01/04/2035 No 01/10/2012 PSUSA/00000252/203501 NAP
DLP was updated on 05/04/2023

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

DLP was updated on 03/04/2019


ascorbic acid / potassium aspartate / potassium
257 Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000257/204001 NAP
bicarbonate
DLP was updated on 27/03/2018

DLP was updated on 28/03/2017


258 atazanavir 02/03/2004 3 years 19/06/2024 17/09/2024 No 19/09/2024 PSUSA/00000258/202406 Tiphaine Vaillant France CAP
PRAC representative
Next DLP was amendedwason
updated on 22/12/2021
07/04/2016
259 atenolol 19/02/1976 12 years 19/02/2025 20/05/2025 No 28/02/2013 PSUSA/00000259/202502 Terhi Lehtinen Finland NAP
DLP was was
The DLP updated on 03/06/2020
amended on
01/04/2014
PRAC representative was
260 atenolol / chlortalidone 09/09/1997 5 years 09/09/2024 08/12/2024 No 03/06/2020 updated on 06/05/2020 PSUSA/00000260/202409 Anna Mareková Slovakia NAP
PRAC representative was
updated on 19/10/2022
PRAC representative was added
on 21/11/2018
262 atomoxetine 26/11/2002 5 years 26/11/2028 24/02/2029 No 31/07/2024 DLP was
PRAC amended onwas
representative 31/07/2024 PSUSA/00000262/202811 Maria del Pilar Rayon Spain NAP
updated
Lead MS on
was17/11/2021
added on
DLP corrected on 27/03/2024
06/03/2015
263 momelotinib 15/09/2023 6 months 14/09/2024 23/11/2024 14/03/2025 23/05/2025 No 27/03/2024 DLP was updated on 20/10/2021 PSUSA/00000263/202409 PSUSA/00000263/202503 Mari Thorn Sweden CAP
New CAP authorised on
25/01/2024
PRAC representative was
updated on 25/09/2019
264 atosiban 20/01/2000 5 years 31/01/2029 01/05/2029 No 19/10/2022 PSUSA/00000264/202901 Amelia Cupelli Italy CAP NAP
DLP was updated on 23/10/2018
Next DLP was updated on
Reference to NAP added on
28/06/2023
265 atovaquone 25/11/1992 13 years 30/11/2027 28/02/2028 No 19/09/2024
25/09/2017
PSUSA/00000265/202711 Zoubida Amimour France NAP
Lead MS and PRAC Rapporteur
Next DLP
name was amended
amended on
on 19/12/2018
266 atovaquone / proguanil 21/10/1996 5 years 31/10/2027 29/01/2028 No 28/06/2023 29/10/2015 PSUSA/00000266/202710 Ana Sofia Diniz Martins Portugal NAP
DLP was updated on 04/07/2018
PRAC Rapporteur name amended
on
PRAC representative and Lead
267 atracurium 16/12/1982 10 years 16/12/2032 16/03/2033 No 20/09/2023 DLP amended on 20/09/2023
Member State were added on
PSUSA/00000267/203212 Martin Huber Germany NAP
28/03/2017

268 atropine 31/08/1945 14 years 31/08/2026 29/11/2026 No 01/10/2012 PSUSA/00000268/202608 NAP

269 atropine / diphenoxylate 29/09/1960 14 years 01/01/2026 01/04/2026 No 01/10/2012 PSUSA/00000269/202601 NAP

atropine sulfate / hyoscine hydrobromide /


270 Not available* 14 years 01/01/2026 01/04/2026 No 01/10/2012 PSUSA/00000270/202601 NAP
hyoscyamine sulfate / phenobarbital
PRAC Rapporteur name was
amended on 18/10/2023
273 etrasimod 12/10/2023 6 months 11/10/2024 20/12/2024 11/04/2025 20/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00000273/202410 PSUSA/00000273/202504 Karin Bolin Sweden CAP
Reference to CAP added on
28/07/2021
PSUR frequency amended and
274 azacitidine 17/12/2008 5 years 18/05/2029 16/08/2029 No 05/02/2025 New CAP authorised on PSUSA/00000274/202905 Bianca Mulder Netherlands CAP
DLP updated on 05/02/2025
21/06/2021

DLP was updated on 31/07/2019


275 azathioprine 13/12/1965 6 years 12/12/2024 12/03/2025 Yes 31/07/2019 PSUSA/00000275/202412 Karin Erneholm Denmark CAP NAP
PRAC Rapporteur name was
amended on 21/11/2018
PSUR frequency amended and
276 azelaic acid 27/10/1988 8 years 03/06/2025 01/09/2025 No 03/07/2024 PSUSA/00000276/202506 Jan Neuhauser Austria NAP
DLP updated on 03/07/2024
PRAC Representative and Lead
Member state assigned on
04/07/2018
277 azelastine 20/11/1990 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00000277/202612 Jan Neuhauser Austria NAP
PRAC Rapporteur name updated
on 05/11/2018
azilsartan medoxomil, azilsartan
280 07/12/2011 3 years 24/08/2026 22/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000280/202608 Bianca Mulder Netherlands CAP NAP
medoxomil/chlortalidone

hydroxyethyl salicylate / mephenesin / methyl


282 19/07/2003 10 years 19/07/2035 17/10/2035 Yes 30/04/2024 New entry added on 30/04/2024 PSUSA/00000282/203507 none none NAP
nicotinate

PSUR frequency amended and


283 aztreonam (inhalation use) 21/09/2009 5 years 11/09/2028 10/12/2028 No 05/06/2024 PSUSA/00000283/202809 Liana Martirosyan Netherlands CAP
DLP updated on 05/06/2024

PSUR frequency amended and


284 bacillus clausii multi-antibioresistant spores 03/11/1978 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUSA/00000284/202711 Amelia Cupelli Italy NAP
DLP updated on 26/07/2023
bacitracin, bacitracin / neomycin, bacitracin /
Active substance name, PSUR
polymyxin, bacitracin / neomycin / polymyxin,
285 02/04/1962 9 years 03/05/2029 01/08/2029 No 20/12/2023 frequency and DLP were PSUSA/00000285/202905 none NAP
bacitracin / hydrocortisone / neomyicin, bacitracin
amended on 20/12/2023
zinc / cysteine / glycine / neomycin/ threonine
Active substance name and DLP
286 efbemalenograstim alfa 06/05/2023 6 months 05/11/2024 14/01/2025 05/05/2025 14/07/2025 No 18/12/2024 DLP was
were amended
updated on 18/12/2024
on 20/10/2021 PSUSA/00000286/202411 PSUSA/00000286/202505 Bianca Mulder Netherlands CAP

Next DLP was amended on


19/10/2016
293 baclofen (intrathecal use) 16/01/1963 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 PSUSA/00000293/202601 Adam Przybylkowski Poland NAP
DLP was amended on 06/10/2015

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

Next DLP was updated on


295 bambuterol 07/12/1990 5 years 07/12/2027 06/03/2028 No 26/07/2023 PSUSA/00000295/202712 Jana Lukačišinová Czech Republic NAP
26/07/2023

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# 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

PSUR frequency and DLP


297 bamipine Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00000297/203506 NAP
amended on 23/10/2024

EURD was amended on


299 barium sulphate, barium sulphate combinations 03/07/1973 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000299/204001 NAP
02/07/2014

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

301 basiliximab 09/10/1998 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP


PSURwas amended
frequency onDLP
and 05/02/2025
were PSUSA/00000301/202704 Gabriele Maurer Germany CAP
updated on 01/07/2020

PSUR Frequency amended and


302 bazedoxifene 17/04/2009 5 years 16/10/2024 14/01/2025 No 01/07/2020 PSUSA/00000302/202410 Martin Huber Germany CAP
DLP updated on 23/05/2017

Next DLP was amended on


303 BCG (bacillus calmette-guérin) for Immunotherapy 02/03/1988 5 years 02/03/2028 31/05/2028 No 15/11/2023 03/06/2016
DLP was amended on 15/11/2023 PSUSA/00000303/202803 Gabriele Maurer Germany 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

PRAC representative and Lead


PSUR frequency and DLP
331 bentazepam 01/07/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 Member
Active State were
substance added
name wason PSUSA/00000331/202811 NAP
amended on 31/07/2024
18/11/2016
amended on 23/10/2024

benzalkonium (exluding vaginal use), benzalkonium PSUR frequency


Information amended
included and
in column
332 Not available* 7 years 01/11/2028 30/01/2029 No 23/10/2024 PSUSA/00000332/202811 Amelia Cupelli Italy NAP
chloride / hexylresorcinol DLP updated
"Are on 23/10/2024
PSURs required for products
referred to in Articles 10(1), 10a,
Active
14, 16asubstance name
of Directive changed
2001/83/EC
339 benzalkonium chloride / dequalinium chloride Not available* 9 years 03/06/2029 01/09/2029 Yes 23/10/2024 on amended?"
as 28/04/2022 was amended on PSUSA/00000339/202906 none NAP
23/10/2024
PSUR frequency and DLP
amended on 27/03/2024
benzalkonium chloride / ethyl alcohol, benzalkonium PSUR frequency amended and
342 Not available* 7 years 03/07/2024 01/10/2024 No 27/03/2024
DLP updated on 28/08/2024
PSUSA/00000342/202407 Guðrún Stefánsdóttir Iceland NAP
chloride / isopropyl alcohol
Active substance name was
updated on 25/09/2019
acetylcysteine / tuaminoheptane, acetylcysteine / PSUR frequency amended and
349 01/03/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00000349/202806 Amelia Cupelli Italy NAP
benzalkonium chloride / tuaminoheptane DLP updated on 28/08/2024

PSUR frequency and DLP


354 benzbromarone 15/10/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUSA/00000354/202805 NAP
amended on 31/07/2024

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

benzocaine / hamamelis water / racephedrine


363 Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00000363/203001 NAP
hydrochloride

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

PSUR frequency amended and


372 benzoxonium chloride / lidocaine hydrochloride 17/04/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00000372/202901 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


373 benzoyl peroxide 01/03/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00000373/203212 NAP
amended on 23/10/2024

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# Classified as internal/staff contractors by the Europ Page 7 / 223
PRAC representative was
updated on 27/07/2022

DLP was updated on 29/06/2022

PRAC representative was


updated on 30/06/2021
PRAC representative was
375 benzydamine 10/07/1964 3 years 31/10/2024 29/01/2025 No 27/07/2022 updated on 27/07/2022 PSUSA/00000375/202410 Amelia Cupelli Italy NAP
DLP was updated on 03/07/2019
PRAC representative was
Next DLP was amended on
updated on 30/06/2021
28/07/2016
378 benzydamine / cetylpyridine Not available* 7 years 01/01/2026 01/04/2026 No 27/07/2022 PSUSA/00000378/202601 Amelia Cupelli Italy NAP
DLP was updated on 25/09/2019
PRAC Rapporteur's
Information includedname
in column
amended
"Are PSURsonrequired
27/11/2105.
for products
PRAC Representative and Lead
379 benzylbenzoate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 referred to in Articles 10(1), PSUSA/00000379/203001 NAP
Member state assigned on 10a,
Lead16a
14, MSof
added on 16/06/2015
Directive 2001/83/EC
04/07/2018
as amended?" was amended on
380 benzylnicotinate Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 27/03/2024 PSUSA/00000380/203001 NAP
Active substance name was
benzylpenicillin, benzathine benzylpenicillin, amended on 27/03/2024
383 benzathine benzylpenicillin / lidocaine, procaine 27/06/1952 5 years 15/06/2025 13/09/2025 No 27/03/2024 PSUSA/00000383/202506 Maia Uusküla Estonia NAP
benzylpenicillin DLP
DLP was
was updated
amendedon
on03/03/2021
15/11/2023

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

389 betahistine 16/05/1968 3 years 31/12/2026 31/03/2027 No 25/09/2024 New CAPamended


DLP was authorised
onon
25/09/2024 PSUSA/00000389/202612 Zane Neikena Latvia NAP
05/05/2022

DLP was updated on 21/10/2020


390 betaine anhydrous (centrally authorised product only) 15/02/2007 3 years 28/02/2026 29/05/2026 Yes 15/11/2023 PSUSA/00000390/202602 Martin Huber Germany CAP
PRAC Rapporteur name was
amended
DLP on 31/07/2018
was updated on 22/09/2021
391 betamethasone 25/09/1961 9 years 01/01/2030 01/04/2030 No 22/09/2021
PSUR Frequency amended and
PSUSA/00000391/203001 Eamon O'Murchu Ireland NAP
PRAC representative and LMS
DLP updated
were on01/07/2020
added on 17/10/2017
DLP was updated on 22/09/2021
393 betamethasone dipropionate / calcipotriol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 Next DLP was amended on PSUSA/00000393/203001 Eamon O'Murchu Ireland NAP
PRAC representative and LMS
19/10/2016
LMS was updated on 27/07/2022
were added on 01/07/2020
DLP
DLP amended on 06/10/2015
was updated on 22/09/2021
394 betamethasone dipropionate / clotrimazole Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 PSUSA/00000394/203001 Portugal NAP
Activerepresentative
PRAC substance nameandwas
LMS
DLP was updated
amended onon on 22/09/2021
13/03/2015
were
New added
CAP 01/07/2020
authorised on
395 betamethasone dipropionate / salicylic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 26/07/2024 PSUSA/00000395/203001 Eamon O'Murchu Ireland NAP
PRAC representative and LMS
were added on 01/07/2020
PSUR frequency
DLP was updatedand
on DLP were
22/09/2021
updated on 19/10/2022
397 betamethasone sodium phosphate / neomycin sulfate Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 PSUSA/00000397/203001 Eamon O'Murchu Ireland NAP
PRAC representative and LMS
New
were CAP authorised
updated on
on 01/07/2020
DLP was updated on 22/09/2021
17/08/2022
398 betamethasone valerate / clioquinol Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 PSUSA/00000398/203001 Eamon O'Murchu Ireland NAP
PRACwas
DLP representative and LMS
updated on 20/10/2021
were updated on 01/07/2020
DLP was updated on 22/09/2021
New CAPsupdated
DLP was authorised on
on 01/02/2023
399 betamethasone valerate / fusidic acid Not available* 9 years 01/01/2030 01/04/2030 No 22/09/2021 21/04/2021 PSUSA/00000399/203001 Eamon O'Murchu Ireland NAP
PRAC representative and LMS
were updated
PRAC on 01/07/2020
representative was
New CAPs
updated onauthorised
06/05/2020on
401 betaxolol 10/05/1982 5 years 10/05/2027 08/08/2027 No 01/02/2023 DLP was updated on 03/03/2021
26/03/2021 PSUSA/00000401/202705 Melinda Palfi Hungary NAP
DLP was amended on 31/01/2018
PRAC representative was added
on 06/05/2020
updated
Lead MS on
and31/03/2021
PRAC Rapporteur
402 bethanechol Not available* 5 years 15/06/2025 13/09/2025 No 03/03/2021
name was added on 19/10/2016
PSUSA/00000402/202506 Jan Neuhauser Austria NAP
LMS was
New CAP added on 01/04/2020
authorised on
11/01/2021
PSUR frequency and DLP were
403 bevacizumab 12/01/2005 3 years 25/02/2025 26/05/2025 No 19/10/2022
updated
PSUSA/00000403/202502 Karin Erneholm Denmark CAP
DLP was on 05/06/2019
updated on 21/10/2020

New CAP authorised on


404 bexarotene 29/03/2001 3 years 15/09/2026 14/12/2026 No 05/06/2024 19/08/2020
DLP was amended on 05/06/2024 PSUSA/00000404/202609 Tiphaine Vaillant France CAP

PRAC representative and New


CAP authorised
PRAC on 24/09/2020
representative updated on
405 bezafibrate 21/07/1978 7 years 01/01/2026 01/04/2026 No 31/01/2024 PSUSA/00000405/202601 Carla Torre Portugal NAP
31/01/2024
DLP were updated on 21/10/2019

PSUR frequency and on


DLP
406 bibrocathol Not available* 7 years 03/08/2024 01/11/2024 No 27/03/2024 New CAP authorised PSUSA/00000406/202408 Karin Bolin Sweden NAP
amended onand
14/02/2019 27/03/2024
PRAC Rapporteur
name was amended on
03/04/2019
407 bicalutamide 28/02/1995 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended on 15/11/2023 PSUSA/00000407/202602 Karin Erneholm Denmark NAP
DLP was updated on 26/09/2018

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

PSUR frequency and DLP


412 bifonazole / urea 02/06/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00000412/202812 NAP
amended
PRAC on 31/07/2024
Rapporteur name was
corrected on 03/04/2019

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

Next DLP was amended on


424 bortezomib 26/04/2004 3 years 25/04/2026 24/07/2026 Yes 20/12/2023 03/05/2016
DLP was amended on 20/12/2023 PSUSA/00000424/202604 Amelia Cupelli Italy CAP NAP

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# Classified as internal/staff contractors by the Europ Page 8 / 223
DLP was updated on 21/09/2022

Active substance name updated


425 bosentan 15/05/2002 3 years 19/11/2024 17/02/2025 Yes 19/09/2024 on 02/03/2022 PSUSA/00000425/202411 Zoubida Amimour France CAP NAP
DLP was updated on 25/09/2019
botulinum toxin a (except for centrally authorised DLP was updated on 21/09/2022
426 29/12/1989 3 years 31/12/2024 31/03/2025 Yes 21/09/2022 PRAC Rapporteur name updated PSUSA/00000426/202412 Eamon O'Murchu Ireland NAP
products) DLP23/10/2018
was updated on 29/06/2022
on
DLP was updated on 25/09/2019
Lead DLP
Next MS and
wasPRAC Rapporteur
updated on
427 botulinum toxin a - haemagglutinin complex 06/12/1990 3 years 31/12/2024 31/03/2025 Yes 21/09/2022 Next DLP
name was updated
amended
22/09/2016
on
on 19/12/2018 PSUSA/00000427/202412 Karin Bolin Sweden NAP
22/09/2016
Nextwas
DLP
Lead DLP wasadded
amended
MS updated
was on on on
29/06/2022
brimonidine (except for the centrally authorised Lead MS was added on
27/06/2017
430 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 13/07/2015
13/07/2015
PSUSA/00000430/202609 Eamon O'Murchu Ireland NAP
product) Lead MS and PRAC Rapporteur
PRAC
PRAC Representative
representative updated
and Lead on
name amended on 19/12/2018
16/11/2022
Member State were added on
431 brimonidine / timolol 06/09/1996 5 years 30/09/2026 29/12/2026 No 29/06/2022 03/05/2016
Next DLP was amended on PSUSA/00000431/202609 Martin Huber Germany NAP
DLP was updated on 28/04/2022
27/06/2017
Name of active substance was
PSUR Frequency
amended amended and
on 02/05/2014
PRAC representative and Lead
432 brinzolamide 09/03/2000 5 years 31/08/2026 29/11/2026 No 28/04/2022 DLP updated on 23/05/2017
Member State were added on
PSUSA/00000432/202608 Maria del Pilar Rayon Spain CAP NAP
03/05/2016
Reference to NAP products added
on 18/11/2016
433 brinzolamide / timolol 25/11/2008 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000433/202904 Karin Erneholm Denmark CAP NAP
DLP was updated on 01/04/2020
PRAC Representative amended
on
LMS28/06/2016
and PRAC representative
434 brivudine 06/07/2000 5 years 05/07/2024 03/10/2024 No 01/04/2020 added on 31/07/2019 PSUSA/00000434/202407 Martin Huber Germany NAP

Changes to PSUR frequency


introduced on 06/03/2019
435 bromazepam 01/09/1973 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00000435/202608 Tiphaine Vaillant France NAP

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

Next DLP was updated on


437 bromhexine 01/07/1963 3 years 30/09/2025 29/12/2025 No 27/07/2022 PSUSA/00000437/202509 Amelia Cupelli Italy NAP
31/05/2023

PSUR frequency amended and


438 bromocriptine 15/10/1975 7 years 15/10/2030 13/01/2031 No 03/07/2024 PSUSA/00000438/203010 Maria del Pilar Rayon Spain NAP
DLP updated on 03/07/2024
PRAC Rapporteur name was
amended on 28/04/2022
Next DLP was updated on
439 bromperidol 30/09/1980 5 years 15/11/2027 13/02/2028 No 26/07/2023 PSUSA/00000439/202711 Liana Martirosyan Netherlands NAP
26/07/2023
DLP updated on 22/12/2021

brompheniramine / caffeine / paracetamol, PRAC Rapporteur


Entry name name
updated on was
443 Not available* 11 years 03/03/2040 01/06/2040 No 25/09/2024 amended on 21/11/2018 PSUSA/00000443/204003 none NAP
brompheniramine / caffeine / calcium / paracetamol 25/09/2024

Entry name was corrected on


Next DLP was updated on
07/05/2018
444 brotizolam 15/05/1983 3 years 01/12/2025 01/03/2026 No 26/07/2023 PSUSA/00000444/202512 Ana Sofia Diniz Martins Portugal NAP
26/07/2023
DLP was amended on 20/11/2024
Next DLP updated on 30/01/2017
buclizine / codeine / paracetamol, acetylsalicylic acid / Active substance name was
448 codeine / paracetamol, caffeine / codeine / Not available* 7 years 03/08/2025 01/11/2025 No 20/11/2024 amended
Next on 20/11/2024
DLP and Submission PSUSA/00000448/202508 Rhea Fitzgerald Ireland NAP
paracetamol deadline were corrected on
PSUR frequency and DLP
04/03/2016
amended on 27/03/2024 Marie Louise Schougaard
449 budesonide (nationally authorised products only) 30/04/1992 5 years 30/04/2026 29/07/2026 No 22/12/2021 PSUSA/00000449/202604
Christiansen Denmark NAP
PSUR Frequency amended and
DLP updated on 04/02/2016
PSUR frequency amended and
454 bumetanide 30/09/1972 9 years 03/06/2028 01/09/2028 No 28/08/2024 PRACwas
DLP Rapporteur
updated and Lead
on 21/09/2022 PSUSA/00000454/202806 NAP
DLP updated on 28/08/2024
Member State added on
New CAP authorised on
27/11/2015.
DLP was updated on 25/09/2019
19/12/2024
459 buprenorphine (all formulations except implants) 30/03/1982 4 years 30/09/2027 29/12/2027 No 05/06/2024 Transferred from the Listwas
of PSUSA/00000459/202709 Tiphaine Vaillant France CAP NAP
PRAC Rapporteur name updated
PSUR frequency
substances amended and
on
amended
DLP updatedonunder
23/10/2018 PSUR Work
22/09/2022
on 05/06/2024
Sharing scheme and other
461 bupropion 30/12/1985 3 years 31/12/2024 31/03/2025 No 21/09/2022 substances
PRAC
DLP contained
Representative
was updated in
updated
on 28/04/2022on PSUSA/00000461/202412 Liana Martirosyan Netherlands NAP
Nationally Authorised Products
26/09/2018
PRAC
PRAC Representative
with DLP synchronised
Rapporteur nameupdated
on on
updated
16/11/2022
06/03/2015
Next
on DLP was updated on
23/10/2018
462 buserelin 16/08/1984 5 years 16/08/2026 14/11/2026 No 28/04/2022
22/09/2016
PSUSA/00000462/202608 Mari Thorn Sweden NAP
PRAC representative
Rapporteur
Next DLP wasupdated
name
was amended added
on
on 06/05/2020
05/11/2018
Lead MS was added on
26/04/2017
PSUR frequency amended and
463 buspirone 29/04/1983 3 years 30/04/2027 29/07/2027 No 05/02/2025 13/07/2015 PSUSA/00000463/202704 Karin Erneholm Denmark NAP
DLP updated
PSUR onand
05/02/2025
PRAC freqency
representativeDLP
andand LMS
Lead
were updated
Member State on 01/04/2020
were added on
04/03/2016to NAP added on
Reference
464 busulfan 09/07/2003 5 years 08/07/2024 06/10/2024 No 01/04/2020 Reference to CAP removed on
02/03/2022 and DLP was updated PSUSA/00000464/202407 Monica Martinez Redondo Spain NAP
05/02/2020
on that date
DLP was
PSUR
New updated
frequency
CAP on on
and
authorised 28/03/2017
DLP
468 butamirate 18/03/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUR frequency and DLP were PSUSA/00000468/203407 NAP
amendedon
28/08/2020
updated on16/11/2022
23/10/2024
PRAC Representative amended
on 28/06/2016
DLP was updated on 17/11/2021
PRAC
PSUR representative
frequency was and
amended
469 butamirate / guaifenesin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 updated 29/07/2020
on 19/10/2022 PSUSA/00000469/202906 NAP
DLP updated
The DLP on 28/08/2024
was amended on
PRAC representative was
01/04/2014
updated
PSUR on 06/05/2020
frequency amended
PRAC representative was and
471 butoconazole 24/10/2003 5 years 28/02/2026 29/05/2026 No 17/11/2021 DLP updated
updated on 06/02/2019
on 17/11/2021 PSUSA/00000471/202602 Melinda Palfi Hungary NAP
Next DLP was updated on
18/11/2016
PRAC Rapporteur name
representative wasupdated
on 21/07/2017
updated on 30/06/2021
PSUR frequency and DLP
474 hyoscine butylbromide 01/01/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 Lead MS was added on PSUSA/00000474/202712 NAP
amended on 31/07/2024
06/10/2015
PSUR Frequency and
frequency and DLP
Nextwere
DLP
30/01/2017
updated on 23/10/2019
476 cabazitaxel 17/06/2010 3 years 17/06/2024 15/09/2024 Yes 02/03/2022 PSUSA/00000476/202406 Tiphaine Vaillant France CAP NAP
PRAC frequency
PSUR Rapporteuramended
name wasand
amended on 28/07/2016
DLP updated on 21/11/2018

477 cabergoline 13/03/1992 5 years 12/03/2027 10/06/2027 No 16/11/2022 representative


PRAC Rapporteur namewasamended PSUSA/00000477/202703 Amelia Cupelli Italy NAP
updated
on on 03/06/2020
04/07/2018

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.

Lead MS was added on


484 caffeine / diphenhydramine Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 04/02/2015 PSUSA/00000484/204001 NAP

PSUR frequency amended and


485 caffeine / ergotamine Not available* 3 years 30/11/2025 28/02/2026 Yes 26/07/2023 PSUSA/00000485/202511 Tiphaine Vaillant France NAP
DLP updated on 26/07/2023

486 caffeine / isometheptene / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000486/204001 NAP

Entry name updated on


487 caffeine / metamizole Not available* 28 years 01/01/2040 31/03/2040 No 07/05/2018 PSUSA/00000487/204001 NAP
07/05/2018

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# Classified as internal/staff contractors by the Europ Page 9 / 223
488 caffeine / phenazone Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000488/204001 NAP

PSUR frequency and DLP were


489 caffeine citrate / glyceryl trinitrate Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 updated on 01/02/2023 PSUSA/00000489/204001 NAP
PSUR frequency
PRAC and DLP
Representative were on
updated
updated on 02/03/2022
16/11/2022
491 calcifediol Not available* 3 years 23/06/2025 21/09/2025 No 01/02/2023 PSUSA/00000491/202506 Martin Huber Germany NAP
PRAC representative
LMS and was
PRAC representative
PSUR frequency and DLP were
updated on 19/10/2022
were added on 28/04/2021
updated on 02/03/2022
PSUR frequency amended and
492 calcipotriol 30/11/1990 8 years 03/06/2025 01/09/2025 No 30/10/2024 PRAC
PSUR representative
frequency and was were
DLP
PSUSA/00000492/202506 Rhea Fitzgerald Ireland NAP
DLP updated
Next DLP wason 03/07/2024
updated on
updated
updated on
on 27/07/2022
03/02/2021
06/03/2019

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

DLP was updated on 26/09/2018


Next DLP was updated on
496 calcium 15/06/1935 15 years 01/01/2027 01/04/2027 No 01/10/2012 04/03/2016 PSUSA/00000496/202701 NAP
PRAC Rapporteur name amended
on 04/07/2018
Active substance
Lead MS added onname was
01/04/2015
antacids: including any combinations or amended on 28/04/2022
500 monocomponents of aluminium, calcium, magnesium, Not available* 15 years 01/01/2027 01/04/2027 No 28/04/2022 DLP updated on 06/10/2015 PSUSA/00000500/202701 NAP
potassium, sodium salts Active substance name was
Lead MS was
amended added on
on 06/03/2015
22/12/2014
501 calcium bromolactobionate Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000501/202701 NAP

PSUR frequency amended and


502 calcium carbonate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00000502/202906 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


507 calcium chloride Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00000507/204003 NAP
amended on 23/10/2024
calcium chloride / dipotassium phosphate / magnesium
chloride hexahydrate / potassium chloride / potassium
New active substances added to
508 phosphate monobasic / sodium chloride, disodium Not available* 15 years 01/01/2027 01/04/2027 No 31/07/2018 PSUSA/00000508/202701 NAP
the entry on 31/07/2018
phosphate dihydrate/ potassium dihydrogen
phosphate/ potassium hydroxide
calcium chloride / glucose anhydrous / glutathione
509 Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000509/202701 NAP
disulphide / magnesium chloride hexahydrate

calcium chloride / glycine / magnesium aspartate


511 Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000511/202701 NAP
dihydrate / sodium succinate hexahydrate

calcium chloride / glucose monohydrate / magnesium


513 Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000513/202701 NAP
chloride hexahydrate

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

DLP was updated on 02/03/2022


519 calcium folinate 5-hydrate / glutamine Not available* 15 years 01/01/2027 01/04/2027 No 01/10/2012 PSUSA/00000519/202701 NAP
PSUR frequency amended and
DLP updated on 06/02/2019
PSUR frequency and DLP
520 calcium gluconate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00000520/204003 NAP
amended on 23/10/2024
DLP was amended on 31/01/2018
PSUR frequency and DLP
521 calcium carbonate / calcium lactate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 Next DLP was amended on PSUSA/00000521/203506 NAP
amended on 23/10/2024
30/01/2017
DLP was updated on 21/12/2022
PSURDLP
Next frequency amended
was amended onand
525 camphor, camphor and other terpene derivates Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUSA/00000525/202907 NAP
DLP updated
28/07/2016
PRAC on 28/08/2024
Rapporteur name was
amended on 22/09/2022
PSUR Frequency amended and
526 canakinumab 23/10/2009 3 years 30/06/2024 28/09/2024 No 02/03/2022 DLP updated
PRAC on 04/03/2016
Rapporteur name updated PSUSA/00000526/202406 Gabriele Maurer Germany CAP
on 23/10/2018
DLP
PSURwas updatedamended
Frequency on 02/02/2022
and
DLP updated
PRAC on 04/02/2016
Rapporteur name was
527 candesartan, candesartan / hydrochlorothiazide 29/04/1997 5 years 28/04/2027 27/07/2027 No 21/12/2022 Correction of 31/07/2018
PRAC Rapporteur PSUSA/00000527/202704 Mari Thorn Sweden NAP
amended on
name on 28/02/2017
Next DLP was amended on
31/07/2015
PRAC Rapporteur name updated
PSUR frequency
'PSUR submission amended
frequencyandand
531 capecitabine 30/04/1998 5 years 29/04/2029 28/07/2029 No 05/02/2025 28/02/2018 PSUSA/00000531/202904 Martin Huber Germany CAP NAP
DLP updated
Nextwere on
updated
DLP was 05/02/2025
on 30/01/2017
amended on
04/02/2015
DLP was amended on 31/01/2018
'PRAC Rapporteur name was
PSUR frequency and DLP
532 capreomycin 19/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 amended
Next DLP
Lead on 20/12/2016
was
MS and amended
PRAC on
Rapporteur PSUSA/00000532/202804 NAP
amended on 31/07/2024
PRAC representative
08/08/2014
name was
was added on 19/10/2016
'PRAC
updated Rapporteur name updated
on 22/12/2021
on
Next04/02/2016
DLP was amended on
533 capsaicin 15/05/2009 5 years 15/05/2026 13/08/2026 No 02/02/2022 PSUSA/00000533/202605 Ana Sofia Diniz Martins Portugal CAP NAP
DLP was
31/01/2014updated on 16/12/2020
'Information included in column
"Are
Next PSURs
PRAC required
representative
DLP was for
wasproducts
corrected on
535 captopril 15/04/1980 5 years 14/04/2025 13/07/2025 No 16/12/2020 referred
updated
08/01/2014to
onin Articles 10(1), 10a,
06/05/2020 PSUSA/00000535/202504 Anna Mareková Slovakia NAP
14, 16a of Directive 2001/83/EC
as amended?"
Lead MS and PRAC was amended
Rapporteuron
22/12/2014
name amended on 19/12/2018
536 captopril / hydrochlorothiazide 15/04/1980 5 years 14/04/2026 13/07/2026 No 19/09/2024 PSUSA/00000536/202604 Zoubida Amimour France NAP
Rapporteur
Next name
DLP was amended
updated on on
04/11/2014
21/12/2015.
PSURand
DLP frequency and DLP
PRAC representative
537 carbachol 10/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00000537/203406 NAP
amended
were
The DLP on 23/10/2024
updated
was on 22/09/2021
amended on
08/01/2014
PRAC representative was added
PSUR frequency and DLP
538 carbaethopendecinium Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 on 06/05/2020 PSUSA/00000538/203506 NAP
amended on 23/10/2024
LMS was added on 01/04/2020
539 carbamazepine 12/12/1961 7 years 11/12/2027 10/03/2028 No 22/09/2021 PSUSA/00000539/202712 Liana Martirosyan Netherlands NAP
DLP was corrected on 20/11/2019

PSUR frequency, "Are PSURs


PSUR frequency and DLP
541 carbasalate 16/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 required for products referred to PSUSA/00000541/202811 NAP
amended on 31/07/2024
in Articles 10(1), 10a, 14, 16a of
Directive 2001/83/EC as
amended?Yes/No"
PSUR frequency andand
DLPDLP were
543 carbazochrome 19/03/1951 11 years 03/11/2036 01/02/2037 No 23/10/2024 updated on PSUSA/00000543/203611 NAP
amended on25/09/2019
23/10/2024

boric acid / carbethopendecinium bromide / sodium PSURwas


DLP frequency
updatedand
on DLP
01/03/2023
545 Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 DLP was updated on 29/06/2022 PSUSA/00000545/204003 NAP
tetraborate amended on 23/10/2024
Lead MS and PRAC Rapporteur
DLP updated on 05/06/2019
name amended on 19/12/2018
546 carbetocin 24/06/1997 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUSA/00000546/202706 Jana Lukačišinová Czech Republic NAP
Reference to NAP added on
DLP was updated on 27/03/2018
06/02/2019
Lead MS and PRAC Rapporteur
547 carbidopa / entacapone / levodopa 17/10/2003 3 years 17/10/2024 15/01/2025 No 29/06/2022 Next DLP was amended on
name was added on 20/12/2016
PSUSA/00000547/202410 Terhi Lehtinen Finland CAP NAP
03/06/2016

"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

PSUR frequency and DLP


586 cefalotin Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00000586/203506 NAP
amended on 23/10/2024

PSUR frequency amended and


PSURupdated
frequency and DLP
587 cefamandole 29/08/1977 9 years 03/11/2028 01/02/2029 No 15/01/2025 DLP on 05/02/2025 PSUSA/00000587/202811 Zane Neikena Latvia NAP
amended on 31/07/2024
Information included in column
"Are
PSURPSURs required
frequency for products
and DLP
588 cefatrizine 27/08/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 referred PSUSA/00000588/202811 NAP
was to
amended
DLP onin31/07/2024
Articles
updated 10(1), 10a,
on 27/07/2022
14, 16a of Directive 2001/83/EC
as amended?"
Next was amended
DLP was amended on on
589 cefazolin 29/11/1972 5 years 30/11/2026 28/02/2027 No 27/07/2022 18/12/2024
25/09/2017 PSUSA/00000589/202611 Jan Neuhauser Austria NAP
DLP
Leadwas
MS updated
and PRACon 02/03/2022
Rapporteur
DLP was amended on 23/10/2024
name was added on 28/07/2016
592 cefditoren 01/04/1994 8 years 31/03/2025 29/06/2025 No 30/10/2024 Next DLP was updated on PSUSA/00000592/202503 Maria del Pilar Rayon Spain NAP
PSUR frequency and DLP
06/03/2019
amended on 31/07/2024
Correction of PRAC Rapporteur
593 cefepime 29/06/1993 5 years 28/06/2029 26/09/2029 Yes 05/02/2025 PSUSA/00000593/202906 Ana Sofia Diniz Martins Portugal NAP
name on 28/02/2017

PRAC Rapporteur name was


PSUR frequency amended and
594 cefixime 30/06/1987 8 years 03/06/2025 01/09/2025 No 30/10/2024 amended on 20/12/2016 PSUSA/00000594/202506 Eva Jirsová Czech Republic NAP
DLP updated on 03/07/2024
Next DLP was amended on
DLP was updated on 22/09/2021
04/03/2016
PSUR frequency amended and
596 cefonicid Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUSA/00000596/202907 NAP
DLP updated on 28/08/2024
PRAC Rapporteur
Information name
included was
in column
amended
"Are PSURs onrequired
06/03/2019
DLP was updated on for products
22/09/2021
597 cefoperazone 12/01/1981 5 years 11/01/2026 11/04/2026 No 22/09/2021 referred to in Articles 10(1), 10a, PSUSA/00000597/202601 Rugile Pilviniene Lithuania NAP
Next DLPofwas
14, 16a updated
Directive on
2001/83/EC
PRAC Rapporteur name was
22/09/2016
as amended?" was amended on
amended on 06/03/2019
04/03/2016
DLP
598 cefoperazone / sulbactam 12/01/1981 5 years 11/01/2026 11/04/2026 No 22/09/2021 Leadwas
MS updated
was added on on
21/09/2022 PSUSA/00000598/202601 Rugile Pilviniene Lithuania NAP
Next DLP was updated on
13/07/2015
Leadwas
MS updated
added onon 01/04/2015
22/09/2016
DLP 31/07/2019

599 cefotaxime 18/12/1979 3 years 18/12/2024 18/03/2025 No 21/09/2022 Lead DLP


Next MS was
wasadded on on
updated PSUSA/00000599/202412 Sonja Hrabcik Austria NAP
13/07/2015
22/09/2016

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

PSUR frequency amended and


601 cefoxitin 16/03/1977 9 years 03/10/2028 01/01/2029 No 28/08/2024 PSUSA/00000601/202810 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


603 cefpirome 04/09/1992 8 years 03/07/2025 01/10/2025 No 31/07/2024 PSUSA/00000603/202507 NAP
amended on 31/07/2024

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

PSUR frequency amended and


606 cefradine 23/11/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00000606/202806 NAP
DLP updated on 28/08/2024

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

PSUR frequency and DLP


612 ceftizoxime 07/12/1981 9 years 03/11/2028 01/02/2029 No 15/01/2025 PSUSA/00000612/202811 Ana Sofia Diniz Martins Portugal NAP
amended on 31/07/2024

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

DLP was updated on 19/12/2017


PSUR frequency amended and
614 ceftriaxone sodium / lidocaine hydrochloride 27/05/1982 8 years 03/05/2025 01/08/2025 No 30/10/2024 Lead MS and PRAC Rapporteur PSUSA/00000614/202505 Amelia Cupelli Italy NAP
DLP updated on 03/07/2024
name was added on 19/10/2016

Name of entry was amended on


615 cefuroxime sodium (except for intracameral use) 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 PSUSA/00000615/202704 Maia Uusküla Estonia NAP
03/03/2014

Information included in column


616 celecoxib 31/12/1998 3 years 31/12/2026 31/03/2027 No 25/09/2024 "Are PSURs
DLP was required
amended onfor products
25/09/2024 PSUSA/00000616/202612 Karin Bolin Sweden NAP
referred
DLP was to in Articles
updated 10(1), 10a,
on 23/09/2020
14, 16a of Directive 2001/83/EC
as amended?"
PRAC was amended
representative was addedon
617 celiprolol 17/01/1983 8 years 16/01/2028 15/04/2028 No 23/09/2020 30/11/2012 PSUSA/00000617/202801 Maia Uusküla Estonia NAP
on 06/05/2020

LMS was added on 31/07/2019


624 certolizumab 01/10/2009 3 years 06/03/2026 04/06/2026 No 15/11/2023 DLP was amended
DLP was updated on
on21/12/2022
15/11/2023 PSUSA/00000624/202603 Karin Bolin Sweden CAP
PRAC representative added on
21/09/2022
625 certoparin Not available* 5 years 01/04/2027 30/06/2027 No 21/12/2022 PSUSA/00000625/202704 Martin Huber Germany NAP
LMS was added on 02/02/2022

PSUR frequency and DLP updated


626 cetalkonium / choline salicylate 24/04/1995 8 years 03/08/2025 01/11/2025 No 16/01/2025
on 17/11/2021
PSUSA/00000626/202508 Zoubida Amimour France NAP
amended on 31/07/2024
PRAC representative was
updated on 19/10/2022
Next DLP was updated on
628 cetirizine 06/11/1986 5 years 05/11/2027 03/02/2028 No 26/07/2023 PSUSA/00000628/202711 Terhi Lehtinen Finland NAP
26/07/2023
DLP and PRAC Representative
were updated on 28/04/2022
629 cetirizine / pseudoephedrine 04/09/1995 5 years 31/08/2026 29/11/2026 No 28/04/2022 PSUSA/00000629/202608 Jo Robays Belgium NAP
DLP was updated on 23/05/2017

PRAC Representative amended


PSUR frequency amended and
630 cetrimide / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 on 18/11/2016 PSUSA/00000630/202907 NAP
DLP updated on 28/08/2024
Lead MS and PRAC Rapporteur
name
DLP was
was added on
updated on 07/04/2016
21/12/2022
cetrimide / lidocaine, cetrimide / lidocaine PSUR frequency and DLP
631 Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00000631/203506 Jo Robays Belgium NAP
hydrochloride / zinc sulphate amended on
Reference to 23/10/2024
NAP added on
29/06/2022
PSUR frequency amended and
632 cetrimide / quinisocain chlorhydrate Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 DLP was updated on 18/12/2019 PSUSA/00000632/202512 NAP
DLP updated on 31/07/2024
PRAC Rapporteur name was
amended on 31/07/2018
633 cetrorelix 13/04/1999 3 years 12/04/2025 11/07/2025 No 21/12/2022 PSUSA/00000633/202504 Martin Huber Germany CAP NAP
Next DLP was amended on
20/12/2016
PSUR frequency amended and
635 cetuximab 29/06/2004 5 years 30/09/2028 29/12/2028 No 05/06/2024 PSUSA/00000635/202809 Mari Thorn Sweden CAP
DLP updated on 05/06/2024
Lead MS was amended on
06/03/2015
PSUR frequency and DLP
636 cetylpyridinium 23/03/1939 11 years 03/11/2036 01/02/2037 No 23/10/2024 The DLP was amended on PSUSA/00000636/203611 NAP
amended on 23/10/2024
08/01/2014
Active substance name was
amended on 18/12/2024
cetylpyridinium / lidocaine, lidocaine / chlorocresol /
639 Not available* 10 years 03/06/2035 01/09/2035 No 18/12/2024 PSUSA/00000639/203506 none NAP
cetylpyridinium
PSUR frequency and DLP
amended on 23/10/2024
PSUR frequency and DLP
640 cetylpyridinium / lysozyme 12/01/1994 8 years 03/08/2025 01/11/2025 No 16/01/2025 PSUSA/00000640/202508 Zoubida Amimour France NAP
amended on 31/07/2024

645 charcoal activated 06/04/1949 28 years 01/01/2040 31/03/2040 No 01/10/2012 PSUSA/00000645/204001 NAP

PSUR frequency and DLP


646 bismuth subgallate / charcoal activated / citric acid Not available* 7 years 03/08/2031 01/11/2031 No 27/03/2024 PSUSA/00000646/203108 Jana Lukačišinová Czech Republic NAP
amended on 27/03/2024

PSUR frequency and DLP


650 chlorambucil 14/09/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00000650/203401 NAP
amended on 23/10/2024

651 chloramphenicol 25/06/1949 18 years 30/06/2030 28/09/2030 No 01/10/2012 PSUSA/00000651/203006 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

PSUR frequency and DLP


660 chlordiazepoxide 31/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUR frequency amended and PSUSA/00000660/203404 NAP
amended on 23/10/2024
DLP updated on 23/10/2024

chlordiazepoxide / clidinium, amitriptyline / Active substance name was


661 Not available* 3 years 10/01/2027 10/04/2027 No 23/10/2024 PSUSA/00000661/202701 none NAP
chlordiazepoxide amended on 23/10/2024

PSUR frequency and DLP


PSUR frequency amended and
662 chlorhexidine 11/08/1976 8 years 03/03/2025 01/06/2025 No 26/07/2024 amended on 23/10/2024 PSUSA/00000662/202503 Rugile Pilviniene Lithuania NAP
DLP updated on 03/07/2024

PSUR frequency amended and


663 cetrimonium / chlorhexidine Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUSA/00000663/202907 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


664 chlorhexidine / dexpanthenol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00000664/202911 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP updated


Updated
on & published on
21/10/2022
665 chlorhexidine / lidocaine 11/09/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00000665/203405 NAP
23/10/2024
Information included in column
"Are PSURs required for products
PSUR frequency amended and
669 chlorhexidine gluconate / isopropyl alcohol Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 referred to in Articles 10(1), 10a, PSUSA/00000669/202512 Jo Robays Belgium NAP
DLP updated on 31/07/2024
14, 16a of Directive 2001/83/EC
as amended?"
PSUR frequency and
andDLP was
DLP updated
amended
on on 29/06/2022
21/10/2022
677 chlormadinone 18/11/1974 3 years 31/01/2027 01/05/2027 Yes 21/10/2022 PSUSA/00000677/202701 Martin Huber Germany NAP
Next DLP was amended on
25/09/2017
29/06/2022
679 chlormadinone acetate / ethinylestradiol Not available* 3 years 31/01/2027 01/05/2027 No 21/10/2022 PSUSA/00000679/202701 Martin Huber Germany NAP
Lead DLP
Next MS and
wasPRAC Rapporteur
amended on
name was added
25/09/2017
DLP updated on 28/07/2016
on 22/12/2021
PSUR frequency amended and
682 chlorocresol Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 The DLP PSUSA/00000682/202911 NAP
Lead
DLP MS was
and amended
updated
was PRAC
on
updated on
onRapporteur
28/08/2024
03/06/2020
01/04/2014
name was added on 28/07/2016
PSUR frequency and DLP were
PSUR frequency amended and
684 chloropyramine Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 amended on 30/04/2019 PSUSA/00000684/202512 Zane Neikena Latvia NAP
DLP updated on 31/07/2024
European Union reference date,
DLP and Submission date were
685 chloroquine 20/08/1947 5 years 18/04/2026 17/07/2026 No 22/12/2021 PSUSA/00000685/202604 Karin Bolin Sweden NAP
amended on 28/02/2018

PRAC Representative amended


PSUR frequency and DLP
689 chloroxylenol 01/01/1933 11 years 03/05/2040 01/08/2040 No 23/10/2024 on 19/12/2017 PSUSA/00000689/204005 NAP
amended on 23/10/2024
Next DLP was amended on
07/04/2016

Lead MS added on 01/04/2015


© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 12 / 223
PSUR frequency and DLP
692 chlorphenamine 07/06/1954 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00000692/203401 NAP
amended on 23/10/2024
PSUR frequency amended and
DLP updated on 30/04/2024
chlorphenamine / paracetamol / pseudoephedrine,
693 Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 PSUSA/00000693/203505 none NAP
chlorphenamine / paracetamol / phenylephrine
Active substance name was
amended on 30/04/2024
PSUR frequency and DLP
694 acetylsalicylic acid / chlorphenamine / phenylephrine Not available* 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00000694/202511 Adam Przybylkowski Poland NAP
amended on 31/07/2024

Information included in column


696 ascorbic acid / chlorphenamine / paracetamol Not available* 6 years 03/11/2029 01/02/2030 No 19/09/2024 "Are PSURs required for products PSUSA/00000696/202911 Zoubida Amimour France NAP
referred to in Articles 10(1), 10a,
PSUR frequency amended and
14, 16a of Directive 2001/83/EC
DLP updated on 30/04/2024
697 ascorbic acid / caffeine / chlorphenamine / paracetamol Not available* 10 years 03/05/2035 01/08/2035 No 30/04/2024 as amended?" was amended on PSUSA/00000697/203505 none NAP
30/04/2024
Active substance name was
amended on 30/04/2024
DLP was amended on 30/04/2024
chlorphenamine / dextromethorphan hydrobromide /
699 Not available* 6 years 03/11/2024 01/02/2025 Yes 30/04/2024 Information included in column PSUSA/00000699/202411 Monica Martinez Redondo Spain NAP
paracetamol
Active
"Are substance
PSURs name
required for was
products
amendedtoon
referred in30/04/2024
Articles 10(1), 10a,
703 chlorphenamine / paracetamol 22/08/2001 7 years 03/03/2031 01/06/2031 No 20/11/2024 14, 16a
DLP wasof Directiveon
amended 2001/83/EC
20/11/2024 PSUSA/00000703/203103 Zoubida Amimour France NAP
Lead
as MS and PRAC
amended?" Rapporteur
was amended on
name added on 15/11/2023
30/04/2024
chlorphenamine / pseudoephedrine, chlorphenamine /
710 Not available* 10 years 03/05/2035 01/08/2035 Yes 30/04/2024 PSUR frequency and DLP and
amended PSUSA/00000710/203505 none NAP
phenylephrine amended on 26/07/2023
DLP updated on 30/04/2024

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

PSUR frequency and DLP


717 chlorprothixene 31/03/1959 3 years 31/03/2027 29/06/2027 No 18/12/2024 amended on 27/03/2024
DLP was amended on 18/12/2024 PSUSA/00000717/202703 Zane Neikena Latvia NAP

PSUR frequency and DLP


718 chlortalidone 24/06/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00000718/203401 NAP
amended on 23/10/2024

PSUR frequency and DLP


720 chlortalidone / oxprenolol 27/09/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00000720/203503 NAP
amended on 23/10/2024

Updated & published on


721 chlortalidone / reserpine 06/02/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00000721/203405 NAP
23/10/2024

PSUR frequency and DLP


723 chlortetracycline 01/04/1949 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00000723/203611 NAP
amended on 23/10/2024

PSUR frequency and DLP


726 chlorzoxazone 28/06/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00000726/203404 NAP
amended on 23/10/2024

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

chlorobutanol hemihydrate / choline salicylate / PSUR frequency amended and


733 Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00000733/202911 NAP
hexetidine DLP updated on 28/08/2024
Active substance name was
amended on 28/02/2024
736 choriogonadotropin alfa, chorionic gonadotrophin 02/02/2001 3 years 19/09/2025 18/12/2025 No 28/02/2024 PRAC Rapporteur name was PSUSA/00000736/202509 Bianca Mulder Netherlands CAP
amended on 22/09/2022
Next DLP was updated on
31/05/2023
DLP
PSURwas updatedamended
frequency on 28/04/2022
and
738 chrome alum Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00000738/202911 NAP
DLP updated on 28/08/2024
PRAC representative was
DLP was updated on 21/09/2022
updated on 02/03/2022
PSUR frequency and DLP
739 chromium (51 cr) edta 30/11/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 DLP was updated 25/09/2019
on 01/03/2023 PSUSA/00000739/203503 NAP
amended
PRAC on 23/10/2024
representative was
updated on 03/02/2021
Next
PRACDLP was updated
Rapporteur nameon amended
742 ciclesonide 24/02/2004 3 years 23/08/2024 21/11/2024 No 28/04/2022 22/09/2016
on 04/07/2018 PSUSA/00000742/202408 Mari Thorn Sweden NAP
PRAC representative was
updated on 16/12/2020
Lead MS
PSUR was added
Frequency on
amended and
13/07/2015
DLP
DLP updated on 28/02/2018
was amended on 30/04/2019
745 ciclosporin (systemic use) 15/12/1982 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00000745/202412 Maia Uusküla Estonia NAP
ActiveRepresentative
PRAC substance name was was
name
Lead MS and PRAC Rapporteur
amended 16/06/2015
on 17/10/2017
name updated on 23/10/2018
748 cilastatin / imipenem 28/06/1984 5 years 27/06/2027 25/09/2027 No 01/03/2023
Information included and
in column
PSUSA/00000748/202706 Karen Pernille Harg Norway NAP
PRAC representative
Next DLP was amended Lead
on
"Are PSURs
Member required
State for products
were added on
03/05/2016
referred to in Articles 10(1), 10a,
18/11/2016
PRAC representative updated on
749 cilazapril, cilazapril / hydrochlorothiazide 21/02/1990 5 years 20/02/2029 21/05/2029 No 31/01/2024 14, 16a of Directive 2001/83/EC
Lead MS added on 12/05/2015 PSUSA/00000749/202902 Carla Torre Portugal NAP
31/01/2024
as amended?" was amended
Transferred from the List of on
30/11/2012 under PSUR Work
substances
Sharing
PSUR scheme amended
frequency and other and
753 cimetidine 09/11/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 substances PSUSA/00000753/202809 NAP
DLP updatedcontained in
on 28/08/2024
Nationally
PRAC Authorised amended
Representative Products
with
on DLP synchronised on
21/12/2022
755 cimicifuga racemosa (L.) nutt., rhizoma Not available* 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 06/03/2015
DLP amended on 20/09/2023 PSUSA/00000755/202801 Jan Neuhauser Austria NAP
DLP was updated on 16/11/2022

New CAP authorised on


756 cinacalcet 22/10/2004 3 years 28/02/2025 29/05/2025 No 16/11/2022 PSUSA/00000756/202502 Mari Thorn Sweden CAP
03/04/2020

DLP was updated on 23/10/2019


PSUR frequency amended and
757 cinchocaine Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00000757/202512 Martin Huber Germany NAP
DLP updated on 31/07/2024
Next DLP was amended on
19/10/2016
1,3-butanediol / cinchocaine hydrochloride / PSUR frequency and DLP
759 23/09/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00000759/202812 NAP
dexamethasone amended on 31/07/2024

PSUR frequency and DLP


761 cinchocaine hydrochloride / hydrocortisone Not available* 7 years 03/08/2024 01/11/2024 No 27/03/2024 PSUSA/00000761/202408 John Joseph Borg Malta NAP
amended on 27/03/2024

PSUR frequency amended and


762 cinchocaine hydrochloride / policresulen Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00000762/202911 NAP
DLP updated on 28/08/2024

Updated & published on


766 cinnarizine 01/11/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00000766/203405 NAP
23/10/2024
PRAC representative was
updated on 27/07/2022
PSUR frequency and DLP
767 cinnarizine / dimenhydrinate 19/03/1996 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00000767/202511 Jan Neuhauser Austria NAP
amended
DLP on 31/07/2024
was updated on 29/07/2020

PRAC representative was


PSUR frequency amended and
768 cinnarizine / piracetam Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 updated on 06/05/2020 PSUSA/00000768/202911 NAP
DLP updated on 28/08/2024
PRAC representative was added
DLP was updated on 27/07/2022
on 21/11/2018
769 cinolazepam 02/12/1994 5 years 01/12/2024 01/03/2025 Yes 27/07/2022 PSUSA/00000769/202412 Anna Mareková Slovakia NAP
Lead MS and PRAC Rapporteur
Next DLP and 'Are PSURs
name amended on 19/12/2018
required for products referred to
771 ciprofibrate 09/12/1983 5 years 09/12/2026 09/03/2027 No 27/07/2022 in Articles 10(1), 10a, 14, 16a of PSUSA/00000771/202612 Jean-Michel Dogné Belgium NAP
Next DLP was amended on
Directive 2001/83/EC as
25/09/2017
amended?' was amended on
21/12/2015.
Lead MS and PRAC Rapporteur
name was added on 28/07/2016
Lead MS was added on
22/12/2014
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 13 / 223
772 ciprofloxacin / fluocinolone acetonide 25/03/2002 7 years 02/04/2031 01/07/2031 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00000772/203104 Maria del Pilar Rayon Spain 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

777 cisatracurium 07/08/1995 5 years 31/07/2025 29/10/2025 No 31/03/2021 DLP


Leadwas
MS updated
and PRAConRapporteur
21/09/2022 PSUSA/00000777/202507 Jana Lukačišinová Czech Republic NAP
name amended on 19/12/2018
PRAC Rapporteur name was
amended
Next on 31/07/2018
DLP was amended on Marie Louise Schougaard
778 cisplatin 19/12/1978 5 years 18/12/2027 17/03/2028 No 20/09/2023 DLP amended on 20/09/2023
03/06/2016
PSUSA/00000778/202712
Christiansen Denmark NAP
Next DLP was amended on
25/09/2017
Lead MS added on 01/04/2015
Information included in column
779 citalopram 31/12/1989 5 years 31/12/2026 31/03/2027 No 21/09/2022 PSUSA/00000779/202612 Karin Bolin Sweden NAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
PSUR frequency and DLP
780 citicoline 31/12/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 as amended?" was amended on PSUSA/00000780/203407 NAP
amended on 23/10/2024
25/09/2017

Lead MS and PRAC Rapporteur


781 citric acid Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 name was added on 28/07/2016 PSUSA/00000781/204001 NAP

citric acid / magnesium / sodium, citric acid


PSUR frequency amended and
782 anhydrous / light magnesium oxide / sodium Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00000782/202911 none NAP
DLP updated on 28/08/2024
picosulfate

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

PRAC representative was


785 citric acid / sodium Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 updated on 31/03/2021 PSUSA/00000785/204001 NAP

PRAC representative was


786 citric acid / urea Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 updated on 25/09/2019 PSUSA/00000786/204001 NAP
LMS and PRAC representative
were updated on 05/06/2019
cladribine (apart from products with multiple sclerosis Marie Louise Schougaard
787 26/02/1993 3 years 25/02/2027 26/05/2027 No 20/10/2021 PRAC Representative updated on PSUSA/00000787/202702
Christiansen Denmark CAP NAP
indication)
DLP was updated on 21/11/2018
16/11/2022

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

PSUR frequency and DLP


792 clemastine / dexamethasone Not available* 7 years 03/08/2031 01/11/2031 No 27/03/2024 PSUSA/00000792/203108 none NAP
amended on 27/03/2024
DLP was updated on 29/06/2022
DLP was amended on 25/09/2024
Next DLP was updated on
794 clenbuterol 12/12/1980 3 years 30/09/2025 29/12/2025 Yes 03/06/2020 PSUSA/00000794/202509 Amelia Cupelli Italy NAP
31/05/2023
PRAC representative was
Information included in column
updated on 31/03/2021
"Are PSURs required for products
referred to in Articles 10(1), 10a,
795 clindamycin 16/10/1969 3 years 15/10/2024 13/01/2025 No 29/06/2022 DLP was updated on 03/07/2019
14, 16a of Directive 2001/83/EC
PSUSA/00000795/202410 Sonja Hrabcik Austria NAP
as amended?" was amended on
Next DLP was updated on
25/09/2024
28/06/2016
PSUR frequency amended and
796 benzoyl peroxide / clindamycin phosphate 26/01/1983 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00000796/202505 Rugile Pilviniene Lithuania NAP
DLP
PSURupdated on 03/07/2024
frequency, DLP and PSURs
Leadwas
DLP MS added onon 16/06/2015
required updated
for products21/10/2020
referred to
in Articles 10(1), and
PSUR frequency 10a,DLP
16a of
797 clioquinol Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PRAC representative
Directive 2001/83/EC was
as PSUSA/00000797/202912 NAP
amended on 28/08/2024.
updated on
amended 23/09/2020
19/10/2022
were updated on
28/07/2021
representative was
PRAC Representative added
amended
798 clobazam 06/02/1970 8 years 06/02/2028 06/05/2028 No 21/10/2020 PSUSA/00000798/202802 Kimmo Jaakkola Finland NAP
DLP06/05/2020
on 28/04/2022
and PRAC representative
were updated on 29/07/2020
LMS was
DLP was updated
added onon 01/04/2020
21/10/2020
799 clobetasol 21/02/1973 5 years 28/02/2025 29/05/2025 No 28/04/2022 Reference to NAP added on PSUSA/00000799/202502 Jo Robays Belgium NAP
PSUR frequency
PRAC and DLP
Representative
01/07/2020 were
amended
updated
on on 25/09/2019
18/11/2016
PSURCAP
New frequency and on
authorised DLP
800 clobetasone 17/09/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00000800/202808 NAP
Next DLP was
amended
14/11/2019 amended on
on 31/07/2024
29/10/2015
DLP and Information included in
805 clofarabine 29/05/2006 3 years 28/12/2026 28/03/2027 Yes 25/09/2024 Lead MS"Are
column added on 04/02/2015
PSURs required for PSUSA/00000805/202612 Tiphaine Vaillant France CAP NAP
products referred to in Articles
10(1), 10a, 14, 16a of Directive
2001/83/EC
PSUR frequencyas amended?"
and DLP were
806 clofazimine 24/04/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024
updated on 31/07/2019
PSUSA/00000806/202805 none NAP
amended on 31/07/2024

PRAC representative was


PSUR frequency
updated and DLP
on 03/06/2020
809 clomethiazole 01/11/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00000809/203401 NAP
amended on 23/10/2024
PRAC representative was
updated
PSUR on 03/06/2020
frequency amended and
810 clomifene Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 DLP PSUSA/00000810/202512 Eva Jirsová Czech Republic NAP
DLP was updated
updated on 03/03/2021
on 31/07/2024
DLP was updated on 31/07/2018
DLP correction on 19/12/2018
PSUR frequency
DLP updated andamended
PRAC and
811 clomipramine 18/10/1965 8 years 03/03/2025 01/06/2025 No 03/07/2024 PSUSA/00000811/202503 Martin Huber Germany NAP
DLP
Next updated
DLP was
Rapporteur on 03/07/2024
amended
name amendedon on
04/03/2016
21/07/2017
Information included in column
812 clonazepam 27/06/1973 5 years 26/06/2025 24/09/2025 Yes 03/03/2021 "Are PSURs required for products PSUSA/00000812/202506 Maia Uusküla Estonia NAP
Next
PRACDLP updatedname
Rapporteur on 29/10/2015
was
referred to in Articles 10(1), 10a,
amended on 28/07/2016
14, 16a of Directive 2001/83/EC
DLP corrected to the original on
as amended?" was amended on
11/09/2015
Next DLP and PRAC Rapporteur
813 clonidine 16/08/1967 9 years 16/08/2025 14/11/2025 No 05/01/2025 26/07/2023 PSUSA/00000813/202508 Carla Torre Portugal NAP
name updated was amended on
DLP amended on 16/07/2015
28/07/2016
Update of PSUR frequency & DLP
resulting
PSUR from PRAC
frequency and re-allocation
DLP
815 clonixin 28/02/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 Lead
PRAC MS added on
Rapporteur 01/04/2015
name updated PSUSA/00000815/203503 NAP
exercise for
amended onentries with DLPs in
23/10/2024
on 03/06/2016
2025 on 26/07/2023
PSUR frequency and DLP
816 clopamide / dihydroegocrystine / reserpine 30/04/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUSA/00000816/203407 NAP
amended on 23/10/2024

PSUR frequency and DLP


819 cloperastine 12/08/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00000819/202811 NAP
amended on 31/07/2024

Next DLP was updated on


820 acetylsalicylic acid / clopidogrel, clopidogrel 15/07/1998 3 years 17/11/2025 15/02/2026 No 26/07/2023 PSUSA/00000820/202511 Carla Torre Portugal CAP NAP
26/07/2023

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 14 / 223
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 amended and


822 clorazepate 03/08/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00000822/202803 NAP
DLP updated 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.

PRAC Representative amended


PSUR frequency and DLP
826 clotiapine Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 on 28/04/2022 PSUSA/00000826/202912 NAP
amended on 28/08/2024.
DLP was updated on 03/02/2021
827 clotiazepam 18/05/1978 5 years 31/05/2025 29/08/2025 No 28/04/2022 PSUSA/00000827/202505 Jo Robays Belgium NAP
PRAC Representative amended
on 18/11/2016
clotrimazole / hexamidine diisetionate / prednisolone PSUR frequency amended and
828 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 Next DLP was amended on PSUSA/00000828/202901 NAP
acetate DLP updated on 28/08/2024
04/02/2016

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

PSUR frequency and DLP


830 clotrimazole / dexamethasone Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000830/202411 Ana Sofia Diniz Martins Portugal NAP
amended on 27/03/2024

PSUR frequency and DLP


831 clotrimazole / hydrocortisone Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000831/202411 Ireland NAP
amended on 27/03/2024

PSUR frequency and DLP


832 clotrimazole / metronidazole Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000832/202411 Roxana Dondera Romania NAP
amended on 27/03/2024

PSUR frequency amended and


833 clotrimazole / zinc oxide Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00000833/202512 Martin Huber Germany NAP
DLP updated on 31/07/2024

PSUR frequency amended and


834 clotrimazole / hexamidine diisetionate 13/11/1991 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00000834/202901 NAP
DLP updated on 28/08/2024

Updated & published on


835 cloxacillin 05/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00000835/203405 NAP
23/10/2024

PSUR frequency amended and


836 clozapine 24/10/1969 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00000836/202503 Amelia Cupelli Italy NAP
DLP updated on 03/07/2024

cobamamide, hydroxocobalamin (except for products


PSUR frequency and DLP
838 for chemical poisoning), hydroxocobalamin / 27/11/1969 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00000838/203409 NAP
amended on 23/10/2024
cobamamide

PSUR frequency amended and


840 cocaine 14/04/1999 5 years 13/04/2026 12/07/2026 No 31/01/2024 PSUSA/00000840/202604 none NAP
DLP updated on 31/01/2024

PSUR frequency and DLP


841 cocarboxylase Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000841/202411 Guðrún Stefánsdóttir Iceland NAP
amended on 27/03/2024

PSUR frequency amended and


843 codeine 06/09/1954 8 years 31/01/2025 01/05/2025 No 30/04/2024 PSUSA/00000843/202501 Petar Mas Croatia NAP
DLP updated on 30/04/2024

PSUR frequency and DLP


845 codeine / diclofenac 07/07/1992 8 years 03/07/2025 01/10/2025 No 31/07/2024 PSUSA/00000845/202507 NAP
amended on 31/07/2024

PSUR frequency amended and


847 codeine / erysimum Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00000847/202512 Zoubida Amimour France NAP
DLP updated on 31/07/2024

PSUR frequency amended and


848 codeine / ethylmorphine hydrochloride Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00000848/202512 Zoubida Amimour France NAP
DLP updated on 31/07/2024

PSUR frequency amended and


850 codeine / ibuprofen 05/03/1993 5 years 02/12/2028 02/03/2029 No 31/07/2024 PSUSA/00000850/202812 Tiphaine Vaillant France NAP
DLP updated on 31/07/2024

PSUR frequency amended and


851 codeine / paracetamol 01/09/1972 8 years 03/03/2025 01/06/2025 No 03/07/2024 PSUSA/00000851/202503 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

PSUR frequency and DLP


863 colecalciferol / sodium fluoride 22/01/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00000863/202811 NAP
amended on 31/07/2024

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

PSUR frequency and DLP


865 colestipol 25/06/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00000865/202808 NAP
amended on 31/07/2024

PSUR frequency amended and


866 colestyramine 02/04/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00000866/202803 NAP
DLP updated on 28/08/2024

Updated & published on


868 colistin sulphate 17/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00000868/203405 NAP
23/10/2024

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

DLP was updated on 01/07/2020


875 corifollitropin alfa 25/01/2010 3 years 24/07/2026 22/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00000875/202607 Bianca Mulder Netherlands CAP
PRAC Rapporteur name updated
on 06/10/2015
876 corticorelin 01/10/1988 5 years 31/10/2024 29/01/2025 No 01/07/2020 PSUSA/00000876/202410 Jan Neuhauser Austria NAP
PSUR Frequency and Next DLP
amended on 16/07/2015
PSUR frequency and DLP
878 cortisone 18/06/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PRAC Rapporteur name and PSUSA/00000878/203401 NAP
amended on 23/10/2024
country updated on 01/12/2014
DLP was updated on 19/10/2022
chloramphenicol / cortisone acetate / ethacridine PSUR frequency and DLP
879 25/06/1949 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUSA/00000879/204005 NAP
lactate / zinc oxide amended
PRAC on 23/10/2024
Rapporteur name updated
on 23/10/2018

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

DLP was amended on 15/11/2017


PSUR frequency and DLP
884 crotamiton 14/11/1946 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00000884/203611 NAP
Lead MS was
amended added on
on 23/10/2024
22/09/2016
PSUR frequency and DLP
885 crotamiton / hydrocortisone 17/12/1963 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00000885/203406 NAP
amended on 23/10/2024

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 15 / 223
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

PSUR frequency and DLP


888 cyanocobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00000888/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


889 cyanocobalamin / folic acid Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000889/202411 Martin Huber Germany NAP
amended on 27/03/2024

PSUR frequency and DLP


892 cyanocobalamin / folic acid / potassium iodide Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000892/202411 Ana Sofia Diniz Martins Portugal NAP
amended on 27/03/2024

PSUR frequency and DLP


893 cyanocobalamin / folic acid / pyridoxine Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00000893/202411 Martin Huber Germany NAP
amended on 27/03/2024

cyanocobalamin / l-arginine l-2 pyrrolidone-5- PSUR frequency and DLP


894 Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00000894/202603 NAP
carboxylate amended on 31/07/2024.

PSUR frequency amended and


896 cyclizine 02/02/1956 6 years 01/02/2032 01/05/2032 No 31/01/2024 PSUSA/00000896/203202 none NAP
DLP updated on 31/01/2024

PSUR frequency and DLP


898 cyclobenzaprine Not available* 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUSA/00000898/204006 NAP
amended on 23/10/2024

PSUR frequency and DLP


899 cyclopenthiazide 11/01/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00000899/203906 NAP
amended on 23/10/2024

PSUR frequency and DLP


900 cyclopentolate 19/02/1957 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00000900/203401 NAP
amended on 23/10/2024

PSUR frequency amended and


901 cyclophosphamide 13/10/1958 8 years 31/01/2025 01/05/2025 No 19/07/2024 PSUSA/00000901/202501 Martin Huber Germany NAP
DLP updated on 30/04/2024

PSUR frequency amended and


902 cyproheptadine 21/12/1961 5 years 31/12/2028 31/03/2029 No 25/09/2024 PSUSA/00000902/202812 Melinda Palfi Hungary NAP
DLP updated on 25/09/2024

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 and DLP


907 cyproterone acetate / estradiol valerate Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00000907/202603 NAP
amended on 31/07/2024.

PSUR frequency and DLP


908 cystine Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00000908/204003 NAP
amended on 23/10/2024

PSUR frequency and DLP


910 cystine / pyridoxine hydrochloride Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00000910/202603 NAP
amended on 31/07/2024.
Information included in column
911 cytarabine 11/07/2001 2 years 31/03/2025 29/06/2025 No 20/12/2023 "Are was
DLP PSURs required
amended onfor products
20/12/2023 PSUSA/00000911/202503 Melinda Palfi Hungary NAP
referred to in Articles 10(1), 10a,
PRAC representative was
14, 16a of Directive 2001/83/EC
updated on 01/03/2023
as amended?" was amended on
913 cytisine, cytisinicline 25/02/2009 13 years 24/02/2031 25/05/2031 Yes 28/02/2024 28/02/2024 PSUSA/00000913/203102 none NAP
DLP was updated on 20/10/2021
DLP was amended on 28/02/2024
Next DLP was amended on
914 cytomegalovirus immunoglobulin 29/12/1995 5 years 31/01/2026 01/05/2026 Yes 20/10/2021 19/10/2016
Active substance name was
PSUSA/00000914/202601 Gabriele Maurer Germany NAP
amended on 28/02/2024
The DLP was amended on
30/09/20145.
PSUR frequency amended and Marie Louise Schougaard
918 dabigatran 18/03/2008 3 years 18/03/2026 16/06/2026 No 15/11/2023 PSUSA/00000918/202603
Christiansen Denmark CAP
DLP updated on 15/11/2023
Lead MS was added on
13/07/2015
Next DLP was updated on
919 dacarbazine 01/02/1978 5 years 01/02/2028 01/05/2028 No 18/10/2023 PSUSA/00000919/202802 Jan Neuhauser Austria NAP
18/10/2023
PSUR frequency updated on
21/09/2022
PSUR frequency amended and
920 dactinomycin 01/07/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00000920/202803 NAP
DLP updated on 28/08/2024
DLP was updated on 28/04/2021

PRAC Rapporteur name was


922 dalteparin sodium 26/08/1985 2 years 31/08/2024 29/11/2024 No 21/09/2022 PSUSA/00000922/202408 Rugile Pilviniene Lithuania NAP
amended on 06/03/2019

Next DLP was amended on


923 danaparoid 01/12/1992 5 years 01/12/2028 01/03/2029 No 31/07/2024 03/05/2016
DLP was amended on 31/07/2024 PSUSA/00000923/202812 Eamon O'Murchu Ireland NAP

Lead MS added on 12/05/2015


PSUR frequency and DLP
924 danazol 10/06/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00000924/202808 NAP
amended on 31/07/2024

PSUR frequency and DLP


925 dantrolene 31/01/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00000925/202808 NAP
amended on 31/07/2024

PSUR frequency and DLP


927 dapiprazole 06/08/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00000927/202812 NAP
amended on 31/07/2024
DLP was updated on 25/05/2022

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

PRAC Rapporteur name was


amended on 03/04/2019
936 daunorubicin 08/06/1966 3 years 07/06/2027 05/09/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00000936/202706 Sonja Hrabcik Austria NAP
DLP was updated on 06/02/2019

DLP was amended on 31/01/2018

Next DLP was amended on


© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ30/01/2017 Page 16 / 223

Next DLP was amended on


04/02/2016

The DLP was amended on


04/02/2015
DLP was updated on 28/04/2022

PRAC representative was


updated on 29/07/2020

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

PSUR frequency amended and


939 deferasirox 28/08/2006 3 years 31/10/2025 29/01/2026 Yes 28/06/2023 DLP was amended
updated on 28/06/2023
on 03/04/2019 PSUSA/00000939/202510 Tiphaine Vaillant France CAP NAP
PSUR frequency and DLP were
updated
DLP was on 19/10/2022
updated on 07/05/2018
940 deferiprone 25/08/1999 3 years 31/08/2024 29/11/2024 No 28/04/2022 PRAC PSUSA/00000940/202408 Tiphaine Vaillant France CAP
PRAC representative
Rapporteur namewaswas
updated on
amended on29/07/2020
21/07/2017
PSUR frequency
PRAC amended and
representative
941 deferoxamine 01/12/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 DLP was updated andwas
PRAC PSUSA/00000941/202803 NAP
DLP updated
updated on 28/08/2024
on 03/06/2020
Representative amended on
28/03/2017
DLP was updated on 23/10/2019
PSUR frequency and DLP
943 deflazacort 26/03/1982 9 years 03/11/2028 01/02/2029 No 31/07/2024 PRAC Rapporteur name was PSUSA/00000943/202811 NAP
amended on 31/07/2024
PRAC Rapporteur
amended name updated
on 28/07/2016
on 21/07/2017
944 degarelix 17/02/2009 5 years 17/02/2027 18/05/2027 No 19/10/2022 Next DLP and PRAC Rapporteur PSUSA/00000944/202702 Tiphaine Vaillant France CAP
PSUR
name Frequency amended
were amended on and
New
DLP CAP authorised
updated on
on 22/09/2016
07/04/2016
16/05/2024
PSUR frequency and DLP
945 dehydrocholic acid Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PRAC Rapporteur name was PSUSA/00000945/202411 Roxana Dondera Romania NAP
amended
PRAC on 27/03/2024
Representative amended
amended on 28/07/2016
on 21/12/2022
PRAC frequency
PSUR Rapporteurand
name
DLPupdated
949 delorazepam 24/02/1978 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUR frequency
on 03/06/2016 and DLP were PSUSA/00000949/202811 NAP
amended on 31/07/2024
updated on 29/06/2022
Next DLP was amended on
PSUR frequency and DLP were
30/09/2015.
951 demeclocycline 23/08/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00000951/203408 NAP
amendedon
updated on06/05/2020
23/10/2024
DLP was amended on
denosumab (indicated for osteoporosis and for bone DLP was updated on 30/04/2019
01/04/2015.
954 loss associated with hormone ablation in prostate 26/05/2010 3 years 26/09/2024 25/12/2024 No 29/06/2022 PSUSA/00000954/202409 Mari Thorn Sweden CAP
cancer) DLP was updated on 07/05/2018

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

PSUR frequency and DLP


1000 dexpanthenol / dimethyl sulfoxide / heparin Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00001000/202603 NAP
amended on 31/07/2024.

Next DLP was updated on


1001 dexrazoxane 17/02/1992 1 year 28/02/2025 09/05/2025 28/02/2026 09/05/2026 No 18/10/2023 PSUSA/00001001/202502 PSUSA/00001001/202602 Tiphaine Vaillant France CAP NAP
18/10/2023

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 17 / 223
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

PRAC Representative was


1009 dextromethorphan 01/01/1966 5 years 01/11/2026 30/01/2027 No 26/07/2023 PSUSA/00001009/202611 Jean-Michel Dogné Belgium NAP
amended on 28/04/2022

DLP was updated on 03/07/2019


PSUR frequency and DLP
1010 dextromethorphan / guaifenesin Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001010/202411 Monica Martinez Redondo Spain NAP
amended on 27/03/2024
PRAC Representative was
amended on 18/11/2016
dextromethorphan hydrobromide / dichlorobenzyl PSUR frequency and DLP
1012 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 Next DLP was amended on PSUSA/00001012/202411 Amelia Cupelli Italy NAP
alcohol amended on 27/03/2024
28/07/2016

dextromethorphan hydrobromide / diphenhydramine PSUR frequency and DLP


1013 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 Lead MS added on 16/06/2015 PSUSA/00001013/202411 John Joseph Borg Malta NAP
hydrochloride / levomenthol amended on 27/03/2024

PSUR frequency and DLP were


dextromethorphan hydrobromide / paracetamol / PSUR frequency
updated amended and
on 22/09/2021
1015 Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00001015/203008 NAP
phenylpropanolamine hydrochloride DLP updated on 28/08/2024
PRAC representative was
dextromethorphan hydrobromide / pseudoephedrine updated
PSUR on 26/05/2021
frequency and DLP
1017 Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00001017/202603 NAP
hydrochloride amended on 31/07/2024.
PRAC Representative updated on
26/09/2018
dextromethorphan hydrobromide / pseudoephedrine PSUR frequency and DLP
1021 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001021/202411 Monica Martinez Redondo Spain NAP
hydrochloride / triprolidine hydrochloride amended
DLP on 27/03/2024
was updated on 31/07/2018

PSUR Frequency amended and


dextromethorphan hydrobromide / triprolidine PSUR frequency and DLP
1023 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 next DLP updated on 25/09/2017 PSUSA/00001023/202411 NAP
hydrochloride amended on 27/03/2024
'PRAC Rapporteur name updated
on 21/07/2017
1026 diacerein 12/08/2007 5 years 15/12/2025 15/03/2026 Yes 22/09/2021 PSUSA/00001026/202512 Tiphaine Vaillant France NAP
Next DLP and PRAC Rapporteur
name were amended on
PSUR frequency and DLP
1028 diamorphine Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 28/07/2016 PSUSA/00001028/202411 Liana Martirosyan Netherlands NAP
amended on 27/03/2024
DLP amended on 31/07/2015
PSUR frequency amended and
1029 diazepam 29/11/1963 8 years 03/03/2025 01/06/2025 No 26/07/2024 'Leadupdated
MS wason
added on PSUSA/00001029/202503 Karin Erneholm Denmark NAP
DLP 03/07/2024
22/12/2014

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

dicycloverine, dicyloverine/ paracetamol, PSUR frequency and DLP


1051 11/05/1950 11 years 03/05/2040 01/08/2040 Yes 23/10/2024 PSUSA/00001051/204005 NAP
dicycloverine/ doxylamine 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

PSUR frequency and DLP


1058 diethylamine salicylate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00001058/204003 NAP
amended on 23/10/2024

PSUR frequency amended and


1059 diethylcarbamazine 09/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001059/202806 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1060 diethylstilbestrol Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001060/202411 NAP
amended on 27/03/2024

PSUR frequency amended and


1061 diflucortolone Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00001061/203008 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1062 diflucortolone valerate / isoconazole nitrate Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00001062/203008 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1063 diflunisal Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001063/203011 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1064 digitoxin 11/09/1952 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00001064/203401 NAP
amended on 23/10/2024

PSUR frequency amended and


1065 digoxin, metildigoxin 01/11/1930 10 years 03/11/2032 01/02/2033 No 18/10/2023 PSUSA/00001065/203211 none NAP
DLP updated on 18/10/2023

PSUR frequency and DLP


1066 digoxin specific antibody fragments 05/10/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00001066/202812 NAP
amended on 31/07/2024

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

PSUR frequency amended and


1082 diiodohydroxyquinoline Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001082/203011 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1083 diisopropylamine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001083/203011 NAP
DLP updated on 28/08/2024

PRAC Rapporteur name was


1084 diltiazem 02/05/1979 5 years 02/05/2027 31/07/2027 No 16/10/2023 PSUSA/00001084/202705 Karin Erneholm Denmark NAP
amended on 18/10/2023

Active substance name, PSUR


1088 caffeine / dimenhydrinate, dimenhydrinate 10/02/1950 8 years 01/12/2025 01/03/2026 No 15/01/2025 frequency and DLP were PSUSA/00001088/202512 Maria del Pilar Rayon Spain NAP
amended on 18/10/2023

PSUR frequency and DLP


1089 dimercaptosuccinic acid (dmsa) 31/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00001089/202812 NAP
amended on 31/07/2024

PSUR frequency and DLP


1093 dimethyl sulfoxide Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001093/202411 Polona Golmajer Slovenia NAP
amended on 27/03/2024

PSUR frequency and DLP


1094 dimeticone 17/11/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00001094/203406 NAP
amended on 23/10/2024

aluminium hydroxide gel / dimeticone / magnesium PSUR frequency amended and


1095 Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00001095/202903 NAP
hydroxide DLP updated on 28/08/2024

PSUR frequency and DLP


1097 clebopride / dimeticone Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUSA/00001097/202912 NAP
amended on 28/08/2024.
Active substance name was
amended on 25/09/2024
dihydroxyaluminum sodium carbonate,
1098 Not available* 7 years 03/11/2024 01/02/2025 No 25/09/2024 PSUSA/00001098/202411 Ana Sofia Diniz Martins Portugal NAP
dihydroxyaluminum sodium carbonate / dimeticone
PSUR frequency and DLP
amended on 27/03/2024
PSUR frequency and DLP
1099 dimeticone / guaiazulene Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00001099/202603 NAP
amended on 31/07/2024.

dimeticone / metoclopramide / oxazepam PSUR frequency and DLP


1100 Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00001100/203506 NAP
hemisuccinate / polyenzymes amended on 23/10/2024
PRAC representative was
Updated on
updated & published on
27/07/2022
1101 dimetindene 01/08/1961 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00001101/203405 NAP
23/10/2024
DLP was updated on 31/03/2021

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

PSUR frequency and DLP


1105 diosmectite 12/11/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00001105/202808 NAP
amended on 31/07/2024

PSUR frequency amended and


1106 diosmin Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001106/203011 NAP
DLP updated on 28/08/2024

diosmin / hesperidin, ascorbic acid/ dry Ruscus extract


PSUR frequency amended and
1107 titrated in sterolic heterosides/ Hesperidin methyl Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001107/203011 Polona Golmajer Slovenia NAP
DLP updated on 28/08/2024
chalcone

PSUR frequency and DLP


1110 diphenhydramine / paracetamol Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001110/202411 Rhea Fitzgerald Ireland NAP
amended on 27/03/2024

PSUR frequency amended and


1112 dexamethasone / diphenhydramine hydrochloride Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00001112/203003 NAP
DLP updated on 28/08/2024

allantoin / dexpanthenol / diphenhydramine PSUR frequency amended and


1113 Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00001113/202903 NAP
hydrochloride DLP updated on 28/08/2024

codeine phosphate / diphenhydramine hydrochloride / PSUR frequency amended and


1115 Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00001115/203003 NAP
levomenthol DLP updated on 28/08/2024

PSUR frequency amended and


1116 diphenhydramine hydrochloride / lorazepam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001116/203011 NAP
anhydrous caffeine / codeine phosphate / DLP updated on 28/08/2024
diphenhydramine hydrochloride / paracetamol,
caffeine / codeine phosphate / diphenhydramine
PSUR frequency amended and
1117 hydrochloride / paracetamol / phenylephrine Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00001117/202903 NAP
DLP updated on 28/08/2024
hydrochloride / ascorbic acid, caffeine / codeine
phosphate / diphenhydramine hydrochloride /
paracetamol / phenylephrine
diphenhydramine hydrochloride
hydrochloride / paracetamol / PSUR frequency amended and
1118 Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001118/203011 NAP
pseudoephedrine hydrochloride DLP updated on 28/08/2024

ammonium chloride / diphenhydramine hydrochloride / PSUR frequency amended and


1119 Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00001119/202903 NAP
sodium citrate DLP updated on 28/08/2024

PSUR frequency and DLP


1120 diphenhydramine hydrochloride / zinc oxide Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001120/202411 Guðrún Stefánsdóttir Iceland NAP
amended on 27/03/2024
diphtheria / tetanus / pertussis antigens (pertussis
toxoid, filamentous haemagglutinin, pertactin)
1122 (acellular, component) / hepatitis b (rdna) / 23/10/2000 3 years 22/10/2026 20/01/2027 No 03/07/2024 DLP was
PRAC amended onwas
representative 03/07/2024 PSUSA/00001122/202610 Jean-Michel Dogné Belgium CAP
poliomyelitis (inactivated) / haemophilus type b updated on 01/03/2023
conjugate vaccines (adsorbed)
diphtheria / tetanus / pertussis (acellular, component) / Active substance name corrected
1124 27/06/1997 3 years 13/11/2026 11/02/2027 No 31/07/2024 DLP was amended
DLP DLP
was updated on
on16/11/2022
31/07/2024 PSUSA/00001124/202611 Gabriele Maurer Germany NAP
poliomyelitis (inactivated) / haemophilus type b and was updated on
conjugate vaccine (adsorbed) 03/03/2021
DLP was updated on 19/12/2017
diphtheria / tetanus / pertussis (acellular, component)
vaccine (adsorbed), diphtheria / tetanus / pertussis PRAC Rapporteur name was
1125 17/03/1995 5 years 16/03/2027 14/06/2027 No 16/11/2022 Lead MS and PRAC Rapporteur PSUSA/00001125/202703 Gabriele Maurer Germany NAP
(acellular, component) vaccine (adsorbed) reduced amended on 03/04/2019
name was added on 19/10/2016
antigens contents
diphtheria / tetanus / pertussis (acellular, component)
and poliomyelitis (inactivated) vaccine (adsorbed), Nextwas
DLP DLPupdated
was amended on
on 05/04/2023
The DLP was amended on Marie Louise Schougaard
1126 diphtheria / tetanus / pertussis (acellular, component) 08/07/1991 5 years 08/07/2025 06/10/2025 No 03/03/2021 07/04/2016
30/09/2015
PSUSA/00001126/202507
Christiansen Denmark NAP
and poliomyelitis (inactivated) vaccine (adsorbed, PRAC representative was
reduced antigen(s) content) EURD and
updated Next DLP was
Name of on 01/03/2023
active substance was
diphtheria / tetanus / poliomyelitis (inactivated) amended on 21/12/2015.
1127 05/02/1999 5 years 04/08/2027 02/11/2027 No 05/04/2023 amended on 28/03/2013 PSUSA/00001127/202708 Gabriele Maurer Germany NAP
vaccine (adsorbed, reduced antigens(s) content) 07/05/2018
DLP was updated on 03/02/2021
Lead MS added on 01/04/2015.
PRAC name
Entry representative and Lead
updated on
diphtheria / tetanus vaccines (adsorbed), diphtheria
1128 10/05/1990 5 years 09/05/2025 07/08/2025 No 03/02/2021 Name of State
Member
07/05/2018activewere
substance
added was
on PSUSA/00001128/202505 Gabriele Maurer Germany NAP
vaccines (adsorbed) amended on 28/03/2013
30/01/2017
Next DLP was amended on
04/02/2016
PSUR frequency and DLP
1135 diprophylline, diprophylline / turpentine oil Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUSA/00001135/204004 Amelia Cupelli Italy NAP
amended on 23/10/2024
Lead MS was added on
06/03/2015
PSUR frequency and DLP
1138 dipyridamole 11/11/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00001138/202712 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 19 / 223
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

disodium phosphate dodecahydrate / sodium PSUR frequency and DLP


1142 31/12/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00001142/203401 NAP
dihydrogen phosphate dihydrate amended on 23/10/2024

PSUR frequency and DLP


1143 disopyramide 18/04/1967 9 years 02/04/2028 01/07/2028 No 15/01/2025 PSUSA/00001143/202804 Jean-Michel Dogné Belgium NAP
amended on 31/07/2024

PSUR frequency and DLP


1144 distigmine 01/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00001144/202811 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

Correction of DLP on 23/09/2020


1151 dobutamine 21/03/1977 3 years 01/03/2027 30/05/2027 No 19/09/2024 PSUSA/00001151/202703 Zoubida Amimour France NAP
PSUR frequency and DLP were
updated on 29/07/2020
DLP was
PSUR updatedamended
frequency on 27/07/2022
and
1152 docetaxel 25/11/1995 5 years 30/11/2027 28/02/2028 No 26/07/2023 DLP was updated on 21/07/2017 PSUSA/00001152/202711 Tiphaine Vaillant France CAP NAP
DLP updated on 26/07/2023
Lead MS and PRAC Rapporteur
PRAC Representative
name amended
amended on 19/12/2018
on 18/11/2016
1158 domperidone 01/03/1978 5 years 19/11/2024 17/02/2025 No 28/04/2022 PSUSA/00001158/202411 Jo Robays Belgium NAP
Next DLP was amended on
PRAC Request to receive a PSUR
25/09/2017
early 2017. Therefore the next
1160 donepezil 25/11/1996 5 years 25/11/2026 23/02/2027 No 27/07/2022 PSUR MS
Lead willand
cover the Rapporteur
PRAC period from PSUSA/00001160/202611 Martin Huber Germany NAP
the DLP
name of added
was the lastonPSUR
28/07/2016
submitted to 19/11/2016.
Information
PSUR included
frequency in column
and DLP
1161 dopamine 09/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSURPSURs
Frequency and for
DLPproducts
was PSUSA/00001161/202808 NAP
"Are
amended onrequired
31/07/2024
amendedtoon
referred in30/09/2015
Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
PSUR
DLP
Lead
as frequency
was
MS amended
was added
amended?" amended
was on andon
on03/05/2023
amended
1162 dopexamine 13/11/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00001162/202901 NAP
DLP updated on 28/08/2024
22/12/2014
30/11/2012
Lead MS and PRAC Rapporteur
name amended
The active on 19/12/2018
substance name was
1164 dornase alfa 03/09/1993 5 years 02/09/2027 01/12/2027 No 03/05/2023 amended on 01/12/2014 PSUSA/00001164/202709 Jana Lukačišinová Czech Republic NAP
DLP was updated on 06/06/2018

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

PSUR frequency amended and


1167 dosulepin 17/04/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001167/202806 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1168 doxapram hydrochloride 18/12/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00001168/203408 NAP
amended on 23/10/2024

PSUR frequency amended and


1169 doxazosin 18/12/1986 7 years 17/12/2030 17/03/2031 No 25/09/2024 PSUSA/00001169/203012 Karin Erneholm Denmark NAP
DLP updated on 25/09/2024

PSUR frequency and DLP


1170 doxepin 01/08/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUSA/00001170/202805 NAP
amended on 31/07/2024

PSUR frequency amended and


1172 doxorubicin 21/06/1996 5 years 12/11/2027 10/02/2028 No 28/06/2022 PSUSA/00001172/202711 Eva Jirsová Czech Republic CAP NAP
DLP updated on 28/06/2023

PSUR frequency amended and


1173 doxycycline 05/05/1967 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00001173/202503 Liana Martirosyan Netherlands NAP
DLP updated on 03/07/2024

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

PRAC representative updated on


1184 drospirenone / estradiol 07/03/2000 5 years 10/12/2024 10/03/2025 No 31/01/2024 PSUSA/00001184/202412 Bianca Mulder Netherlands NAP
31/01/2024

PSUR frequency amended and


1186 drotaverine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001186/203011 none NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1187 duloxetine 11/08/2004 5 years 03/08/2028 01/11/2028 No 30/04/2024 PSUSA/00001187/202808 Maria del Pilar Rayon Spain CAP NAP
DLP updated on 30/04/2024
Correction of DLP on 20/11/2024
1188 ossein hydroxyapatite compound Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 PSUSA/00001188/202611 Gudrun Thengilsdottir Iceland NAP
PSUR frequency and DLP
amended on 23/10/2024
PSUR frequency amended and
1190 dydrogesterone 22/04/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUSA/00001190/202802 NAP
DLP updated on 28/08/2024
PSUR frequency and DLP were
updated on 21/12/2022
Next DLP was updated on Marie Louise Schougaard
1191 ebastine 01/01/1996 5 years 31/05/2028 29/08/2028 No 31/01/2024 PSUSA/00001191/202805
Christiansen Denmark NAP
31/01/2024
PSUR frequency and DLP were
updated on 18/12/2019
Next DLP was updated on
1195 econazole, econazole nitrate / triamcinolone acetonide 04/01/1974 5 years 16/11/2027 14/02/2028 No 26/07/2023 DLP was updated on 19/12/2018 PSUSA/00001195/202711 Melinda Palfi Hungary NAP
26/07/2023
DLP was updated on 19/12/2017
1198 eculizumab 20/06/2007 2 years 01/10/2025 30/12/2025 No 05/06/2024 Entry re-introduced
DLP was amended on and
05/06/2024 PSUSA/00001198/202510 Monica Martinez Redondo Spain CAP
Reference to
reference to NAP
NAP added
added on
on
23/05/2017
27/03/2024

1200 efavirenz 28/05/1999 5 years 16/04/2027 15/07/2027 No 21/12/2022 Correction ofincluded


Information PRAC Rapporteur
in column PSUSA/00001200/202704 Ana Sofia Diniz Martins Portugal CAP NAP
namePSURs
"Are on 28/02/2017
required for products
referred to in Articles 10(1), 10a,
Next16a
14, DLPofwas updated
Directive on
2001/83/EC
1201 efavirenz / emtricitabine / tenofovir 13/12/2007 5 years 12/07/2026 10/10/2026 Yes 27/03/2024
18/11/2016
PSUSA/00001201/202607 Martin Huber Germany CAP NAP
as amended?" and PSUR
frequency amended on
PSUR Frequency and Next DLP
28/04/2022
was amended on 21/12/2015.
Next DLP was updated on
"Are PSURs required for products
06/03/2019
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Classified as internal/staff contractors by the Europreferred to in Articles 10(1), 10a, Page 20 / 223
14 and 16a of Directive
#

Next DLP updated on 04/03/2016


2001/83/EC as amended?Yes/No"
was amended on 06/03/2015
DLP was updated on 20/10/2021

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

Next DLP was amended on


03/05/2016
1209 emtricitabine 24/10/2003 3 years 02/04/2026 01/07/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00001209/202604 Ana Sofia Diniz Martins Portugal 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

PRAC Rapporteur name was


1212 enalapril / hydrochlorothiazide 24/03/2002 5 years 26/07/2027 24/10/2027 No 16/10/2023 PSUSA/00001212/202707 Karin Erneholm Denmark NAP
amended on 18/10/2023

DLP and PSUR frequency


1213 enalapril / nitrendipine 08/01/2002 7 years 08/01/2030 08/04/2030 No 20/09/2023 PSUSA/00001213/203001 Maria del Pilar Rayon Spain NAP
amended on 20/09/2023

PSUR frequency amended and


1214 enalapril maleate / felodipine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001214/203011 NAP
DLP updated on 28/08/2024

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

DLP was updated on 17/11/2021


PSUR frequency and DLP
1216 enflurane 29/04/1972 10 years 01/12/2024 01/03/2025 No 23/10/2024 PSUSA/00001216/202412 NAP
amended on 23/10/2024
PRAC Rapporteur name was
amended on 31/07/2018
1217 enfuvirtide 27/05/2003 5 years 12/03/2026 10/06/2026 No 17/11/2021 PSUSA/00001217/202603 Mari Thorn Sweden CAP
Next DLP and PSUR frequency
was amended on 19/10/2016
PSUR frequency amended and
1220 enoximone 27/10/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 Next DLP was amended on PSUSA/00001220/202901 NAP
DLP updated on 28/08/2024
29/10/2015

PSUR frequency amended and


1221 enoxolone 28/09/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUSA/00001221/202901 NAP
updated
DLP was on 28/08/2024
updated on 21/09/2022

DLP was updated on 25/09/2019


1223 entacapone 16/09/1998 3 years 16/01/2025 16/04/2025 No 21/09/2022 PSUSA/00001223/202501 Terhi Lehtinen Finland CAP
Nextwas
DLP DLPupdated
was updated and
on 21/12/2022
reference to NAP products
deleted
PRAC on 22/09/2016
Rapporteur name was
1224 entecavir 26/06/2006 5 years 28/03/2027 26/06/2027 No 21/12/2022 PSUSA/00001224/202703 Mari Thorn Sweden CAP
amended on 31/07/2018

DLP was amended on 15/11/2017


PSUR frequency and DLP
1225 eosine Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00001225/202603 NAP
amended on 31/07/2024.

PSUR frequency and DLP


1228 ephedrine 15/05/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00001228/203212 NAP
amended on 23/10/2024

PSUR frequency amended and


1229 ephedrine hydrochloride / glaucine hydrobromide Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 Next DLP was updated on PSUSA/00001229/203011 NAP
DLP updated on 28/08/2024
28/06/2023

DLP was updated on 04/07/2018


1231 epinastine 18/10/2002 5 years 31/10/2027 29/01/2028 No 28/06/2023 PSUSA/00001231/202710 Karin Bolin Sweden NAP
PRAC representative and Lead
Member State were added on
Active
DLP substance
was updated name was
on 30/06/2021
1232 epinephrine (except for nasal use) 15/05/1952 5 years 15/07/2025 13/10/2025 No 16/01/2025 28/03/2017 PSUSA/00001232/202507 Zoubida Amimour France NAP
amended on 25/09/2024
PRAC representative was added
on 06/05/2020
1233 epinephrine / lidocaine 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 PSUSA/00001233/202809 Eamon O'Murchu Ireland NAP
LMS was
DLP was updated
added onon
01/04/2020
28/04/2022

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

belladonna alkaloids / caffeine / ergotamine tartrate / PSUR frequency and DLP


1252 Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00001252/202905 NAP
paracetamol amended on 31/07/2024
New CAP authorised on
15/07/2022
belladonna alkaloids / ergotamine tartrate / PSUR frequency and DLP
1253 Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00001253/202905 NAP
phenobarbital amended
PSUR on 31/07/2024
frequency, DLP and
Information included in column
"Are
PSURPSURs required
frequency for products
amended and
1254 eribulin 15/11/2010 5 years 14/11/2028 12/02/2029 No 31/07/2024 referred to in Articles 10(1), 10a, PSUSA/00001254/202811 Mari Thorn Sweden CAP
DLP updated on 31/07/2024
14, 16a of Directive 2001/83/EC
as amended?" were updated on
PSUR frequency amended and
16/12/2020 Marie Louise Schougaard
1255 erlotinib 19/09/2005 3 years 17/11/2026 15/02/2027 No 31/07/2024 PSUSA/00001255/202611
Christiansen Denmark CAP NAP
DLP updated on 31/07/2024
Reference to NAP added on
25/09/2019
1256 ertapenem 18/04/2002 5 years 29/03/2025 27/06/2025 No 16/12/2020 PSUSA/00001256/202503 Ana Sofia Diniz Martins Portugal CAP NAP
DLP
LMS was
and updated on 29/06/2022
PRAC representative
updated 05/06/2019
PRAC representative was
PSUR frequency amended and
1258 benzoyl peroxide / erythromycin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 updated on 22/12/2021 PSUSA/00001258/202906 NAP
was amended
DLP updated on 15/11/2017
on 28/08/2024
PRAC
PRAC representative
Representative was
was
udpated on
on06/05/2020
1259 erythromycin / tretinoin 24/10/2001 5 years 24/10/2026 22/01/2027 No 29/06/2022 amended 28/03/2017 PSUSA/00001259/202610 Anna Mareková Slovakia NAP
Next
PRACDLP was amended
Rapporteur on
name updated
27/06/2017
on 30/09/2015
PSUR
PRAC frequency amended
representative was and
1260 erythromycin / zinc acetate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001260/203011 NAP
DLP updated
updated on 28/08/2024
on 01/03/2023
PRAC representative
The next and Lead
DLP was amended on
Member State were added on
01/12/2014
DLP was updated on 31/03/2021
03/05/2016
1263 escherichia coli lysate 11/12/1987 5 years 31/07/2025 29/10/2025 No 31/03/2021 PSUSA/00001263/202507 Gabriele Maurer Germany NAP
Next DLP was amended on
07/04/2016
DLP was updated on 21/09/2022
Entry name amended on
1264 escherichia coli (living cells) Not available* 15 years 31/12/2026 31/03/2027 No 19/12/2018 DLP PSUSA/00001264/202612 NAP
Leadwas
MS updated
added onon
19/12/2018 28/04/2022
01/04/2015.
PRAC Rapporteur name was
amended
Entry nameonupdated
31/07/2018
on
1265 escitalopram 31/12/2001 5 years 31/12/2026 31/03/2027 No 21/09/2022 05/02/2020 PSUSA/00001265/202612 Karin Bolin Sweden NAP
Next DLP was amended on
25/09/2017
DLP was updated and
information included in column
1266 esketamine (except for centrally authorised products) 01/08/1997 5 years 31/08/2026 29/11/2026 No 28/04/2022 Lead PSURs
"Are MS andrequired
PRAC Rapporteur
for products PSUSA/00001266/202608 Terhi Lehtinen Finland NAP
name was
referred to added on 28/07/2016
in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?" was amended on
1267 eslicarbazepine acetate 21/04/2009 3 years 21/04/2027 20/07/2027 No 18/12/2024 DLP was amended on 18/12/2024
23/05/2017
PSUSA/00001267/202704 Martin Huber Germany CAP NAP

Lead MS and PRAC Rapporteur


PSUR
name frequency
was addedand DLP
on 07/04/2016
1268 esmolol 13/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00001268/202812 NAP
amended on 31/07/2024
DLP was updated on 01/02/2023
PSUR frequency amended and
1269 esomeprazole 10/03/2000 5 years 10/03/2029 08/06/2029 No 20/11/2024 PRAC Rapporteur name updated PSUSA/00001269/202903 Rugile Pilviniene Lithuania CAP NAP
DLP updated on 20/11/2024
on 23/10/2018

PRAC Representative updated on


1270 esomeprazole / naproxen Not available* 5 years 30/04/2027 29/07/2027 No 01/02/2023 PSUSA/00001270/202704 Liana Martirosyan Netherlands NAP
26/09/2018

DLP was amended on 31/01/2018


PSUR frequency and DLP
1271 estazolam 30/04/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00001271/202808 NAP
amended on 31/07/2024
Lead MS and PRAC Rapporteur
name was added on 19/10/2016
1276 dydrogesterone / estradiol 22/02/1995 7 years 02/12/2030 02/03/2031 No 19/09/2024 PSUSA/00001276/203012 Zoubida Amimour France NAP
DLP was updated on 21/12/2022
PSUR frequency and DLP
1277 estradiol / levonorgestrel Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PRAC Rapporteur name was PSUSA/00001277/202605 NAP
amended on 31/07/2024
amended on 22/09/2022

PRAC Rapporteur name updated


1278 estradiol / norethisterone 22/06/1996 5 years 31/03/2027 29/06/2027 No 21/12/2022 PSUSA/00001278/202703 Karin Bolin Sweden NAP
on 23/10/2018

DLP was updated on 19/12/2017


PSUR frequency and DLP
1279 estradiol / testosterone 01/03/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00001279/203503 NAP
amended on 23/10/2024
Lead MS and PRAC Rapporteur
name was added on 19/10/2016
PSUR frequency and DLP
1280 estradiol valerate / norgestrel Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PSUSA/00001280/202605 NAP
amended on 31/07/2024
Correction of DLP on 20/11/2024
1281 estramustine 02/09/1971 10 years 01/12/2034 01/03/2035 No 05/01/2025 PSUSA/00001281/203412 Tiphaine Vaillant France NAP
PSUR frequency and DLP
amended on 23/10/2024

1282 estriol 01/01/1957 15 years 31/12/2025 31/03/2026 No 01/10/2012 PSUSA/00001282/202512 NAP

PSUR frequency amended and


1283 estradiol / estriol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001283/203011 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1284 estradiol / estriol / levonorgestrel Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001284/203011 NAP
DLP updated on 28/08/2024

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

PSUR frequency and DLP


1293 etacrynic acid 14/05/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUSA/00001293/203912 NAP
amended on 23/10/2024

PSUR frequency amended and


1294 etamsylate 22/04/1987 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00001294/202506 Jana Lukačišinová Czech Republic NAP
DLP updated on 03/07/2024

PSUR frequency amended and


1296 ethacridine Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001296/203011 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1297 albumin tannate / ethacridine lactate monohydrate Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00001297/202903 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1298 ethambutol 17/10/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00001298/202712 NAP
amended on 31/07/2024

ethanol / povidone iodinated, povidone iodinated / PSUR frequency and DLP


1304 22/02/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00001304/202808 Zoubida Amimour France NAP
isopropyl alcohol amended on 31/07/2024

PSUR frequency and DLP


1305 ethanolamine Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001305/202606 NAP
amended on 31/07/2024

PSUR frequency amended and


1306 ethinylestradiol 01/06/1976 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00001306/202503 Amelia Cupelli Italy NAP
DLP updated on 03/07/2024

PRAC representative updated on


1307 ethinylestradiol / etonogestrel 12/06/2001 5 years 01/07/2025 29/09/2025 No 31/01/2024 PSUSA/00001307/202507 Bianca Mulder Netherlands NAP
31/01/2024

© 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

DLP was updated on 17/11/2021


DLP was updated on 21/12/2022
Active substance name was
amended on 05/06/2019
PRAC Rapporteur name was
amended on 28/04/2022
PRAC Rapporteur name was
amended on 03/04/2019
DLP was udpated on 18/12/2019
Next DLP was updated on
PRAC Rapporteur name was Marie Louise Schougaard
18/11/2016
1308 ethinylestradiol / gestodene 09/07/1986 5 years 16/03/2026 14/06/2026 No 17/11/2021 amended on 03/04/2019 PSUSA/00001308/202603
Christiansen Denmark NAP
Lead MS was added on
Next DLP was amended on
30/09/2015
20/12/2016 Marie Louise Schougaard
1309 ethinylestradiol / levonorgestrel 22/04/1965 3 years 13/04/2025 12/07/2025 No 21/12/2022 PSUSA/00001309/202504
Christiansen Denmark NAP
Name of entry was amended on
Lead Member State and PRAC
28/05/2014
DLP was updated on 29/07/2020
Rapporteur added on
1311 ethinylestradiol / norelgestromin 20/11/2001 5 years 19/11/2024 17/02/2025 No 29/07/2020 27/11/2015.
DLP was PSUSA/00001311/202411 Bianca Mulder Netherlands CAP
Next DLPupdated
Information onon
included
amended 29/06/2022
in column
"Are PSURs required for products
13/07/2015
Transferred
PRAC from the
Rapporteur nameListwas
of
referred to in Articles 10(1), 10a,
substances
PRAC under
representative
amended PSUR Work on
updated
1312 ethinylestradiol / norethisterone 07/08/1974 5 years 06/08/2027 04/11/2027 No 31/01/2024 14, 16a ofon 28/04/2022
Directive 2001/83/EC PSUSA/00001312/202708 Bianca Mulder Netherlands NAP
Sharing scheme
31/01/2024 and other
as amended?" was amended on
substances containedand
PRAC representative in LMS
30/11/2012
Nationally Authorised
were added on 31/03/2021 Products
Marie Louise Schougaard
1313 ethinylestradiol / norgestimate 29/10/1986 5 years 30/10/2026 28/01/2027 No 29/06/2022 with DLP synchronised on PSUSA/00001313/202610
Christiansen Denmark NAP
06/03/2015
Lead MS and PRAC Rapporteur
name removed on 05/02/2020
1316 ethosuximide 09/03/1961 3 years 09/03/2026 07/06/2026 No 15/11/2023 DLP was amended on 15/11/2023
DLP was updated on 21/07/2017
PSUSA/00001316/202603 Karin Erneholm Denmark NAP

Lead MS and PRAC Rapporteur


PSUR
name frequency
was addedamended and
1317 ethyl loflazepate 03/11/1980 8 years 03/03/2025 01/06/2025 No 26/07/2024 on 03/06/2016 PSUSA/00001317/202503 Jo Robays Belgium NAP
DLP updated on 03/07/2024

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

PSUR frequency and DLP


1319 ethylmorphine 19/07/1944 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUSA/00001319/204005 NAP
amended on 23/10/2024

Next DLP was updated on


1320 etidronate 30/09/1977 5 years 30/09/2027 29/12/2027 Yes 19/12/2018 PSUSA/00001320/202709 Rugile Pilviniene Lithuania NAP
31/05/2023

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

PSUR frequency and DLP


1322 etilefrine (except for treatment of priapism) 17/04/1952 12 years 03/06/2040 01/09/2040 No 23/10/2024 PSUSA/00001322/204006 Terhi Lehtinen Finland NAP
amended on 23/10/2024

PSUR frequency amended and


1323 etizolam 21/09/1983 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00001323/202505 Amelia Cupelli Italy NAP
DLP updated on 03/07/2024

PSUR frequency amended and


1324 etodolac 02/08/1984 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00001324/202505 Karin Erneholm Denmark NAP
DLP updated on 03/07/2024

PSUR frequency amended and


1325 etofenamate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001325/203011 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1326 benzyl nicotinate / etofenamate Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUSA/00001326/202512 NAP
DLP updated on 31/07/2024

PSUR frequency and DLP


1327 etofylline Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00001327/203506 NAP
amended on 23/10/2024

PSUR frequency and DLP


1329 etofylline / theophylline Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001329/202606 NAP
amended on 31/07/2024

Next DLP was updated on


1330 etomidate Not available* 5 years 30/09/2027 29/12/2027 No 06/06/2018 PSUSA/00001330/202709 Martin Huber Germany NAP
31/05/2023

PRAC representative updated on


1331 etonogestrel 25/08/1998 3 years 01/09/2024 30/11/2024 No 31/01/2024 PSUSA/00001331/202409 Bianca Mulder Netherlands NAP
31/01/2024

Next DLP was updated on


1333 etoposide 09/07/1980 3 years 16/02/2026 17/05/2026 No 18/10/2023 PSUSA/00001333/202602 Martin Huber Germany NAP
18/10/2023

PRAC representative updated on


1334 etoricoxib 13/02/2002 5 years 31/03/2027 29/06/2027 No 31/01/2024 PSUSA/00001334/202703 Carla Torre Portugal NAP
31/01/2024

Information included in column


1335 etravirine 28/08/2008 3 years 27/09/2026 26/12/2026 No 19/09/2024 "Are PSURs required for products PSUSA/00001335/202609 Zoubida Amimour France CAP
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?"
PSUR frequency was
andamended
DLP on
1337 etynodiol 25/10/1972 10 years 01/12/2024 01/03/2025 No 23/10/2024 18/12/2024 PSUSA/00001337/202412 NAP
amended on 23/10/2024
PSUR frequency amended and
PSUR frequency
DLP updated amended and
on 18/12/2024
1342 eugenol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00001342/203011 NAP
DLP updated on 28/08/2024
DLP updated on 22/12/2021
everolimus (indicated for astrocytoma (SEGA), renal
1343 02/09/2011 5 years 31/03/2029 29/06/2029 Yes 18/12/2024 Active substance name was PSUSA/00001343/202903 Martin Huber Germany CAP
angiomyolipoma, refractory seizures)
updated on 03/02/2021

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

Next DLP was amended on


1356 felodipine 31/12/1987 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023
03/03/2014 PSUSA/00001356/202712 Anna Mareková Slovakia NAP

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

PSUR frequency and DLP


1361 fenipentol Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00001361/202412 Anna Mareková Slovakia NAP
amended on 27/03/2024

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

PSUR frequency and DLP


1365 fenoprofen Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001365/202606 NAP
amended on 31/07/2024

Next DLP was updated on


1366 fenoterol (respiratory indications) 27/09/1965 5 years 27/09/2027 26/12/2027 No 06/06/2018 PSUSA/00001366/202709 Barbara Kovacic Bytyqi Croatia NAP
31/05/2023

PRAC representative updated on


1367 fenoterol / ipratropium 28/05/1980 5 years 02/02/2028 02/05/2028 No 31/01/2024 PSUSA/00001367/202802 Bianca Mulder Netherlands NAP
31/01/2024

Next DLP was updated on


1369 fentanyl (transmucosal route of administration) 04/04/2008 3 years 30/04/2026 29/07/2026 No 31/01/2024 PSUSA/00001369/202604 Tiphaine Vaillant France CAP NAP
31/01/2024

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

EURD was amended on


1392 finasteride 17/04/1998 2 years 31/08/2025 29/11/2025 No 30/04/2024 DLP was amended on 30/04/2024
01/10/2013
PSUSA/00001392/202508 Mari Thorn Sweden NAP

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

PSUR frequency amended and


1411 fludroxycortide Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 DLP PSUSA/00001411/203012 NAP
DLP was updated
updated on 21/09/2022
on 28/08/2024
DLP was updated on 25/09/2019
PSUR frequency and DLP
1412 fluindione 02/09/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUSA/00001412/202805 NAP
amended
PRAC on 31/07/2024
Rapporteur name updated
on 23/10/2018

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

PRAC Rapporteur name was


amended on 28/07/2016
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Classified as internal/staff contractors by the EuropLead Page 24 / 223
#

MS added on 31/07/2015.

Transferred from the List of


substances under PSUR Work
Sharing scheme and other
substances contained in
fluocinolone acetonide (all routes of administration PSUR frequency and DLP
1419 26/02/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00001419/203406 NAP
apart from intravitreal implant in applicator) amended on 23/10/2024

PSUR frequency amended and


1420 fluocinolone / metronidazole / nystatin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001420/203012 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1421 clioquinol / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 PSUSA/00001421/202912 NAP
amended on 28/08/2024.

PSUR frequency amended and


1423 fluocinolone acetonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001423/203012 NAP
DLP updated on 28/08/2024

bismuth subgallate / fluocinolone acetonide / PSUR frequency amended and


1424 Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00001424/202906 NAP
lidocaine / menthol DLP updated on 28/08/2024

PSUR frequency and DLP


1425 fluocinonide Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001425/202606 NAP
amended on 31/07/2024

PSUR frequency amended and


1426 fluocinonide / hexetidine / ruscogenin Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001426/203012 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1427 fluocinonide / lidocaine Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001427/203012 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1430 fluocortolone pivalate / lidocaine hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00001430/203012 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1431 fluorescein (topical ophthalmic use) 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00001431/203906 NAP
amended on 23/10/2024

PSUR frequency and DLP


1432 fluorescein / oxybuprocaine 12/04/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PRAC representative was PSUSA/00001432/203906 NAP
amended on 23/10/2024
updated on 29/07/2020

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

Lead MS and PRAC Rapporteur


name was added on 28/02/2017
1445 flupentixol / melitracene 31/01/1971 13 years 30/11/2036 28/02/2037 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001445/203611 Jana Lukačišinová Czech Republic NAP

PSUR frequency and DLP


1446 fluphenazine 18/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUSA/00001446/203905 NAP
amended on 23/10/2024

PSUR frequency and DLP


1448 fluprednidene / miconazole Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001448/202606 NAP
amended on 31/07/2024

PSUR frequency amended and


1449 flurazepam 02/03/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001449/202806 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1450 flurbiprofen 10/11/1976 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUSA/00001450/202711 Amelia Cupelli Italy NAP
DLP updated on 26/07/2023

PRAC Rapporteur name was


PSUR frequency
amended and DLP
on 22/09/2022
1452 fluspirilene 01/09/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 DLP was updated on 16/11/2022 PSUSA/00001452/202811 NAP
amended on 31/07/2024
DLP was updated on 01/07/2020
PRAC representative was
1453 flutamide 24/03/1982 5 years 23/10/2028 21/01/2029 Yes 03/07/2024 updated
DLP was on 28/07/2021
amended on 03/07/2024 PSUSA/00001453/202810 Martin Huber Germany NAP
PRAC Rapporteur name updated
on 23/10/2018
PRAC representative was
updated on 28/04/2021
1454 fluticasone propionate 08/03/1990 5 years 28/02/2027 29/05/2027 No 16/11/2022 PRAC Rapporteur name was PSUSA/00001454/202702 Polona Golmajer Slovenia NAP
amended on 31/07/2018
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
Entry name amended on
fluticasone / salmeterol (for nationally authorised
1455 25/10/1990 5 years 31/10/2024 29/01/2025 No 01/07/2020 18/11/2016
DLP was amended on 15/11/2017
PSUSA/00001455/202410 Mari Thorn Sweden NAP
products)
Next DLP was amended on
Lead MS was added on
28/07/2016
PSUR frequency and DLP
1456 flutrimazole 01/12/1994 8 years 03/08/2025 01/11/2025 No 05/01/2025 22/09/2016 PSUSA/00001456/202508 Monica Martinez Redondo Spain NAP
amended on 31/07/2024
DLP
"Are was
PSURsamended
updated onfor
on
required 03/05/2023
05/04/2023
products
PRAC Rapporteur
referred name
to in Articles was 10a,
10(1),
DLP
PRAC was updated
Rapporteur
amended on on2001/83/EC
06/06/2018
name
28/04/2022 was
1457 fluvastatin 23/08/1993 5 years 31/08/2027 29/11/2027 No 03/05/2023 14, 16a of Directive PSUSA/00001457/202708 Eva Jirsová Czech Republic NAP
amended on 06/03/2019
as amended? Yes/No" was
Lead
PRAC MS and PRAC
Rapporteur Rapporteur
name
amended on 16/07/2015 was
nameMS
Lead
amendedwas added
and
on PRAConRapporteur
28/02/2017
03/04/2019
1458 fluvoxamine 13/07/1983 5 years 31/07/2027 29/10/2027 No 05/04/2023 name Rapporteur
PRAC amended onname19/12/2018
and PSUSA/00001458/202707 Rugile Pilviniene Lithuania NAP
PSUR frequency
country updated amended and
on 01/12/2014
DLP
DLP was
was updated
updated
updated on
on 29/06/2022
07/05/2018
on 31/01/2018
Marie Louise Schougaard
1459 folic acid 13/12/1947 10 years 13/12/2027 12/03/2028 No 31/01/2018 PRAC Rapporteur PSUSA/00001459/202712 Denmark NAP
PRAC MS
Lead and PRACname
representative andwas
Lead
Rapporteur Christiansen
amended
Member
name wason
State28/04/2022
addedwere
on added on
19/10/2016
30/01/2017
1461 folic acid / nicotinamide Not available* 28 years 01/01/2040 31/03/2040 No 01/10/2012 PRAC representative
Information included was
in column PSUSA/00001461/204001 NAP
updated on required
"Are PSURs 31/03/2021for products
referred to in Articles 10(1), 10a,
PRAC representative
14, 16a was
of Directive 2001/83/EC
PRAC representative updated on
1463 follitropin alfa 20/10/1995 3 years 19/10/2024 17/01/2025 No 31/01/2024 updated on 25/09/2019
as amended?" was amended on PSUSA/00001463/202410 Bianca Mulder Netherlands CAP
31/01/2024
30/11/2012
NAP flag removed on 25/09/2019
Marie Louise Schougaard
1464 follitropin alfa / lutropin alfa 25/06/2007 3 years 19/10/2024 17/01/2025 No 29/06/2022 PSUSA/00001464/202410
Christiansen Denmark CAP
updated on
DLP was amended on03/07/2019
25/09/2024

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

LMS was added


Information on 01/04/2020
included in column
1476 fosphenytoin 05/08/1996 5 years 05/08/2025 03/11/2025 No 31/03/2021 PSUSA/00001476/202508 Eamon O'Murchu Ireland NAP
"Are PSURs required for products
PSUR frequency,
referred "Are 10(1),
to in Articles PSURs10a,
required
14, 16a offor products2001/83/EC
Directive referred to
1477 fotemustine 14/04/1989 8 years 03/06/2025 01/09/2025 No 30/10/2024 in Articles
as amended?"10(1),
was10a, 14, 16aon
amended of PSUSA/00001477/202506 Amelia Cupelli Italy NAP
Directive 2001/83/EC as
28/06/2023
amended?Yes/No" and DLP were
updated
PSUR on 25/09/2019
frequency amended
and DLP and
1478 framycetin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUSA/00001478/204004 NAP
DLP updated
amended on 28/06/2023
on 23/10/2024

PSUR frequency and DLP


1479 framycetin sulfate / lidocaine hydrochloride Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUSA/00001479/203101 NAP
amended on 23/10/2024

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

PSUR frequency amended and


1489 fulvestrant 10/03/2004 5 years 25/04/2028 24/07/2028 No 20/12/2023 PSUSA/00001489/202804 Mari Thorn Sweden CAP
DLP updated on 20/12/2023

PSUR frequency and DLP


1490 furazolidone Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001490/202606 NAP
amended on 31/07/2024

PRAC representative updated on


1491 furosemide 01/01/1955 5 years 01/01/2028 31/03/2028 No 31/01/2024 PSUSA/00001491/202801 Carla Torre Portugal NAP
31/01/2024

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

PSUR frequency and DLP


1494 furosemide / triamterene Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUSA/00001494/203101 NAP
amended on 23/10/2024
DLP was updated on 19/10/2022

DLP was updated on 23/10/2019


PSUR frequency and DLP
1498 fusidic acid / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 PSUSA/00001498/203101 NAP
amended on 23/10/2024
Next DLP was amended on
19/10/2016
1499 gabapentin 05/02/1993 3 years 01/02/2025 02/05/2025 No 19/10/2022 PSUSA/00001499/202502 Martin Huber Germany NAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14 and 16a of Directive
1500 gadobenic acid 22/07/1997 2 years 30/04/2025 29/07/2025 Yes 31/01/2024 PRAC Rapporteur
2001/83/EC
DLP was amended name was
as amended?Yes/No"
on 31/01/2024 PSUSA/00001500/202504 Martin Huber Germany NAP
amended
was on 22/09/2022
amended on 27/11/2015

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

DLP was updated on 18/11/2020


1509 gadoxetic acid disodium Not available* 2 years 30/04/2025 29/07/2025 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00001509/202504 Mari Thorn Sweden NAP
PRAC Rapporteur name was
amended on 31/07/2018
PSUR frequency and DLP
1511 galactose / palmitic acid 21/06/1995 8 years 03/08/2025 01/11/2025 No 31/07/2024 Next DLP was updated and PSUSA/00001511/202508 NAP
amended on 31/07/2024
information included in column
"Are PSURs required for products
referred to in Articles 10(1), 10a,
1512 galantamine 01/03/2000 5 years 01/03/2029 30/05/2029 No 18/11/2020 PSUSA/00001512/202903 Karin Bolin Sweden NAP
14, 16a of Directive 2001/83/EC
as amended?" was amended on
18/11/2016
PSUR frequency and DLP
1513 gallium (67ga) citrate 31/03/1972 10 years 01/12/2024 01/03/2025 No 05/01/2025 PSUSA/00001513/202412 Eva Jirsova Czech Republic NAP
amended on 23/10/2024
PRAC Rapporteur name amended
on 29/10/2015
PSURwas
DLP frequency
updatedamended and
on 01/03/2023
1514 gallopamil 30/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 Lead MS was onadded on PSUSA/00001514/202901 NAP
DLP updated 28/08/2024
30/09/2015
PRAC representative and DLP
were updated on 04/03/2020
PSUR frequency
PRAC amended
representative was and
1515 galsulfase 31/05/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 PSUSA/00001515/202705 Ana Sofia Diniz Martins Portugal CAP
DLP updated
updated on 05/02/2025
on 19/10/2022
PRAC Representative updated on
26/09/2018
DLP and PSUR frequency were
1516 ganciclovir 15/06/1988 3 years 14/06/2025 12/09/2025 No 01/03/2023 DLP was updated on 16/11/2022 PSUSA/00001516/202506 Liana Martirosyan Netherlands NAP
updated
Next DLPon
was02/03/2022
amended on
28/02/2017
New CAP authorised on
Next DLP was updated on
15/07/2022
1517 ganirelix 17/05/2000 5 years 28/02/2027 29/05/2027 No 16/11/2022 06/03/2019
Lead MS and PRAC Rapporteur PSUSA/00001517/202702 Kimmo Jaakkola Finland CAP
werewas
DLP added on 04/02/2016
updated on 17/10/2017
New CAP authorised on
27/09/2018
PSUSARapporteur
number was amended on
PRAC name amended
1518 gefitinib 24/06/2009 5 years 05/07/2026 03/10/2026 No 02/03/2022 06/10/2014
on 29/10/2015.
PSUSA/00001518/202607 Mari Thorn Sweden CAP
PRAC Rapporteur name was
amended on 23/10/2018
1519 gemcitabine 12/01/1995 5 years 12/01/2028 11/04/2028 No 20/09/2023 DLP amended on 20/09/2023
PSUR Frequency amended and
PSUSA/00001519/202801 Mari Thorn Sweden NAP
DLP updated on 04/02/2016
PSUR frequency amended
on and
1520 gemeprost 30/05/1984 8 years 03/05/2025 01/08/2025 No 30/10/2024 The DLP was amended PSUSA/00001520/202505 Karin Bolin Sweden NAP
DLP updated on 03/07/2024
06/03/2015

The DLP was amended on


03/03/2014

© 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

PSUR frequency amended and


1523 betamethasone / gentamicin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00001523/202906 NAP
28/06/2023
DLP updated on 28/08/2024

PSUR frequency amended and


1524 dexamethasone / gentamicin / tetryzoline Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00001524/203003 NAP
DLP updated on 28/08/2024

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

European Union reference date


PRAC representative
was amendedupdated on
1534 glimepiride 20/06/1995 5 years 20/06/2027 18/09/2027 No 31/01/2024 (EURD) on PSUSA/00001534/202706 Bianca Mulder Netherlands NAP
31/01/2024
28/06/2016

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

PSUR frequency and DLP


1536 glipizide / metformin Not available* 9 years 03/03/2031 01/06/2031 Yes 23/10/2024 PSUSA/00001536/203103 NAP
amended on 23/10/2024

PSUR frequency and DLP


1537 gliquidone 16/09/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00001537/204003 none NAP
amended on 23/10/2024
DLP amended on 20/11/2024
1538 glucagon (except for centrally authorised products) Not available* 8 years 30/06/2026 28/09/2026 No 31/07/2024 PSUSA/00001538/202606 Terhi Lehtinen Finland NAP
PSUR frequency and DLP
amended on 31/07/2024
PRAC Rapporteur name was
1539 glucosamine 31/07/1996 5 years 31/03/2027 29/06/2027 No 16/10/2023 PSUSA/00001539/202703 Karin Erneholm Denmark NAP
amended on 18/10/2023

calcium / glucose / glutathione disulphide / magnesium PSUR frequency amended and


1541 Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00001541/202906 NAP
/ potassium / sodium / sodium bicarbonate DLP updated on 28/08/2024

PSUR frequency and DLP


1544 benfotiamine / glutamate sodium / inositol Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00001544/202905 NAP
amended on 31/07/2024

PSUR frequency and DLP


1545 glutathione Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001545/202606 NAP
amended on 31/07/2024

PSUR frequency and DLP


1546 glutethimide 15/04/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00001546/203503 NAP
amended on 23/10/2024

PSUR frequency and DLP


1548 glycerol Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001548/202606 none NAP
amended on 31/07/2024

PSUR frequency and DLP


1549 glycerol / paraffin liquid / vaselin Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00001549/202606 NAP
amended on 31/07/2024

PSUR frequency and DLP


1550 glycerol / sucrose Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PRAC representative was PSUSA/00001550/203103 NAP
amended on 23/10/2024
updated on 28/07/2021

glycerol / lecithin / soybean oil / triglycerides medium- PSUR frequency


PRAC and DLP
representative was
1551 Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00001551/203103 NAP
chain amendedon
updated on28/04/2021
23/10/2024

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

PSUR frequency and DLP


1561 gonadorelin 29/08/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 DLP was updated on 02/02/2022 PSUSA/00001561/203503 NAP
amended on 23/10/2024
Next DLP was amended on
30/01/2017
1562 goserelin 12/05/1987 5 years 12/05/2026 10/08/2026 No 02/02/2022 PSUSA/00001562/202605 Martin Huber Germany NAP
PRAC Rapporteur and Lead
Member State added on
PSUR frequency and DLP
1563 gramicidin Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 27/11/2015. PSUSA/00001563/203103 NAP
amended on 23/10/2024
Name of active substance was
benzocaine / cetylpyridinium chloride / dichlorobenzyl amended
PSUR on 25/05/2022
frequency amended and
1564 Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00001564/202512 Terhi Lehtinen Finland NAP
alcohol / gramicidin DLP updated on 31/07/2024
PRAC representative was
updated on 22/12/2021
PSUR frequency and DLP
1567 gramicidin / neomycin sulfate / polymyxin b sulphate Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUSA/00001567/202608 NAP
amended
DLP on 23/10/2024
was updated on 20/10/2021

PRAC representative was


1568 granisetron (all formulations except transdermal patch) 19/02/1991 5 years 18/02/2026 19/05/2026 No 25/05/2022 updated on 06/05/2020 PSUSA/00001568/202602 Anna Mareková Slovakia NAP

Next DLP was updated on


18/11/2016
PSUR frequency and DLP
1572 griseofulvin 16/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00001572/203401 NAP
amended on 23/10/2024
PRAC Rapporteur name and
country updated on 29/10/2015.
PSUR frequency and DLP
1573 guaiazulene Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00001573/203103 NAP
amended
Name on 23/10/2024
of active substance was
amended on 31/05/2013

© 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

ammonium chloride / codeine phosphate PSUR frequency and DLP


1575 Not available* 8 years 03/11/2025 01/02/2026 No 31/07/2024 PSUSA/00001575/202511 NAP
hemihydrate / guaifenesin / thyme oil amended on 31/07/2024

PSUR frequency and DLP


1576 codeine / guaifenesin Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00001576/202411 Jan Neuhauser Austria NAP
amended on 27/03/2024
Active substance name was
amended on 23/10/2024
guaifenesin / pseudoephedrine / triprolidine,
1580 Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUSA/00001580/202608 none NAP
guaifenesin / pseudoephedrine
PSUR frequency and DLP
haemophilus influenzae / klebsiella ozaenae / klebsiella amended on 23/10/2024
pneumoniae / moraxella catarrhalis / staphylococcus
1582 26/09/1983 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001582/202712 Gabriele Maurer Germany NAP
aureus / streptococcus pneumoniae / streptococcus
pyogenes / streptococcus viridans vaccine
haemophilus type b and meningococcal group C Next DLP was updated on
1583 19/12/2005 3 years 01/02/2026 02/05/2026 No 18/10/2023 PSUSA/00001583/202602 Jean-Michel Dogné Belgium NAP
conjugate vaccine 18/10/2023

Next DLP was updated on


1584 haemophilus type b conjugate vaccines 06/02/1992 3 years 06/02/2026 07/05/2026 No 18/10/2023 PSUSA/00001584/202602 Jean-Michel Dogné Belgium NAP
18/10/2023

1587 haloperidol 25/04/1960 14 years 24/01/2025 24/04/2025 No 01/10/2012 PSUSA/00001587/202501 Maia Uusküla Estonia NAP

PSUR frequency and DLP


1588 halothane Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUSA/00001588/202608 NAP
amended on 23/10/2024

PSUR frequency and DLP


1589 heparin 31/03/1939 9 years 08/11/2027 06/02/2028 No 31/07/2024 PSUSA/00001589/202711 none NAP
amended on 31/07/2024

PSUR frequency and DLP


1591 heparinoid 01/05/1964 10 years 03/06/2034 01/09/2034 No 15/01/2025 PSUSA/00001591/203406 Anna Mareková Slovakia NAP
amended on 23/10/2024
DLP was updated on 25/05/2022
PSUR frequency and DLP
1592 heparinoid / ibuprofen Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 DLP was updated on 05/06/2019 PSUSA/00001592/202611 NAP
amended on 23/10/2024
Lead MS and PRAC Rapporteur
hepatitis a (inactivated) / hepatitis b (rdna) vaccines name added on 21/11/2018
1593 20/09/1996 3 years 20/09/2024 19/12/2024 No 25/05/2022 PSUSA/00001593/202409 Jean-Michel Dogné Belgium CAP
(adsorbed) DLP was updated on 19/10/2022
PRAC Representative amended
on 28/03/2017
DLP was updated on 21/10/2020
hepatitis a (inactivated) / typhoid polysaccharide
1594 22/06/1999 3 years 22/06/2026 20/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00001594/202606 Gabriele Maurer Germany NAP
vaccine (adsorbed)
PSUR Frequency
PRAC amended
representative was and
DLP updated
updated on 03/05/2016
01/03/2023
on 23/09/2020
1596 hepatitis A vaccines (inactivated, adsorbed) 01/01/1992 5 years 01/01/2029 01/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00001596/202901 Gabriele Maurer Germany NAP
PSUR frequency
Reference to NAPand DLP were
removed on
updated on 21/10/2020
01/07/2020

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

PSUR submission frequency was


PSUR frequency and DLP
1603 chlorocresol / chlorhexidine / hexamidine Not available* 7 years 03/08/2024 01/11/2024 No 27/03/2024 corrected on 06/03/2015 PSUSA/00001603/202408 Zoubida Amimour France NAP
amended on 27/03/2024
PRAC Rapporteur name was
Name of active
amended substance was
on 22/09/2022
amended
PSUR on 31/05/2013
frequency and DLP
1604 hexamidine / lidocaine 29/03/1951 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUSA/00001604/203612 Zoubida Amimour France NAP
amended
DLP on 23/10/2024
was updated on 03/06/2020

PRAC Rapporteur name was


1606 hexaminolevulinate hydrochloride 17/09/2004 5 years 16/09/2024 15/12/2024 No 03/06/2020 amended on 23/10/2018 PSUSA/00001606/202409 Mari Thorn Sweden NAP

PRAC Rapporteur name was


amended
PSUR on 31/07/2018
frequency and DLP
1607 hexetidine Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUSA/00001607/203502 NAP
amended on 31/07/2024
PRAC Rapporteur name and
country updated on 01/12/2014
PSUR frequency and DLP
1608 hexylresorcinol Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUSA/00001608/203106 NAP
amended on 23/10/2024

PSUR frequency and DLP


1609 hidrosmin Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUSA/00001609/203106 NAP
amended on 23/10/2024
PRAC representative was
updated on 01/03/2023
1610 histamine (indicated for acute myeloid leukemia) 07/10/2008 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/00001610/202410 PSUSA/00001610/202510 Eamon O Murchu Ireland CAP
Lead MS and PRAC
Representative name added on
1614 human anti-d immunoglobulin 28/03/1969 3 years 28/03/2027 26/06/2027 No 20/11/2024 19/10/2022
DLP was Gabriele Maurer Germany
Next DLPamended on 20/11/2024
was updated on PSUSA/00001614/202703 NAP
28/06/2023
DLP was updated on 01/04/2020

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

Next DLP was amended on


1633 human normal immunoglobulin (IgG) 25/01/1985 5 years 31/05/2025 29/08/2025 No 03/02/2021 PSUSA/00001633/202505 Gabriele Maurer Germany CAP NAP
30/01/2017

The name of the active


substance was amended on
22/09/2016
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the EuropNextDLP was amended on Page 28 / 223
04/02/2016

DLP was amended on 04/02/2015

Next DLP was updated on


31/01/2014
DLP was updated on 01/02/2023

PSUR frequency and DLP were


updated on 03/06/2020

DLP was updated on 05/02/2020

DLP was updated on 06/02/2019


PRAC representative was
PRAC Rapporteur
updated name was
on 01/03/2023
1634 human papillomavirus vaccine (rDNA) - 4-valent 20/09/2006 3 years 31/05/2025 29/08/2025 No 01/02/2023 amended on 31/07/2018 PSUSA/00001634/202505 Mari Thorn Sweden CAP
DLP and Information included in
DLP was"Are
column amended
PSURson 31/01/2018
required for
human plasma (pooled and treated for virus products referred to
1635 31/05/2006 3 years 28/02/2026 29/05/2026 No 15/11/2023 DLP was amended onin15/11/2023
Articles PSUSA/00001635/202602 Gabriele Maurer Germany NAP
inactivation) Next DLP
10(1), was
10a, 14,amended on
16a of Directive
30/01/2017 as amended?" were
2001/83/EC
amended
PRAC on 22/12/2021
representative was
1638 human prothrombin complex Not available* 5 years 30/04/2026 29/07/2026 Yes 22/12/2021 Next DLPon
updated was amended on
01/03/2023 PSUSA/00001638/202604 Gabriele Maurer Germany NAP
04/02/2016
Next DLP was amended on
30/01/2017
DLP was updated on 21/12/2022
DLP was amended on 22/12/2014
1639 human rabies immunoglobulin 27/04/1984 5 years 26/04/2027 25/07/2027 No 21/12/2022
Lead
PSUSA/00001639/202704 Gabriele Maurer Germany NAP
PSUR MS was amended
frequency amendedon and
22/09/2016
DLP updated on 31/01/2018
PSUR frequency amended
Leadand
1642 human von willebrand factor 30/09/2003 5 years 30/09/2028 29/12/2028 No 05/06/2024 PRAC MS
Lead Rapporteur
and PRACand
Rapporteur PSUSA/00001642/202809 Gabriele Maurer Germany NAP
DLP updated
Member on
State 05/06/2024
added on
name was added on 19/10/2016
27/11/2015.
PSUR frequency and DLP
1644 hyaluronic acid Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUSA/00001644/203106 NAP
amended on 23/10/2024

PSUR frequency and DLP


1645 hyaluronidase 31/05/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00001645/203404 NAP
amended on 23/10/2024

PSUR frequency and DLP


1646 hydralazine, dihydralazine 13/03/1952 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00001646/202712 none NAP
amended on 31/07/2024

PSUR frequency and DLP


1650 hydrochlorothiazide 22/12/1958 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00001650/202712 NAP
amended on 31/07/2024

PRAC representative updated on


1655 hydrochlorothiazide / losartan 15/02/1995 5 years 15/02/2028 15/05/2028 No 31/01/2024 PSUSA/00001655/202802 Bianca Mulder Netherlands NAP
31/01/2024

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

PSUR frequency amended and


1662 hydrochlorothiazide / spironolactone Not available* 5 years 01/01/2029 01/04/2029 No 25/09/2024 PSUSA/00001662/202901 Barbara Kovacic Bytyqi Croatia NAP
DLP updated on 25/09/2024

Active substance name, PSUR


hydrochlorothiazide / triamterene,
1664 Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 frequency and DLP were PSUSA/00001664/203106 none NAP
hydrochlorothiazide / propranolol / triamterene
amended on 19/10/2023

PSUR frequency and DLP


1672 hydrocortisone / natamycin / neomycine sulphate 20/06/1995 8 years 03/08/2025 01/11/2025 No 30/10/2024 PSUSA/00001672/202508 Terhi Lehtinen Finland NAP
amended on 31/07/2024

PSUR frequency and DLP


1674 hydrocortisone / propanocaine Not available* 7 years 01/12/2024 01/03/2025 No 23/01/2025 PSUSA/00001674/202412 Monica Martinez Redondo Spain NAP
amended on 27/03/2024

PSUR frequency amended and


1675 hydrocortisone / urea 31/12/1986 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUSA/00001675/202901 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1676 benzocaine / hydrocortisone acetate Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00001676/202906 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1678 gentamicin sulphate / hydrocortisone acetate Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUSA/00001678/203502 NAP
amended on 31/07/2024

PSUR frequency and DLP


1679 lidocaine / hydrocortisone Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUSA/00001679/203502 NAP
amended
Active on 31/07/2024
substance name was
amended on 23/10/2024
hydrocortisone acetate / lidocaine hydrochloride / PSUR frequency and DLP
1680 Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 DLP was updated 27/07/2022
on 01/03/2023 PSUSA/00001680/203502 NAP
mefenidramium metilsulfate amended on 31/07/2024
PRAC representative
Representative was
updated on
PSUR frequency
updated and DLP
on 28/07/2021
16/11/2022
1684 hydrocortisone acetate / zinc sulfate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00001684/202611 NAP
amended on 23/10/2024
PRAC representative was
28/04/2021
updated on 20/10/2021
1686 hydromorphone 25/11/1998 3 years 30/11/2024 28/02/2025 No 27/07/2022 PSUSA/00001686/202411 Polona Golmajer Slovenia NAP
DLP was updated
European on 31/07/2019
Union reference date,
DLP and submission dates
Next DLPon
updated was updated on
07/05/2018
1688 quinidine, hydroquinidine 02/07/1973 5 years 02/07/2027 30/09/2027 No 23/10/2024
22/09/2016
PSUSA/00001688/202707 Maria del Pilar Rayon Spain NAP
PSUR frequency amended and
Leadupdated
DLP MS was on
added on
15/11/2017
PSUR frequency and DLP
13/07/2015
1689 hydroquinone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00001689/202611 NAP
amended on 23/10/2024
Lead MS was added on
22/09/2016
hydroxycarbamide (for centrally authorised product
1692 29/06/2007 1 year 28/06/2025 06/09/2025 28/06/2026 06/09/2026 No 05/02/2025 DLP was amended
Transferred fromandon List
the 05/02/2025
of PSUSA/00001692/202506 PSUSA/00001692/202606 Jo Robays Belgium CAP
only) PSUR frequency DLP were
substances
updated on under PSUR Work
22/12/2021
Sharing scheme and other
Marie Louise Schougaard
1693 hydroxychloroquine 18/04/1955 5 years 18/04/2026 17/07/2026 No 22/12/2021 substances contained in
LMS and PRAC representative PSUSA/00001693/202604
Christiansen Denmark NAP
Nationally Authorised Products
were added on 23/09/2020
with DLP synchronised on
06/03/2015
DLP
Nextwas
DLPupdated on 03/06/2020
was updated on
1694 hydroxyethyl starch Not available* 1 year 01/03/2025 10/05/2025 01/03/2026 10/05/2026 No 18/10/2023 PSUSA/00001694/202503 PSUSA/00001694/202603 Martin Huber Germany NAP
18/10/2023

PSUR frequency amended and


1696 hydroxyzine, hydroxyzine combination 14/12/1955 5 years 01/11/2028 30/01/2029 No 03/07/2024 PSUSA/00001696/202811 Tiphaine Vaillant France NAP
DLP updated on 03/07/2024

PSUR frequency and DLP


1697 hymecromone 27/07/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00001697/203406 NAP
amended on 23/10/2024

PSUR frequency and DLP


1698 hyoscine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 DLP was updated on 02/03/2022 PSUSA/00001698/203212 NAP
amended on 23/10/2024

Reference to NAP added on


PSUR frequency and DLP
02/03/2022
1699 hyoscyamine 01/02/1966 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00001699/203406 NAP
amended on 23/10/2024
PRAC Rapporteur name was
amended on 03/04/2019
1701 hypericum perforatum L., herba 07/04/1998 5 years 01/01/2028 31/03/2028 Yes 20/09/2023 DLP amended on 20/09/2023 PSUSA/00001701/202801 Melinda Palfi Hungary NAP
Next DLP was updated on
06/03/2019
1702 ibandronic acid 25/06/1996 3 years 24/06/2024 22/09/2024 No 02/03/2022 PSUSA/00001702/202406 Karin Erneholm Denmark CAP NAP
Reference to NAP products
removed on 28/02/2018

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

LMS was added on 01/04/2020


The DLP was amended on
1725 imatinib 07/11/2001 3 years 10/05/2027 08/08/2027 No 05/02/2025 06/03/2015
DLP was amended on 05/02/2025 PSUSA/00001725/202705 Monica Martinez Redondo Spain CAP NAP

The DLP was amended on


03/03/2014
1726 imidapril 10/10/1993 7 years 02/12/2030 02/03/2031 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00001726/203012 John Joseph Borg Malta NAP

PSUR frequency amended and


1727 imiglucerase 23/05/1994 3 years 23/05/2026 21/08/2026 No 31/01/2024 PSUR frequency and DLP were PSUSA/00001727/202605 Liana Martirosyan Netherlands CAP
DLP updated on 31/01/2024
updated on 31/03/2021

LMS and PRAC representative


1728 imipramine 13/03/1958 8 years 15/07/2028 13/10/2028 No 31/03/2021 PSUSA/00001728/202807 Martin Huber Germany NAP
were added on 04/03/2020

PSUR frequency and DLP were


Next DLP was updated on
1729 imiquimod 18/09/1998 3 years 26/01/2026 26/04/2026 Yes 18/10/2023 updated on 05/06/2019 PSUSA/00001729/202601 Adam Przybylkowski Poland CAP NAP
18/10/2023
PRAC representative was
DLP was on
updated updated on 28/07/2021
19/10/2022
17/11/2021 Marie Louise Schougaard
PSUR frequency amended and
1730 indacaterol 30/11/2009 5 years 30/11/2027 28/02/2028 No 26/07/2023 PSUSA/00001730/202711
Christiansen Denmark CAP
DLP updated on 26/07/2023
Rapporteur name
Representative
PRAC representative was
was
was
amendedon
updated 31/07/2018
on30/06/2021
28/04/2022
1731 indapamide 25/02/2002 5 years 25/11/2025 23/02/2026 No 28/07/2021 PSUSA/00001731/202511 Martin Huber Germany NAP
Nextwas
DLP DLPcorrected
was amended
updated on on
on30/03/2022
26/05/2021
28/07/2016
Information
PSUR included
frequency in column
and DLP were
1734 indium (111In) chloride, indium (111In) oxine Not available* 8 years 15/07/2029 13/10/2029 Yes 28/04/2022 Lead PSURs
"Are MS on
updated was added on
required
03/02/2021 for products PSUSA/00001734/202907 Jo Robays Belgium NAP
16/06/2015
referred to in Articles 10(1), 10a,
14, 16a
DLP wasof Directiveon
amended 2001/83/EC
31/01/2018
as amended?" and DLP were
1736 indobufen 05/05/1984 5 years 04/05/2025 02/08/2025 No 26/05/2021
updated on 03/02/2021
PSUSA/00001736/202505 Amelia Cupelli Italy NAP
PRAC Rapporteur name was
amended on 28/02/2017
LMS and PRAC representative
1737 indocyanine green 16/04/2003 7 years 03/05/2031 01/08/2031 No 05/02/2025 were
Lead added
MS
DLP was andon
amended 18/12/2019
PRAC Rapporteur
on 05/02/2025 PSUSA/00001737/203105 Jean-Michel Dogné Belgium NAP
name was added on 19/10/2016
05/06/2019
DLP was updated on 29/06/2022
Transferred from the List of
1738 indometacin Not available* 3 years 15/07/2026 13/10/2026 No 27/03/2024 DLP was
PRAC amended
Rapporteur
substances on 27/03/2024
under name
PSUR was
Work PSUSA/00001738/202607 Monica Martinez Redondo Spain NAP
amended on 28/04/2022
Sharing scheme and other
New CAP authorised
substances containedonin
03/06/2024
PRAC representative
Authorisedwas
1742 influenza vaccine (intranasal, live attenuated) 27/01/2011 1 year 31/08/2024 09/11/2024 31/08/2025 09/11/2025 No 30/04/2024 Nationally Products PSUSA/00001742/202408 PSUSA/00001742/202508 Jean-Michel Dogné Belgium CAP
updated
with DLP on 31/03/2021on
synchronised
DLP was amended on 30/04/2024
06/03/2015
PRACDLP
Next representative
was updated was
on
1744 influenza vaccine (surface antigen, inactivated) 16/02/1998 1 year 15/03/2025 24/05/2025 15/03/2026 24/05/2026 No 18/10/2023 updated on 25/09/2019 PSUSA/00001744/202503 PSUSA/00001744/202603 Amelia Cupelli Italy NAP
18/10/2023
PSUR frequency and DLP were
PSUR frequency
updated amended and
on 05/06/2019
1749 insulin aspart 07/09/1999 3 years 30/09/2026 29/12/2026 No 05/06/2024 PSUSA/00001749/202609 Mari Thorn Sweden CAP
DLP updated on 05/06/2024
PRAC Rapporteur name was
amended on 03/04/2019
Marie Louise Schougaard
1750 insulin detemir 01/06/2004 3 years 31/10/2024 29/01/2025 No 29/06/2022 PSUSA/00001750/202410
Christiansen Denmark CAP
DLP was updated on 04/07/2018

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

Reference to NAP added on


Marie Louise Schougaard
1752 insulin glulisine 16/04/2004 3 years 16/04/2026 15/07/2026 No 20/12/2023 25/09/2017
DLP was amended on 20/12/2023 PSUSA/00001752/202604
Christiansen Denmark CAP

Next DLP was amended on


insulin human, insulin human / insulin isophane 27/06/2017
PSUR frequency amended and Marie Louise Schougaard
1753 (subcutaneous and intravenous routes of 26/10/1980 5 years 26/10/2028 24/01/2029 No 03/07/2024 PSUSA/00001753/202810
Christiansen Denmark CAP NAP
DLP updated on 03/07/2024
administration) Next DLP was amended on
DLP was updated on 19/10/2022
03/06/2016
1755 insulin lispro 30/04/1995 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was
DLP was amended
updated onon30/03/2022
05/02/2025 PSUSA/00001755/202704 Mari Thorn Sweden CAP
PRAC representative
PSUR Frequency and was
Next DLP
LMS and on
updated
amended PRAC representative
on04/03/2020
16/07/2015
updated 05/06/2019
1759 interferon beta-1b 30/11/1995 3 years 23/07/2024 21/10/2024 No 30/03/2022 DLP was updated on 25/10/2019 PSUSA/00001759/202407 Martin Huber Germany CAP
DLP was updated on 03/04/2019
PRAC Rapporteur name was
Next DLP was
amended amended on
on 31/07/2018
1760 interferon gamma 28/09/1992 3 years 31/01/2025 01/05/2025 No 19/10/2022
07/04/2016
PSUSA/00001760/202501 Liana Martirosyan Netherlands NAP
Next DLP was amended on
19/10/2016
1761 iobitridol 24/08/1994 5 years 30/04/2029 29/07/2029 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00001761/202904 Eamon O'Murchu Ireland NAP
The DLP was amended on
30/09/2015
PSUR frequency and DLP
1763 iodine (123i) iobenguane 31/01/1995 8 years 03/08/2025 01/11/2025 No 30/10/2024 Lead MS was added on PSUSA/00001763/202508 Adam Przybylkowski Poland NAP
amended on 31/07/2024
13/07/2015
DLP was updated on 05/04/2023
PSUR frequency amended and
1764 iodine (131i) iobenguane 01/06/1991 5 years 01/05/2029 30/07/2029 No 05/02/2025 PSUSA/00001764/202905 Karin Erneholm Denmark NAP
DLP updated on 05/02/2025
New CAP authorised on
DLP was updated on 03/02/2021
17/06/2021
PRAC representative was added
1766 iodixanol 01/05/1993 8 years 30/04/2028 29/07/2028 No 03/02/2021 PRAC representative was PSUSA/00001766/202804 Karen Pernille Harg Norway NAP
on 06/05/2020
updated on 29/07/2020
LMS was added on 25/09/2019
PRAC representative was
1767 ioflupane (123i) 27/07/2000 5 years 27/07/2027 25/10/2027 No 05/04/2023 PSUSA/00001767/202707 Tiphaine Vaillant France CAP
updated on 03/06/2020
DLP was updated on 03/03/2021
New CAP authorised on
PRAC representative was added
1768 iohexol 04/06/1982 8 years 30/06/2028 28/09/2028 No 03/03/2021 25/06/2019 PSUSA/00001768/202806 Karen Pernille Harg Norway NAP
on 06/05/2020
DLP was updated on 03/02/2021
LMS and PRAC representative
LMS was added on 01/04/2020
updated
PRAC 05/06/2019 was added
representative
1769 iomeprol 11/12/1992 8 years 30/04/2028 29/07/2028 No 03/02/2021 PSUSA/00001769/202804 Karen Pernille Harg Norway NAP
on 06/05/2020
DLP was updated on 27/03/2018
LMS was added on 25/09/2019

© 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

LMS was added on 01/04/2020


PSUR frequency amended and
1775 ioversol 01/06/1989 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00001775/202506 Rhea Fitzgerald Ireland NAP
DLP updated on 03/07/2024
EURD, PSUR frequency and DLP
updated on 30/04/2024
1779 ioxitalamate 11/03/2003 8 years 10/03/2036 08/06/2036 No 30/04/2024 PSUSA/00001779/203603 none NAP
Active substance name was
amended on 30/04/2024
Next DLP was updated on
1780 ipratropium 14/08/1974 3 years 31/01/2026 01/05/2026 No 18/10/2023 PSUSA/00001780/202601 Melinda Palfi Hungary NAP
18/10/2023

PRAC Rapporteur updated on


1781 ipratropium / salbutamol 22/03/1994 3 years 31/01/2026 01/05/2026 No 15/11/2023 PSUSA/00001781/202601 Petar Mas Croatia NAP
15/11/2023

PSUR frequency amended and


1783 irinotecan (except for liposomal formulations) 05/05/1995 5 years 04/05/2028 02/08/2028 No 31/01/2024 PSUSA/00001783/202805 Tiphaine Vaillant France NAP
DLP updated on 31/01/2024

PSUR frequency and DLP


1784 isocarboxazid Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUSA/00001784/204005 NAP
amended on 23/10/2024
Next DLP was updated on
28/06/2023
PSUR frequency and DLP
1785 isoconazole Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUSA/00001785/203107 NAP
amended
DLP on 23/10/2024
was updated on 01/07/2020

PRAC representative was


1786 isoflurane 07/10/1981 3 years 31/10/2025 29/01/2026 No 28/06/2023 updated on 06/05/2020 PSUSA/00001786/202510 Melinda Palfi Hungary NAP

PSUR Frequency amended and


DLP
DLP was updated
updated on 01/07/2020
on 21/07/2017
dichloralphenazone / isometheptene mucate / PSUR frequency amended and
1788 Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00001788/203008 NAP
paracetamol DLP updated on 28/08/2024
PRAC Rapporteur
Lead MS and PRACname was
Rapporteur
amended
name wason 31/07/2018
added on 03/06/2016
1789 isoniazid 28/02/1973 5 years 01/11/2024 30/01/2025 No 01/07/2020 PSUSA/00001789/202411 Mari Thorn Sweden NAP
PSUR Frequency and Next DLP
amended on 16/07/2015
PSUR frequency and DLP
1791 isoniazid / pyridoxine hydrochloride Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PRAC Rapporteur name and PSUSA/00001791/202412 Maria del Pilar Rayon Spain NAP
amended on 27/03/2024
country updated on 01/12/2014

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

1793 isoprenaline 04/04/1977 13 years 03/04/2034 02/07/2034 No 05/01/2025 DLP was


DLP was amended on21/12/2022
updated on 18/12/2024 PSUSA/00001793/203404 Pernille Harg Norway NAP

PRAC Rapporteur name was


1794 isosorbide 01/05/1980 13 years 30/04/2034 29/07/2034 No 05/01/2025 amended on 28/04/2022
DLP was amended on 18/12/2024 PSUSA/00001794/203404 Martin Huber Germany NAP
PRAC Rapporteur name was
amended on 03/04/2019
PSUR frequency amended and
1797 isradipine 03/01/1989 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00001797/202506 Jana Lukačišinová Czech Republic NAP
DLP updated on 03/07/2024
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
Marie Louise Schougaard
1798 itraconazole 31/08/1974 5 years 31/03/2027 29/06/2027 No 21/12/2022 PSUSA/00001798/202703
Christiansen Denmark NAP
DLP was updated on 19/12/2017

Lead MS and PRAC Rapporteur


PRAC representative updated on
1799 ivabradine 25/04/2005 3 years 25/04/2026 24/07/2026 No 31/01/2024 name was added on 19/10/2016 PSUSA/00001799/202604 Bianca Mulder Netherlands CAP NAP
31/01/2024
Information included in column
"Are PSURs required for products
1801 japanese encephalitis virus (inactivated) 31/03/2009 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was to
referred amended on 10(1),
in Articles 18/12/2024
10a, PSUSA/00001801/202703 Gabriele Maurer Germany CAP
14, 16a of Directive 2001/83/EC
as amended?" was amended on
PSUR frequency and DLP
30/11/2012
1802 josamycin 01/03/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 DLP was updated on 27/07/2022 PSUSA/00001802/202805 NAP
amended on 31/07/2024
PRAC Representative amended
PSUR
on frequency and DLP
28/04/2022
1803 kanamycin Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUSA/00001803/203502 NAP
amended on 31/07/2024
DLP was updated on 31/07/2019

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

PRAC Rapporteur name was


1811 ketorolac (systemic formulations) 20/07/1989 5 years 19/07/2027 17/10/2027 No 16/10/2023 PSUSA/00001811/202707 Karin Erneholm Denmark NAP
amended
PSUR on 18/10/2023
frequency and DLP were
updated on 01/03/2023

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

Lead MS and PRAC Rapporteur


name frequency
PSUR was addedamended
on 20/12/2016
and
1813 ketotifen (oral formulations) 15/10/1977 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUSA/00001813/202810 Amelia Cupelli Italy NAP
DLP updated
New on 03/07/2024
CAP updated
authorised
DLP was on on
21/10/2020
31/05/2023
PRAC representative was added
1814 labetalol 04/03/1977 8 years 28/02/2028 28/05/2028 No 21/10/2020 DLP was updated on 28/04/2022 PSUSA/00001814/202802 Karen Pernille Harg Norway NAP
on 06/05/2020
DLP was updated on 29/06/2022
New was
LMS CAP added
authorised on
on 31/07/2019
DLP was updated on 21/07/2017
26/08/2019
1815 lacidipine 07/11/1990 5 years 31/10/2026 29/01/2027 No 29/06/2022 PSUSA/00001815/202610 Maia Uusküla Estonia NAP
Leadwas
DLP MS updated
and PRAConRapporteur
30/04/2019
name was added on 03/06/2016
1816 lacosamide 29/08/2008 3 years 31/08/2024 29/11/2024 No 28/04/2022 PRAC Rapporteur name was PSUSA/00001816/202408 Karin Bolin Sweden CAP
amended on 31/07/2018

Next DLP was amended on


1817 lactic acid Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001817/203001 NAP
03/05/2016

"Are PSURs required for products


PSUR frequency and DLP
1818 lactic acid / salicylic acid 25/04/1977 9 years 03/11/2028 01/02/2029 No 24/09/2024 referred to in Articles 10(1), 10a, PSUSA/00001818/202811 Adam Przybylkowski Poland NAP
amended
14, 16a on 31/07/2024
DLP wasof Directive
updated on2001/83/EC
26/05/2021
as amended? Yes/No" was
amended
Next on 16/07/2015
DLP was amended on
1819 lactitol 03/09/1985 5 years 23/09/2025 22/12/2025 No 26/05/2021 PSUSA/00001819/202509 Jan Neuhauser Austria NAP
03/06/2016

Lead MS added on 12/05/2015

© 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

DLP was updated on 02/02/2022

PRAC representative was


updated on 30/06/2021

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

PRAC Rapporteur name updated


1822 lactose monohydrate / lactulose Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 PSUSA/00001822/203001 NAP
on 04/02/2016

PRAC Rapporteur and Lead


1823 lactulose / paraffin liquid / vaseline Not available* 18 years 01/01/2030 01/04/2030 No 01/10/2012 Member State added on PSUSA/00001823/203001 NAP
27/11/2015

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

1837 leflunomide 10/09/1998 3 years 10/09/2026 09/12/2026 No 05/06/2024 DLP was


PRAC
DLP was updated on
representative
amended on01/07/2020
was
05/06/2024 PSUSA/00001837/202609 Liana Martirosyan Netherlands CAP NAP
updated on 03/06/2020
PRAC representative was
updated
PSUR on 03/06/2020
frequency and DLP updated
DLP and PSUR frequency
1838 lenalidomide 14/06/2007 3 years 26/12/2025 26/03/2026 Yes 20/09/2023 on 03/07/2019 PSUSA/00001838/202512 Tiphaine Vaillant France CAP NAP
amended on 20/09/2023
DLP updated and PRAC
DLP was updated on 06/05/2020
Rapporteur
PRAC name name
Rapporteur amended on
updated
21/07/2017
on 21/07/2017
1839 lenograstim 11/10/1991 5 years 31/10/2027 29/01/2028 No 28/06/2023 LMS and PRAC representatives PSUSA/00001839/202710 Tiphaine Vaillant France NAP
were added on 31/07/2019
PRAC Frequency
PSUR Rapporteuramended
name wasand
amended
next on 28/07/2016
DLP updated on 27/06/2017
Transferred from the List of
1841 lercanidipine 22/03/1996 5 years 31/08/2024 29/11/2024 No 06/05/2020 PSUSA/00001841/202408 Kimmo Jaakkola Finland NAP
substances
PRAC under PSUR
representative Work
waswas
Lead
PRAC MS and PRACname
Rapporteur Rapporteur
Sharing scheme
updated on and other
19/10/2022
name
amendedwas added
on on 03/06/2016
28/07/2016
substances contained in
1842 letrozole 24/07/1996 3 years 31/10/2024 29/01/2025 No 29/06/2022 Nationally
DLP was Authorised Products PSUSA/00001842/202410 Tiphaine Vaillant France NAP
Next DLPupdated
Transferred from
was on 27/07/2022
the
updated List
onof
with DLP synchronised on
substances under PSUR Work
28/06/2016
06/03/2015
PRAC Representative amended
Sharing scheme and other
1845 levamisole 14/06/1966 10 years 14/01/2025 14/04/2025 No 01/10/2012 on 28/04/2022
substances
PRAC contained
Rapporteur name inupdated PSUSA/00001845/202501 Romania NAP
Nationally
on Authorised Products
07/04/2016
DLP
with was
DLP updated on 31/07/2019
synchronised on
06/03/2015
PRAC Rapporteur name updated
1846 levetiracetam 29/09/2000 3 years 30/11/2024 28/02/2025 No 27/07/2022 PRAC Representative
on 04/02/2016 amended PSUSA/00001846/202411 Jo Robays Belgium CAP NAP
on 18/11/2016
DLP amended on 30/06/2015
Next DLP was updated on
1848 levobupivacaine 01/01/1999 5 years 31/12/2027 30/03/2028 No 20/09/2023 DLP amended on 20/09/2023
22/09/2016
PSUSA/00001848/202712 Karin Bolin Sweden NAP
PRAC Rapporteur name and
country updated on 01/12/2014
"Are PSURs required for products
PRAC Rapporteur name was 10a,
1849 levocabastine 22/02/1993 5 years 14/11/2027 12/02/2028 No 16/10/2023 referred to inincluded
Information Articles 10(1),
in column PSUSA/00001849/202711 Karin Erneholm Denmark NAP
amended
14, 16a ofon 18/10/2023
Directive
"Are PSURs required2001/83/EC
for products
as amended?
referred Yes/No" 10(1),
to in Articles was 10a,
PRAC
14, Rapporteur
amended
16a ofon name
16/07/2015
Directive was
2001/83/EC
1850 levocetirizine 03/01/2001 6 years 02/07/2029 30/09/2029 No 28/02/2024 DLP was amended
amended on 28/02/2024
on 01/02/2023 PSUSA/00001850/202907 Martin Huber Germany NAP
as amended?" was amended on
30/11/2012
PRAC Rapporteur name was
DLP was updated on 01/02/2023
1853 levodropropizine 08/05/1997 7 years 02/01/2031 02/04/2031 No 25/09/2024 amended
DLP on 22/09/2022
was amended on 25/09/2024 PSUSA/00001853/203101 Melinda Palfi Hungary NAP
PSUR frequency and DLP were
PSUR frequency and DLP were
updated on 05/02/2020
updated on 03/06/2020
1855 levomethadone 22/03/1969 3 years 01/05/2025 30/07/2025 No 01/02/2023 PSUSA/00001855/202505 Jan Neuhauser Austria NAP
LMS and PRAC representative
PRAC Rapporteur name updated
added on 31/07/2019
on 23/10/2018
1858 levosimendan 22/09/2000 5 years 22/09/2024 21/12/2024 No 03/06/2020 PSUR frequency amended and PSUSA/00001858/202409 Karin Bolin Sweden NAP
PRAC Rapporteur name was
DLP updated on 06/06/2018
amended on 31/07/2018
PSUR frequency amended and
1859 levosulpiride, sulpiride 01/04/1986 8 years 03/06/2025 01/09/2025 No 30/10/2024 Next DLP was amended on PSUSA/00001859/202506 Amelia Cupelli Italy NAP
DLP updated on 03/07/2024
27/06/2017

PRAC representative and Lead


1860 levothyroxine 01/01/1952 5 years 31/01/2027 01/05/2027 No 19/09/2024 Member State were added on PSUSA/00001860/202701 Zoubida Amimour France NAP
03/05/2016

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

Lead MS and PRAC Rapporteur


name was added on 19/10/2016

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# 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

PSUR frequency amended and


1898 lodoxamide 02/07/1990 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00001898/202506 Terhi Lehtinen Finland NAP
DLP updated on 03/07/2024

PSUR frequency and DLP


1899 lofepramine 27/02/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00001899/202808 NAP
amended on 31/07/2024

Next DLP was updated on


1902 lomustine 26/01/1976 5 years 26/01/2028 25/04/2028 No 18/10/2023 PSUSA/00001902/202801 Anna Mareková Slovakia NAP
18/10/2023

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

PSUR frequency and DLP


1911 lornoxicam Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00001911/202412 Monica Martinez Redondo Spain NAP
amended on 27/03/2024

PRAC representative updated on


1912 losartan 02/09/1994 8 years 01/09/2025 30/11/2025 No 31/01/2024 PSUSA/00001912/202509 Bianca Mulder Netherlands NAP
31/01/2024

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 frequency amended and


1916 loxapine 20/12/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUSA/00001916/202802 NAP
DLP updated on 28/08/2024

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

PRAC Rapporteur name was


updated on 04/07/2018
1932 manidipine 29/06/1990 3 years 29/06/2024 27/09/2024 No 02/03/2022 PSUSA/00001932/202406 Amelia Cupelli Italy NAP
Next DLP updated on 04/03/2016
DLP and PSUR frequency were
PSUR frequency and DLP
1933 maprotiline 23/09/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PRAC Rapporteur
updated name updated
on 30/03/2022 PSUSA/00001933/202805 NAP
amended on 31/07/2024
on 04/02/2016
DLP was updated on 03/04/2019
PRAC representative
PRAC Rapporteur amended
was on
1934 maraviroc 18/09/2007 5 years 05/08/2026 03/11/2026 No 30/03/2022 27/11/2015. PSUSA/00001934/202608 Mari Thorn Sweden CAP
PRAC Rapporteur
updated name was
on 01/03/2023
amended on 31/07/2018
Leadwas
DLP MS updated
added onon01/04/2015.
25/05/2022
1936 measles / mumps / rubella / varicella vaccines (live) 26/07/2006 3 years 05/09/2024 04/12/2024 No 25/05/2022 Next DLP was amended on PSUSA/00001936/202409 Gabriele Maurer Germany CAP NAP
07/04/2016
DLP was updated on 05/06/2019

PSUR Frequency amended and


1937 measles / mumps / rubella vaccines (live, attenuated) 28/11/1997 3 years 04/05/2027 02/08/2027 No 05/02/2025 DLP was amended on 05/02/2025
DLP updated on 03/05/2016
PSUSA/00001937/202705 Gabriele Maurer Germany CAP 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

PSUR frequency amended and


1940 mebeverine 10/11/1964 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00001940/202803 NAP
DLP updated on 28/08/2024

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

PSUR frequency and DLP


1943 mecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00001943/202811 NAP
amended on 31/07/2024

1945 meclozine 08/05/1953 15 years 31/08/2025 29/11/2025 No 05/01/2025 PSUSA/00001945/202508 Jo Robays Belgium NAP

PSUR frequency and DLP


1946 meclozine hydrochloride / pyridoxine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUSA/00001946/203502 NAP
amended on 31/07/2024

PSUR frequency and DLP


1947 mecobalamin 22/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00001947/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


1948 medazepam Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUSA/00001948/203109 NAP
amended on 23/10/2024

© 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

PSUR frequency amended and


1950 conjugated estrogens / medrogestone Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00001950/203003 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


1951 medroxyprogesterone 20/08/1959 5 years 19/08/2026 17/11/2026 No 31/01/2024 PSUSA/00001951/202608 none NAP
DLP updated on 31/01/2024

PSUR frequency amended and


1954 mefenamic acid 28/03/1962 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUSA/00001954/202802 NAP
DLP updated on 28/08/2024

Next DLP was updated on


1955 mefloquine 20/02/1984 3 years 19/02/2026 20/05/2026 No 18/10/2023 PSUSA/00001955/202602 Karen Pernille Harg Norway NAP
18/10/2023

PSUR frequency and DLP


1956 mefruside / nifedipine 10/07/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00001956/202812 NAP
amended on 31/07/2024

PSUR frequency amended and


1957 megestrol 18/08/1971 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00001957/202806 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


1959 meglumine antimonate 22/01/1947 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00001959/203611 NAP
amended on 23/10/2024

PSUR frequency and DLP


1962 melarsoprol 02/05/1997 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00001962/202511 Zoubida Amimour France NAP
amended on 31/07/2024

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

PSUR frequency and DLP


1965 melperone 17/01/1968 9 years 02/04/2028 01/07/2028 No 31/07/2024 PSUR frequency amended and PSUSA/00001965/202804 NAP
amended on 31/07/2024
DLP updated on 18/12/2024

Reference to CAP added on


1966 melphalan 26/09/1963 8 years 26/09/2030 25/12/2030 No 18/12/2024 PSUSA/00001966/203009 Mari Thorn Sweden CAP NAP
03/03/2021
PSUR frequency and DLP were
updated
New CAPon 18/11/2020
authorised on
1967 memantine 15/05/2002 5 years 15/09/2028 14/12/2028 No 05/06/2024 16/11/2020
DLP was amended on 05/06/2024 PSUSA/00001967/202809 Maria del Pilar Rayon Spain CAP NAP
Active substance name was
corrected on 21/10/2020
DLP was updated on 29/06/2022
meningococcal group a, c, w135, y conjugate vaccine
1969 (conjugated to Corynebacterium diphtheriae CRM197 15/03/2010 5 years 14/03/2025 12/06/2025 No 18/11/2020 DLP was amended on 15/11/2017 PSUSA/00001969/202503 Liana Martirosyan Netherlands CAP
DLP was updated on 03/07/2019
protein)
PRAC representative name was
PRAC Representative and LMS
meningococcal group c polysaccharide conjugate amended on 01/04/2015.
1971 15/10/1999 3 years 15/10/2024 13/01/2025 No 29/06/2022 updated on 19/12/2018 PSUSA/00001971/202410 Jean-Michel Dogné Belgium NAP
vaccine
Name of active substance was
Next DLP was updated on
amended on 28/03/2013
28/06/2016
PSUR frequency and DLP
1972 menotrophin Not available* 7 years 31/12/2024 31/03/2025 No 27/03/2024 PSUSA/00001972/202412 Jana Lukačišinová Czech Republic NAP
amended on 27/03/2024
Lead MS added on 16/06/2015
PSUR frequency and DLP
1974 mepartricin 28/02/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00001974/203503 NAP
amended on 23/10/2024

PSUR frequency and DLP


1978 mephenoxalone Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00001978/202611 NAP
amended on 23/10/2024

epinephrine / mepivacaine hydrochloride, mepivacaine PSUR frequency amended and


1979 01/04/1956 7 years 31/03/2030 29/06/2030 No 20/12/2023 PSUSA/00001979/203003 Karin Erneholm Denmark NAP
/ norepinephrine, mepivacaine DLP updated on 20/12/2023

PSUR frequency and DLP


1982 mepivacaine hydrochloride / polyestradiol phosphate Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUSA/00001982/204005 NAP
amended on 23/10/2024

PSUR frequency and DLP


1984 meptazinol Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUSA/00001984/203109 NAP
amended on 23/10/2024

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

caffeine / drotaverine hydrochloride / metamizole PSUR frequency amended and


1996 24/11/1992 4 years 07/01/2028 06/04/2028 No 25/09/2024 PSUSA/00001996/202801 Anna Mareková Slovakia NAP
sodium DLP updated on 25/09/2024

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

DLP was updated


Information on 01/02/2023
included in column
2001 metformin 19/03/1959 3 years 01/04/2027 30/06/2027 No 18/12/2024 "Are PSURs
DLP was required
amended onfor products
18/12/2024 PSUSA/00002001/202704 Amimour Zoubida France NAP
Correction
referred to to
in DLP and10(1),
Articles submission
10a,
date on of
14, 16a 04/03/2020
Directive 2001/83/EC
as amended?" was amended on
2002 glibenclamide / metformin hydrochloride 18/06/1993 3 years 18/06/2024 16/09/2024 No 19/09/2024 PSUR frequency and DLP were
06/02/2019 PSUSA/00002002/202406 Zoubida Amimour France NAP
updated on 05/02/2020

LMS and PRAC representative


2004 methadone 01/01/1930 3 years 01/05/2025 30/07/2025 No 01/02/2023 PSUSA/00002004/202505 Eamon O'Murchu Ireland NAP
added on 31/07/2019

Transferred from the List of


PSUR frequency and DLP
2005 methenamine 02/08/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 substances under PSUR Work PSUSA/00002005/203710 NAP
amended on 23/10/2024
Sharing scheme and other
substances contained in
Nationally Authorised Products
with DLP synchronised 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 34 / 223
boric acid / calcium thiocyanate / camphor / menthol / PSUR frequency amended and
2006 Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00002006/202906 NAP
methenamine DLP updated on 28/08/2024

PSUR frequency amended and


2007 calcium thiocyanate / methenamine Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00002007/202906 NAP
DLP updated on 28/08/2024

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

PSUR frequency and DLP


2014 methotrexate 01/01/1962 2 years 31/10/2025 29/01/2026 Yes 03/07/2024 DLP was amended on 03/07/2024
amended on 23/08/2023
PSUSA/00002014/202510 Martin Huber Germany CAP NAP

PSUR frequency and DLP


2016 methoxsalen 31/03/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00002016/203401 NAP
amended on 23/10/2024
DLP was updated on 01/03/2023

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

PRAC Rapporteur name updated


2019 methylaminolevulinate 15/06/2001 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUR frequency and DLP were PSUSA/00002019/202706 Mari Thorn Sweden NAP
on 23/10/2018
updated on 29/06/2022
DLP was updated on 27/03/2018
PSUR
PSUR frequency
frequency amended and
and DLP were
2021 methyldopa 01/01/1960 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUSA/00002021/202802 NAP
DLP updated
updated on 28/08/2024
Lead MS 03/06/2020
and PRAC Rapporteur
DLP
namewas updated
was on 20/12/2016
added on 21/12/2022
DLP was
PSUR update and
frequency on 03/07/2019
DLP
2022 methylergometrine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 DLP was updated on 20/11/2019 PSUSA/00002022/203112 NAP
amended on 23/10/2024
PRAC Representative and LMS
PRAC Rapporteur
updated name was
on 19/12/2018
amended on 31/07/2018
2023 methylnaltrexone bromide 02/07/2008 3 years 27/03/2025 25/06/2025 No 21/12/2022 PSUSA/00002023/202503 Martin Huber Germany CAP
DLP was updated on 04/07/2018
PSUR Frequency amended and
DLP updated
Next DLP wason 18/11/2016
amended on
2024 methylphenidate 06/10/1954 3 years 31/10/2024 29/01/2025 No 29/06/2022 27/06/2017 PSUSA/00002024/202410 Martin Huber Germany NAP
The Next DLP was amended on
29/10/2015.
Next DLP was updated on
28/06/2016
2025 methylphenobarbital Not available* 5 years 31/03/2028 29/06/2028 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002025/202803 Benjamin Micallef Malta NAP
PSUR frequency amended and
Leadupdated
DLP MS added
on on 16/06/2015
25/09/2024

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

DLP was amended on 31/01/2018


PSUR frequency amended and
2037 metolazone 01/01/1991 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00002037/202506 Mari Thorn Sweden NAP
DLP updated on 03/07/2024
Next DLP was updated on
28/06/2016
PSUR frequency amended and
2039 metoprolol 28/02/1975 8 years 03/03/2025 01/06/2025 No 26/07/2024 Leadupdated
MS added PSUSA/00002039/202503 Martin Huber Germany NAP
DLP on on 16/06/2015
03/07/2024

PSUR frequency and DLP


2041 metronidazole 29/07/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00002041/202712 NAP
amended on 31/07/2024
Active substance name was
amended on 18/12/2024
metronidazole / miconazole, chlorquinaldol /
2042 18/12/1992 8 years 03/07/2025 01/10/2025 No 18/12/2024 PSUSA/00002042/202507 Eva Jirsová Czech Republic NAP
metronidazole
PSUR frequency and DLP
amended on 31/07/2024
PSUR frequency and DLP
2045 metronidazole / spiramycin 29/07/1959 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00002045/203401 NAP
amended on 23/10/2024

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

PSUR frequency and DLP


2047 mexazolam Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002047/202412 John Joseph Borg Malta NAP
amended on 27/03/2024

PSUR frequency and DLP


2048 mexiletine (nationally authorised products only) 06/10/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00002048/202808 NAP
amended on 31/07/2024

PSUR frequency amended and


2050 mianserin 01/01/1974 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00002050/202806 NAP
DLP
PRACupdated on 28/08/2024
Rapporteur name was
amended on 22/09/2022
Next DLP was updated on
2051 micafungin 25/04/2008 2 years 08/10/2024 06/01/2025 No 01/03/2023 PRACwas
DLP Rapporteur
amendedname updated
on 03/05/2023 PSUSA/00002051/202410 Martin Huber Germany CAP
31/05/2023
on 23/10/2018
DLP correction on 19/12/2018
miconazole, hydrocortisone / miconazole nitrate, PSUR Frequency and Next DLP
2052 31/07/1971 10 years 09/10/2024 07/01/2025 No 16/07/2015 PSUSA/00002052/202410 Karin Bolin Sweden NAP
miconazole nitrate / zinc oxide amended
DLP on 16/07/2015
was updated on 06/06/2018

midazolam (all pharmaceutical forms and indications PRAC Rapporteur


Name of entry wasname and
amended,
2057 apart from oromucosal solution indicated for the 10/09/1982 5 years 09/09/2027 08/12/2027 No 03/05/2023 country
and Leadupdated
MS added on 01/12/2014
on PSUSA/00002057/202709 Martin Huber Germany NAP
treatment of prolonged, acute, convulsive seizures) 12/05/2015.
PSUR frequency and DLP were
DLP
Name was
updatedof amended
active
on on 25/09/2024
substance
16/11/2022 was
Active substance name was
amended
Name
PSUR on 26/07/2023
of entry
frequency
amended on 28/03/2013
was
andamended
DLP on
2058 midecamycin 24/05/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 Information PSUSA/00002058/202812 NAP
06/10/2014
amended
DLP onincluded
31/07/2024
was updated in column
on 23/10/2019
"Are PSURs required for products
PRAC Representative amended
referred
Name
PRAC of to in Articles
active 10(1),
substance
Representative 10a,
was
updated on
on 21/12/2022
2059 mifamurtide 06/03/2009 5 years 05/03/2027 03/06/2027 No 16/11/2022 14, 16a ofon
amended
26/09/2018 Directive 2001/83/EC
30/04/2013 PSUSA/00002059/202703 Bianca Mulder Netherlands CAP
as amended?" was amended on
DLP was updated on 29/06/2022
25/09/2024
PSUR Frequency amended and
DLP updated
PSUR frequency on 19/10/2016
and
2060 mifepristone 31/05/1988 3 years 31/05/2026 29/08/2026 No 31/01/2024 DLP was amended
updated on onDLP were
31/01/2024
02/02/2022 PSUSA/00002060/202605 Karin Bolin Sweden NAP
updated on 05/06/2019
Next DLP was updated on
PRAC representative was
30/09/2015
New CAP authorised on
2062 miglustat (all other indications) 20/11/2002 3 years 19/10/2024 17/01/2025 No 26/07/2023 updated on 29/07/2020 PSUSA/00002062/202410 Mari Thorn Sweden CAP
18/02/2019
PRACwas
DLP representative
amendedname onwas
03/05/2023
PRAC Rapporteur was
updated on 03/06/2020
amended on 31/07/2018
2063 milnacipran 06/12/1966 3 years 30/04/2028 29/07/2028 Yes 25/09/2024 DLP was
PRAC updated on 29/06/2022
Representative name was PSUSA/00002063/202804 Tiphaine Vaillant France NAP
DLP was updated
corrected on 06/02/2019
on 29/07/2020
DLP was updated on 06/06/2018
DLP was updated on 03/07/2019
representative was
PRACwas
Representative updated on
2064 milrinone 16/10/1987 3 years 16/10/2024 14/01/2025 No 29/06/2022 DLP
DLP was
updated
updated on
updated on 30/06/2021
23/05/2017 PSUSA/00002064/202410 Jan Neuhauser Austria NAP
Next DLPon
26/09/2018was03/06/2020
updated on
28/06/2016
Next DLP was amended on
PRAC Rapporteur
PRACwas
Rapporteur name updated
DLP updated name
03/06/2016
updated
on 06/06/2018
2065 minocycline 07/08/1961 5 years 31/08/2027 29/11/2027 No 03/05/2023 on 23/10/2018
on 21/07/2017
Lead MS added on 16/06/2015 PSUSA/00002065/202708 Maria del Pilar Rayon Spain NAP
Information
DLP was included
amended onin16/06/2015
column
Next
PRAC DLP was amended
Rapporteur name on
was
"Are PSURs required for products
28/07/2016
amendedtoon
referred in28/07/2016
Articles 10(1), 10a,
2066 minoxidil (non topical formulations) 18/10/1979 5 years 31/10/2025 29/01/2026 No 30/06/2021
14, 16a of Directive 2001/83/EC
PSUSA/00002066/202510 Eamon O'Murchu Ireland NAP
"Are
Next PSURs
DLP wasrequired
amendedfor on
products
as amended?" was amended on
referred to in Articles 10(1), 10a,
04/02/2016
28/03/2017
14, 16a of Directive 2001/83/EC
2067 minoxidil (topical formulation) 18/10/1979 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024
as amended? Yes/No"
PSUSA/00002067/202610 Eamon O'Murchu Ireland NAP
was PRAC
Lead MS and added onwas
Rapporteur
amended on 16/07/2015
06/03/2015
name was added on 28/02/2017
Lead MS added on 16/06/2015

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 35 / 223
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

PSUR frequency and DLP


2070 misoprostol / naproxen Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002070/202412 NAP
amended on 27/03/2024

PSUR frequency amended and


2074 mitomycin 05/10/1962 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002074/202803 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


2075 mitotane 28/04/2004 5 years 28/04/2028 27/07/2028 Yes 20/12/2023 PRAC Rapporteur name updated PSUSA/00002075/202804 Maria del Pilar Rayon Spain CAP
DLP updated on 20/12/2023
on 23/10/2018

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

Information included in column


2077 mivacurium 22/01/1992 10 years 31/01/2028 30/04/2028 No 23/10/2018 "Are PSURs required for products PSUSA/00002077/202801 Eamon O'Murchu Ireland NAP
referred to in Articles 10(1), 10a,
DLP wasof
14, 16a updated
Directiveon2001/83/EC
21/12/2022
as amended?"
Next was amended
DLP was updated on on
2078 mizolastine 21/11/1995 5 years 21/11/2027 19/02/2028 No 26/07/2023 PRAC Rapporteur name updated
21/07/2017
PSUSA/00002078/202711 Jana Lukačišinová Czech Republic NAP
26/07/2023
on 23/10/2018
Lead MS and PRAC Rapporteur
PRAC
name Representative updated on
2079 moclobemide 26/10/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 was added on 27/06/2017 PSUSA/00002079/202704 Liana Martirosyan Netherlands NAP
26/09/2018

DLP was updated on 19/12/2017


PSUR frequency and DLP
2081 moexipril 31/12/1994 8 years 03/08/2025 01/11/2025 No 31/07/2024 PSUSA/00002081/202508 NAP
amended on 31/07/2024
Lead MS and PRAC Rapporteur
name was added on 19/10/2016
PSURwas
DLP frequency
updatedand
on DLP
30/03/2022
2084 molsidomine Not available* 9 years 02/12/2031 01/03/2032 No 23/10/2024 PSUSA/00002084/203112 NAP
amended on 23/10/2024
DLP was updated and PRAC
Representative
PSUR frequencywas amended
amended andon
2085 mometasone 22/01/1997 5 years 22/05/2028 20/08/2028 No 31/01/2024 03/04/2019 PSUSA/00002085/202805 Karin Bolin Sweden NAP
DLP updated on 31/01/2024
PRAC Representative amended
PSUR
on frequency and DLP
19/12/2017
2086 mometasone / salicylic acid 22/01/1997 8 years 03/11/2025 01/02/2026 No 31/07/2024 PSUSA/00002086/202511 NAP
amended on 31/07/2024
Next DLP was amended on
07/04/2016
PRAC Rapporteur name was
2087 montelukast 25/08/1997 3 years 30/07/2024 28/10/2024 No 30/03/2022 amended on 28/04/2022 PSUSA/00002087/202407 Kimmo Jaakkola Finland NAP
Information included in column
"Are PSURs
Correction
PSUR ofrequired
frequency, on for
DLPDLP products
20/11/2024
and active
referred to name
substance in Articles
were10(1), 10a,
updated
2088 morniflumate Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025
14,28/04/2021
16a of Directive
PSUSA/00002088/202611 Amelia Cupelli Italy NAP
PSUR
on frequency and2001/83/EC
DLP
as amended?"
amended was amended on
on 23/10/2024
DLP was
was updated
04/03/2016
DLP amendedon on02/02/2022
30/04/2019
Marie Louise Schougaard
2089 moroctocog alfa 13/04/1999 4 years 26/08/2024 24/11/2024 No 28/04/2021 PSUSA/00002089/202408
Christiansen Denmark CAP
Next
PRACDLP was amended
Rapporteur on
updated
name was
30/01/2017
on 30/09/2015
amended on 03/04/2019
PSUR frequency and DLP
2093 caffeine / moxastine teoclate Not available* 11 years 03/03/2040 01/06/2040 No 23/10/2024 'Are
LeadPSURs required
MS added for products
on 01/04/2015. PSUSA/00002093/204003 NAP
Next DLP
amended was amended
on 23/10/2024 on
referred to in Articles 10(1), 10a,
26/04/2017
14, 16a of Directive 2001/83/EC
as
DLPamended?
was was
updated on 19/10/2022
2094 moxifloxacin (topical ophthalmic use) 31/05/1999 5 years 31/05/2026 29/08/2026 No 02/02/2022 The
DLP DLP
waswas amended
updated on
on 21/12/2022 PSUSA/00002094/202605 Martin Huber Germany NAP
Yes/No'
01/04/2014 amended on
27/11/2015.
PRAC representative was
PRAC representative was
updated on 06/05/2020
2095 moxonidine 23/01/1991 5 years 23/01/2027 23/04/2027 No 19/10/2022 updated
PRAC on 28/07/2021
Rapporteur and Lead PSUSA/00002095/202701 Melinda Palfi Hungary NAP
Member
DLP was state wason
updated added on
17/10/2017
PRAC representative was
27/11/2015
updated on 28/04/2021
Lead MS and PRAC Rapporteur
2096 mupirocin 26/03/1985 5 years 31/03/2027 29/06/2027 No 21/12/2022 Name was
name of active
addedsubstance was
on 28/07/2016
PSUSA/00002096/202703 Polona Golmajer Slovenia NAP
Lead MS and
amended PRAC Rapporteur
on 21/12/2012
name Rapporteur
PRAC amended onname19/12/2018
updated
2100 nabilone Not available* 6 years 02/12/2029 02/03/2030 Yes 31/07/2024 on 23/10/2018
DLP was amended on 31/07/2024 PSUSA/00002100/202912 Jan Neuhauser Austria NAP
DLP was updated on 19/12/2017
PRAC Representative updated on
Lead MS and PRAC Rapporteur
26/09/2018
2101 nabumetone 15/03/1984 10 years 01/03/2027 30/05/2027 No 15/11/2017 name was added on 19/10/2016 PSUSA/00002101/202703 Liana Martirosyan Netherlands NAP
DLP was updated on 02/02/2022
PSUR frequency amended and
DLP updated on 15/11/2017
Next DLP updated on 30/01/2017
2102 nadifloxacin 06/07/2000 5 years 31/05/2026 29/08/2026 No 02/02/2022 PRAC Representative updated on PSUSA/00002102/202605 Martin Huber Germany NAP
Lead MS was added on
16/11/2022
PRAC Rapporteur and Lead
22/09/2016
Member State added on
PSUR frequency and DLP were
27/11/2015.
PSUR frequency and DLP
2103 nadolol 22/07/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 updated
DLP was on 22/12/2021
updated on 20/10/2021 PSUSA/00002103/202808 NAP
amended on 31/07/2024
19/12/2018
DLP was updated on 23/10/2018
2104 nadroparin 04/03/1985 5 years 31/03/2026 29/06/2026 No 22/12/2021 PSUSA/00002104/202603 Monica Martinez Redondo Spain NAP
PRAC Rapporteur name was
amendedon
updated on04/07/2018
25/09/2017

2105 nafarelin 15/02/1990 5 years 14/02/2029 15/05/2029 No 20/10/2021 Next DLP


PRAC was updated
Rapporteur nameonwas PSUSA/00002105/202902 Karen Pernille Harg Norway NAP
21/12/2015.
amended on 27/06/2017

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

Lead MS was added on


PSUR frequency amended and
04/02/2015
2108 naftidrofuryl 30/10/1970 9 years 06/03/2028 04/06/2028 No 28/08/2024 DLP was updated on 31/03/2021 PSUSA/00002108/202803 NAP
DLP updated on 28/08/2024
PRAC representative was added
on 06/05/2020
2109 naftifine Not available* 8 years 01/08/2028 30/10/2028 No 31/03/2021 PSUSA/00002109/202808 Maia Uusküla Estonia NAP
LMS was added on 01/04/2020

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

PSUR frequency and DLP


2112 naloxone (for use in medical settings only) 14/04/1975 9 years 03/08/2028 01/11/2028 No 24/09/2024 PSUSA/00002112/202808 Adam Przybylkowski Poland NAP
amended on 31/07/2024

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

PSUR frequency amended and


2114 naloxone / oxycodone 31/05/2006 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUSA/00002114/202608 Martin Huber Germany NAP
DLP updated on 30/04/2024

Next DLP was updated on


2117 naltrexone 20/11/1984 3 years 19/11/2025 17/02/2026 Yes 26/07/2023 PSUSA/00002117/202511 Eamon O'Murchu Ireland NAP
26/07/2023

PSUR frequency and DLP


2118 nandrolone 01/01/1960 10 years 03/03/2034 01/06/2034 No 23/10/2024 PSUSA/00002118/203403 NAP
amended on 23/10/2024

PSUR frequency and DLP


2120 methylthioninium / naphazoline Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00002120/203608 NAP
amended on 23/10/2024

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

Lead MS was added on


22/09/2016

© 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

PRAC representative was


updated on 01/03/2023

DLP and PSUR frequency were


updated on 30/03/2022

DLP was updated on 31/03/2021

DLP was updated on 04/03/2020


2127 natalizumab 27/06/2006 3 years 07/08/2024 05/11/2024 No 30/03/2022 PSUSA/00002127/202408 Gabriele Maurer Germany CAP
Next DLP was updated on
06/03/2019
2129 nebivolol 18/10/1995 6 years 31/03/2030 29/06/2030 No 18/12/2024 DLP was amended on 18/12/2024
DLP was updated on 27/03/2018
PSUSA/00002129/203003 Bianca Mulder Netherlands NAP
DLP was updated on 21/12/2022
DLP was updated on 28/03/2017
PSUR frequency and DLP
2130 nedocromil 24/04/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 DLP was updated on 18/12/2019 PSUSA/00002130/202812 NAP
amended on 31/07/2024
Next DLP was amended on
07/04/2016
Next DLP was updated on
30/01/2017
2131 nefopam Not available* 3 years 30/03/2025 28/06/2025 No 21/12/2022 The DLP was amended on PSUSA/00002131/202503 Barbara Kovacic Bytyqi Croatia NAP
01/04/2014
PRAC Representatie amended on
18/11/2016
Marie Louise Schougaard
2132 nelarabine 22/08/2007 3 years 27/10/2026 25/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002132/202610
Christiansen Denmark CAP
Lead Member State added on
27/11/2015.
PSUR frequency and DLP
2134 neomycin 24/06/1954 10 years 31/01/2034 01/05/2034 No 15/01/2025 PSUSA/00002134/203401 Ana Sofia Diniz Martins Portugal NAP
amended on 23/10/2024
PSUR frequency and DLP were
updatde on 01/02/2023
PSUR frequency and DLP
2135 hydrocortisone / neomycin Not available* 11 years 02/04/2040 01/07/2040 No 23/10/2024 PSUSA/00002135/204004 NAP
amended on 23/10/2024
PRAC Representative updated on
16/11/2022
PSUR frequency and DLP
2139 neomycin sulfate / nystatin / polymyxin b sulfate Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 PSUSA/00002139/202411 Tiphaine Vaillant France NAP
amended on
Reference to 23/10/2024
NAP added on
29/06/2022

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

DLP was updated


Information on 25/09/2019
included in column
2157 niflumic acid Not available* 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00002157/202412 Melinda Palfi Hungary NAP
"Are PSURs required for products
PRAC Rapporteur
Next DLP nameon was
referred towas updated
in Articles 10(1), 10a,
amended
22/09/2016 on 28/04/2022
14, 16a of Directive
PSUR frequency and DLP2001/83/EC
2158 nifuratel 04/05/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 as amended?" was amended on PSUSA/00002158/203406 NAP
amended
DLP on 23/10/2024
Leadand
MS PSUR
25/09/2024
frequency
was added on were
updated
13/07/2015on 22/09/2021
amended
PSUR frequency and and
DLP were
2159 nifuratel / nystatin 12/10/1976 9 years 02/09/2028 01/12/2028 No 28/08/2024 PRAC representative was PSUSA/00002159/202809 NAP
DLP updated
updated on 28/08/2024
on 28/04/2022
updated on 31/03/2021
PSUR frequency, DLP and
2160 nifuroxazide 18/08/1992 5 years 18/08/2026 16/11/2026 No 25/09/2024 DLP was updated on 23/09/2020 PSUSA/00002160/202608 Jana Lukačišinová Czech Republic NAP
Information included in column
PSUR frequency
"Are PSURs and DLP
required were
for products
PRAC representative
updated onin19/10/2022and DLP
referred to Articles 10(1), 10a,
were updated on 25/09/2019
14, 16a of Directive 2001/83/EC Marie Louise Schougaard
2162 nilotinib 19/11/2007 3 years 31/01/2027 01/05/2027 No 22/09/2021 PRAC representative
as amended" was
were updated on
PSUSA/00002162/202701
Christiansen Denmark CAP
PRAC Rapporteur
updated on name was
27/07/2022
06/05/2020
amended on 03/04/2019
PRACwas
representative updated on
2163 nilutamide 02/07/1986 6 years 02/07/2024 30/09/2024 No 31/01/2024 DLP
LMS and updated on 20/10/2021
PRAC representatives
DLP was updated on 26/09/2018
PSUSA/00002163/202407 Bianca Mulder Netherlands NAP
31/01/2024
were added on 31/07/2019
Information included in column
Next PSURs
"Are DLP was amended
required on
PSUR Frequency and for products
Next DLP
2165 nimesulide (topical formulations) 10/12/1999 5 years 30/06/2028 28/09/2028 No 28/02/2024 25/09/2017
DLP was to
referred
amended amended
on on 10(1),
in16/07/2015
Articles 28/02/2024
10a, PSUSA/00002165/202806 Amelia Cupelli Italy NAP
14, 16a
PRAC of Directive 2001/83/EC
representative was
Next
as DLP was updated
amended?" and DLP onwere
updated
22/09/2016on 19/10/2022
2166 nimodipine 01/11/1987 5 years 01/11/2028 30/01/2029 No 03/07/2024 updated
DLP was on 25/08/2021
amended on 03/07/2024 PSUSA/00002166/202811 Karen Pernille Harg Norway NAP
DLP was
Next updated on 21/09/2022
PRACDLP was updated
representative on
was
30/09/2015
updated on 30/06/2021
PRAC
PSUR Representative
frequency amended
and DLP
2168 nisoldipine 01/07/1995 8 years 02/09/2025 01/12/2025 No 31/07/2024 on 28/04/2022 PSUSA/00002168/202509 NAP
amended on 31/07/2024
Information included in column
"Are PSURs
PRAC required for
representative wasproducts
referred to
updated onin Articles 10(1), 10a,
23/10/2019
2169 nitisinone 21/02/2005 3 years 20/02/2025 21/05/2025 No 19/10/2022 PSUSA/00002169/202502 Amelia Cupelli Italy CAP
14, 16a of Directive 2001/83/EC
as amended?"
PSUR frequency and
andDLP
DLPwere
were
updated on 21/10/2020
updated on 31/07/2019
2170 nitrazepam 02/03/1965 3 years 02/03/2027 31/05/2027 No 20/11/2024 DLP was
Active amendedname
substance on 20/11/2024
was PSUSA/00002170/202703 Karin Erneholm Denmark NAP
DLP
Lead was
MS updated
and PRAC
amended on 18/10/2023on 25/09/2019
Rapporteur
name amended on 06/03/2019
DLP was
PSURwas updatedand
frequency on DLP
26/09/2018
were
2171 nitrendipine 31/03/1985 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP amended on 18/12/2024 PSUSA/00002171/202703 Jan Neuhauser Austria NAP
DLP was on
updated updated on 28/02/2018
17/11/2021
PRAC Rapporteur name amended
on 04/07/2018
European
Active Union reference
substance name was date
2172 nitric oxide 23/12/1999 3 years 23/12/2024 23/03/2025 Yes 21/09/2022 28/03/2017
amended on 22/09/2021 PSUSA/00002172/202412 Jo Robays Belgium CAP NAP
DLP was updated on 17/10/2017
Next DLP
PRAC was amended
Rapporteur on
name was
Next DLP
28/02/2017
PSUR was
frequency
amended updated
and DLP
on 06/03/2019 on
2173 nitrofural Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 22/09/2016 PSUSA/00002173/204005 none NAP
amended on 23/10/2024
Nextwas
DLP DLPupdated
was amended on
on 21/11/2018
Next DLP was updated on
04/02/2016
2174 nitrofurantoin, nitrofurantoin / pyridoxine hydrochloride 28/02/1953 5 years 28/02/2026 29/05/2026 No 18/10/2023 30/09/2015
Information included in column PSUSA/00002174/202602 Rugile Pilviniene Lithuania NAP
PSURPSURs
"Are Frequency and for
required Next DLP
products
Next DLP
was amended
referred amended on
on 30/09/2015.
to in Articles 10(1), 10a,
13/07/2015
14, 16a of Directive
2180 nizatidine 03/08/1985 8 years 03/05/2025 01/08/2025 No 03/07/2024
PSUR
DLP frequency
was updated on2001/83/EC
amended and
20/10/2021 PSUSA/00002180/202505 NAP
Next
as
DLP DLP wason
amended?"
updated amended
was on on
amended
03/07/2024
06/03/2015
17/10/2017
DLP was updated on 23/10/2018

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

PSUR frequency and DLP


2191 norgestimate Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002191/202412 Maia Uusküla Estonia NAP
amended on 27/03/2024

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

PSUR frequency and DLP


2193 diazepam / nortriptyline hydrochloride 17/03/1969 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00002193/203408 NAP
amended on 23/10/2024

PSUR frequency and DLP


2194 noscapine Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00002194/203608 NAP
amended on 23/10/2024

PSUR frequency and DLP


2195 nystatin 13/08/1954 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00002195/203401 NAP
amended on 23/10/2024
PSUR frequency and DLP were
updated on 21/09/2022
PSUR frequency and DLP
2197 obidoxime 29/01/1964 11 years 03/07/2039 01/10/2039 No 15/01/2025 PRAC Rapporteur name was PSUSA/00002197/203907 Martin Huber Germany NAP
amended on 23/10/2024
amended on 06/03/2019
DLP was amended on 03/05/2023
Next DLP was amended on
2199 octenidine dihydrochloride / phenoxyethanol Not available* 10 years 01/01/2032 31/03/2032 Yes 21/09/2022 PSUSA/00002199/203201 Rugile Pilviniene Lithuania NAP
25/09/2017
PRAC representative was
updated on 01/03/2023
Lead MS and PRAC Rapporteur
2200 octocog alfa 04/08/2000 3 years 26/08/2025 24/11/2025 No 03/05/2023 name
DLP was
was added on
updated on 28/07/2016
06/05/2020 PSUSA/00002200/202508 Gabriele Maurer Germany CAP 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

Next DLP was amended on


PSUR frequency amended and
27/06/2017
2204 ofloxacin (topical use) 02/05/1989 5 years 16/04/2029 15/07/2029 No 18/12/2024 PSUSA/00002204/202904 Petar Mas Croatia NAP
DLP updated on 18/12/2024
PRAC representative and Lead
Member State were added on
2207 olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 03/05/2016 PSUSA/00002207/202610 Martin Huber Germany NAP
DLP was updated on 29/06/2022
The DLP was amended on
PRAC Rapporteur name was
08/01/2014
PRAC representative updated on
2208 amlodipine / olmesartan 25/04/2012 5 years 24/04/2027 23/07/2027 No 31/01/2024 amended on 31/07/2018 PSUSA/00002208/202704 Bianca Mulder Netherlands NAP
31/01/2024
Information included in column
Next DLP was
"Are PSURs amended
required for on
products
27/06/2017
DLP was to
updated on 21/12/2022
2209 hydrochlorothiazide / olmesartan 25/04/2002 5 years 24/10/2026 22/01/2027 No 29/06/2022 referred in Articles 10(1), 10a, PSUSA/00002209/202610 Martin Huber Germany NAP
14, 16a of Directive 2001/83/EC
PRAC
Lead representative
MS and PRAC
as amended?" and Leadon
Rapporteur
was amended
Member
name State were
amended
30/11/2012 added on
on 19/12/2018
amlodipine besilate / hydrochlorothiazide / olmesartan
2210 02/12/2010 5 years 24/04/2027 23/07/2027 No 21/12/2022 03/05/2016 PSUSA/00002210/202704 Jana Lukačišinová Czech Republic NAP
medoxomil
DLP was amended on 31/01/2018
EURD and DLP were amended on
08/01/2014
Lead MS
PSUR and PRAC
frequency Rapporteur
amended and
2211 olopatadine 17/05/2002 5 years 30/04/2029 29/07/2029 No 05/02/2025
name was added on 19/10/2016
PSUSA/00002211/202904 Eamon O Murchu Ireland CAP NAP
DLP updated on 05/02/2025
DLP was updated on 01/02/2023

DLP was amended on 31/01/2018


2213 olsalazine 01/06/1986 5 years 31/05/2027 29/08/2027 No 01/02/2023 PSUSA/00002213/202705 Terhi Lehtinen Finland NAP
Leadwas
DLP MS updated
and PRAConRapporteur
21/12/2022
New
DLP CAP updated
was authoriised on
on 19/10/2016
17/11/2021
name was added on
16/05/2024
2214 omalizumab 25/10/2005 3 years 31/12/2025 31/03/2026 No 20/09/2023 PRAC representative was PSUSA/00002214/202512 Mari Thorn Sweden CAP
PRAC representative
updated was updatedwason
DLP amended
updated on on 20/09/2023
28/07/2021
04/03/2020
2215 omeprazole 15/04/1987 5 years 15/04/2027 14/07/2027 No 21/12/2022 PRAC representative PSUSA/00002215/202704 Liana Martirosyan Netherlands NAP
DLP was updated andwas
PRAC
updated on 28/04/2021
Representative amended on
19/12/2017
PSURwas
DLP frequency
updatedamended and
on 21/11/2018
2216 omoconazole 23/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUSA/00002216/202901 NAP
DLP updated on 28/08/2024
Lead MS and PRAC Rapporteur
Lead MS
name was
was amended
added on
on 19/10/2016
22/09/2016
2217 ondansetron 23/02/1990 3 years 28/02/2027 29/05/2027 No 17/11/2021 PSUSA/00002217/202702 Polona Golmajer Slovenia NAP
The next DLP was amended on
29/10/2015
PSUR frequency amended and
2218 opipramol 12/10/1961 9 years 01/02/2028 01/05/2028 No 28/08/2024 PSUSA/00002218/202802 NAP
Leadupdated
DLP MS was on
added on
28/08/2024
04/02/2015

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

Updated & published on


2228 oxacillin 01/01/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00002228/203405 NAP
23/10/2024

PSUR frequency amended and


2229 oxaliplatin 12/04/1996 5 years 12/04/2029 11/07/2029 Yes 18/12/2024 PSUSA/00002229/202904 Tiphaine Vaillant France NAP
DLP updated on 18/12/2024

PSUR frequency and DLP


2232 oxaprozin Not available* 8 years 03/11/2024 01/02/2025 No 23/10/2024 PSUSA/00002232/202411 NAP
amended on 23/10/2024

PSUR frequency amended and


2234 oxazepam 11/12/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002234/202803 NAP
DLP updated on 28/08/2024

PRAC Rapporteur name was


2235 oxcarbazepine 10/08/1999 3 years 31/08/2024 29/11/2024 No 16/10/2023 PSUSA/00002235/202408 Karin Erneholm Denmark NAP
amended on 18/10/2023

© 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

PSUR frequency amended and


2240 oxetorone 20/08/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00002240/202806 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


2241 oxiconazole Not available* 10 years 03/08/2036 01/11/2036 No 23/10/2024 PSUSA/00002241/203608 NAP
amended on 23/10/2024

PSUR frequency and DLP


2244 oxitriptan Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUSA/00002244/203203 NAP
amended on 23/10/2024

PSUR frequency and DLP


2246 oxolamine 18/06/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00002246/203906 NAP
amended on 23/10/2024

Updated & published on


2247 oxolamine / propyphenazone 05/03/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00002247/203405 NAP
23/10/2024

PSUR frequency and DLP


2248 guaifenesin / oxolamine citrate 25/07/1972 10 years 01/12/2024 01/03/2025 No 23/10/2024 PSUSA/00002248/202412 NAP
amended on 23/10/2024

PSUR frequency and DLP


2249 oxomemazine 11/03/1964 10 years 03/06/2034 01/09/2034 No 23/10/2024 PSUSA/00002249/203406 NAP
amended on 23/10/2024

PSUR frequency and DLP


2250 oxprenolol 26/02/1968 11 years 01/02/2040 01/05/2040 No 23/10/2024 PSUSA/00002250/204002 none NAP
amended on 23/10/2024
DLP was updated on 05/04/2023
PSUR frequency and DLP
2251 oxybuprocaine 20/03/1957 11 years 03/10/2037 01/01/2038 No 23/10/2024 PRAC representative was PSUSA/00002251/203710 NAP
amended on 23/10/2024
updated on 19/10/2022

PRAC Representative amended


2253 oxybutynin 17/07/1984 5 years 17/07/2027 15/10/2027 No 05/04/2023 PSUSA/00002253/202707 Jo Robays Belgium CAP NAP
on 28/04/2022

DLP was updated on 27/03/2018


PSUR frequency amended and
2254 oxycodone 12/12/1995 3 years 12/04/2027 11/07/2027 No 20/11/2024 PSUSA/00002254/202704 Liana Martirosyan Netherlands NAP
DLP updated on 20/11/2024
PRAC Representative amended
on 18/11/2016
PSUR frequency amended and
2255 acetylsalicylic acid / oxycodone hydrochloride Not available* 9 years 03/03/2029 01/06/2029 Yes 28/08/2024 PSUSA/00002255/202903 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


2256 oxycodone hydrochloride / paracetamol Not available* 3 years 03/07/2027 01/10/2027 Yes 05/02/2025 PSUSA/00002256/202707 Amelia Cupelli Italy NAP
DLP updated on 05/02/2025

PSUR frequency and DLP


2257 oxygen Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002257/202412 Italy NAP
amended on 27/03/2024
DLP was updated on 31/03/2021

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

DLP was updated on 23/05/2017


PSURwas
DLP frequency
amendedamended and
on 03/05/2023
2284 panthenol Not available* 8 years 11/03/2026 09/06/2026 No 28/08/2024 PSUSA/00002284/202603 NAP
DLP updated on 28/08/2024
PRAC Representative amended
LMS28/03/2017
on and PRAC representative
updated 05/06/2019
2285 pantoprazole 23/08/1994 5 years 23/08/2027 21/11/2027 No 03/05/2023 Next DLP was amended on PSUSA/00002285/202708 Rugile Pilviniene Lithuania CAP NAP
DLP was updated on 07/05/2018
03/05/2016
PRAC
PSUR Representative
frequency
Conditional amended
and DLP
approval
2286 amoxicillin / clarithromycin / pantoprazole 23/08/1994 8 years 03/08/2025 01/11/2025 No 31/07/2024 PSUSA/00002286/202508 NAP
on 28/03/2017
amended on 31/07/2024
Next DLP was amended on
28/05/2014
PSUR frequency and DLP
2287 papaverine 21/02/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00002287/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


2289 paracetamol (non IV formulations) 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 PSUSA/00002289/203905 NAP
amended on 23/10/2024

PSUR frequency and DLP


2290 acetylsalicylic acid / paracetamol Not available* 8 years 03/11/2025 01/02/2026 No 31/07/2024 PSUSA/00002290/202511 NAP
amended on 31/07/2024

PSUR frequency and DLP


2291 acetylsalicylic acid / caffeine / paracetamol 24/10/1972 10 years 01/12/2024 01/03/2025 No 05/01/2025 PSUSA/00002291/202412 Martin Huber Germany NAP
amended on 23/10/2024

PSUR frequency and DLP


2294 caffeine / paracetamol 24/06/1969 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00002294/204003 NAP
amended on 23/10/2024

PSUR frequency amended and


2297 caffeine / paracetamol / phenylephrine hydrochloride Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00002297/202906 NAP
DLP updated on 28/08/2024

caffeine / paracetamol / propyphenazone, paracetamol PSUR frequency amended and


2298 Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUSA/00002298/202512 Roxana Dondera Romania NAP
/ propyphenazone 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 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

LMS and PRAC representative


2301 dicyclomine hydrochloride / paracetamol Not available* 5 years 15/07/2025 13/10/2025 No 03/03/2021 PSUSA/00002301/202507 Zane Neikena Latvia NAP
were added on 06/05/2020

DLP was updated on 05/06/2019


PSUR frequency amended and
2302 caffeine / guaifenesin / paracetamol Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00002302/202906 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


2303 hyoscine butylbromide / paracetamol 10/08/1983 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00002303/202505 Martin Huber Germany NAP
DLP updated on 03/07/2024

ascorbic acid / paracetamol / pheniramine PSUR frequency amended and


2304 18/06/1991 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00002304/202506 Jan Neuhauser Austria NAP
hydrogenomaleate / phenylephrine hydrochloride DLP updated on 03/07/2024

ascorbic acid / caffeine / paracetamol / phenylephrine PSUR frequency and DLP


2305 Not available* 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00002305/202511 Melinda Pálfi Hungary NAP
hydrochloride / terpine amended on 31/07/2024
Information included in column
guaifenesin / paracetamol / phenylephrine PSURPSURs
"Are frequency and DLP
required for products
2306 Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUSA/00002306/202608 NAP
hydrochloride amended
referred
DLP on
and to in23/10/2024
PSUR Articles 10(1),
frequency 10a,
were
14, 16a of
updated onDirective 2001/83/EC
02/02/2022
paracetamol / pseudoephedrine, dextromethorphan / as amended?" was amended on
2307 paracetamol / pseudoephedrine, ascorbic acid / Not available* 5 years 28/06/2028 26/09/2028 Yes 23/10/2024 23/10/2024
PRAC representative was PSUSA/00002307/202806 Jo Robays Belgium NAP
dextromethorphan / paracetamol / pseudoephedrine updated on 29/07/2020
Active substance name was
amended
PSUR on 23/10/2024
PRAC frequency and DLP
representative was
2308 ascorbic acid / paracetamol / pseudoephedrine Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00002308/202905 NAP
amended
updated onon03/06/2020
31/07/2024
DLP was amended on 28/02/2024
PSUR frequency amended and
2310 paracetamol / tramadol Not available* 5 years 01/08/2028 30/10/2028 No 27/03/2024 DLP was amended
updated on 27/03/2024
on 19/12/2018 PSUSA/00002310/202808 Tiphaine Vaillant France NAP

DLP was updated on 19/12/2017


2311 paracetamol (IV formulation) Not available* 5 years 07/05/2026 05/08/2026 Yes 02/02/2022 PSUSA/00002311/202605 Tiphaine Vaillant France NAP
PRAC Rapporteur name updated
on 21/07/2017
PSUR frequency amended and
DLP updated
PSUR on 23/10/2024
frequency amended and
caffeine / codeine / paracetamol / propyphenazone,
2312 01/06/1957 7 years 01/06/2025 30/08/2025 Yes 05/01/2025 Nextupdated
DLP DLP wason
amended on
03/05/2023 PSUSA/00002312/202506 Petar Mas Croatia NAP
acetylsalicylic acid / caffeine / codeine / paracetamol
20/12/2016
Active substance name was
amended
PRAC on 23/10/2024
Representative updated on
PRAC Rapporteur name was
16/11/2022
2314 parecoxib 22/03/2002 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on
amended on 28/07/201620/12/2023 PSUSA/00002314/202603 Rhea Fitzgerald Ireland CAP
DLP was updated on 06/05/2020
Next DLP was updated on
2316 paricalcitol 17/04/1998 5 years 17/08/2027 15/11/2027 No 03/05/2023 21/12/2015.
PRAC Representative updated on PSUSA/00002316/202708 Monica Martinez Redondo Spain NAP
26/09/2018
Lead MS was added on
PSUR frequency and DLP were
06/03/2015
Next DLP
PSUR was amended
frequency and DLPon
2317 parnaparin 16/02/1993 8 years 03/08/2025 01/11/2025 No 30/10/2024 updated on
26/04/2017
29/06/2022 PSUSA/00002317/202508 Amelia Cupelli Italy NAP
amended on 31/07/2024
PRAC Rapporteur name was
PRAC representative
amended and Lead
on 28/04/2022
PSUR frequency
Member andadded
State were DLP on
2318 paromomycin 29/11/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00002318/203404 NAP
amended on 23/10/2024
04/03/2016
DLP was updated on 30/06/2021

2319 paroxetine 11/12/1990 5 years 10/12/2027 09/03/2028 No 20/09/2023 PRAC representative


DLP amended was
on 20/09/2023 PSUSA/00002319/202712 Liana Martirosyan Netherlands NAP
updated on 31/03/2021

DLP was updated on 03/06/2020


2320 patent blue V sodium 31/03/1974 5 years 30/04/2028 29/07/2028 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00002320/202804 Melinda Palfi Hungary NAP
PRAC representative was
updated on 25/09/2019
Marie Louise Schougaard
2321 pazopanib 14/06/2010 3 years 18/10/2024 16/01/2025 No 29/06/2022 PSUSA/00002321/202410
Christiansen Denmark CAP
DLP was updated on 05/06/2019

PRAC Rapporteur name was


2322 pefloxacin 07/08/1984 3 years 31/08/2026 29/11/2026 Yes 30/04/2024 amended on 03/04/2019
DLP was amended on 30/04/2024 PSUSA/00002322/202608 Polona Golmajer Slovenia NAP
New CAP authorised on
DLP was updated on 06/06/2018
09/12/2022
PRAC representative updated on
2326 pegfilgrastim 31/01/2002 3 years 31/01/2025 01/05/2025 No 31/01/2024 DLP was
was updated
updated on
on 20/10/2021
23/05/2017 PSUSA/00002326/202501 Bianca Mulder Netherlands CAP
31/01/2024
DLP
Next DLP
PRAC was amended
representative wason
2328 pegvisomant 13/11/2002 3 years 30/11/2025 28/02/2026 No 19/09/2024 03/06/2016
updated on 29/07/2020 PSUSA/00002328/202511 Zoubida Amimour France CAP

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

PRAC Representative amended


2338 pentamidine 15/06/1988 5 years 15/06/2027 13/09/2027 No 01/03/2023 on 28/04/2022 PSUSA/00002338/202706 Jo Robays Belgium NAP

DLP was updated on 28/02/2018


PSUR frequency amended and
2339 pentazocine 15/09/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002339/202803 NAP
PRACupdated
DLP representative and Lead
on 28/08/2024
Member State were added on
18/11/2016
PSUR frequency and DLP
2340 pentobarbital Not available* 8 years 03/11/2024 01/02/2025 No 23/10/2024 PSUSA/00002340/202411 NAP
amended on 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

2345 pentoxyverine 15/12/1954 5 years 31/12/2028 31/03/2029 No 25/09/2024 DLP was


PRAC amended onwas
representative 25/09/2024 PSUSA/00002345/202812 Martin Huber Germany NAP
updated on 19/10/2022

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

PRAC Rapporteur name was


amended on 31/07/2018

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

PRAC Rapporteur name was


2354 perindopril 22/06/1988 5 years 22/10/2025 20/01/2026 No 16/10/2023 PSUSA/00002354/202510 Karin Erneholm Denmark NAP
amended on 18/10/2023

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

PSUR frequency and DLP were


2358 phenazone Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 DLP was on
updated on 23/09/2020 PSUSA/00002358/203203 NAP
updated
amended on05/06/2019
23/10/2024
LMS and PRAC representative
were added on 31/07/2019
2359 lidocaine / phenazone Not available* 5 years 01/01/2025 01/04/2025 Yes 23/09/2020 PSUSA/00002359/202501 Rugile Pilviniene Lithuania NAP
Reference to NAP added and
Active substance name was
Updated & published on
2363 phenelzine 01/03/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 amended on 06/02/2019 PSUSA/00002363/203405 NAP
23/10/2024

PSUR frequency and DLP


2366 phenindione Not available* 8 years 03/11/2024 01/02/2025 No 23/10/2024 PSUSA/00002366/202411 NAP
amended on 23/10/2024
18/11/2020
DLP was updated on 21/10/2020

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

PSUR frequency and DLP


2376 phentolamine 02/04/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00002376/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


2377 phenylbutazone 19/02/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00002377/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


2381 phenylephrine / zinc sulfate Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002381/202412 NAP
amended on 27/03/2024

ascorbic acid / guaifenesin / paracetamol / PSUR frequency and DLP


2382 Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00002382/202905 NAP
phenylephrine hydrochloride amended on 31/07/2024
Active substance name was
amended on 18/12/2024
2386 mepyramine / phenylephrine Not available* 9 years 02/09/2031 01/12/2031 No 18/12/2024 PSUSA/00002386/203109 none NAP
PSUR frequency and DLP
amended on 23/10/2024
PSUR frequency and DLP
2387 paracetamol / phenylephrine hydrochloride Not available* 9 years 03/03/2032 01/06/2032 No 23/10/2024 PSUSA/00002387/203203 NAP
amended on 23/10/2024

PSUR frequency amended and


2388 phenylephrine hydrochloride / prednisolone acetate Not available* 7 years 01/01/2025 01/04/2025 No 30/04/2024 PSUSA/00002388/202501 Belgium NAP
DLP updated on 30/04/2024

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

PSUR frequency and DLP


2403 picloxydine 13/04/1962 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUSA/00002403/203907 NAP
amended on 23/10/2024

PSUR frequency and DLP


2406 pidotimod Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 PSUSA/00002406/202411 Amelia Cupelli Italy NAP
amended on 23/10/2024

PRAC Rapporteur name was


2408 pilocarpine / timolol 13/02/1989 5 years 15/07/2026 13/10/2026 No 16/10/2023 PSUSA/00002408/202607 Karin Erneholm Denmark NAP
amended on 18/10/2023

PRAC Rapporteur updated on


2409 pilocarpine (non ophthalmic formulations) 01/04/1994 5 years 31/07/2027 29/10/2027 No 15/11/2023 PSUSA/00002409/202707 Petar Mas Croatia NAP
15/11/2023

PRAC Rapporteur updated on


2410 pilocarpine (ophthalmic formulation) 01/04/1994 7 years 31/08/2028 29/11/2028 No 15/11/2023 PSUSA/00002410/202808 Petar Mas Croatia NAP
15/11/2023

PRAC representative updated on


Marie Louise Schougaard
2411 pimecrolimus 14/12/2001 3 years 31/03/2026 29/06/2026 No 20/12/2023 28/04/2022
DLP was amended on 20/12/2023 PSUSA/00002411/202603
Christiansen Denmark NAP

DLP was updated on 30/03/2022

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

PSUR frequency and DLP and


amended
2414 pinaverium 01/12/1975 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00002414/202808 NAP
amended on 31/07/2024
DLP updated on 03/04/2019

PRAC Rapporteur name was


PSUR frequency and DLP
2415 pindolol 10/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 amended on 23/10/2018 PSUSA/00002415/202805 NAP
amended on 31/07/2024
PSUR Frequency amended and
glimepiride / pioglitazone hydrochloride, metformin / DLP updated on 28/03/2017
2417 13/10/2000 3 years 31/07/2024 29/10/2024 No 30/03/2022 PSUSA/00002417/202407 Rhea Fitzgerald Ireland CAP
pioglitazone, pioglitazone
Next DLP was amended on
07/04/2016
2420 pipamperone 14/10/1965 15 years 14/10/2025 12/01/2026 No 01/10/2012 PSUSA/00002420/202510 NAP
Name of active substance was
amended on 28/02/2013
PSUR frequency and DLP
2422 pipecuronium Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 Information PSUSA/00002422/203205 NAP
amended onincluded in column
23/10/2024
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?" was amended on
01/08/2013
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Classified as internal/staff contractors by the Europ Page 41 / 223
Next DLP was amended on
#

01/10/2013
DLP was amended on 03/05/2023

PRAC representative was


PSUR frequency
updated amended and
on 27/07/2022
2424 piperacillin 07/05/1980 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00002424/202503 Amelia Cupelli Italy NAP
DLP updated on 03/07/2024
PRAC representative was
updated on 06/05/2020
2425 piperacillin / tazobactam 02/07/1992 5 years 01/09/2027 30/11/2027 No 03/05/2023 PSUSA/00002425/202709 Anna Mareková Slovakia NAP
Lead MS and PRAC Rapporteur
name amended on 19/12/2018
PSUR frequency amended and
2426 piperazine Not available* 10 years 03/11/2036 01/02/2037 No 15/01/2025
was updated on 06/06/2018
PSUSA/00002426/203611 Ana Sofia Diniz Martins Portugal NAP
DLP updated on 31/01/2024
DLP was updated on 01/02/2023
Lead MS and PRAC Rapporteur
DLP was amended on28/02/2017
31/01/2018
2429 piracetam 19/04/1971 5 years 30/04/2027 29/07/2027 No 01/02/2023 name was added on PSUSA/00002429/202704 Terhi Lehtinen Finland NAP
New CAP authorised on
Lead MS and PRAC Rapporteur
10/01/2023
name was added on 19/10/2016
PSUR frequency amended and
2430 dihydroergocristine / piracetam Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 New CAP authorised on PSUSA/00002430/203011 NAP
DLP updated on 28/08/2024
20/06/2022

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

DLP was updated on 21/10/2020


PSUR frequency and DLP
2434 piretanide / ramipril, piretanide 17/10/1980 8 years 03/08/2025 01/11/2025 No 16/01/2025 PSUSA/00002434/202508 Zoubida Amimour France NAP
amended on 31/07/2024
DLP was updated on 25/09/2019

Lead MS and PRAC Rapporteur


2435 pirfenidone 28/02/2011 3 years 27/02/2027 28/05/2027 No 20/10/2021 PSUSA/00002435/202702 Rhea Fitzgerald Ireland CAP
name updated on 30/04/2019

DLP was updated on 26/09/2018


2436 piribedil 10/10/1990 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002436/202603 Zane Neikena Latvia NAP
DLP was updated on 17/10/2017

Next DLP was amended on


2437 piritramide 01/04/1969 14 years 31/03/2025 29/06/2025 No 05/01/2025 19/10/2016 PSUSA/00002437/202503 Jo Robays Belgium NAP

Next DLP was updated on


2438 piroxicam 03/04/1979 3 years 01/04/2026 30/06/2026 No 20/12/2023 30/09/2015
DLP was amended on 20/12/2023 PSUSA/00002438/202604 Melinda Palfi Hungary NAP

Next DLP was amended on


fenpiverinium bromide / metamizole sodium / 02/05/2014
PSUR frequency amended and
2441 Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00002441/203011 NAP
pitofenone hydrochloride DLP updated on 28/08/2024

codeine phosphate hemihydrate / fenpiverinium PSUR frequency and DLP


2442 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00002442/202411 Anna Mareková Slovakia NAP
bromide / paracetamol / pitofenone hydrochloride amended on 27/03/2024

PSUR frequency and DLP


2443 metamizole sodium / pitofenone hydrochloride Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002443/202412 Anna Mareková Slovakia NAP
amended on 27/03/2024

PSUR frequency and DLP


2444 pivampicillin 31/10/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00002444/202808 NAP
amended on 31/07/2024

PSUR frequency and DLP


2445 pivmecillinam 31/05/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002445/202811 NAP
amended on 31/07/2024

PRAC representative was


PSUR frequency and DLP
2446 pizotifen 14/07/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 updated on 01/03/2023 PSUSA/00002446/202805 NAP
amended on 31/07/2024
DLP was updated on 22/12/2021
2449 plasma protein fraction Not available* 5 years 30/04/2026 29/07/2026 No 22/12/2021 PSUSA/00002449/202604 Gabriele Maurer Germany NAP
PRAC Rapporteur updated on
21/12/2015.

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.

PSUR frequency amended and


2453 pneumococcal polysaccharide vaccine 06/02/1981 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00002453/202505 Pernille Harg Norway NAP
updated
DLP was on 03/07/2024
updated on 26/05/2021

PRAC representative and LMS


2454 podophyllotoxin Not available* 6 years 15/09/2026 14/12/2026 No 26/05/2021 were added on 04/03/2020 PSUSA/00002454/202609 Terhi Lehtinen Finland NAP

PSUR frequency and DLP were


updated on 05/06/2019
2455 policresulen Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002455/202612 NAP

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

PSUR frequency, DLP and


2472 polystyrene sulfonate 26/10/1955 8 years 26/10/2030 24/01/2031 No 31/05/2023 PSUSA/00002472/203010 Jana Lukačišinová Czech Republic NAP
PRAC representative and PSURs
required for products referred to
in Articles 10(1), 10a, 16a of
PSUR frequency and DLP
2475 povidone, polyvinyl alcohol / povidone 01/01/1981 8 years 02/09/2025 01/12/2025 No 30/10/2024 Directive 2001/83/EC as PSUSA/00002475/202509 Adam Przybylkowski Poland NAP
amended on 31/07/2024
amended? were updated on
30/06/2021
PSUR frequency and DLP were
PSUR frequency and DLP
2476 polyvinyl alcohol 27/08/1965 10 years 03/06/2034 01/09/2034 No 23/10/2024 updated
LMS wereon 28/04/2021
added on 01/04/2020 PSUSA/00002476/203406 NAP
amended on 23/10/2024
PRAC representative
The DLP was amended was
onadded
on 06/05/2020
2478 poractant alfa 06/08/1992 5 years 31/08/2025 29/11/2025 No 28/04/2021 30/09/2015 PSUSA/00002478/202508 Terhi Lehtinen Finland NAP
LMS was added on 01/04/2020

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

PSUR frequency and DLP


2483 potassium chloride Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUSA/00002483/203205 NAP
amended on 23/10/2024

PSUR frequency and DLP


2485 potassium iodate 06/03/1978 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00002485/203503 NAP
amended on 23/10/2024

PSUR frequency and DLP


2486 perchlorates Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002486/202412 NAP
amended on 27/03/2024

PSUR frequency amended and


2487 povidone iodinated 24/04/1996 5 years 02/01/2029 02/04/2029 No 25/09/2024 PSUSA/00002487/202901 Zoubida Amimour France NAP
DLP updated on 25/09/2024

© 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

PSUR frequency and DLP


2489 prajmalium 22/12/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUSA/00002489/203501 NAP
amended on 23/10/2024

PSUR frequency and DLP


2490 pralidoxime 02/07/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00002490/203408 NAP
amended on 23/10/2024

DLP was updated on 03/06/2020


PSUR frequency amended and
2491 pramipexole 14/10/1997 3 years 06/04/2026 05/07/2026 No 15/11/2023 PSUSA/00002491/202604 Karin Erneholm Denmark CAP NAP
DLP updated on 15/11/2023
Next DLP amended on
13/07/2015
2492 pramiracetam Not available* 5 years 30/09/2024 29/12/2024 No 03/06/2020 DLP was updated on 20/10/2021 PSUSA/00002492/202409 Zane Neikena Latvia NAP
'PRAC Rapporteur name
amended
PRAC on 16/06/2015
Rapporteur name was
corrected
PSUR on 03/04/2019
frequency and DLP
2496 pranoprofen 12/12/1995 8 years 03/10/2025 01/01/2026 No 30/10/2024 PRAC Rapporteur name and PSUSA/00002496/202510 Adam Przybylkowski Poland NAP
amended on 31/07/2024
country
PSUR updated and
Frequency on 01/12/2014
DLP
updated on 26/09/2018
PSUR frequency and DLP
2498 estradiol / prasterone enantate Not available* 10 years 03/06/2035 01/09/2035 No 23/10/2024 PSUSA/00002498/203506 NAP
amended
PRAC on 23/10/2024
Rapporteur name was
amended on 06/06/2018
Marie Louise Schougaard
2499 prasugrel 23/02/2009 5 years 25/02/2029 26/05/2029 No 20/10/2021 DLP was updated and PRAC PSUSA/00002499/202902
Christiansen Denmark CAP
representative amended on
17/10/2017
2500 pravastatin 31/03/1989 5 years 30/03/2028 28/06/2028 No 19/09/2024
Next DLP was updated on
PSUSA/00002500/202803 Zoubida Amimour France NAP
22/09/2016
PSUR frequency amended
on and
2502 prazepam 18/12/1974 8 years 03/03/2025 01/06/2025 No 26/07/2024 Next DLP was updated PSUSA/00002502/202503 Jo Robays Belgium NAP
DLP updated on 03/07/2024
30/09/2015

The next DLP was amended on


2503 praziquantel 30/04/1980 3 years 30/04/2027 29/07/2027 No 05/02/2025 DLP was amended on 05/02/2025
01/04/2014 PSUSA/00002503/202704 Zoubida Amimour France NAP

PSUR frequency and DLP


2504 prazosin 24/05/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00002504/202808 NAP
amended on 31/07/2024

PSUR frequency and DLP


2505 prednicarbate 02/10/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00002505/202812 NAP
amended on 31/07/2024

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

PSUR frequency and DLP


2508 estradiol benzoate / prednisolone / salicylic acid Not available* 8 years 03/05/2026 01/08/2026 No 31/07/2024 PSUSA/00002508/202605 NAP
amended on 31/07/2024

PSUR frequency amended and


2510 prednisone 18/05/1955 8 years 31/01/2025 01/05/2025 No 30/04/2024 PSUSA/00002510/202501 Karin Erneholm Denmark NAP
DLP updated on 30/04/2024

PSUR frequency amended and


2511 pregabalin 06/07/2004 3 years 31/01/2026 01/05/2026 No 18/10/2023 PSUSA/00002511/202601 Liana Martirosyan Netherlands CAP NAP
DLP updated on 18/10/2023

PSUR frequency amended and


2522 prilocaine 01/01/1963 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002522/202803 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


2523 epinephrine / prilocaine hydrochloride Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002523/202412 Martin Huber Germany NAP
amended on 27/03/2024
DLP was updated on 03/03/2021
PSUR frequency and DLP
2524 felypressin / prilocaine hydrochloride Not available* 10 years 12/02/2035 13/05/2035 No 31/07/2024 PSUSA/00002524/203502 NAP
amended
LMS on 31/07/2024
and PRAC representative
were added on 04/03/2020

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

PSUR frequency and DLP


2529 procaine Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002529/203611 NAP
amended on 23/10/2024

magnesium chloride hexahydrate / potassium PSUR frequency and DLP


2532 Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002532/202412 Jana Lukačišinová Czech Republic NAP
chloride / procaine hydrochloride amended on 27/03/2024

PSUR frequency and DLP


2533 phenazone / procaine hydrochloride Not available* 11 years 03/05/2040 01/08/2040 No 23/10/2024 PSUSA/00002533/204005 none NAP
amended on 23/10/2024

PSUR frequency amended and


2534 procarbazine 07/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002534/202803 NAP
DLP updated on 28/08/2024

Active substance name, PSUR


2536 perazine 06/12/1957 9 years 02/12/2027 01/03/2028 No 31/01/2024 frequency amended and DLP PSUSA/00002536/202712 none NAP
updated on 31/01/2024
DLP was updated on 01/02/2023
2537 procyanidolic oligomers 11/05/1977 10 years 11/05/2032 09/08/2032 No 01/02/2023 PSUSA/00002537/203205 Melinda Palfi Hungary NAP
LMS and PRAC representative
were added on 20/10/2021
PSUR frequency and DLP
2538 procyclidine 07/03/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00002538/203401 NAP
amended on 23/10/2024
DLP was amended on 18/12/2024
2540 progesterone 09/09/1971 8 years 09/09/2025 08/12/2025 No 18/12/2024 PSUSA/00002540/202509 Mari Thorn Sweden NAP
PSUR frequency amended and
DLP updated on 03/07/2024
PSUR frequency and DLP
2541 proglumetacin 01/02/1980 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002541/202811 Carla Torre Portugal NAP
amended on 31/07/2024

PSUR frequency and DLP


2543 promazine 13/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00002543/203401 NAP
amended on 23/10/2024

PSUR frequency and DLP


2544 promegestone 31/07/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002544/202811 NAP
amended on 31/07/2024

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

PRAC representative was


updated on 28/07/2021

PRAC representative was


updated on 28/04/2021

Lead MS and PRAC Rapporteur


2550 propafenone 10/12/1978 5 years 31/01/2026 01/05/2026 No 20/10/2021 name amended on 19/12/2018 PSUSA/00002550/202601 Polona Golmajer Slovenia NAP

Next DLP was amended on


19/10/2016
PSUR frequency and DLP
2554 propiverine 22/10/1981 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002554/202811 NAP
amended on 31/07/2024
The DLP was amended on
30/09/2015
Next DLP was updated on
2555 propofol 08/11/1995 5 years 07/11/2027 05/02/2028 No 26/07/2023 PSUSA/00002555/202711 Karen Pernille Harg Norway NAP
26/07/2023
Lead MS was added on
13/07/2015
PSUR frequency amended and
2558 propylthiouracil Not available* 7 years 31/01/2025 01/05/2025 No 30/04/2024 PSUSA/00002558/202501 Maia Uusküla Estonia NAP
DLP updated on 30/04/2024

PSUR frequency amended and


PSURupdated
DLP frequency amended and
on 05/04/2023
2559 propyphenazone Not available* 7 years 31/01/2025 01/05/2025 No 30/04/2024 PSUSA/00002559/202501 NAP
DLP updated on 30/04/2024
PRAC representative was
updated on 01/03/2023
PSUR frequency amended and
2562 protamine 31/12/1951 11 years 31/12/2034 31/03/2035 No 18/12/2024 PSUSA/00002562/203412 none NAP
DLP updated on 18/12/2024
DLP was updated on 31/03/2021

DLP was updated on 03/04/2019


2563 human protein C 16/07/2001 3 years 31/07/2025 29/10/2025 No 05/04/2023 PSUSA/00002563/202507 Gabriele Maurer Germany CAP NAP
PSUR Frequency amended and
PSUR frequency amended and
DLP updated on 28/03/2017
DLP updated on 23/10/2024
2564 prothipendyl 07/10/2005 3 years 07/10/2025 05/01/2026 No 23/10/2024 PSUSA/00002564/202510 none NAP
Active substance name and next
EURD added on 23/10/2024
DLP was amended on 07/04/2016
PSUR frequency amended and
2565 protionamide Not available* 7 years 31/01/2025 01/05/2025 No 19/07/2024 The DLP was amended on PSUSA/00002565/202501 Martin Huber Germany NAP
DLP updated on 30/04/2024
01/04/2014

PSUR frequency and DLP


2567 proxymetacaine 01/03/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00002567/203409 NAP
amended on 23/10/2024

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

doxylamine hydrogen succinate / paracetamol / PSUR frequency and DLP


2575 Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00002575/202411 Tiphaine Vaillant France NAP
pseudoephedrine hydrochloride amended on 27/03/2024

PSUR frequency and DLP


2578 pyrantel 30/12/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00002578/203409 NAP
amended on 23/10/2024

PSUR frequency and DLP


2579 pyrazinamide 25/01/1956 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00002579/202712 NAP
amended on 31/07/2024

PSUR frequency and DLP


2580 pyridostigmine 01/12/1953 10 years 01/01/2034 01/04/2034 No 23/10/2024 PSUSA/00002580/203401 NAP
amended on 23/10/2024

PSUR frequency and DLP


2582 pyrimethamine 01/01/1952 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00002582/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


2583 pyrimethamine / sulfadoxine 14/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUSA/00002583/202805 NAP
amended on 31/07/2024

PSUR frequency and DLP


2584 pyrithione zinc Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUSA/00002584/203206 NAP
amended on 23/10/2024

PSUR frequency and DLP


2585 pyritinol 17/01/1960 10 years 02/04/2034 01/07/2034 No 23/10/2024 PSUSA/00002585/203404 NAP
amended on 23/10/2024

PSUR frequency and DLP


2587 pyrvinium Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002587/203611 NAP
amended on 23/10/2024
PRAC Rapporteur name was
amended on 22/09/2022
2589 quetiapine 31/07/1997 3 years 31/07/2026 29/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002589/202607 Liana Martirosyan Netherlands NAP
PRAC Rapporteur name updated
on 23/10/2018
2590 quinagolide 29/06/1993 10 years 31/07/2027 29/10/2027 No 07/05/2018 PSUSA/00002590/202707 Karin Bolin Sweden NAP
PSUR frequency and DLP updated
on 07/05/2018
DLP was
PRAC updated name
Rapporteur on 27/07/2022
was
2591 quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 16/10/2023 PRAC representative
DLP was and Lead
updated on 22/12/2021 PSUSA/00002591/202604 Karin Erneholm Denmark NAP
amended on 18/10/2023
Member State were
PRAC Rapporteur added
name on
updated
30/01/2017
Next DLP was amended on
on 23/10/2018
20/12/2016
2592 hydrochlorothiazide / quinapril 14/04/1989 5 years 13/04/2026 12/07/2026 No 15/01/2025 PSUSA/00002592/202604 Roxana Dondera Romania NAP
Next DLP was amended on
Lead Member State and PRAC
25/09/2017
Rapporteur added on
2598 quinine 15/01/1951 5 years 30/11/2026 28/02/2027 No 27/07/2022 27/11/2015.
PRAC representative and Lead PSUSA/00002598/202611 Eamon O'Murchu Ireland NAP
DLP was State
Member updated onadded
were 29/06/2022
on
30/01/2017
EURD corrected on 05/06/2019
2600 quinisocaine Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00002600/202612 NAP
Next DLP was amended on
Next DLP was amended on
03/06/2016
27/06/2017
2601 rabeprazole 14/10/1997 5 years 13/10/2026 11/01/2027 No 29/06/2022 The 8 digit unique identification PSUSA/00002601/202610 Jan Neuhauser Austria NAP
PSUR
numberFrequency amended and
was corrected.
DLP updated on 28/06/2016
New
PSURCAP authorised
frequency on
amended and
2602 racecadotril Not available* 5 years 31/03/2028 29/06/2028 No 20/12/2023 Lead MS added on 16/06/2015
19/09/2024 PSUSA/00002602/202803 Monica Martinez Redondo Spain NAP
DLP updated on 20/12/2023
The
PSURDLP was amended
frequency on and
amended
01/04/2014
DLP updated on 31/05/2023
2603 raloxifene 05/08/1998 5 years 09/12/2028 09/03/2029 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00002603/202812 Terhi Lehtinen Finland CAP

New CAP authorised on


09/11/2022
PSUR frequency and DLP
2605 raltitrexed 11/08/1995 8 years 02/09/2025 01/12/2025 No 30/10/2024 PSUSA/00002605/202509 Jana Lukačišinová Czech Republic NAP
amended on 31/07/2024
New CAP authorised on
25/08/2022
2607 ramipril 10/01/1989 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00002607/202908 Martin Huber Germany NAP
New CAP authorised on
18/08/2021

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

and DLP were


PSUR frequency amended and
2610 ranitidine 15/06/1981 5 years 31/05/2029 29/08/2029 No 05/02/2025
updated on 03/06/2020
PSUSA/00002610/202905 Amelia Cupelli Italy NAP
DLP updated on 05/02/2025

PSUR Frequency amended and


2611 ranolazine 09/07/2008 3 years 26/01/2027 26/04/2027 No 25/09/2024 DLP was
updated on 23/05/2017
amended on 25/09/2024 PSUSA/00002611/202701 Mari Thorn Sweden CAP

Next DLP was amended on


03/05/2016
2612 rasagiline 21/02/2005 5 years 02/01/2029 02/04/2029 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00002612/202901 Ana Sofia Diniz Martins Portugal CAP NAP
DLP was corrected on 04/03/2016

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

Lead MS and PRAC Rapporteur


name amended on 19/12/2018
2615 reboxetine 10/04/1997 5 years 09/04/2025 08/07/2025 No 24/09/2024 PSUSA/00002615/202504 Karin Bolin Sweden NAP
Next DLP amended on
21/12/2015
DLP and PSUR frequency were
2616 regadenoson 10/04/2008 3 years 09/04/2027 08/07/2027 No 18/12/2024 updated
Lead
DLP MS on
was was02/02/2022
added
amended onon
18/12/2024 PSUSA/00002616/202704 Maria del Pilar Rayon Spain CAP
06/03/2015
PRAC representative and LMS
were added on 23/09/2020
2617 remifentanil 17/05/1996 5 years 16/05/2026 14/08/2026 No 02/02/2022 PSUSA/00002617/202605 Martin Huber Germany NAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a
PRAC of Directive 2001/83/EC
representative updated on
2618 repaglinide 17/08/1998 5 years 31/12/2025 31/03/2026 No 31/01/2024
as amended?Yes/No" was
PSUSA/00002618/202512 Bianca Mulder Netherlands CAP NAP
31/01/2024
amended on 12/05/2015
PSUR frequency and DLP
2620 resorcinol Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002620/203611 NAP
amended on 23/10/2024

PSUR frequency amended and


2625 retinol 13/10/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002625/202803 NAP
DLP updated on 28/08/2024

a-tocopherol / ergocalciferol / phytomenadion / retinol PSUR frequency and DLP


2633 Not available* 8 years 03/11/2025 01/02/2026 No 31/07/2024 PSUSA/00002633/202511 Miroslava Gocova Slovakia NAP
palmitate amended on 31/07/2024
haemophilus influenzae / membrane fraction of
klebsiella pneumoniae / ribosomal fractions of PSUR frequency amended and
2638 30/03/1989 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00002638/202901 NAP
klebsiella pneumoniae / streptococcus pneumoniae / DLP updated on 28/08/2024
streptococcus pyogenes vaccine
PSUR frequency and DLP Marie Louise Schougaard
2639 rifabutin 19/10/1992 8 years 03/07/2025 01/10/2025 No 30/10/2024 PSUSA/00002639/202507
Christiansen Denmark NAP
amended on 31/07/2024

PSUR frequency amended and


2640 rifampicin 01/05/1968 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00002640/202503 Maria Popova-Kiradjieva Bulgaria NAP
DLP updated on 03/07/2024

Marie Louise Schougaard


2641 rifamycin 01/04/1962 11 years 01/04/2034 30/06/2034 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00002641/203404
Christiansen Denmark NAP

DLP was updated on 28/04/2022


PSUR frequency amended and
2642 rifaximin 14/09/1985 8 years 03/05/2025 01/08/2025 No 30/10/2024 PSUSA/00002642/202505 Melinda Pálfi Hungary NAP
DLP updated
PRAC on 03/07/2024
representative was
updated on 23/09/2020
PRAC Rapporteur name was
2643 rilmenidine 23/04/1987 3 years 23/08/2024 21/11/2024 No 28/04/2022 amended
DLP on 22/09/2022
was amended on 30/04/2019 PSUSA/00002643/202408 Melinda Palfi Hungary NAP
Reference to CAP added and
Active
Next substance name and
on DLP
activeDLP was amended
substance name was
updated on 22/12/2021
03/05/2016
PSUR frequency
amended amended and
on 26/07/2023
2645 riluzole 10/12/1995 5 years 12/12/2028 12/03/2029 No 31/07/2024 PSUSA/00002645/202812 Karin Erneholm Denmark CAP NAP
DLP updated on 31/07/2024
Next DLP
Leadwas was amended
MS updated
added onon on
12/05/2015
DLP 01/02/2023
20/12/2016
risedronate, risedronate,
2648 31/03/1998 5 years 31/03/2026 29/06/2026 No 22/12/2021 Active substance name updated PSUSA/00002648/202603 Mari Thorn Sweden NAP
risedronate/calcium/colecalciferol PRAC Rapporteur name amended
on 02/03/2022
on 29/10/2015
DLP was amended on 31/01/2018
2649 risperidone 01/06/1993 5 years 31/05/2027 29/08/2027 No 26/07/2023 Information included in column PSUSA/00002649/202705 Martin Huber Germany CAP NAP
"Are PSURs required for products
Lead MS and PRAC Rapporteur
referred to in Articles 10(1), 10a,
name
DLP was
was added on
updated 19/10/2016
on2001/83/EC
06/05/2020
14, 16a of Directive
2650 ritodrine hydrochloride Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLPamended?"
amended
Reference
as on
to NAP
was23/10/2024
added on on
amended PSUSA/00002650/202612 NAP
Information
PRAC included inwas
representatives
23/10/2024 column
30/11/2012
"Are PSURs
updated on required
04/03/2020 for products
referred
PRAC to in Articleswas
representative 10(1), 10a,
2651 ritonavir 26/08/1996 3 years 31/08/2025 29/11/2025 No 03/05/2023 14, 16a PSUSA/00002651/202508 Liana Martirosyan Netherlands CAP
Next
New DLPof
CAP
updated Directive
was amended
authorised
on 29/07/20202001/83/EC
on on
as amended?" was amended on
26/04/2017
19/09/2024
19/10/2016
PRAC representative was
2652 rituximab 02/06/1998 3 years 17/11/2026 15/02/2027 No 28/08/2024 PRAC frequency
PSUR representative
updated nameand
amended
on 03/06/2020 was PSUSA/00002652/202611 Karin Erneholm Denmark CAP
amended
DLP on 01/04/2015.
updated on 28/08/2024
Reference to NAP added on
PSUR frequency and DLP were
23/10/2024
DLP was on
updated amended on 03/07/2024
25/09/2019
2653 rivaroxaban 30/09/2008 2 years 15/09/2024 14/12/2024 No 23/10/2024 PSUSA/00002653/202409 Mari Thorn Sweden CAP NAP
Next DLP was updated on
Reference toincluded
Information NAP products
in column
31/05/2023
removed
"Are PSURsonrequired
04/07/2018
for products
2654 rivastigmine 12/05/1998 5 years 31/01/2029 01/05/2029 No 25/09/2019 referred to in Articles 10(1), 10a, PSUSA/00002654/202901 Tiphaine Vaillant France CAP NAP
PRAC Rapporteur
14, 16a name
of Directive updated
2001/83/EC
on amended?"
as 21/07/2017 was amended on
2655 rizatriptan 11/02/1998 5 years 11/06/2028 09/09/2028 No 28/02/2024 28/02/2024
DLP was amended on 28/02/2024 PSUSA/00002655/202806 Liana Martirosyan Netherlands NAP
PSUR Frequency amended
DLP was updated on 01/03/2023and
PSUR updated
DLP was
frequencyon 22/09/2016
updated on 16/11/2022
amended and
DLP updated
PRAC on 05/04/2023
representative was
2656 rocuronium 17/03/1994 3 years 28/02/2025 29/05/2025 No 28/02/2024 PRACwas
DLP Rapporteur
updated updated
on name was
on 20/11/2019
29/07/2020 PSUSA/00002656/202502 Eva Jirsová Czech Republic NAP
amended
DLP on 28/07/2016
was updated on 01/04/2020
PRAC representative
PRAC Rapporteur name wasupdated
Next
on
PSUR DLP was
27/06/2017
frequency
Frequency
updated on updated
amendedon and
amended
03/06/2020 and
2658 roflumilast 05/07/2010 5 years 05/01/2029 05/04/2029 No 25/09/2024 30/09/2015 PSUSA/00002658/202901 Monica Martinez Redondo Spain CAP
DLP 25/09/2024
updated on 28/02/2017
Nextwas
DLP DLPupdated
was updated on
01/04/2020
Rapporteur
18/11/2016
PRAC amended amended
Representative on
2660 romiplostim 04/02/2009 5 years 31/07/2027 29/10/2027 No 05/04/2023 04/11/2014
on 28/06/2016
PRAC Rapporteur name updated PSUSA/00002660/202707 Monica Martinez Redondo Spain CAP
Lead
on Member State updated on
21/07/2017
30/09/2015
Next DLP was updated on
04/03/2016
DLP
DLP was updated
was updated onon 05/04/2023
28/03/2017
2661 ropinirole 08/07/1996 3 years 08/07/2025 06/10/2025 No 01/03/2023 PSUSA/00002661/202507 Tiphaine Vaillant France NAP
The DLP
PRAC
PSUR was amended
Rapporteur
frequency name
and on
DLP was
were
06/03/2015
amended
updated on04/03/2020
28/07/2016
Next DLPon was updated on
2662 ropivacaine 15/09/1995 5 years 14/09/2027 13/12/2027 No 06/06/2018 PSUSA/00002662/202709 Liana Martirosyan Netherlands NAP
31/05/2023
The
LeadDLP
DLP MS was
was and amended on
PRAConRapporteur
updated 06/02/2019
01/04/2014
name updated on 04/02/2016
PRACwas
DLP representative updated on
updated on 28/02/2018
2664 rosuvastatin 06/11/2002 5 years 06/11/2027 04/02/2028 No 31/01/2024 Transferred PSUSA/00002664/202711 Bianca Mulder Netherlands NAP
31/01/2024 from the List of
substances
Next DLP was under PSUR Work
amended on
PRAC representative
Sharing was
scheme and other
28/02/2017
2665 rotavirus vaccine monovalent (live, oral) 21/02/2006 3 years 11/07/2025 09/10/2025 No 05/04/2023 updated
substanceson contained
19/10/2022in PSUSA/00002665/202507 Jean-Michel Dogné Belgium CAP
Nationally
PRAC Authorised amended
Representative Products
DLP
with
on was
DLP updated on 21/09/2022
synchronised
18/11/2016 on
06/03/2015
2666 rotavirus vaccine pentavalent (live, oral) 27/06/2006 3 years 27/11/2026 25/02/2027 No 31/07/2024 DLP was
PRAC amended onwas
representative
Next DLP
31/07/2024
was updated on
PSUSA/00002666/202611 Mari Thorn Sweden CAP
updated
04/03/2016on 27/07/2022

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

PRAC Rapporteur name amended


on 04/07/2018
DLP and PSUR frequency
2671 rufinamide 16/01/2007 5 years 15/01/2028 14/04/2028 Yes 20/09/2023 PSUSA/00002671/202801 Tiphaine Vaillant France CAP
amended on 20/09/2023
Next DLP was amended on
25/09/2017
PSUR frequency amended and
2673 rupatadine 12/12/2005 5 years 30/12/2028 30/03/2029 No 25/09/2024 PSUSA/00002673/202812 Monica Martinez Redondo Spain NAP
DLP updated
PSUR on 25/09/2024
Frequency and Next DLP
was amended on 30/09/2015
Updated & published on
2674 rutoside 31/10/1962 10 years 03/05/2034 01/08/2034 No 03/10/2024 Lead MS was added on PSUSA/00002674/203405 NAP
23/10/2024
22/12/2014

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

DLP was updated on 30/06/2021


DLP was updated on 27/07/2022
Lead MS and PRAC Rapporteur
nameCAP
New amended on 19/12/2018
authorised on
PSUR frequency, DLP and PRAC
16/02/2022
representative were updated on
Next DLP was amended on
2681 salmeterol 25/10/1990 5 years 31/10/2025 29/01/2026 No 30/06/2021 25/09/2019 PSUSA/00002681/202510 Mari Thorn Sweden NAP
28/07/2016
PSUR frequency and DLP were
updated on 03/07/2019
Lead MS and PRAC Rapporteur
"Are PSURs required for products
name updated on 30/04/2019
2682 samarium (153sm) lexidronam 05/02/1998 5 years 04/02/2029 05/05/2029 No 25/09/2019 referred
PRAC to in Articles
Rapporteur name10(1), 10a,
updated PSUSA/00002682/202902 Karin Erneholm Denmark CAP
14,19/12/2018
on 16a of Directive 2001/83/EC
PRAC Representative amended
as amended? Yes/No" was
on 28/03/2017
amended
PRAC on 16/07/2015
Rapporteur name updated
2683 sapropterin 02/12/2008 3 years 01/12/2024 01/03/2025 No 27/07/2022 PSUSA/00002683/202412 Eamon O Murchu Ireland CAP
on 23/10/2018
Next DLP was updated on
Lead MS added on 16/06/2015
22/09/2016
DLP was updated on 04/07/2018
2685 saxagliptin, metformin / saxagliptin 01/10/2009 3 years 30/07/2026 28/10/2026 No 27/03/2024 DLP was amended on 27/03/2024 PSUSA/00002685/202607 Bianca Mulder Netherlands CAP
Next DLP was amended on
27/06/2017
PSUR frequency and DLP
2687 secnidazole Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 Next DLP was updated on PSUSA/00002687/203206 NAP
amended on 23/10/2024
28/06/2016
PRAC representative was
updated on 19/10/2022
PSUR frequency amended and
2688 selegiline 14/03/1980 8 years 03/03/2025 01/06/2025 No 26/07/2024 Next DLP amended on PSUSA/00002688/202503 Jana Lukačišinová Czech Republic NAP
DLP updated
13/07/2015 on 03/07/2024
DLP was updated on 29/06/2022

PRAC Representative updated on


2690 selenium Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024
28/04/2022 PSUSA/00002690/202612 none NAP

PSUR frequency and DLP were


PSUR frequency
updated and DLP
on 03/07/2019
2693 serrapeptase 30/09/1968 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00002693/203408 NAP
amended on 23/10/2024
DLP was updated on 21/12/2022
DLP was updated on 04/07/2018
PSUR
PRAC frequency
Rapporteuramended and
name updated
2694 sertaconazole 10/03/1992 8 years 03/06/2025 01/09/2025 No 30/10/2024 Next DLP wason
amended on PSUSA/00002694/202506 Ana Sofia Martins Portugal NAP
DLP updated
on 23/10/2018 03/07/2024
27/06/2017
PRAC Representative updated on
2695 sertindole 11/07/2002 3 years 11/01/2026 11/04/2026 Yes 20/09/2023 PRAC Representative
DLP amended updated on
on 20/09/2023 PSUSA/00002695/202601 Melinda Palfi Hungary NAP
26/09/2018
18/11/2016
DLP was updated on 19/12/2017
Next DLP was updated on
2696 sertraline 01/03/1990 5 years 31/03/2027 29/06/2027 No 21/12/2022 28/06/2016 PSUSA/00002696/202703 Liana Martirosyan Netherlands NAP
Lead MS and PRAC Rapporteur
DLP was
name wasupdated
added on on 19/10/2016
21/10/2020
Next DLP amended on
13/07/2015
PRAC Rapporteur name
2697 sevelamer 30/10/1998 3 years 30/10/2024 28/01/2025 No 29/06/2022 DLP was updated
Transferred from the Listwas
on 21/09/2022
of PSUSA/00002697/202410 Jo Robays Belgium CAP NAP
amended onunder
substances 23/10/2018
PSUR Work
PRAC representative
Reference to NAPand wason
added
Sharing scheme other
amended
The on 04/02/2015
next DLP
25/05/2022 was amended on
substances contained in
2698 sevoflurane 23/01/1990 5 years 31/01/2025 01/05/2025 No 21/10/2020 29/10/2015
Nationally Authorised Products PSUSA/00002698/202501 Eamon O'Murchu Ireland NAP
The DLP
PSUR and Nextamended
Frequency DLP were
with DLP synchronised on and
corrected
The
next DLP
DLP on 07/01/2015
was corrected
updated on on
25/09/2017
06/03/2015
17/03/2015
2699 sildenafil (indicated for erectile dysfunction) 14/09/1998 5 years 31/12/2026 31/03/2027 No 21/09/2022 DLP was amendedpublished
on 22/12/2014 PSUSA/00002699/202612 Liana Martirosyan Netherlands CAP NAP
PSUSA procedure on
Lead MS wasInformation
01/04/2014. added on included
Rapporteur
04/02/2015
in name
column "Are was required
PSURs amended
2700 sildenafil (indicated for pulmonary hypertension) 28/10/2005 3 years 31/05/2027 29/08/2027 No 05/02/2025 on
DLP04/11/2014
for products referred
was amended on to in
05/02/2025 PSUSA/00002700/202705 Bianca Mulder Netherlands CAP NAP
Articles 10(1), 10a, 14, 16a of
Next DLP 2001/83/EC
Directive and EURD was as
amended
amended?"
Next
DLP onwas
28/05/2014
DLPupdated
was was amended
updated on on
on 26/05/2021
2701 silodosin 29/01/2010 3 years 30/01/2026 30/04/2026 No 18/10/2023 30/11/2012 PSUSA/00002701/202601 Amelia Cupelli Italy CAP
18/10/2023
Next DLP
PRAC and EURD was
representative was added
amended
on on 02/05/2014
06/05/2020
2702 silver sulfadiazine 25/01/1973 5 years 15/09/2025 14/12/2025 No 26/05/2021 PSUSA/00002702/202509 Maia Uusküla Estonia NAP
The DLP
LMS was was
added amended on
on 01/04/2020
08/01/2014
Active substance name, PSUR
PSUR frequency and DLP were
2703 cerium nitrate / silver sulfadiazine 25/01/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 The name
frequency and country
DLP were of the PSUSA/00002703/203501 NAP
updated
amended on
on05/06/2019
23/10/2024
Rapporteur
amended onwas published on
18/10/2023
06/10/2014.
PSUR frequency and DLP were
simeticone, pancreatin / simeticone, dimethicone /
Information
updated included in column
on 16/12/2020
2705 pancreatin, pancreatic enzymes, pancreatic extracts, 28/04/1967 9 years 02/04/2028 01/07/2028 No 18/10/2023 PSUSA/00002705/202804 none NAP
"Are PSURs required for products
pancreatin
referred
Lead MS to
andin PRAC
Articles 10(1), 10a,
Rapporteur
14, 16a
name of Directive
amended 2001/83/EC
on 19/12/2018
PSUR frequency amended and
2706 aluminium oxide / magnesium hydroxide / simeticone Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 as amended?" was amended on PSUSA/00002706/202903 NAP
DLP updated on 28/08/2024
30/11/2012
DLP was updated on 19/12/2017

Lead MS and PRAC Rapporteur


2709 simvastatin 06/04/1988 5 years 05/04/2025 04/07/2025 No 16/12/2020 PSUSA/00002709/202504 Terhi Lehtinen Finland NAP
name was added on 19/10/2016

Transferred from the List of


2710 sirolimus (for prophylaxis of organ rejection indication) 13/03/2001 3 years 14/09/2026 13/12/2026 No 05/06/2024 substances under PSUR
DLP was amended Work
on 05/06/2024 PSUSA/00002710/202609 Mari Thorn Sweden CAP
Sharing scheme and other
substances contained in
Nationally
PSUR Authorised
frequency Products
and DLP
2713 sobrerol Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 with DLP synchronised on PSUSA/00002713/203206 NAP
amended on 23/10/2024
06/03/2015

PSUR frequency and DLP


2719 sodium benzoate / sodium phenylacetate Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUSA/00002719/203206 NAP
amended on 23/10/2024

sodium bicarbonate / sodium hydrogen phoshate / PSUR frequency and DLP


2723 11/01/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUSA/00002723/203912 NAP
sodium sulphate amended on 23/10/2024

PSUR frequency amended and


solutions for haemofiltration and haemodiafiltration, PSUR frequency and DLP
2724 Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 DLP updated on 23/10/2024 PSUSA/00002724/203208 none NAP
solutions for haemodialysis amended on 23/10/2024
succinylated gelatin, sodium chloride / sodium
hydroxide / succinylated gelatin, calcium chloride / EURD added on 23/10/2024
magnesium chloride / potassium chloride / sodium
2731 27/09/2006 15 years 26/09/2033 25/12/2033 No 23/10/2024 PSUSA/00002731/203309 Liana Martirosyan Netherlands NAP
acetate /sodium chloride / succinylated gelatin, gelatin Active substance name was
/ sodium chloride / potassium chloride / magnesium amended on 01/04/2020
chloride hexahydrate / sodium lactate
2732 sodium chloride / urea Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 Active substance
DLP amended name was
on 23/10/2024 PSUSA/00002732/202612 NAP
amended on 05/02/2020

PSUR frequency and DLP


2733 sodium chromate (51cr) 31/12/1997 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00002733/202511 Monica Martinez Redondo Spain NAP
amended on 31/07/2024
Active substance name was
amended on 25/09/2024
sodium citrate / sodium lauryl sulfoacetate, sodium
2735 Not available* 7 years 31/01/2025 01/05/2025 No 25/09/2024 PSUSA/00002735/202501 Tiphaine Vaillant France NAP
citrate / sodium lauryl sulfoacetate / sorbitol
PSUR frequency
Active substanceamended
name wasand
DLP updated
amended on 30/04/2024
on 03/06/2016
disodium hydrogen phosphate / sodium dihydrogen
2737 06/01/2005 13 years 06/01/2025 06/04/2025 No 03/06/2016 PSUSA/00002737/202501 NAP
phosphate, phosphate sodium Name of active substance and
EURD were amended on
disodium edetate dihydrate / sodium dihydrogen 28/02/2013
PSUR frequency amended and
2738 phosphate dihydrate / sodium hydrogen phosphate Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00002738/203011 none NAP
DLP updated on 28/08/2024
dodecahydrate / water for injection

glucose monohydrate / sodium dihydrogen phosphate PSUR frequency and DLP


2739 Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00002739/203103 NAP
dihydrate / zinc acetate dihydrate amended on 23/10/2024

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

PSUR frequency and DLP


2748 sodium hydrogen carbonate Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 PSUSA/00002748/203208 NAP
amended on 23/10/2024

PRAC Rapporteur name was


2752 sodium iodide (123i) 31/01/1995 7 years 31/03/2027 29/06/2027 No 16/10/2023 PSUSA/00002752/202703 Karin Erneholm Denmark NAP
amended on 18/10/2023

PRAC representative updated on


2753 sodium iodide (131i) 01/10/1973 5 years 01/03/2027 30/05/2027 No 31/01/2024 PSUSA/00002753/202703 Carla Torre Portugal NAP
31/01/2024

© 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

PSUR frequency amended and


2767 sodium tetradecyl sulphate Not available* 3 years 30/04/2026 29/07/2026 Yes 20/12/2023 PSUSA/00002767/202604 Jana Lukačišinová Czech Republic NAP
DLP updated on 20/12/2023

PRAC representative updated on


2769 solifenacin 08/06/2004 5 years 08/06/2025 06/09/2025 No 31/01/2024 PSUSA/00002769/202506 Liana Martirosyan Netherlands NAP
31/01/2024

PSUR frequency and DLP


2770 somatorelin 01/01/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00002770/202812 NAP
amended on 31/07/2024

PSUR frequency amended and


2771 somatostatin 03/12/1989 8 years 03/06/2025 01/09/2025 No 30/10/2024 PSUSA/00002771/202506 Monica Martinez Redondo Spain NAP
DLP updated
New on 03/07/2024
CAP authorised on
09/11/2022

2772 somatropin 28/04/1988 3 years 31/03/2026 29/06/2026 No 20/12/2023 DLP was


PRAC amended onwas
representative 20/12/2023 PSUSA/00002772/202603 Karin Erneholm Denmark CAP NAP
updated on 19/10/2022

PSUR frequency and DLP was


2773 sorafenib 19/07/2006 5 years 31/12/2024 31/03/2025 No 23/09/2020 PSUSA/00002773/202412 Mari Thorn Sweden CAP
updated on 23/09/2020

PRAC Rapporteur name was


PRAC Rapporteur name was
2774 sotalol 22/08/1973 5 years 21/08/2024 19/11/2024 No 16/10/2023 amended on 23/10/2018 PSUSA/00002774/202408 Karin Erneholm Denmark NAP
amended on 18/10/2023
Next DLP was amended on
25/09/2017
PSUR frequency and DLP
2775 spaglumic acid Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00002775/203211 NAP
amended on 23/10/2024

PSUR frequency and DLP


2777 spectinomycin 21/08/1970 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00002777/203409 NAP
amended on 23/10/2024

PRAC representative was


PSUR frequency
updated and DLP
on 01/03/2023
2778 spiramycin 08/02/1955 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00002778/202712 NAP
amended on 31/07/2024
DLP was updated on 22/12/2021

2780 spironolactone 01/03/1962 3 years 08/03/2027 06/06/2027 No 20/11/2024 DLP was


Entry amended
name on 20/11/2024
and EURD were PSUSA/00002780/202703 Terhi Lehtinen Finland CAP NAP
amended on 31/01/2018

2781 bacterial lysate of haemophilus influenzae / klebsiella


altizide / spironolactone 21/01/1964 3 years 21/01/2027 21/04/2027 No 25/09/2024 Next DLPamended
DLP was was amended on
on 25/09/2024 PSUSA/00002781/202701 Barbara Kovacic Bytyqi Croatia NAP
pneumoniae / moraxella catarrhalis / staphylococcus 20/12/2016
aureus / streptococcus mitis / streptococcus
pneumoniae / streptococcus pyogenes, bacterial lysate DLP was corrected on
2786 of haemophilus influenzae / klebsiella pneumoniae / 11/01/1974 5 years 31/03/2026 29/06/2026 No 22/12/2021 04/02/2016. PSUSA/00002786/202603 Gabriele Maurer Germany NAP
moraxella catarrhalis / staphylococcus aureus /
streptococcus pneumoniae / streptococcus pyogenes, Active Substance and DLP was
streptococcus pneumoniae / streptococcus agalactiae / amended
PSUR on 21/12/2015.
frequency and DLP
2788 stibogluconate 30/03/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUSA/00002788/203407 NAP
staphylococcus aureus / haemophilus influenzae amended on 23/10/2024
PRAC representative name was
amended on 31/07/2015
2789 stiripentol 04/01/2007 1 year 04/11/2024 13/01/2025 04/11/2025 13/01/2026 Yes 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00002789/202411 PSUSA/00002789/202511 Maia Uusküla Estonia CAP
Active Substance name amended
on 16/07/2015
PSUR frequency and DLP
2791 streptodornase / streptokinase 01/03/1933 11 years 03/11/2036 01/02/2037 No 23/10/2024 Lead MS was added on PSUSA/00002791/203611 NAP
amended on 23/10/2024
04/02/2015

PSUR frequency and DLP


2792 streptokinase Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002792/203611 NAP
amended on 23/10/2024

PSUR frequency and DLP


2793 streptomycin 15/04/1956 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00002793/203401 NAP
amended
Referenceon
to 23/10/2024
NAP added on
03/07/2024
PSURwas
DLP frequency
updatedand
on DLP
27/07/2022
2794 streptozocin 07/05/1982 9 years 01/12/2028 01/03/2029 No 31/07/2024 New CAP authorised on PSUSA/00002794/202812 NAP
amended on 31/07/2024
23/06/2023
DLP was updated on 31/07/2019
PSURCAP
New frequency and on
authorised DLP
2796 sucralfate 23/02/1968 9 years 02/04/2028 01/07/2028 No 15/01/2025 Next DLP was updated on PSUSA/00002796/202804 Amelia Cupelli Italy NAP
amended on 31/07/2024
26/05/2023
22/09/2016
New CAP authorised on
PRAC Rapporteur and Lead
2798 sufentanil 30/11/1978 3 years 30/11/2024 28/02/2025 No 27/07/2022 10/01/2023 PSUSA/00002798/202411 Adam Przybylkowski Poland CAP NAP
Member State amended on
21/12/2015.
New CAP authorised on
15/07/2022
2799 sugammadex 25/07/2008 5 years 31/01/2029 01/05/2029 No 23/10/2019 New CAP authorised on PSUSA/00002799/202901 Terhi Lehtinen Finland CAP NAP
18/09/2015.
New CAP authorised on
15/11/2021
Lead MS
PSUR was added
frequency and on
DLP
2801 sulbutiamine 28/08/1996 8 years 03/11/2025 01/02/2026 No 30/10/2024 13/07/2015 PSUSA/00002801/202511 Zoubida Amimour France NAP
amended on 31/07/2024
DLP and frequency were updated
on 23/10/2019
PSUR frequency amended and
2802 sulconazole 30/09/1987 9 years 01/01/2029 01/04/2029 No 28/08/2024 DLP was updated on 25/09/2019 PSUSA/00002802/202901 NAP
updated on 28/08/2024

Next DLP was updated on


PSUR frequency and DLP
22/09/2016
2805 sulfacetamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002805/203611 NAP
amended on 23/10/2024
The DLP was amended on
08/01/2014
PSUR frequency and DLP
2806 sulfadiazine Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUSA/00002806/202708 NAP
amended on 23/10/2024

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

PSUR frequency amended and


2808 sulfafurazole Not available* 7 years 31/01/2025 01/05/2025 No 19/07/2024 PSUSA/00002808/202501 Roxana Dondera Romania NAP
DLP updated on 30/04/2024

PSUR frequency and DLP


2809 sulfaguanidine 07/01/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00002809/203503 NAP
amended on 23/10/2024

PSUR frequency amended and Marie Louise Schougaard


2816 sulfasalazine 25/04/1942 10 years 02/12/2033 02/03/2034 No 31/07/2024 PSUSA/00002816/203312
Christiansen Denmark NAP
DLP updated on 31/07/2024

PSUR frequency and DLP


2817 ephedrine hydrochloride / sulfathiazole Not available* 7 years 03/11/2024 01/02/2025 No 27/03/2024 PSUSA/00002817/202411 Maria Popova-Kiradjieva Bulgaria NAP
amended on 27/03/2024

PSUR frequency and DLP


2818 sulfinpyrazone 25/09/1958 10 years 31/01/2034 01/05/2034 No 23/10/2024 PSUSA/00002818/203401 NAP
amended on 23/10/2024

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

PRAC Rapporteur name and


2833 sunitinib 19/07/2006 3 years 30/04/2026 29/07/2026 No 31/01/2024 DLP was amended on 31/01/2024
country updated on 01/12/2014
PSUSA/00002833/202604 Amelia Cupelli Italy CAP

Information included in column


2834 suxamethonium 14/08/1952 3 years 13/08/2026 11/11/2026 No 30/04/2024 "Are PSURs
DLP was required
amended onfor products
30/04/2024 PSUSA/00002834/202608 Barbara Kovacic Bytyqi Croatia NAP
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?"
PSUR frequency was
andamended
DLP on
2835 suxibuzone Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 30/11/2012 PSUSA/00002835/203611 NAP
amended on 23/10/2024

PSUR frequency and DLP


2838 tacalcitol Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUSA/00002838/202708 NAP
amended on 23/10/2024

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

PSUR frequency amended and


2842 tafamidis 16/11/2011 2 years 15/05/2026 13/08/2026 No 18/12/2024 PSUSA/00002842/202605 Tiphaine Vaillant France CAP
DLP updated on 18/12/2024

DLP was updated on 03/02/2021


2843 tafluprost 30/04/2008 3 years 29/04/2027 28/07/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00002843/202704 Martin Huber Germany NAP
PRAC Rapporteur name was
amended on 23/10/2018
2846 tamoxifen 29/04/1974 5 years 29/04/2025 28/07/2025 No 03/02/2021 PSUSA/00002846/202504 Eamon O'Murchu Ireland NAP
Next DLP was amended on
DLP was updated on 27/07/2022
04/02/2016
PRAC frequency
PSUR representative updated
and on
DLP wereon
2847 tamsulosin 02/07/1993 5 years 01/07/2026 29/09/2026 No 31/01/2024 Lead MS was added PSUSA/00002847/202607 Liana Martirosyan Netherlands NAP
31/01/2024
updated on 31/07/2019
06/03/2015
PSUR frequency and DLP were
updated on 28/04/2021
PSUR frequency amended and
2849 tapentadol 20/11/2008 3 years 20/11/2024 18/02/2025 No 27/07/2022 DLP updated on 31/07/2018 PSUSA/00002849/202411 Martin Huber Germany NAP
PRAC representative was
updated on 31/03/2021
Next DLP amended on
13/07/2015
2850 tasonermin 13/04/1999 5 years 14/08/2025 12/11/2025 No 28/04/2021 PRAC representative was PSUSA/00002850/202508 Karin Erneholm Denmark CAP
updated on 25/09/2019
PRAC Rapporteur name and
country updated on 01/12/2014
PRAC frequency
PSUR Rapporteurand
name
DLPwas
were
2855 technetium (99mtc) albumin nanocolloid 29/11/1993 15 years 29/11/2027 27/02/2028 No 25/09/2019 PSUSA/00002855/202711 NAP
amendedon
updated on25/09/2019
03/04/2019

DLP was updated on 07/05/2018


PRAC Rapporteur name was
2856 technetium (99mTc) bicisate 08/10/1993 15 years 07/10/2034 05/01/2035 No 16/10/2023 PSUSA/00002856/203410 Karin Erneholm Denmark NAP
amended on 18/10/2023
PSUR frequency and DLP were
updated on 25/09/2019
2857 technetium (99mtc) depreotide 29/11/2000 15 years 15/09/2027 14/12/2027 No 25/09/2019 PSUSA/00002857/202709 NAP
DLP was updated on 05/06/2019
PSUR frequency and DLP were
2859 technetium (99mtc) human albumin Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUSA/00002859/202701 NAP
updated on 25/09/2019

PRAC Rapporteur name was


2860 technetium (99mtc) macrosalb 02/03/1990 15 years 28/02/2028 28/05/2028 No 16/10/2023 PSUSA/00002860/202802 Karin Erneholm Denmark NAP
amended on 18/10/2023

PRAC Rapporteur name was


2861 technetium (99mtc) mebrofenin 29/11/1993 15 years 01/11/2030 30/01/2031 No 16/10/2023 PSUSA/00002861/203011 Karin Erneholm Denmark NAP
amended on 18/10/2023

Active substance name was


PSUR frequency and DLP were
2862 technetium (99mtc) medronic acid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 amended and 'Are PSURs PSUSA/00002862/202701 NAP
updated on 25/09/2019
required for products referred to
in Articles 10(1), 10a, 16a of
technetium (99mTc) mertiatide, technetium (99mTc) Directive 2001/83/EC as
2863 Not available* 15 years 01/01/2027 01/04/2027 Yes 29/07/2020 PSUSA/00002863/202701 NAP
betiatide amended?' was updated on
29/07/2020
PSUR frequency and DLP were
2864 technetium (99mtc) oxidronate 21/03/1983 15 years 21/03/2027 19/06/2027 No 25/09/2019 PSUR frequency and DLP were PSUSA/00002864/202703 NAP
updated on 25/09/2019
updated on 25/09/2019

PSUR frequency and DLP were


2865 technetium (99mtc) pentetate 21/06/1990 15 years 21/06/2027 19/09/2027 No 25/09/2019 PSUSA/00002865/202706 NAP
updated on 25/09/2019

PSUR frequency and DLP were


PRAC Rapporteur name was
2866 technetium (99mTc) pertechnetate 01/06/1983 15 years 01/06/2032 30/08/2032 No 16/10/2023 updated on 25/09/2019 PSUSA/00002866/203206 Karin Erneholm Denmark NAP
amended on 18/10/2023
Entry name amended and
sodium pyrophosphate, technetium (99mtc) information included in column
2867 04/02/1991 15 years 04/02/2027 05/05/2027 Yes 25/09/2019 PSUSA/00002867/202702 NAP
pyrophosphate (for diagnosistic purpose) "Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
PRAC Rapporteur name was
2868 technetium (99mtc) sestamibi 09/12/1987 15 years 08/06/2032 06/09/2032 Yes 16/10/2023 as amended?" was amended on PSUSA/00002868/203206 Karin Erneholm Denmark NAP
amended on 18/10/2023
21/07/2017

PSUR frequency and DLP were


2869 technetium (99mTc) succimer Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUSA/00002869/202701 NAP
updated on 25/09/2019

PRAC Rapporteur name was


2870 technetium (99mTc) tetrofosmin, tetrofosmin 31/05/1993 15 years 31/05/2032 29/08/2032 No 16/10/2023 PSUSA/00002870/203205 Karin Erneholm Denmark NAP
amended on 18/10/2023

PSUR frequency and DLP were


2872 technetium (99mTc) tin colloid Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUSA/00002872/202701 NAP
updated on 25/09/2019

technetium (99mTc) PSUR frequency and DLP were


2873 Not available* 15 years 01/01/2027 01/04/2027 No 25/09/2019 PSUSA/00002873/202701 NAP
trimethylphenylcarbamoylmethyliminodiacetic acid updated on 25/09/2019

© 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

PRAC representative was


PSUR frequency
updated and DLP were
on 17/11/2021
updated on 20/10/2021
PRAC representative was
PSURwas
DLP Frequency,
updated updated
on DLP and PRAC
on 29/06/2022
30/06/2021
Representative were updated on
PSUR frequency and DLP
2874 tegafur Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 26/09/2018
Are
DLP PSURs required
was corrected for05/02/2020
on products PSUSA/00002874/202708 NAP
amended on 23/10/2024
referred to in Articles 10(1), 10a,
Next16a
14,
PSUR DLPofwas amended
Directive
frequency DLPon
and2001/83/EC
were
25/09/2017
as amended?
updated on 18/12/2019
2875 gimeracil / oteracil monopotassium / tegafur 14/03/2011 5 years 24/01/2026 24/04/2026 No 20/10/2021 PSUSA/00002875/202601 Bianca Mulder Netherlands CAP
Yes/No was corrected on
Nextwas
DLPupdated
07/05/2018
DLP was updated on
on 19/12/2018
22/09/2016
2878 teicoplanin 01/11/1986 5 years 01/11/2026 30/01/2027 No 29/06/2022 DLP was
PRAC updated name
Rapporteur and was PSUSA/00002878/202611 Eva Jirsová Czech Republic NAP
Next DLPon
information
updated was updated
included
04/07/2018 in on
column
30/09/2015
"Are PSURs required for products
referred
DLP was to in Articles
updated 10(1), 10a,
on 19/12/2017
2882 hydrochlorothiazide / telmisartan, telmisartan 11/12/1998 3 years 31/03/2025 29/06/2025 No 21/12/2022 Next16a
14, DLPofwas amended
Directive on
2001/83/EC
PSUSA/00002882/202503 Amelia Cupelli Italy CAP NAP
28/05/2014
as
Next DLP was amended on on
amended?" was amended
21/07/2017
20/12/2016
PSUR frequency and DLP
2883 temazepam 26/11/1969 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUSA/00002883/202805 NAP
amended
Lead on 31/07/2024
MS and
Next DLP wasPRAC Rapporteur
updated on
name was added on 03/06/2016
27/11/2015.
PSUR frequency and DLP
2884 temocillin 25/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 The next DLP was amended on PSUSA/00002884/202812 NAP
amended on 31/07/2024
01/12/2014
Information included in column
"Are
PSUR PSURs required
frequency for products
amended and
2885 temoporfin 24/10/2001 13 years 30/04/2037 29/07/2037 No 05/02/2025 Information
referred to inincluded
Articles in column
10(1), 10a, PSUSA/00002885/203704 Bianca Mulder Netherlands CAP
DLP updated
"Are PSURs on 05/02/2025
required for products
14, 16a of Directive 2001/83/EC
referred
as to in Articles
amended?" 10(1), 10a,
was amended on
14, 16a of Directive 2001/83/EC
18/12/2024
2886 temozolomide 26/01/1999 3 years 12/07/2026 10/10/2026 No 27/03/2024 DLPamended?"
as was amended wason 27/03/2024
amended on PSUSA/00002886/202607 Martin Huber Germany CAP
29/11/2013
PSUR frequency amended and
DLP updated on 18/12/2024
2887 temsirolimus 19/11/2007 5 years 31/03/2029 29/06/2029 Yes 18/12/2024 Name of active substance was PSUSA/00002887/202903 Martin Huber Germany CAP
amended
PRAC
DLP was on 30/04/2013
representative
updated was
on 22/12/2021
updated
DLP was on 19/10/2022
amended on 03/05/2023
DLP was updated on 21/11/2018
2888 tenecteplase 23/02/2001 3 years 31/08/2025 29/11/2025 No 03/05/2023 PRAC representative was were PSUSA/00002888/202508 Martin Huber Germany CAP
PSUR frequency and DLP
updated
Next DLPon
updated on 27/07/2022
and PRAC Rapporteur
06/05/2020
amended on 27/11/2015.
PSURand
DLP frequency and DLP were
PSUR frequency
2889 teniposide 05/04/1976 9 years 03/08/2028 01/11/2028 No 31/07/2024 PSUSA/00002889/202808 NAP
amended
updated on
on 31/07/2024
17/11/2021
PRAC Representative amended
on 31/07/2015
PRAC representative
PSUR frequency was
and DLP
2891 eucalyptus / paracetamol / tenoate sodium 15/05/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 updated PSUSA/00002891/203912 NAP
amendedon on30/06/2021
23/10/2024
DLP was updated on 21/11/2018
2892 tenofovir disoproxil 05/02/2002 3 years 31/03/2026 29/06/2026 No 19/09/2024 PSUSA/00002892/202603 Zoubida Amimour France CAP
PRAC Rapporteur name was
PSUR frequency
updated amended and
on 04/07/2018
DLP updated on 31/05/2023
2893 tenoxicam 20/02/1986 5 years 28/02/2026 29/05/2026 No 19/10/2022 Information included in column PSUSA/00002893/202602 Amelia Cupelli Italy NAP
PRAC
New representative
CAP
"Are PSURs authorised
required on wasproducts
for
updated
12/01/2023
referred onin
to 27/07/2022
Articles 10(1), 10a,
14, 16a
PSUR of Directive
frequency 2001/83/EC
amended and
2895 terazosin 30/11/1984 8 years 20/11/2031 18/02/2032 No 31/07/2024 PRAC
New representative
CAPs
as amended?"authorised was
on PSUSA/00002895/203111 Liana Martirosyan Netherlands NAP
DLP updated onwas amended
31/07/2024 on
updated
18/11/2022
17/10/2017on 06/05/2020
PLP was updated on 21/09/2022
DLP
DLP was
PRACand updated name
Information on 06/06/2018
included in
2896 terbinafine 03/10/1990 3 years 30/09/2025 29/12/2025 No 31/05/2023 Rapporteur updated PSUSA/00002896/202509 Anna Mareková Slovakia NAP
column
on "Are
04/02/2016 PSURs
PRAC representative was required for
Information
products included
referred inArticles
to in column
updated on 23/09/2020
"Are PSURs
10(1),
PRAC required
10a, 14, 16a offor
Representative products
Directive
amended
2897 terbutaline 31/12/1970 5 years 31/12/2026 31/03/2027 No 21/09/2022 referred
2001/83/EC
on to inasArticles
27/11/2015. 10(1),were
amended?" 10a, PSUSA/00002897/202612 Melinda Palfi Hungary NAP
Next DLP was amended on
14, 16a ofon
amended Directive 2001/83/EC
25/05/2022
25/09/2017
as amended?"
The Next DLP was wasamended
amendedon on
23/05/2017
PSUR
New frequency
CAP
29/10/2015 and on
authorised DLP
2898 guaifenesin / terbutaline sulfate Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 Lead MS and PRAC Rapporteur PSUSA/00002898/203103 NAP
amended on 23/10/2024
24/03/2022
name was added on 28/07/2016
Lead
Lead MS
MS and
was PRAC
addedRapporteur
on
name
PRAC was added on 28/02/2017
representative
04/02/2015 was
2903 teriparatide 10/06/2003 3 years 12/09/2024 11/12/2024 Yes 25/05/2022 updated
DLP was on 26/05/2021
updated on 26/05/2021 PSUSA/00002903/202409 Tiphaine Vaillant France CAP NAP

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

PSUR frequency amended and


2911 tetrabenazine 23/10/1995 5 years 31/10/2028 29/01/2029 No 03/07/2024 PSUSA/00002911/202810 Eamon O'Murchu Ireland NAP
DLP updated on 03/07/2024

PSUR frequency amended and


2912 tetracaine 01/06/1973 9 years 03/06/2028 01/09/2028 No 28/08/2024 PSUSA/00002912/202806 NAP
DLP updated on 28/08/2024
PSUR frequency amended and
DLP
PSURupdated on 31/05/2023
frequency and DLP
2913 nitrofural / phenazone / tetracaine hydrochloride Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00002913/202412 Polona Golmajer Slovenia NAP
amended on 27/03/2024
New CAP authorised on
19/09/2022
PSUR frequency amended and
2914 tetracosactide 07/05/1965 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002914/202803 NAP
DLP was
DLP updated on 28/08/2024
updated on 25/05/2022

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

PSUR Frequency amended and


2929 thiopental 15/10/1945 15 years 31/03/2031 29/06/2031 No 20/12/2016 DLP updated on 20/12/2016 PSUSA/00002929/203103 Eamon O'Murchu Ireland NAP

Lead Member State and PRAC


Representative
PSUR frequencyadded on
and DLP
2931 thioridazine 01/02/1959 9 years 02/12/2027 01/03/2028 No 31/07/2024 PSUSA/00002931/202712 NAP
27/11/2015.
amended on 31/07/2024

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

DLP was updated on 31/07/2019


DLP
PSURwas updatedand
frequency on DLP
02/03/2022
2936 thiamphenicol glycinate acetylcysteinate Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002936/203611 Amelia Cupelli Italy NAP
amended
PRAC on 23/10/2024
Rapporteur name updated
PRAC representative was
on 19/12/2018
updated on 29/07/2020
DLP was updated on 02/03/2022
2940 thyrotropin alfa 30/11/1998 3 years 30/11/2024 28/02/2025 No 27/07/2022 PRAC Rapporteur name was PSUSA/00002940/202411 Rhea Fitzgerald Ireland CAP
PRAC representative was
amended
PRAC on 23/10/2018
representative was
updated on 03/06/2020
updated on 29/07/2020
DLP
Nextwas
DLPupdated on 30/03/2022
was amended on
2942 tiagabine 14/06/1996 3 years 30/06/2024 28/09/2024 Yes 02/03/2022 Next DLP was updated on
28/07/2016
PSUSA/00002942/202406 Tiphaine Vaillant France NAP
PRAC representative was
06/03/2019
PRAC representative was
updated on 03/06/2020
updated on 29/07/2020
Active substance name amended
PRAC Rapporteur name updated
2943 tianeptine 06/02/1987 3 years 30/06/2024 28/09/2024 No 02/03/2022 on 12/05/2015
Next DLP was updated on
on 21/07/2017
PSUSA/00002943/202406 Tiphaine Vaillant France NAP
PRAC representative was
06/03/2019
updated on 03/06/2020
Next DLP updated on 04/03/2016
PRAC Rapporteur name updated
2944 tiapride 27/07/1988 3 years 27/07/2024 25/10/2024 No 30/03/2022 DLP was updated on 03/04/2019
on 21/07/2017
PSUSA/00002944/202407 Tiphaine Vaillant France NAP
Lead MS added on 01/04/2015.
PRAC Rapporteur name updated
Next
PRAC DLP updatedname
Rapporteur on 04/03/2016
on 21/07/2017
PSUR frequency and DLPwas
2945 tiaprofenic acid 26/08/1974 9 years 03/08/2028 01/11/2028 No 31/07/2024 amended on PSUSA/00002945/202808 NAP
amended
Lead on 01/02/2023
MS added31/07/2024
on 01/04/2015.
Next DLP was amended on
PRAC Rapporteur
07/04/2016 name was
PSUR frequency
amended and DLP
on 22/09/2022
2946 tibezonium iodide 23/11/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00002946/203503 NAP
amended on 23/10/2024
Lead MS added on 01/04/2015.
PSUR freqency and DLP were
updated on 29/07/2020
2947 tibolone 01/12/1987 5 years 01/12/2024 01/03/2025 No 29/07/2020 PSUSA/00002947/202412 Karin Bolin Sweden NAP
PRAC Rapporteur name updated
on 23/10/2018
2948 ticagrelor 03/12/2010 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024
Next DLP was amended on
PSUSA/00002948/202612 Bianca Mulder Netherlands CAP
25/09/2017
PSUR frequency
Lead MS andRapporteur
and PRAC DLP
2950 clavulanate / ticarcillin 12/09/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00002950/203503 NAP
amended
PRAC wason 23/10/2024
name representative
added was
on 28/07/2016
updated on 27/07/2022
Next DLP was updated on
2951 tick-borne encephalitis vaccine (inactivated) 29/01/2001 3 years 31/01/2026 01/05/2026 No 18/10/2023 DLP was updated on 03/02/2021 PSUSA/00002951/202601 Gabriele Maurer Germany NAP
18/10/2023
PRAC representative was
updated on 25/09/2019
2952 ticlopidine 08/05/1978 5 years 08/05/2025 06/08/2025 No 27/07/2022 PSUSA/00002952/202505 Amelia Cupelli Italy NAP
Next DLP was amended on
04/02/2016
PSUR frequency amended and
2954 tigecycline 24/04/2006 5 years 14/06/2028 12/09/2028 No 28/02/2024 PSUSA/00002954/202806 Maria del Pilar Rayon Spain CAP
DLP updated on 28/02/2024
PRAC Representative amended
on 27/11/2015Lead MS was
addedfrequency
PSUR on 06/03/2015
and DLP
2955 tilactase Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00002955/203211 NAP
amended on 23/10/2024
PSUR frequency and DLP were
updated
PSUR on 27/07/2022
frequency and DLP
2957 tilidine 08/07/1970 9 years 03/05/2028 01/08/2028 No 31/07/2024 PSUSA/00002957/202805 NAP
amended on 31/07/2024
DLP was updated on 31/07/2019

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

Reference to NAP added on


2961 bimatoprost / timolol 19/06/2006 5 years 19/11/2026 17/02/2027 No 27/07/2022 19/12/2018 PSUSA/00002961/202611 Karin Erneholm Denmark CAP NAP

PRAC Rapporteur name was


amended
PSUR on 06/06/2018
frequency amended and
2962 timolol / travoprost 24/04/2006 5 years 28/02/2028 28/05/2028 No 15/11/2023 PSUSA/00002962/202802 Maria del Pilar Rayon Spain CAP NAP
DLP updated on 15/11/2023
PRAC Representative amended
on 17/10/2017
PSUR frequency amended and
2963 bendroflumethiazide / timolol maleate Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUSA/00002963/202512 NAP
DLP updated
Next DLP wason 31/07/2024
amended on
28/07/2016

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

PSUR frequency amended and


2969 tioguanine 18/01/1966 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00002969/202803 NAP
DLP updated on 28/08/2024

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

Next DLP was updated on


2981 tocofersolan 24/07/2009 1 year 31/07/2024 09/10/2024 31/07/2025 09/10/2025 No 27/03/2024 18/11/2016
DLP was amended on 27/03/2024 PSUSA/00002981/202407 PSUSA/00002981/202507 Melinda Palfi Hungary CAP

Next DLP was amended on


03/06/2016
PSUR frequency amended and
2982 tofisopam Not available* 7 years 31/01/2025 01/05/2025 No 19/07/2024 PSUSA/00002982/202501 Melinda Palfi Hungary NAP
DLP updated on 30/04/2024
Next DLp was updated on
27/11/2015.
DLP was updated on 17/11/2021
PSUR frequency and DLP
2984 tolbutamide Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00002984/203611 NAP
amended
Next DLP on 23/10/2024
was amended on
PRAC Rapporteur name updated
01/12/2014
on 19/12/2018
2985 tolcapone 27/08/1997 3 years 01/03/2027 30/05/2027 No 17/11/2021 Nextand
DLPPRAC
was amended onname PSUSA/00002985/202703 Eamon O Murchu Ireland CAP
DLP Rapporteur
28/05/2014
updated on 23/10/2018
PSUR frequency
NextNext
DLP and DLP
was was
amended
2986 tolfenamic acid Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 The DLP amended on PSUSA/00002986/202708 NAP
amended on 23/10/2024
30/11/2013
29/10/2015

PSUR frequency and DLP


2988 tolnaftate 16/10/1977 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00002988/202811 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 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

PSUR frequency and DLP


2990 tolnaftate / triclosan Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00002990/203211 NAP
amended on 23/10/2024
PRAC Rapporteur name was
amended on 22/09/2022
PSUR frequency amended and
2991 tolperisone Not available* 3 years 01/06/2027 30/08/2027 Yes 05/02/2025 PSUSA/00002991/202706 Melinda Palfi Hungary NAP
updated
DLP was on 05/02/2025
updated on 25/05/2022

PRAC Rapporteur name updated


2993 tolterodine 05/09/1997 5 years 05/09/2026 04/12/2026 No 25/05/2022 DLP was updated on 21/09/2022
on 23/10/2018 PSUSA/00002993/202609 Karin Bolin Sweden NAP
PRAC Rapporteuramended
PSUR Frequency name wasand
tolvaptan (indicated for adults with hyponatraemia amended on 31/07/2018
DLP
PRAC updated on 23/05/2017
representative
2994 secondary to syndrome of inappropriate antidiuretic 03/08/2009 3 years 18/05/2027 16/08/2027 No 05/02/2025 DLP was amended onwas 05/02/2025 PSUSA/00002994/202705 Amelia Cupelli Italy CAP
hormone secretion (SIADH)) updated on 19/10/2022
Next
Lead DLP wasPRAC
MS and amended on
Rapporteur
25/09/2017
name was added on
DLP was updated on 07/04/2016
03/02/2021
Information included in column
2996 topiramate 18/07/1995 5 years 18/01/2027 18/04/2027 No 21/09/2022 PSUSA/00002996/202701 Karin Bolin Sweden NAP
"Are PSURs required for products
PRAC Rapporteur name was
referred to in Articles 10(1), 10a,
amended on 23/10/2018
14, 16a of Directive 2001/83/EC
2997 topotecan 12/11/1996 5 years 28/05/2025 26/08/2025 No 03/02/2021 as amended?" was amended on PSUSA/00002997/202505 Mari Thorn Sweden CAP NAP
PSUR Frequency amended and
25/09/2017
DLP updated on 04/02/2016
Information included in column
Lead MS
PSUR and PRAC
frequency Rapporteur
amended and
2998 torasemide 14/04/1987 8 years 03/06/2025 01/09/2025 No 30/10/2024 "Are PSURs required for products
name was added on 28/07/2016 PSUSA/00002998/202506 Martin Huber Germany NAP
DLP updated on 03/07/2024
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?"
PSUR frequency was amended
amended andon
2999 toremifene 14/02/1996 5 years 30/09/2028 29/12/2028 No 05/06/2024 04/02/2016 PSUSA/00002999/202809 Tiphaine Vaillant France CAP
DLP updated on 05/06/2024

PSUR frequency and DLP


3000 tosylchloramide Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 PSUSA/00003000/202411 Amelia Cupelli Italy NAP
amended on 28/08/2024

PSUR frequency amended and Marie Louise Schougaard


3001 trabectedin 17/09/2007 3 years 17/09/2025 16/12/2025 No 03/05/2023 PSUSA/00003001/202509
Christiansen Denmark CAP
DLP updated on 03/05/2023

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

PSUR frequency and DLP


3003 tramazoline 01/02/1964 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUSA/00003003/203912 NAP
amended on 23/10/2024

PRAC representative updated on


3004 trandolapril 19/02/1992 8 years 18/02/2027 19/05/2027 No 31/01/2024 New CAP authorised on PSUSA/00003004/202702 Bianca Mulder Netherlands NAP
31/01/2024
19/09/2024

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 representative was


PSUR frequency
updated amended and
on 01/03/2023
3006 tranexamic acid 21/01/1966 8 years 03/03/2025 01/06/2025 No 26/07/2024 PSUSA/00003006/202503 Rhea Fitzgerald Ireland NAP
DLP updated on 03/07/2024
DLP was updated on 29/06/2022
PSUR frequency and DLP
3007 transfer factor porcine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUR frequency and DLP were PSUSA/00003007/203211 NAP
amended on 23/10/2024
updated on 05/06/2019
Correction of DLP on 20/11/2024
3008 tranylcypromine Not available* 8 years 03/11/2027 01/02/2028 No 05/01/2025 New CAP authorised on PSUSA/00003008/202711 Martin Huber Germany NAP
PSUR frequency and DLP
12/12/2018
PSUR frequency
amended and DLP were
on 28/08/2024
updated on 16/11/2022
PSUR Frequency amended and
3010 trastuzumab 25/09/1998 3 years 24/09/2024 23/12/2024 No 29/06/2022 DLP updated on 26/04/2017 PSUSA/00003010/202409 Gabriele Maurer Germany CAP
DLP was updated on 20/11/2019
Next DLP was amended on
PSUR Frequency amended and
03/05/2016
3011 travoprost 27/11/2001 5 years 28/02/2027 29/05/2027 No 16/11/2022 DLP updated on 19/10/2016 PSUSA/00003011/202702 Maria del Pilar Rayon Spain CAP NAP
The Next DLP was amended on
PRACwas
DLP Representative amended
updated on 21/12/2022
29/10/2015
on 28/06/2016
3012 trazodone 15/10/1971 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00003012/202908 Rugile Pilviniene Lithuania NAP
PRACDLP
Next representative
was amendedwason
The Nexton
updated DLP was amended on
16/07/2015,19/10/2022
and the 1-yearly
29/10/2015
cycle PSUR should be submitted
3013 treprostinil 21/05/2002 1 year 21/05/2025 30/07/2025 21/05/2026 30/07/2026 No 05/02/2025 DLP was
PRAC
after amended onwas
representative
the current Next 05/02/2025
DLP PSUSA/00003013/202505 PSUSA/00003013/202605 Zane Neikena Latvia CAP NAP
updated on 17/11/2021
(24/09/2015).

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

carbethopendecinium bromide / salicylic acid / PSUR frequency amended and


3019 Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUSA/00003019/202907 NAP
triamcinolone DLP updated on 28/08/2024

PSUR frequency amended and


3020 chloroxine / triamcinolone Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00003020/202911 NAP
DLP updated on 28/08/2024

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

Updated & published on


3022 triamterene 19/06/1963 10 years 03/05/2034 01/08/2034 No 03/10/2024 PSUSA/00003022/203405 NAP
23/10/2024
DLP was updated on 05/04/2023

DLP was updated on 07/05/2018


3023 triazolam 08/03/1997 5 years 31/07/2027 29/10/2027 No 05/04/2023 PSUSA/00003023/202707 Kimmo Jaakkola Finland NAP
PRAC representative and Lead
Member State were added on
30/01/2017
PSUR frequency and DLP
3024 tribenoside 06/04/1967 10 years 03/07/2034 01/10/2034 No 23/10/2024 PSUSA/00003024/203407 NAP
amended on 23/10/2024

PSUR frequency and DLP


3025 lidocaine / tribenoside 01/06/1971 10 years 02/09/2034 01/12/2034 No 23/10/2024 PSUSA/00003025/203409 NAP
amended on 23/10/2024

PSUR frequency and DLP


3027 triclocarban Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00003027/203211 Tiphaine Vaillant France NAP
amended on 23/10/2024

PSUR frequency and DLP


3028 triclosan 01/01/1985 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00003028/202812 NAP
amended on 31/07/2024

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

PSUR frequency and DLP


3031 salicylate / triethanolamine Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUSA/00003031/203206 NAP
amended on 23/10/2024

PSUR frequency and DLP


3033 trifluperidol 31/01/1964 11 years 03/07/2039 01/10/2039 No 23/10/2024 PSUSA/00003033/203907 NAP
amended on 23/10/2024

© 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

PSUR frequency and DLP


3036 trihexyphenidyl 05/06/1956 11 years 03/10/2037 01/01/2038 No 23/10/2024 PSUSA/00003036/203710 NAP
amended on 23/10/2024

PSUR frequency amended and


3038 trimebutine 15/03/1988 9 years 01/01/2029 01/04/2029 No 28/08/2024 PSUSA/00003038/202901 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


3039 ruscogenin / trimebutine 10/12/1973 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00003039/203503 NAP
amended on 23/10/2024

PSUR frequency and DLP


3040 trimecaine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00003040/203211 NAP
amended on 23/10/2024

carbaethopendecinium bromide / trimecaine PSUR frequency amended and


3041 Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00003041/202512 Eva Jirsová Czech Republic NAP
hydrochloride DLP updated 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

PSUR frequency amended and


3045 trimethoprim Not available* 7 years 31/01/2025 01/05/2025 No 19/07/2024 PSUSA/00003045/202501 Maia Uusküla Estonia NAP
DLP updated on 30/04/2024

PSUR frequency and DLP


3046 trimipramine 05/10/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00003046/203906 NAP
amended on 23/10/2024

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

DLP was updated on 19/12/2017


3048 triptorelin 05/03/1986 5 years 31/03/2027 29/06/2027 No 21/12/2022 PSUSA/00003048/202703 Martin Huber Germany NAP
Lead MS and PRAC Rapporteur
name was added on 19/10/2016
PSUR frequency and DLP
3049 trolamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00003049/203211 NAP
amended on 23/10/2024

PSUR frequency and DLP


3050 tromantadine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00003050/203211 NAP
amended on 23/10/2024

disodium phosphate anhydrous / sodium hydrogen PSUR frequency amended and


3051 Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00003051/203011 NAP
carbonate / trometamol DLP updated on 28/08/2024

PSUR frequency and DLP


3053 tropicamide 01/03/1951 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00003053/203212 NAP
amended on 23/10/2024

PSUR frequency and DLP


3055 trospium 17/10/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00003055/202812 NAP
amended on 31/07/2024
DLP correction on 20/11/2024

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

PSUR frequency amended and


3060 bromelain / trypsin Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00003060/202906 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


3061 chymotrypsin / trypsin Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00003061/202512 Carla Torre Portugal NAP
DLP updated
PRAC on 31/07/2024
representative was
updated on 01/03/2023
PSUR frequency and DLP
3062 tryptophan Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 DLP was updated on 21/09/2022 PSUSA/00003062/202411 Martin Huber Germany NAP
amended on 28/08/2024

DLP was updated on 30/06/2021


PRAC Rapporteur name was
3063 tuberculin purified protein derivative 16/11/1979 7 years 01/09/2028 30/11/2028 No 16/10/2023 PSUSA/00003063/202809 Karin Erneholm Denmark NAP
amended
DLP on 18/10/2023
and Information included in
column "Are PSURs required for
products referred to in Articles
3065 typhoid polysaccharide vaccine 05/08/1998 3 years 05/08/2026 03/11/2026 No 30/04/2024 DLP was
10(1), amended
10a, on 30/04/2024
16a of Directive PSUSA/00003065/202608 Gabriele Maurer Germany NAP
2001/83/EC as amended?" was
amended on 31/03/2021
3067 typhoid vaccine (live, attenuated) 12/12/1984 3 years 31/12/2024 31/03/2025 Yes 21/09/2022 PSUSA/00003067/202412 Gabriele Maurer Germany NAP
DLP was updated on 03/03/2021

DLP was updated on 27/03/2018


PSUR frequency and DLP
3068 tyrothricin 20/10/1950 11 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00003068/203611 NAP
amended on 23/10/2024
Lead MS and PRAC Rapporteur
name was added on 20/12/2016
PSUR frequency amended and
3069 benzocaine / tyrothricin Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 Transferred PSUSA/00003069/202512 Ana Sofia Diniz Martins Portugal NAP
DLP updatedfrom the List of
on 31/07/2024
substances under PSUR Work
Sharing scheme and other
PSUR frequency amended
in and
3070 benzalkonium / benzocaine / tyrothricin Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 substances contained PSUSA/00003070/202512 Martin Huber Germany NAP
DLP updated
Nationally on 31/07/2024
Authorised Products
with DLP synchronised on
benzocaine / dequalinium chloride / dexamethasone / 06/03/2015
PSUR frequency amended and
3071 Not available* 9 years 03/06/2029 01/09/2029 No 28/08/2024 PSUSA/00003071/202906 NAP
tyrothricin DLP updated
PSUR on 28/08/2024
Frequency, DLP and
information included in column
"Are PSURs required for products
chlorhexidine digluconate / lidocaine hydrochloride /
3072 Not available* 13 years 01/01/2028 31/03/2028 Yes 21/07/2017 referred to in Articles 10(1), 10a, PSUSA/00003072/202801 NAP
tyrothricin
14, 16a of Directive 2001/83/EC
as amended?" was amended
updated
PSUR on 21/07/2017
frequency and DLP
3073 ubidecarenone Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 PSUSA/00003073/202411 Amelia Cupelli Italy NAP
amended on 28/08/2024

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

PRAC Representative amended


3078 urapidil 31/07/1980 5 years 01/07/2026 29/09/2026 No 02/03/2022 PSUSA/00003078/202607 Eva Jirsová Czech Republic NAP
on 18/11/2016

Lead MS and PRAC Rapporteur


PSUR frequency and DLP
3080 uridine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 name were amended on PSUSA/00003080/203211 NAP
amended on 23/10/2024
28/07/2016

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.

Lead MS added on 01/04/2015.

© 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

3082 urofollitropin 24/03/2004 5 years 23/03/2027 21/06/2027 No 19/12/2018 DLP


DLP was
was updated
updated on
on 21/09/2022
19/12/2017 PSUSA/00003082/202703 Eamon O'Murchu Ireland NAP
New CAP authorised on
12/12/2024
DLP
Leadwas
MS updated
and PRAConRapporteur
31/07/2019
name frequency
PSUR was addedamended
on 19/10/2016
and
3083 urokinase 24/05/1972 8 years 03/03/2025 01/06/2025 No 26/07/2024 New CAP
PRAC authorised on
Representative and Lead PSUSA/00003083/202503 Martin Huber Germany NAP
DLP updated on 03/07/2024
25/09/2024
Member state updated on
04/07/2018
New CAP authorised on
3085 ustekinumab 16/01/2009 2 years 31/12/2025 31/03/2026 No 31/07/2024 PSUSA/00003085/202512 Rhea Fitzgerald Ireland CAP
12/09/2024
PRAC Rapporteur name updated
DLP was updated on 22/12/2021
on 27/06/2017
New CAP authorised on
3086 valaciclovir 20/12/1994 3 years 19/12/2024 19/03/2025 No 21/09/2022 PRAC representative was
22/08/2024 PSUSA/00003086/202412 Jana Lukačišinová Czech Republic NAP
Next
PRAC DLP was updated
Rapporteur nameon was
updated on 04/03/2020
22/09/2016
amended on 28/04/2022
PSUR frequency amended and
PRAC Representative
DLP updated updated on
Lead MS was on
Information 31/07/2024
added on
3089 valganciclovir 29/03/2001 5 years 28/03/2026 26/06/2026 No 22/12/2021 26/09/2018 included in column PSUSA/00003089/202603 Liana Martirosyan Netherlands NAP
13/07/2015
"Are PSURs required for products
referred
Next DLPtowas
in Articles
amended 10(1),
on 10a,
valproic acid, sodium valproate, valproate pivoxil, Information
14, 16a included2001/83/EC
of Directive in column
PSUR frequency
20/12/2016 and DLP were
3090 valproate semisodium, valpriomide, valproate bismuth, 23/01/1967 3 years 23/01/2027 23/04/2027 No 25/09/2024 "Are PSURs
DLPamended?"
as was
updated
required
amended
on wason for products
25/09/2024
amended
28/07/2021 and PSUSA/00003090/202701 Liana Martirosyan Netherlands NAP
calcium valproate, valproate magnesium referred
DLP was to in Articles
updated 10(1), 10a,
onadded
21/10/2020
Lead Member State on
14, 16a of Directive 2001/83/EC
DLP was updated and
27/11/2015.
as amended?"
PRAC Rapporteur
Information
wasname
included
amendedwas on
in column Marie Louise Schougaard
3097 vancomycin 01/01/1955 5 years 31/01/2025 01/05/2025 No 21/10/2020 30/11/2012 PSUSA/00003097/202501
Christiansen Denmark NAP
amended
"Are PSURs onrequired
03/04/2019for products
referred to in Articles 10(1), 10a,
PRAC
14, Representative
16a amended
of Directive 2001/83/EC
3098 vardenafil 04/03/2003 5 years 04/03/2029 02/06/2029 No 20/11/2024 on 17/10/2017
DLPamended?"
as was amended wason 20/11/2024
amended on PSUSA/00003098/202903 Maria del Pilar Rayon Spain CAP
20/11/2019
The Next DLP and Lead Member
DLP
Statewas
was updated
amended on on
16/11/2022
3099 varenicline 26/09/2006 3 years 09/05/2026 07/08/2026 No 31/01/2024 Nextwas
DLP DLPamended
was amended on
on 31/01/2024 PSUSA/00003099/202605 Karin Erneholm Denmark CAP
29/10/2015
25/09/2017
DLP was updated on 21/10/2020
Lead MS wasincluded
Information added on in column
3102 vecuronium bromide 01/11/1990 5 years 30/11/2025 28/02/2026 Yes 28/07/2021 DLP was updated on 23/10/2018
04/02/2015 PSUSA/00003102/202511 Eva Jirsová Czech Republic NAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
PRAC Rapporteur name was
14, 16a of Directive 2001/83/EC
amended on 31/07/2018
as amended?" was amended on
3103 velaglucerase alfa 26/02/2010 2 years 25/02/2026 26/05/2026 No 16/11/2022
25/09/2017
PSUSA/00003103/202602 Martin Huber Germany CAP
PSUR Frequency amended and
Active substance name was
DLP updated on 22/09/2016
Lead MS and
amended PRAC Rapporteur
on 28/02/2024
3104 venlafaxine, desvenlafaxine 23/09/1993 5 years 05/05/2028 03/08/2028 No 28/02/2024 name was added on 28/07/2016
Next DLP was updated on
PSUSA/00003104/202805 Karin Bolin Sweden NAP
PSURwas
DLP frequency
updatedamended and
on 21/10/2020
06/10/2015
Transferred
DLP
DLP updated
was from the
onList
on 20/12/2023
amended of
03/05/2023
substances
PRAC under PSUR
representative wasWork
added
3105 verapamil 25/01/1963 7 years 25/01/2027 25/04/2027 No 21/10/2020 EURD
Sharing
was amended on
scheme andand DLP
otherwere PSUSA/00003105/202701 Terhi Lehtinen Finland NAP
on 06/05/2020
PSUR frequency
21/12/2012
substances
updated on contained
06/05/2020 in
hydrochlorothiazide / verapamil hydrochloride, Nationally
LMS was
Active Authorised
added
substance onname,Products
31/07/2019
PSUR
3107 hydrochlorothiazide / triamterene / verapamil Not available* 9 years 03/06/2031 01/09/2031 No 19/10/2023 with DLP
frequency
PSUR synchronised
and DLP
frequency andwere
DLPonupdated PSUSA/00003107/203106 none NAP
hydrochloride 06/03/2015
amended
on on 19/10/2023
07/05/2018

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

DLP was updated on 23/10/2018


3113 vildagliptin, metformin / vildagliptin 26/09/2007 3 years 28/02/2027 29/05/2027 No 23/10/2024 PSUSA/00003113/202702 Mari Thorn Sweden CAP NAP
PRAC Representative updated on
26/09/2018
PSUR frequency and DLP
3117 vinblastine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00003117/203211 NAP
amended on 23/10/2024
PRAC Rapporteur name was
amended on 31/07/2018
PSUR frequency and DLP
3118 vinburnine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 The Next DLP was amended on PSUSA/00003118/203211 NAP
amended on 23/10/2024
29/10/2015

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

PSUR frequency and DLP


3120 piracetam / vincamine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUSA/00003120/203205 NAP
amended on 23/10/2024

PSUR frequency and DLP were


3121 vincristine 12/04/1995 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was on
updated amended on 30/04/2024
25/05/2022 PSUSA/00003121/202908 Martin Huber Germany NAP

PSUR frequency and DLP were


DLP
PSURcorrected
frequency
updated onand
02/02/2022
DLP
on 05/06/2019
3122 vindesine 11/04/1979 9 years 03/11/2028 01/02/2029 No 31/07/2024 PSUSA/00003122/202811 NAP
amended on 31/07/2024
DLP 21/12/2022
Leadwas
MS updated
and PRAConRapporteur
17/11/2021
name amended on 21/11/2018
3123 vinflunine 21/09/2009 5 years 21/09/2026 20/12/2026 No 25/05/2022 DLP was
PSUR updatedDLP
frequency, on 19/12/2017
and PRAC PSUSA/00003123/202609 Maria del Pilar Rayon Spain CAP
Rapporteur
PSUR amended
Frequency on and
amended
Lead MS and PRAC Rapporteur
23/10/2018
DLP updated on 26/04/2017
name was added on 19/10/2016
3124 vinorelbine 11/04/1989 5 years 01/04/2027 30/06/2027 No 21/12/2022 DLP was updated on 17/10/2017
PRAC Representative amended
PSUSA/00003124/202704 Eva Jirsová Czech Republic NAP
Information included in column
on 28/03/2017
"Are PSURs
PRAC required
Rapporteur for was
name products
referred
PSUR toonin Articles
frequency
amended 10(1), 10a,
and DLP
3125 vinpocetine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 Next DLP was25/09/2017
amended on PSUSA/00003125/203211 NAP
14, 16a ofon
amended Directive 2001/83/EC
23/10/2024
03/05/2016
as amended?"
Next was amended
DLP was amended on on
30/11/2012
19/10/2016
3127 voriconazole 19/03/2002 3 years 28/02/2027 29/05/2027 No 17/11/2021 PSUR frequency amended and PSUSA/00003127/202702 Liana Martirosyan Netherlands CAP NAP
DLP updated on 28/06/2023
NAP products added on
22/09/2016
Information included in column
Marie Louise Schougaard
3129 warfarin 31/05/1962 8 years 31/01/2025 01/05/2025 No 28/06/2023 "Are PSURs required for products
NAP products removed on
PSUSA/00003129/202501
Christiansen Denmark NAP
referred to in Articles 10(1), 10a,
03/06/2016
14, 16a of Directive 2001/83/EC
Active substance name, PSUR
as amended?" was amended on
3133 xipamide, triamterene / xipamide 30/07/1969 7 years 31/01/2025 01/05/2025 No 19/07/2024 The Next DLP
frequency
28/06/2023
andwas
DLPamended
were on PSUSA/00003133/202501 Martin Huber Germany NAP
29/10/2015
amended on 19/10/2023

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

Reference to NAP added on


3136 yohimbine 01/06/1944 5 years 31/05/2029 29/08/2029 Yes 05/02/2025 DLP was amended on 05/02/2025
23/10/2024 PSUSA/00003136/202905 Jan Neuhauser Austria NAP
PRAC representative was
DLP was on
updated updated on 19/10/2022
19/10/2022
DLP was updated on 18/11/2020
3137 yttrium (90y) chloride 24/03/2003 5 years 23/03/2025 21/06/2025 No 23/10/2024 Entrywas
DLP name updated
updated on
on 21/09/2022 PSUSA/00003137/202503 Karin Erneholm Denmark CAP NAP
PRAC Representative updated on
25/09/2019
26/09/2018
PRAC representative was
PRAC Rapporteur
amended on name was
28/04/2022
3141 zanamivir (except for centrally authorised products) 09/02/1999 5 years 31/01/2027 01/05/2027 No 19/10/2022 Next DLP was updated on PSUSA/00003141/202701 Mari Thorn Sweden NAP
amended on 31/07/2018
27/11/2015.
DLP was updated on 29/06/2022
PRAC representative was
DLP was on
updated updated on 17/10/2017
01/04/2020
3142 ziconotide 21/02/2005 3 years 28/12/2024 28/03/2025 No 21/09/2022 PSUR frequency and DLP updated PSUSA/00003142/202412 Jo Robays Belgium CAP
on 05/06/2019
Lead MS and PRAC Rapporteur
PRAC representative was
name was
updated onadded on 28/07/2016
23/10/2019
Lead MS and PRAC Rapporteur
3143 zidovudine 03/03/1987 3 years 30/09/2024 29/12/2024 No 29/06/2022 name amended on 21/11/2018
DLP was updated on 31/07/2019
PSUSA/00003143/202409 Jana Lukačišinová Czech Republic NAP

PSUR Frequency amended and


PRAC Representative amended
DLP updated on 19/12/2017
on 18/11/2016
Lead MS and PRAC Rapporteur
PSUR Frequency amended and
name
© European Medicines Agency, 2011. Reproduction is authorised provided the source was added
on 19/10/2016
is acknowledged.
# Classified as internal/staff contractors by the EuropDLP
updated on 28/07/2016 Page 53 / 223
DLP was updated on 29/06/2022
3144 abacavir / lamivudine / zidovudine 28/12/2000 3 years 31/12/2025 31/03/2026 Yes 19/09/2024 PSUSA/00003144/202512 Zoubida Amimour France CAP NAP
PRAC Rapporteur name updated
on 19/12/2018
3145 zinc acetate dihydrate 13/10/2004 5 years 30/10/2026 28/01/2027 No 29/06/2022 DLP was updated on 31/03/2021 PSUSA/00003145/202610 Eamon O Murchu Ireland CAP
PRAC Rapporteur name was
amended
PRAC on 23/10/2018
Rapporteur name was
amended on 31/07/2018
3146 ziprasidone 05/02/1998 5 years 31/07/2025 29/10/2025 No 31/03/2021 Next DLP was amended on PSUSA/00003146/202507 Karin Bolin Sweden NAP
27/06/2017
Next DLP was amended on
07/04/2016
3147 zofenopril 30/07/1998 7 years 02/01/2031 02/04/2031 No 25/09/2024 DLP was amended on 25/09/2024
Lead MS added on 01/04/2015.
PSUSA/00003147/203101 Amelia Cupelli Italy NAP

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

PSUR frequency and DLP were


updated
DLP was on 21/12/2022
updated on
3149 zoledronic acid (indicated for cancer and fractures) 20/03/2001 3 years 31/08/2026 29/11/2026 No 30/04/2024 DLP was amended on16/11/2022
30/04/2024 PSUSA/00003149/202608 Karin Erneholm Denmark CAP NAP
DLP was
PRAC correctedname
Rapporteur on 03/03/2021
was
amended on 31/07/2018
3150 zolmitriptan 07/03/1997 5 years 06/03/2027 04/06/2027 No 16/11/2022 PSUR frequency and DLP were PSUSA/00003150/202703 Karin Bolin Sweden NAP
updated
DLP was on 18/11/2020
amended on 15/11/2017
DLP
Leadwas
MS updated on on
was added 20/11/2019
PSUR frequency amended and
3151 zolpidem 09/06/1987 3 years 03/08/2026 01/11/2026 No 30/04/2024
22/09/2016
PSUSA/00003151/202608 Amelia Cupelli Italy NAP
DLP updated on 30/04/2024
DLP was updated on 21/11/2018

PRAC Rapporteur name was


3152 zonisamide 10/03/2005 3 years 31/03/2025 29/06/2025 No 21/12/2022 PSUSA/00003152/202503 Rhea Fitzgerald Ireland CAP NAP
amended on 23/10/2018

Reference to NAP added on


PSUR frequency and DLP
3153 zopiclone, eszopiclone 10/12/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 31/07/2018 PSUSA/00003153/202812 NAP
amended on 31/07/2024
DLP was amended on 15/11/2017
PSUR frequency amended and
3154 zotepine 07/12/1981 8 years 03/05/2025 01/08/2025 No 30/10/2024 was updated on 18/11/2016 PSUSA/00003154/202505 Jana Lukačišinová Czech Republic NAP
DLP updated on 03/07/2024

DLP was amended on 29/10/2015


PRAC representative
PSUR frequency was and
amended
3155 zuclopenthixol 31/05/1976 5 years 31/05/2028 29/08/2028 No 31/01/2024 updated on 17/11/2021 PSUSA/00003155/202805 Jean-Michel Dogné Belgium NAP
DLP updated
Requirement on 31/01/2024
to submit generics
PRAC representative was
changed on
updated on 31/05/2023
31/01/2014
PSUR frequency, DLP and active
PSUR frequency
substance name and
wereDLP
updated
3157 ascorbic acid 25/02/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00003157/203906 Roxana Dondera Romania NAP
amended
DLP
on on 23/10/2024
was updated
22/09/2021 on 22/12/2021

PRAC representative was


3158 N(2)-L-alanyl-L-glutamine 29/03/1995 5 years 29/03/2026 27/06/2026 No 22/12/2021 New CAPon
updated authorised on
31/03/2021
30/06/2021 PSUSA/00003158/202603 Irina Sandu Romania NAP
15/09/2023
Next DLP
PSUR was amended
frequency amendedonand
DLP
PSURwas updated
frequency
20/12/2016
DLP updated on DLP
and 28/04/2022
were
on 31/07/2018
3159 antithrombin III 01/01/1983 5 years 31/12/2025 31/03/2026 No 22/09/2021 updated on 21/09/2022 PSUSA/00003159/202512 Amelia Cupelli Italy NAP
PRAC
Next representative
Lead DLP
Member
was State wason on
added
amended
updated
DLP was on 31/03/2021
updated
27/11/2015.
25/09/2017 on 23/09/2020
PSUR frequency and DLP
3160 arginine aspartate 07/10/1964 10 years 03/06/2034 01/09/2034 No 15/01/2025 PSUSA/00003160/203406 Tiphaine Vaillant France NAP
amended
Entry
PSUR nameonwas
23/10/2024
Frequency amended
and DLP on
PSUR Frequency amended and
01/07/2020
updated
DLP on 26/09/2018
updated on 09/09/2016
asparaginase, crisantaspase (L-asparaginase from
3161 03/04/1988 3 years 31/08/2024 29/11/2024 No 28/04/2022 DLP was
Next
PRAC DLP updated on 05/06/2019
was amended
Representative on
amended PSUSA/00003161/202408 Jan Neuhauser Austria CAP NAP
Erwinia chrysanthemi)
25/09/2017
on 27/11/2015.
Active substance name was
amended
Next DLP on 03/06/2016
was updatedon on
3162 bendamustine hydrochloride 07/07/2010 3 years 06/01/2025 06/04/2025 No 21/09/2022 Lead MS was added PSUSA/00003162/202501 Martin Huber Germany NAP
22/09/2016
13/07/2015
Next DLP was amended on
03/05/2016
Lead MS was added on
PSUR frequency amended and
3163 bilastine 08/09/2010 5 years 07/03/2029 05/06/2029 No 20/11/2024 13/07/2015 PSUSA/00003163/202903 Roxana Dondera Romania NAP
DLP
Leadupdated
MS added on on
20/11/2024
12/05/2015
Transferred from the List of
Name of active
substances substance
under
PSUR frequency PSUR Work
amended was
and
3164 chlorquinaldol Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 amended
Sharing on 04/02/2015
scheme and other PSUSA/00003164/202512 Roxana Dondera Romania NAP
DLP updated on 31/07/2024
substances contained in
Nationally Authorised Products
PSUR frequency and DLP
3165 ciclopirox and ciclopirox olamine 02/04/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 with DLP synchronised on PSUSA/00003165/203503 Melinda Palfi Hungary NAP
amended
06/03/2015 on 23/10/2024

PSUR frequency and DLP


3166 cycloserine Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00003166/202603 NAP
amended on 31/07/2024.

PRAC representative updated on


3167 dienogest 02/12/2009 3 years 02/12/2025 02/03/2026 No 31/01/2024 PSUSA/00003167/202512 Bianca Mulder Netherlands NAP
31/01/2024

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

PSUR Frequency amended and


3178 midodrine 06/02/1974 10 years 06/06/2026 04/09/2026 No 28/02/2017 PSUSA/00003178/202606 Irina Sandu Romania NAP
DLP updated on 28/02/2017

Lead MS and PRAC Rapporteur


PSUR frequency and DLP
3179 natamycin Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 name updated on 04/02/2016 PSUSA/00003179/202411 Adam Przybylkowski Poland NAP
amended on 23/10/2024
PSUSA number was amended on
06/10/2014
PSUR frequency and DLP
3180 sodium chloride 24/11/1972 10 years 31/01/2035 01/05/2035 No 23/10/2024 PSUSA/00003180/203501 NAP
amended on 23/10/2024

PSUR frequency and DLP


3181 riboflavin Not available* 10 years 03/11/2036 01/02/2037 No 23/10/2024 PSUSA/00003181/203611 NAP
amended
PRAC on 23/10/2024
representative was
updated on 31/05/2023
PSUR frequency and DLP
3183 silibinin, dry extract from Milk Thistle fruit (silymarin)) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PRAC representative was PSUSA/00003183/203206 Roxana Dondera Romania 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

PRAC Representative updated on


3185 tenonitrozole 11/02/1997 13 years 11/02/2028 11/05/2028 No 29/10/2015 26/09/2018 PSUSA/00003185/202802 Irina Sandu Romania NAP

PRAC Rapporteur amended on


28/02/2018
PSUR frequency and DLP
3186 a-tocopheril, a-tocopherol, vitamin E Not available* 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00003186/202511 Roxana Dondera Romania NAP
amended on 31/07/2024
The PSUR Frequency and Next
DLP was amended on
PSUR frequency amended and
9004 aciclovir / hydrocortisone 31/07/2009 5 years 30/07/2028 28/10/2028 No 27/03/2024 29/10/2015 PSUSA/00009004/202807 Jan Neuhauser Austria NAP
DLP updated on 27/03/2024
Lead MS was added on
04/02/2015

© 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

PSUR frequency and DLP


9050 aluminium chloride hexahydrate Not available* 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00009050/202511 Martin Huber Germany NAP
amended on 31/07/2024

PSUR frequency and DLP


9051 aluminium phosphate Not available* 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00009051/202511 Zoubida Amimour France NAP
amended on 31/07/2024

PSUR frequency amended and


9052 amlodipine / bisoprolol Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00009052/202903 NAP
DLP updated
PRAC on 28/08/2024
Rapporteur name was
amended on 22/09/2022
PSUR frequency amended and
9054 amoxicillin / lansoprazole / metronidazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 DLP was updated on 20/10/2021 PSUSA/00009054/202903 NAP
DLP updated on 28/08/2024
DLP was updated on 23/10/2018
9057 argatroban 31/01/1990 2 years 31/01/2026 01/05/2026 No 20/10/2021 PSUSA/00009057/202601 Mari Thorn Sweden NAP
PRAC Rapporteur name updated
on 27/06/2017
PSUR frequency and DLP
9059 arginine glutamate Not available* 8 years 03/11/2025 01/02/2026 No 31/07/2024 The Next DLP was amended on PSUSA/00009059/202511 NAP
amended on 31/07/2024
29/10/2015

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

atropine sulfate / phenylephrine acetate / prednisolone PSUR frequency and DLP


9068 13/12/1960 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00009068/203906 NAP
acetate amended on 23/10/2024

PSUR frequency and DLP


9071 bacampicillin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00009071/202905 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

9075 belimumab 13/07/2011 3 years 08/03/2027 06/06/2027 No 20/11/2024 Information included


DLP was amended onin column
20/11/2024 PSUSA/00009075/202703 Karin Bolin Sweden CAP
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
9080 bisulepin Not available* 7 years 03/08/2031 01/11/2031 Yes 23/10/2024 as amended?" was amended on PSUSA/00009080/203108 Anna Mareková Slovakia NAP
23/10/2024
DLP was updated on 21/09/2022
PSUR frequency and DLP
9083 bornaprin 13/12/1974 10 years 03/03/2035 01/06/2035 No 23/10/2024 PRAC representative and LMS PSUSA/00009083/203503 NAP
27/03/2024
amended on 23/10/2024
were updated on 26/05/2021

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

PSUR frequency amended and


9091 calcium lactate Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00009091/202512 John Joseph Borg Malta NAP
DLP updated on 31/07/2024

PSUR frequency amended and


9092 calcium pantothenate Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00009092/202512 Polona Golmajer Slovenia NAP
DLP updated on 31/07/2024
DLP was updated on 21/12/2022

DLP was updated on 19/12/2017


9099 cefuroxime axetil 18/08/1987 5 years 07/04/2027 06/07/2027 No 21/12/2022 PSUSA/00009099/202704 Maia Uusküla Estonia NAP
Lead MS and PRAC Rapporteur
name was added on 19/10/2016
PSUR frequency amended and
9100 chloral hydrate 08/02/1967 9 years 03/03/2028 01/06/2028 No 28/08/2024 PSUSA/00009100/202803 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9107 cloricromen hydrochloride 18/06/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00009107/202812 NAP
amended on 31/07/2024

Next DLP was updated on


9112 colistimethate sodium (dry inhalation powder) 13/02/2012 3 years 12/02/2026 13/05/2026 No 18/10/2023 PSUSA/00009112/202602 Adam Przybylkowski Poland CAP
18/10/2023

PSUR frequency and DLP


9113 conjugated estrogens 09/03/1950 10 years 01/12/2032 01/03/2033 No 23/10/2024 PSUSA/00009113/203212 Gudrun Thengilsdottir Iceland NAP
amended on 23/10/2024

PSUR frequency amended and


9114 conjugated estrogens / norgestrel Not available* 9 years 03/03/2030 01/06/2030 No 28/08/2024 PSUSA/00009114/203003 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9115 copper sulfate / zinc oxide 30/10/1995 8 years 03/10/2025 01/01/2026 No 30/10/2024 PSUSA/00009115/202510 Zoubida Amimour France NAP
amended on 31/07/2024

ascorbic acid / cyanocobalamin / folic acid / PSUR frequency and DLP


9116 Not available* 8 years 03/11/2025 01/02/2026 No 30/10/2024 PSUSA/00009116/202511 Amelia Cupelli Italy NAP
nicotinamide amended on 31/07/2024

PSUR frequency amended and


9118 decitabine 02/05/2006 5 years 01/05/2028 30/07/2028 No 31/01/2024 PSUSA/00009118/202805 Tiphaine Vaillant France CAP
DLP updated on 31/01/2024

denosumab (indicated for skeletal related events


9119 associated with bone metastases and for giant cell 13/07/2011 3 years 26/09/2026 25/12/2026 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00009119/202609 Mari Thorn Sweden CAP
tumour of bone)

PSUR frequency and DLP


9120 dexamethasone / heparin sodium 16/08/1961 11 years 03/06/2039 01/09/2039 No 23/10/2024 PSUSA/00009120/203906 NAP
amended on 23/10/2024

PSUR frequency amended and


9121 dexpanthenol / polyvinyl alcohol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00009121/203008 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


9128 diclofenac / pyridoxine / thiamine Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00009128/203008 NAP
DLP updated on 28/08/2024

PSUR frequency amended and


9129 didecyldimethylammonium chloride Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00009129/203008 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9131 diethylamine salicylate / myrtecaine 20/11/1967 10 years 03/08/2034 01/11/2034 No 23/10/2024 PSUSA/00009131/203408 NAP
amended on 23/10/2024

PSUR frequency amended and


9133 dihydroergocristine / etofylline Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00009133/203011 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9136 diphenhydramine / racemic camphor / zinc oxide Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00009136/202603 NAP
amended on 31/07/2024.

PSUR frequency and DLP


9139 dithranol Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00009139/202603 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 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

PSUR frequency and DLP


9143 escin 06/04/1983 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00009143/202812 NAP
amended on 31/07/2024

PSUR frequency and DLP


9144 diethylamine-salicylate / escin Not available* 8 years 03/03/2026 01/06/2026 No 31/07/2024 PSUSA/00009144/202603 NAP
amended on 31/07/2024.

PSUR frequency and DLP


9145 estradiol (17-beta) / progesterone Not available* 7 years 01/12/2024 01/03/2025 No 27/03/2024 PSUSA/00009145/202412 Amelia Cupelli Italy NAP
amended on 27/03/2024

PSUR frequency and DLP


9146 estriol / lactobacillus acidophilus Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00009146/202606 NAP
amended on 31/07/2024

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

PSUR frequency amended and


PSUR frequency and DLP
9150 clonazoline hydrochloride / fluocinolone acetonide Not available* 9 years 01/12/2029 01/03/2030 No 28/08/2024 DLP updated on 23/10/2024 PSUSA/00009150/202912 NAP
amended on 28/08/2024.
Active substance name was
fluocinolone / neomycin, fluocinolone / neomycin / amended on 23/10/2024
9152 01/05/1965 10 years 01/05/2033 30/07/2033 No 23/10/2024 PSUSA/00009152/203305 Martin Huber Germany NAP
polymyxin b
EURD added on 23/10/2024

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

PSUR frequency and DLP


9161 glutaral Not available* 8 years 03/06/2026 01/09/2026 No 31/07/2024 PSUSA/00009161/202606 NAP
amended on 31/07/2024

calcium chloride / glutamic acid / glutathione /


PSUR frequency amended and
9162 histidine / lactobionic acid / magnesium chloride / 25/03/2004 5 years 25/03/2029 23/06/2029 No 20/11/2024 PSUSA/00009162/202903 Maria Popova-Kiradjieva Bulgaria NAP
DLP updated on 20/11/2024
mannitol / potassium chloride / sodium hydroxide

PSUR frequency and DLP


9163 guaiazulene / matricaria oil Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00009163/203103 NAP
amended on 23/10/2024

PSUR frequency and DLP


9164 guaifenesin / herbal extracts Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00009164/203103 NAP
amended on 23/10/2024

PSUR frequency and DLP


9165 guaifenesin / levomenthol Not available* 8 years 03/08/2026 01/11/2026 No 23/10/2024 PSUSA/00009165/202608 NAP
amended on 23/10/2024

PSUR frequency amended and


9166 diphenhydramine / guaifenesin / levomenthol Not available* 9 years 03/11/2030 01/02/2031 No 28/08/2024 PSUSA/00009166/203011 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9167 glucose / guaiphenesin / treacle Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00009167/203103 NAP
amended on 23/10/2024

PSUR frequency and DLP


9168 halometasone Not available* 9 years 03/03/2031 01/06/2031 No 23/10/2024 PSUSA/00009168/203103 NAP
amended on 23/10/2024

PSUR frequency and DLP were


PSUR frequency
updated and DLP
on 20/10/2021
9169 halometasone / triclosan Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUSA/00009169/203106 NAP
amended on 23/10/2024
DLP was updated on 21/10/2020
PSUR frequency amended and
9170 dexpanthenol / heparin Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 DLP PSUSA/00009170/203008 NAP
DLP was updated
updated on 23/10/2019
on 28/08/2024

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

hydroxycarbamide (except for centrally authorised PSUR frequency amended and


9182 07/12/1967 3 years 06/12/2026 06/03/2027 No 31/07/2024 PSUSA/00009182/202612 Petar Mas Croatia NAP
product) DLP updated on 31/07/2024

PSUR frequency amended and


9183 hyetellose / sodium chloride 11/01/1990 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00009183/202901 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9187 ibuprofen / phenylephrine Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00009187/202611 NAP
amended on 23/10/2024

ichthammol / titanium dioxide / zinc oxide and other


9188 18/01/1934 13 years 03/06/2040 01/09/2040 No 23/10/2024 DLP amended
PRAC on 23/10/2024
representative was PSUSA/00009188/204006 NAP
substances, zinc oxide/dimethicone
updated on 19/10/2022

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

PSUR frequency and DLP were


9200 ipilimumab 13/07/2011 3 years 24/03/2027 22/06/2027 No 20/11/2024 updated
DLP was on 19/10/2022
amended on 20/11/2024 PSUSA/00009200/202703 Bianca Mulder Netherlands CAP
Information
DLP included
was updated in column
on 25/09/2019
"Are PSURs required for products
9201 ipratropium / xylometazoline 07/04/2006 6 years 03/08/2029 01/11/2029 No 30/04/2024 DLP was
referred
DLP amended
was to on
in Articles
corrected 30/04/2024
on 10(1), 10a,
28/02/2018 PSUSA/00009201/202908 Petar Mas Croatia NAP
14, 16a of Directive 2001/83/EC
as amended?"
PSUR Frequency was amended
amended on
and
isoniazid / pyrazinamide / rifampicin, ethambutol / 23/10/2024
DLP updated and information
9202 Not available* 8 years 03/11/2026 01/02/2027 Yes 23/10/2024 PSUSA/00009202/202611 none NAP
isoniazid / pyrazinamide / rifampicin included in column "Are PSURs
Active substance
required name
for products was to
referred
amended on 23/10/2024
in Articles 10(1), 10a, 14, 16a of
Next DLP was updated on
9204 ivacaftor 23/07/2012 3 years 23/01/2026 23/04/2026 No 18/10/2023 Directive 2001/83/EC as PSUSA/00009204/202601 Monica Martinez Redondo Spain CAP
18/10/2023
PSUR frequency
amended?" and DLP
amended on
amended on 23/10/2024
23/05/201
9205 ketoprofen (topical use only) 23/01/1975 5 years 23/01/2027 23/04/2027 No 19/10/2022 PSUSA/00009205/202701 Karin Bolin Sweden NAP
Next DLP was amended on
03/06/2016
PSUR frequency and DLP
9206 lactic acid / propylene glycol Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 EURD and DLP amended on PSUSA/00009206/203107 NAP
amended on 23/10/2024
16/07/2015

Lead MS added on 12/05/2015


9207 lamivudine (HIV infections), lamivudine / zidovudine 18/03/1998 3 years 30/11/2024 28/02/2025 No 19/09/2024 PSUSA/00009207/202411 Zoubida Amimour France CAP
For advice on submission for
DLP
DLPswas amended
falling before on 18/12/2024
10/09/2015
9208 white soft paraffin, white soft paraffin combinations 30/06/1982 13 years 30/06/2040 28/09/2040 No 05/01/2025 please consult the List of PSUSA/00009208/204006 Jo Robays Belgium NAP
Name of active
substance undersubstance was
Work sharing
amended
scheme and on other
21/12/2012
substance
contained
PSUR in Nationally
frequency and DLP
9210 levomenthol Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 AuthorisedonProducts with DLPs PSUSA/00009210/202611 NAP
amended 23/10/2024
synchronised.

PSUR frequency and DLP


9212 levothyroxine / potassium iodide Not available* 9 years 02/09/2031 01/12/2031 No 23/10/2024 PSUSA/00009212/203109 NAP
amended on 23/10/2024

PSUR frequency amended and


9213 fluorescein sodium / lidocain hydrochloride Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 PSUSA/00009213/203012 NAP
DLP updated on 28/08/2024

PSUR frequency and DLP


9215 isopropyl myristate / liquid paraffin Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUSA/00009215/203107 NAP
amended on 23/10/2024

PSUR frequency amended and


9216 acetylated wool alcohols / liquid paraffin Not available* 9 years 31/01/2029 01/05/2029 No 28/08/2024 PSUSA/00009216/202901 NAP
DLP updated on 28/08/2024
PRAC Rapporteur name was
PSUR frequency
amended and DLP
on 28/04/2022
9219 magaldrate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00009219/202611 NAP
amended on 23/10/2024
DLP was updated on 03/03/2021
Marie Louise Schougaard
9225 magnesium sulfate Not available* 5 years 30/06/2025 28/09/2025 No 03/03/2021 PRAC Rapporteur name was PSUSA/00009225/202506
Christiansen Denmark NAP
amended on 03/04/2019
PRAC representative updated on
19/10/2022
DLP updated on 04/03/2016
9226 mannitol (indicated in cystic fibrosis) 13/04/2012 3 years 12/04/2025 11/07/2025 No 19/09/2024 PSUSA/00009226/202504 Zoubida Amimour France CAP
PRAC representative
Lead MS was
added on 01/04/2015.
updated on 27/07/2022
9231 moxifloxacin (systemic use) 31/05/1999 4 years 31/05/2027 29/08/2027 No 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00009231/202705 Martin Huber Germany NAP
DLP was updated on 02/03/2022
Correction of DLP on 20/11/2024
PRAC representative was
9234 nicotinamide Not available* 8 years 03/11/2026 01/02/2027 No 05/01/2025 updated on 30/06/2021 PSUSA/00009234/202611 Tiphaine Vaillant France NAP
PSUR frequency and DLP
amended on 23/10/2024
Next DLP was updated on
06/03/2019
9236 nimesulide (systemic formulations) 06/08/1985 3 years 30/06/2024 28/09/2024 No 19/10/2022 PSUSA/00009236/202406 Amelia Cupelli Italy NAP
Next DLP and Information
included in column "Are PSURs
PSUR frequency and DLP
9237 nitroxoline Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 required for products referred to PSUSA/00009237/202411 Martin Huber Germany NAP
amended on 23/10/2024
in Articles 10(1), 10a, 14, 16a of
Directive 2001/83/EC as
amended?"
PSUR was amended on
frequency and
9239 amoxicillin / clarithromycin / omeprazole Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 wereupdated
updatedonon28/08/2024
04/03/2016 PSUSA/00009239/202903 NAP
DLP

PRAC Rapporteur amended on


PSUR frequency and DLP
27/11/2015.
9241 aspergillus orizae / pancreatin Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00009241/202905 NAP
amended on 31/07/2024
Lead MS added on 01/04/2015.
belladonna extract / hyosciamine / papaverine PSUR frequency and DLP
9242 Not available* 9 years 03/05/2029 01/08/2029 No 31/07/2024 PSUSA/00009242/202905 NAP
hydrochloride amended on 31/07/2024

PSUR frequency amended and


9243 dextromethorphan / doxylamine / paracetamol Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00009243/203008 NAP
DLP updated on 28/08/2024

dextromethorphan / doxylamine / ephedrine / PSUR frequency amended and


9244 Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 PSUSA/00009244/203008 NAP
paracetamol updated
DLP was on 28/08/2024
amended on 05/06/2024

Information included in column


dextromethorphan / doxylamine / paracetamol / PSUR frequency amended and
9245 Not available* 9 years 03/08/2030 01/11/2030 No 28/08/2024 "Are PSURs required for products PSUSA/00009245/203008 NAP
pseudoephedrine DLP updated
PSUR on 28/08/2024
frequency and DLP were
referred to in Articles 10(1), 10a,
updated on 01/03/2023
14, 16a of Directive 2001/83/EC
as amended?" was amended on
9247 dextromethorphan / paracetamol / phenylephrine Not available* 6 years 03/11/2024 01/02/2025 Yes 05/06/2024 DLP was updated on 02/03/2022 PSUSA/00009247/202411 Anna Mareková Slovakia NAP
05/06/2024
DLP was updated on 03/03/2021
Lead MS and PRAC Rapporteur
PSUR frequency and DLP
9248 ascorbic acid / paracetamol / propyphenazone 21/12/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 name added on 15/11/2023 PSUSA/00009248/203905 NAP
PRAC representative
amended was
on 23/10/2024
updated on 29/07/2020
PSUR frequency and DLP
chlorpheniramine / dextromethorphan / paracetamol / amended
PSUR on 26/07/2023
9250 16/12/1998 8 years 03/11/2025 01/02/2026 No 30/10/2024 PRAC frequency and DLP
representative was PSUSA/00009250/202511 Rugile Pilviniene Lithuania NAP
pseudoephedrine amended on 31/07/2024
updated on 03/06/2020

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

Next DLP was amended on


06/10/2014
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the EuropNextDLP was amended on Page 57 / 223
03/03/2014

EURD was amended on


21/12/2012
PSUR frequency and DLP
9260 pinazepam 24/03/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00009260/203503 NAP
amended on 23/10/2024

pneumococcal polysaccharide conjugate vaccine DLP and PSUR frequency


9262 30/03/2009 5 years 10/12/2027 09/03/2028 No 20/09/2023 PSUSA/00009262/202712 Mari Thorn Sweden CAP
(adsorbed) - 10 valent amended on 20/09/2023

pneumococcal polysaccharide conjugate vaccine DLP and PSUR frequency


9263 09/12/2009 5 years 09/01/2028 08/04/2028 No 20/09/2023 PSUSA/00009263/202801 Mari Thorn Sweden CAP
(adsorbed) - 13 valent amended on 20/09/2023

PSUR frequency and DLP


9264 magnesium aspartate / potassium aspartate Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00009264/202611 NAP
amended on 23/10/2024

PSUR frequency amended and


9265 ascorbic acid / potassium bicarbonate Not available* 8 years 01/12/2025 01/03/2026 No 30/10/2024 PSUSA/00009265/202512 Monica Martinez Redondo Spain NAP
DLP updated on 31/07/2024

PSUR frequency amended and


9266 potassium canrenoate Not available* 7 years 31/01/2025 01/05/2025 No 19/07/2024 PSUSA/00009266/202501 Amelia Cupelli Italy NAP
DLP updated on 30/04/2024

PSUR frequency and DLP


9268 potassium iodide Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 PSUSA/00009268/203205 NAP
amended on 23/10/2024

chloramphenicol hemisuccinate / prednisolone sodium PSUR frequency


PRAC amended
representative was and
9269 Not available* 9 years 03/08/2029 01/11/2029 No 28/08/2024 PSUSA/00009269/202908 none NAP
succinate DLP updated
updated on 28/08/2024
on 31/03/2021

PSUR frequency and CLP were


PSUR frequency amended and
9271 promestriene (cream and vaginal capsules) 31/01/1974 5 years 31/03/2029 29/06/2029 No 18/12/2024 updated on 03/06/2020 PSUSA/00009271/202903 Irina Sandu Romania NAP
DLP updated on 18/12/2024
PSUR Frequency amended and
DLP updated on 23/05/2017
9272 chlorquinaldol (vaginal tablet) / promestriene 13/06/1977 13 years 30/09/2032 29/12/2032 No 03/06/2020 PSUSA/00009272/203209 Roxana Dondera Romania NAP
EURD date amended on
22/09/2016
PSUR frequency amended and
9273 protirelin 01/01/1974 8 years 01/01/2032 31/03/2032 No 25/09/2024 PSUSA/00009273/203201 Jana Lukačišinová Czech Republic NAP
DLP updated on 25/09/2024
PSUR Frequency amended and
DLP updated on 03/06/2016
PSUR frequency and DLP
9274 fluorescein sodium / proxymetacaine hydrochloride 17/02/1997 8 years 03/11/2025 01/02/2026 No 31/07/2024 Lead MS added on 12/05/2015 PSUSA/00009274/202511 NAP
amended on 31/07/2024

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

PSUR frequency and DLP


9280 a-tocopherol nicotinate / retinol palmitate 31/12/1968 11 years 03/03/2040 01/06/2040 No 23/10/2024 PSUSA/00009280/204003 NAP
amended on 23/10/2024

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

PRAC representative was


PSUR frequency
updated amended and
on 01/03/2023
9284 saccharomyces boulardii Not available* 5 years 07/02/2028 07/05/2028 No 18/10/2023 PSUSA/00009284/202802 Eva Jirsová Czech Republic NAP
DLP updated on 18/10/2023
DLP was updated on 01/02/2023
PSUR frequency amended and
9286 flumetasone / salicylic acid Not available* 9 years 01/12/2030 01/03/2031 No 28/08/2024 DLP PSUSA/00009286/203012 NAP
DLP was udpated
updated on 18/12/2019
on 28/08/2024
DLP was updated on 19/12/2018
PSUR frequency and DLP
9288 scopolamine aminoxide hydrobromide Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUSA/00009288/203206 NAP
amended
DLP on 23/10/2024
was updated on 19/12/2017

Next DLP was amended on


9289 shingles (herpes zoster) vaccine (live) 19/05/2006 3 years 01/05/2025 30/07/2025 No 01/02/2023 20/12/2016 PSUSA/00009289/202505 Gabriele Maurer Germany CAP

Next DLP amended on


21/12/2015
9292 silver nitrate Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 DLP amended on 23/10/2024 PSUSA/00009292/202612 NAP
PSUR Frequency and Next DLP
amended on 16/07/2015
PSUR frequency and DLP
9295 sodium chloride (eye drops) Not available* 9 years 03/06/2032 01/09/2032 No 23/10/2024 PSUSA/00009295/203206 NAP
amended on 23/10/2024
Next DLP was amended on
22/12/2014
PSUR frequency and DLP
9296 sodium chloride (nasal drops) Not available* 9 years 03/08/2032 01/11/2032 No 23/10/2024 Next DLP was amended on PSUSA/00009296/203208 NAP
amended on 23/10/2024
01/06/2014

chamomile extract / glucose / potassium chloride / PSUR frequency amended and


9298 Not available* 9 years 03/07/2029 01/10/2029 No 28/08/2024 PSUSA/00009298/202907 NAP
sodium chloride / sodium hydrogen carbonate DLP updated on 28/08/2024

PSUR frequency and DLP


9300 strontium chloride hexahydrate Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00009300/203211 NAP
amended on 23/10/2024

PSUR frequency and DLP


9302 sucrose Not available* 8 years 03/08/2027 01/11/2027 No 23/10/2024 PSUSA/00009302/202708 NAP
amended on 23/10/2024

hamamelis virginiana l. extract / phenazone / tannic PSUR frequency and DLP


9303 Not available* 9 years 03/06/2031 01/09/2031 No 23/10/2024 PSUSA/00009303/203106 NAP
acid amended on 23/10/2024

DLP was updated on 02/03/2022


Marie Louise Schougaard
9305 teduglutide 30/08/2012 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/00009305/202408 PSUSA/00009305/202508
Christiansen Denmark CAP
Next DLP was updated on
06/03/2019
PSUR frequency and DLP
9310 tetracycline (topical use) 23/08/1984 9 years 01/12/2028 01/03/2029 No 31/07/2024 PRAC Rapporteur name was PSUSA/00009310/202812 NAP
amended on 31/07/2024
amended on 23/10/2018

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

PSUR Frequency amended and


9315 tobramycin (inhalation powder, capsules) 20/07/2011 3 years 30/06/2024 28/09/2024 No 02/03/2022 DLP updated on 04/02/2016 PSUSA/00009315/202406 Liana Martirosyan Netherlands CAP

Next DLP was amended on


tobramycin (nebuliser solution) (apart from centrally 04/02/2015
9316 10/12/1999 3 years 31/12/2026 31/03/2027 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00009316/202612 Amelia Cupelli Italy NAP
authorised product)
Next DLP
PRAC was amended
representative wason
06/10/2014
updated on 19/10/2022
PRAC representative updated on
9317 tobramycin (ophthalmic and otic use) 01/06/1977 5 years 31/03/2026 29/06/2026 No 31/01/2024 PSUSA/00009317/202603 Carla Torre Portugal NAP
31/01/2024
Next DLP was amended
PRAC representative wason
08/08/2014
updated on 27/07/2022
9318 tobramycin (systemic use) 29/10/1973 8 years 15/09/2028 14/12/2028 No 19/10/2022 Nextwas
DLPupdated
was amended on PSUSA/00009318/202809 Amelia Cupelli Italy NAP
DLP on 26/05/2021
03/03/2014
PRAC representative and LMS
were added on 04/03/2020

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 58 / 223
DLP was amended on 03/05/2023

PRAC Rapporteur name was


amended on 28/04/2022

Active substance name amended


on 31/07/2019
Marie Louise Schougaard
9319 treosulfan (except for centrally authorised product) Not available* 5 years 31/08/2027 29/11/2027 No 03/05/2023 PSUSA/00009319/202708
Christiansen Denmark NAP
PRAC Rapporteur name was
amended on 03/04/2019
PSUR frequency and DLP
9321 triamterene / trichlormethiazide Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00009321/203211 NAP
DLP was
was amended
amended
DLP updated on
on06/06/2018
on 23/10/2024
03/05/2023
Lead MS
PRAC and PRAC Rapporteur
representative was
PSUR
name frequency
was addedand DLP
on 28/02/2017
9323 cetrimonium bromide / lidocaine / tyrothricin 28/09/1966 10 years 03/07/2034 01/10/2034 No 23/10/2024 updated on PSUSA/00009323/203407 NAP
amended on19/10/2022
23/10/2024

PSUR frequency and DLP was


PSUR frequency
updated and DLP
on 01/04/2020
9326 urea hydrogen peroxide Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 PSUSA/00009326/202411 Melinda Palfi Hungary NAP
amended on 28/08/2024
DLP was updated on 03/04/2019
Next DLP was updated on
9327 vandetanib 17/02/2012 3 years 06/10/2025 04/01/2026 No 16/11/2022 PRAC Rapporteur name updated PSUSA/00009327/202510 Tiphaine Vaillant France CAP
31/05/2023
on 23/10/2018

DLP was updated on 27/03/2018


9329 vemurafenib 17/02/2012 3 years 16/08/2025 14/11/2025 No 03/05/2023 PSUSA/00009329/202508 Mari Thorn Sweden CAP
DLP was updated on 28/03/2017
PSUR frequency and DLP
9330 xylene 14/05/1957 11 years 02/04/2038 01/07/2038 No 23/10/2024 Next DLP was amended on PSUSA/00009330/203804 NAP
amended on 23/10/2024
07/04/2016

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

Next DLP was amended on


PSUR frequency and DLP
9333 zinc sulfate, zinc histidine 30/03/1973 10 years 31/01/2035 01/05/2035 No 23/10/2024 01/04/2014 PSUSA/00009333/203501 Martin Huber Germany NAP
amended on 23/10/2024
The DLP was corrected on
01/10/2013
9334 zoledronic acid (indicated for Osteoporosis) 15/04/2005 5 years 31/08/2028 29/11/2028 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00009334/202808 Mari Thorn Sweden CAP

PSUR frequency and DLP


9999 levomepromazine Not available* 9 years 03/07/2031 01/10/2031 No 23/10/2024 PSUSA/00009999/203107 NAP
amended on 23/10/2024

PSUR frequency and DLP were


10000 5 fluorouracil (topical application) Not available* 3 years 16/01/2026 16/04/2026 No 20/09/2023 updated
DLP on 21/10/2020
amended on 20/09/2023 PSUSA/00010000/202601 Martin Huber Germany NAP
DLP was amended on 15/11/2017

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

Lead MS was added on


10005 mannitol (all indications apart from cystic fibrosis) Not available* 5 years 28/02/2025 29/05/2025 No 21/10/2020 PSUSA/00010005/202502 Petar Mas Croatia NAP
22/09/2016

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

10034 catridecacog 19/07/2012 3 years 31/07/2026 29/10/2026 No 27/03/2024 PSURwas


DLP Frequency
updatedand
amended Next DLP
on20/10/2021
on 27/03/2024 PSUSA/00010034/202607 Tiphaine Vaillant France CAP
were updated on 27/11/2015.
DLP was updated on 21/10/2020
Next DLP was amended on
10036 insulin degludec, insulin degludec / insulin aspart 28/09/2012 3 years 30/09/2026 29/12/2026 No 05/06/2024 DLP was amended
12/05/2015 on 05/06/2024 PSUSA/00010036/202609 Mari Thorn Sweden CAP
DLP was updated on 25/09/2019

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

DLP updated on 06/10/2015

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

The next DLP was amended on


01/04/2014
PSUR frequency amended and
DLP updated on 31/05/2023

PRAC Rapporteur name was


amended on 28/04/2022

PRAC representative was


updated on 31/03/2021

DLP was updated on 03/06/2020

meningococcal group-B vaccine (rDNA, component, PRAC representative


10043 14/01/2013 3 years 13/01/2027 13/04/2027 No 25/09/2024 DLP was amended onwas
25/09/2024 PSUSA/00010043/202701 Mari Thorn Sweden CAP
adsorbed) updated on 25/09/2019

PRAC Rapporteur name was


meningococcal group a, c, w135, y conjugate vaccine PSUR frequency amended and
10044 20/04/2012 3 years 19/04/2026 18/07/2026 No 20/12/2023 corrected on 03/04/2019 PSUSA/00010044/202604 David Olsen Norway CAP
(conjugated to tetanus toxoid carrier protein) DLP updated on 20/12/2023
PRAC Rapporteur name was
glycopyrronium bromide (for centrally authorised
amended on 06/06/2018 Marie Louise Schougaard
10047 product indicated for chronic obstructive pulmonary 28/09/2012 5 years 28/09/2027 27/12/2027 No 31/05/2023 PSUSA/00010047/202709
Christiansen Denmark CAP
disease)
PRAC Representative amended
on 17/10/2017
PSUR frequency and DLP
10049 zinc gluconate Not available* 8 years 03/11/2024 01/02/2025 No 28/08/2024 PSUSA/00010049/202411 Gudrun Thengilsdottir Iceland NAP
amended on 28/08/2024
PSUR Frequency
PRAC amended
Representative andon
updated
DLP updated on 26/04/2017
16/11/2022
caffeine / dexpanthenol / nicotinamide / pyridoxine / PSUR frequency and DLP
10050 23/06/1966 11 years 02/12/2039 01/03/2040 No 23/10/2024 The name of 23/10/2024
the active PSUSA/00010050/203912 Mari Thorn Sweden NAP
riboflavine / thiamin amended
DLP on
was updated on 30/03/2022
substance was amended on
22/09/2016
PRAC Representative updated on
10051 lovastatin 21/07/1987 5 years 20/07/2026 18/10/2026 No 30/03/2022 26/09/2018 PSUSA/00010051/202607 Maria del Pilar Rayon Spain NAP
Next DLP was amended on
03/05/2016
PSUR Frequency amended and
DLP updated
Next DLP wason 28/03/2017
updated on
10052 vortioxetine 18/12/2013 2 years 29/09/2024 28/12/2024 No 28/04/2022 Next DLP amended on PSUSA/00010052/202409 Jo Robays Belgium CAP
31/05/2023
04/11/2014
Lead MS and PRAC Rapporteur
name updated on 04/02/2016
PSUR frequency
Next DLP amendedamended
on and
10054 afatinib 25/09/2013 5 years 25/09/2028 24/12/2028 No 05/06/2024 PSUSA/00010054/202809 Mari Thorn Sweden CAP
DLP updated on 05/06/2024
02/05/2014

PSUR frequency amended and


10055 alemtuzumab 12/09/2013 3 years 12/09/2025 11/12/2025 No 03/05/2023 PSUSA/00010055/202509 Karin Erneholm Denmark CAP
DLP updated on 03/05/2023

alogliptin, alogliptin / metformin, alogliptin / PRAC representative updated on


10061 16/04/2013 2 years 15/04/2025 14/07/2025 No 31/01/2024 PSUSA/00010061/202504 Bianca Mulder Netherlands CAP
pioglitazone 31/01/2024

10064 amlexanox 24/09/2001 12 years 31/03/2025 29/06/2025 No 02/05/2014 PSUSA/00010064/202503 NAP

PSUR frequency amended and


10066 avanafil 21/06/2013 5 years 21/06/2028 19/09/2028 No 28/02/2024 DLP was updated on 29/06/2022 PSUSA/00010066/202806 Maria del Pilar Rayon Spain CAP
DLP updated on 28/02/2024
DLP was updated on 03/07/2019
10067 azelastine / fluticasone 24/01/2013 3 years 26/10/2024 24/01/2025 No 29/06/2022 DLP was updated on 05/04/2023 PSUSA/00010067/202410 Jan Neuhauser Austria NAP
Next DLP was updated on
28/06/2016
DLP was updated on 01/04/2020
PSUR frequency and DLP were
10068 beclometasone / formoterol (inhalative application) 14/07/2006 3 years 14/07/2025 12/10/2025 No 05/04/2023 Lead MS on
updated added on 16/06/2015
29/06/2022 PSUSA/00010068/202507 Martin Huber Germany NAP
DLP was updated on 28/03/2017
PRAC Rapporteur name was
Lead MS and PRAC Rapporteur
amended on 06/03/2019
10070 benzalkonium chloride / chlorhexidine digluconate 19/11/1998 7 years 01/11/2028 30/01/2029 No 29/06/2022 name updated on 04/02/2016 PSUSA/00010070/202811 Rugile Pilviniene Lithuania NAP
DLP was updated on 21/07/2017

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

PRAC Rapporteur updated on


10072 betamethasone / tetryzoline 17/05/1966 5 years 30/09/2024 29/12/2024 No 15/11/2023 PSUSA/00010072/202409 Petar Mas Croatia NAP
15/11/2023

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

dolutegravir, dolutegravir / abacavir / lamivudine,


10075 16/01/2014 2 years 16/01/2025 16/04/2025 No 20/09/2023 DLP amended on 20/09/2023 PSUSA/00010075/202501 Martin Huber Germany CAP
dolutegravir / lamivudine

PRAC representative updated on


10077 canagliflozin, canagliflozin / metformin 29/03/2013 3 years 28/03/2026 26/06/2026 No 31/01/2024 PSUSA/00010077/202603 Martin Huber Germany CAP
31/01/2024
DLP was updated on 05/04/2023

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

PRAC representative was


10080 clindamycin phosphate / tretinoin 22/03/2013 5 years 31/07/2027 29/10/2027 No 05/04/2023 updated on 06/05/2020 PSUSA/00010080/202707 Anna Mareková Slovakia NAP

DLP was updated on 07/05/2018


10081 cobicistat 27/08/2013 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024
PRAC representative and Lead
PSUSA/00010081/202608 Ana Sofia Diniz Martins Portugal CAP
Member State were added on
30/01/2017
cobicistat / elvitegravir / emtricitabine / tenofovir
10082 27/08/2012 3 years 26/08/2026 24/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010082/202608 Ana Sofia Diniz Martins Portugal CAP
disoproxil

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

PSUR frequency amended and


DLP updated on 03/04/2019
10099 fluticasone furoate / vilanterol 10/05/2013 3 years 09/05/2027 07/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010099/202705 Monica Martinez Redondo Spain CAP
PRAC Representative updated on
26/09/2018
PSUR frequency and DLP
10100 framycetin sulphate / hydrocortisone acetate Not available* 9 years 31/01/2031 01/05/2031 No 24/09/2024 DLP was updated on 27/03/2018 PSUSA/00010100/203101 Jana Lukačišinová Czech Republic NAP
amended on 23/10/2024
DLP was updated on 28/03/2017
10101 granisetron (transdermal patch) 20/04/2012 3 years 19/10/2026 17/01/2027 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010101/202610 Rugile Pilviniene Lithuania CAP
Next DLP was updated on
22/09/2016
human coagulation factor viii / human von willebrand
10102 12/08/2013 5 years 12/08/2026 10/11/2026 No 28/04/2022 PSUR Frequency amended and PSUSA/00010102/202608 Bianca Mulder Netherlands CAP
factor (centrally authorised product only)
DLP updated on 07/04/2016

Next DLP was updated on


10104 human C1-esterase inhibitor 16/07/2001 2 years 15/06/2025 13/09/2025 No 28/02/2024 DLP was amended on 28/02/2024
30/09/2015
PSUSA/00010104/202506 Gabriele Maurer Germany CAP
DLP was updated on 01/02/2023
Next DLP was amended on
PRAC frequency
PSUR Representative nameand
amended was Marie Louise Schougaard
10105 indacaterol / glycopyrronium bromide 19/09/2013 5 years 28/09/2028 27/12/2028 No 05/06/2024 01/04/2015
corrected on 29/07/2020 PSUSA/00010105/202809
Christiansen Denmark CAP
DLP updated on 05/06/2024
Correction of PSUSA number
PSUR frequency and DLP were
(Next DLP) on 06/10/2014
10107 insulin human (Intraperitoneal use only) 19/09/2013 3 years 19/09/2026 18/12/2026 No 05/06/2024 updated
DLP was on 18/12/2019
amended on 05/06/2024 PSUSA/00010107/202609 Jean-Michel Dogné Belgium CAP
PSUR frequency and DLP were
Correction
updated of submission date on
New CAPon 29/06/2022
authorised on
31/01/2014
DLP was updated on 30/03/2022
isopropyl alcohol / propyl alcohol / mecetronium ethyl 14/11/2019
10108 20/01/1984 5 years 30/09/2026 29/12/2026 No 29/06/2022 PRAC representative added on PSUSA/00010108/202609 Martin Huber Germany NAP
sulfate DLP
Name
Next was
of updated
DLP,active on 21/09/2022
PSURsubstance
frequency,was
Lead
25/05/2022
DLP was updated on 19/12/2018
amended
MS and PRACon 30/11/2013
Rapporteur name
Next DLP
were was amended
amended on
LMS was
PRAC addedon on06/03/2019
Representative 03/03/2021
updated on
10109 levobunolol (ophthalmic indication) 02/01/1985 5 years 02/01/2027 02/04/2027 No 21/09/2022 25/09/2017
DLP was updated on 28/04/2022 PSUSA/00010109/202701 Eva Jirsová Czech Republic NAP
26/09/2018
DLP was updated on 28/02/2018
Leadand
DLP MS and PRAC Rapporteur
DLP was frequency
updated onwas amended
19/12/2017
lidocaine / prilocaine (centrally authorised product name
PRAC
on was added on 28/07/2016
Representative
03/04/2019 amended
10110 15/11/2013 3 years 15/05/2025 13/08/2025 No 01/02/2023 PSUSA/00010110/202505 Maria del Pilar Rayon Spain CAP
only) on 28/03/2017
PSUR Frequency amended and
PRACDLP
next Rapporteur
updated name updated
on 27/06/2017
Next
on DLP was amended on
23/10/2018
10111 lipegfilgrastim 25/07/2013 3 years 25/07/2024 23/10/2024 No 30/03/2022 28/02/2017
Next DLP was amended on
PSUSA/00010111/202407 Terhi Lehtinen Finland CAP
PRAC Representative updated on
20/12/2016
PSUR Frequency amended and
26/09/2018
DLP updated on 22/09/2016
10112 lomitapide 31/07/2013 1 year 31/07/2024 09/10/2024 31/07/2025 09/10/2025 No 27/03/2024 Next DLPamended
DLP was was updated on
on 27/03/2024 PSUSA/00010112/202407 PSUSA/00010112/202507 Bianca Mulder Netherlands CAP
DLP was updated on 27/03/2018
28/06/2016
DLP and Nex DLP were updated
on 04/03/2016
DLP
PRACwas updated name
Rapporteur on 28/03/2017
updated
10113 loxapine (pre-dispensed inhalation powder) 20/02/2013 3 years 20/08/2024 18/11/2024 No 28/04/2022 on 03/06/2016 PSUSA/00010113/202408 Liana Martirosyan Netherlands CAP
DLP was
Next DLPamended on 03/05/2023
updated
was amended on
on
30/09/2015
07/04/2016
Next DLP was updated on
DLP was updated on 03/06/2020
10114 lurasidone 28/10/2010 3 years 27/10/2026 25/01/2027 No 03/07/2024 21/12/2015.
DLP was amended on 03/07/2024 PSUSA/00010114/202610 Karin Bolin Sweden CAP
Next
PSUR DLP was amended
Frequency onDLP
and Next
Reference
06/03/2015
was to NAP
amended added on
on 30/09/2015.
Next DLP amended on
18/12/2019
13/07/2015
10115 macitentan 20/12/2013 3 years 17/10/2026 15/01/2027 No 03/07/2024 Next DLPamended
DLP was was amended on
on 03/07/2024 PSUSA/00010115/202610 Maria del Pilar Rayon Spain CAP
PRAC Rapporteur name was
01/04/2015
amended on 23/10/2018
DLP was updated on 20/10/2021
midazolam (oromucosal solution, treatment of Next DLP was amended on
10118 05/09/2011 3 years 09/09/2025 08/12/2025 No 03/05/2023 PRAC Representative updated on
06/10/2014 PSUSA/00010118/202509 Liana Martirosyan Netherlands CAP NAP
prolonged, acute, convulsive seizures) PSUR Frequency and DLP
26/09/2018
updated on 26/09/2018
The DLP was amended on
smallpox and monkeypox vaccine (Live Modified PSUR Frequency amended and
01/04/2014
10119 31/07/2013 6 months 31/07/2024 09/10/2024 31/01/2025 11/04/2025 No 25/09/2024 DLP was
DLP
amended
updated
updated
on17/10/2017
on 25/09/2024
on 26/04/2017
PSUSA/00010119/202407 PSUSA/00010119/202501 Gabriele Maurer Germany CAP
Vaccinia Virus Ankara)
Next
Next DLP
DLP was
was updated
amendedon on
Information
22/09/2016 included in column
10120 nalmefene 25/02/2013 3 years 24/02/2027 25/05/2027 No 20/10/2021 07/04/2016
"Are PSURs required for products
PSUSA/00010120/202702 Martin Huber Germany CAP
PSUR frequency
referred and DLP onwere
Name
updatedof to
Next DLP in Articles
was
entry
on
updated 10(1),
was amended
21/09/2022
10a,
on
14, 16a of Directive 2001/83/EC
30/09/2015
06/10/2014
10122 ocriplasmin 17/10/2012 3 years 16/10/2025 14/01/2026 No 28/06/2023 as
DLPamended?"
was amended wasonamended on
28/06/2023 PSUSA/00010122/202510 Karin Bolin Sweden CAP
DLP
Nextwas
DLPupdated
20/11/2024 on 25/09/2019
was amended on
06/10/2014
New CAP
PSUR authorised
frequency and onDLP were
10123 paclitaxel albumin 11/01/2008 5 years 06/01/2027 06/04/2027 No 21/09/2022 06/05/2019
updated
Next DLPon was20/10/2021
amended on PSUSA/00010123/202701 Bianca Mulder Netherlands CAP
01/04/2014
PRACcorrected
DLP Representative
Correction updated on
on 20/11/2024
to PSUR frequency,
26/09/2018
DLP and submission date on
10124 papaverine / phentolamine Not available* 8 years 03/11/2026 01/02/2027 No 20/11/2024 PSUSA/00010124/202611 Liana Martirosyan Netherlands NAP
PSUR frequency and DLP
05/02/2020
PSUR Frequency
amended amended and
on 23/10/2024
DLP was
DLP updated on 22/09/2016
updated on 25/09/2019 Marie Louise Schougaard
10125 pertuzumab 08/06/2012 3 years 07/06/2027 05/09/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010125/202706
Christiansen Denmark CAP
Lead MS and PRAC Rapporteur
name updated on 30/04/2019
phenol-methanal-urea polycondensate / sulphonated /
10126 Not available* 20 years 22/12/2034 22/03/2035 No 31/01/2014 PSUSA/00010126/203412 NAP
sodium salt DLP was updated on 26/09/2018

Next DLP was amended on


10127 pomalidomide 08/02/2013 5 years 07/02/2029 08/05/2029 Yes 20/11/2024 25/09/2017
PSUR frequency and DLP were PSUSA/00010127/202902 Monica Martinez Redondo Spain CAP
updated on 27/07/2022
Correction of the next DLP and
PSUR
Activefrequency
updatedon
substance 11/04/2017
name was
10128 ponatinib 14/12/2012 3 years 13/12/2026 13/03/2027 No 31/07/2024 DLP
DLP was
was amended on
on28/07/2021
31/07/2024 PSUSA/00010128/202612 Mari Thorn Sweden CAP
corrected and DLP was updated
DLP
on was
was updated
updated and
DLP21/10/2020 PRAC
on 29/07/2020
representative amended on
10130 potassium para-aminobenzoate Not available* 5 years 04/02/2025 05/05/2025 No 21/10/2020 28/03/2017
The
DLP Next DLP wason
was updated amended on
03/07/2019 PSUSA/00010130/202502 Martin Huber Germany NAP
29/10/2015.
Next DLP
PRAC was updatedand
Representative on LMS
22/09/2016
Lead MS on
updated was19/12/2018
added on
10132 radium-223 dichloride 13/11/2013 3 years 14/05/2027 12/08/2027 No 05/02/2025 DLP was amended on 05/02/2025
04/02/2015
PSUSA/00010132/202705 Rugile Pilviniene Lithuania CAP
PSUR frequency and DLP were
Nextwas
DLP DLPupdated
was amended on
on 04/07/2018
updated on 19/10/2022
07/04/2016
10133 regorafenib 26/09/2012 3 years 26/09/2026 25/12/2026 No 05/06/2024 DLP was
PSUR
DLP amended
frequency
was on20/10/2021
05/06/2024
updatedamended
on and PSUSA/00010133/202609 Bianca Mulder Netherlands CAP
Nextupdated
DLP DLP wasonupdated on
31/01/2018
30/09/2015
PRAC representative was
DLP was on
updated updated on 21/07/2017
31/03/2021
10134 sofosbuvir 06/12/2013 3 years 05/12/2024 05/03/2025 No 27/07/2022 Next DLP was amended on PSUSA/00010134/202412 Ana Sofia Diniz Martins Portugal CAP
01/04/2015
PRACwas
Representative amended
DLP updated on 21/10/2020
on 28/03/2017
Next DLP was amended on Martin Huber Germany
10135 teriflunomide 12/09/2013 3 years 12/09/2026 11/12/2026 Yes 05/06/2024 DLP was
PRAC amended onand
representative 05/06/2024
DLP PSUSA/00010135/202609 CAP NAP
06/10/2014
Next DLP was amended on
were
PRAC updated on 25/09/2019
representative was
30/01/2017
updated on 19/10/2022
PRAC Rapporteur name was
10136 trastuzumab emtansine 15/11/2013 2 years 21/02/2026 22/05/2026 No 19/10/2022 Next DLP was amended on PSUSA/00010136/202602 Karin Erneholm Denmark CAP
amended
DLP on 03/04/2019
and PSUR frequency were
28/07/2016
updated on 22/09/2021
DLP was updated on 26/09/2018
PRAC representative updated on
10137 triamcinolone (tablets and injectables) 28/09/1966 8 years 28/09/2028 27/12/2028 No 31/01/2024 Next DLP
DLP
and PRAC Rapporteur
was updated on 23/09/2020 PSUSA/00010137/202809 Carla Torre Portugal NAP
31/01/2024
were amended onon
04/02/2016
DLP was updated 17/10/2017
DLP was updated on 25/09/2019
corrected
Next DLP was on on
updated
10138 turoctocog alfa 15/10/2013 3 years 31/10/2026 29/01/2027 No 03/07/2024 DLP was amended on 03/07/2024
31/07/2015
22/09/2016 PSUSA/00010138/202610 Gabriele Maurer Germany CAP
DLP and PRAC Representative
were updated on 26/09/2018
amended
Next DLP was on on
updated
10139 unsaturated fatty acids (C18:2)(topical use) 28/06/1968 28 years 28/06/2040 26/09/2040 No 29/11/2013 13/07/2015
30/09/2015 PSUSA/00010139/204006 NAP
Next DLP was amended on
25/09/2017
The DLP was amended on
01/04/2014
Next DLP was updated on
10140 vismodegib 30/01/2012 3 years 29/01/2027 29/04/2027 No 22/09/2021 PSUSA/00010140/202701 Mari Thorn Sweden CAP
22/09/2016

PSUR frequency and Next DLP


dimethyl fumarate, diroximel fumarate (multiple
10143 30/01/2014 2 years 26/03/2025 24/06/2025 No 20/12/2023 were updated
DLP was on 04/03/2016
amended on 20/12/2023 PSUSA/00010143/202503 Martin Huber Germany CAP
sclerosis)
Next DLP was updated on
06/10/2015
Next DLP was updated on
10155 felbamate 15/05/1994 3 years 30/09/2025 29/12/2025 Yes 03/06/2020 PSUSA/00010155/202509 Tiphaine Vaillant France NAP
31/05/2023
Next DLP was amended on
06/03/2015

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

Next DLP was amended on


01/04/2014
DLP was updated on 29/06/2022

Submission date corrected on


17/11/2021

PSUR frequency and DLP updated


on 05/06/2019
DLP was updated on 25/05/2022
PRAC representative and Lead
MS amended on 21/11/2018
PSUR frequency was amended on
01/10/2019
DLP was updated on 06/06/2018
PRAC Rapporteur name was
PSUR
PRAC frequency amended
representative and
and LMS
10156 lidocaine / norepinephrine 01/10/1948 8 years 30/09/2021 29/12/2021 No 06/10/2014 updated on 03/07/2019 PSUSA/00010156/202109 Adam Przybylkowski Poland NAP
DLP
wereupdated on03/03/2021
added on 15/11/2017
DLP was updated on 30/04/2019
DLP was updated on 23/05/2017
human plasma protease C1 inhibitor (nationally
10163 23/07/1979 2 years 04/08/2025 02/11/2025 No 30/04/2024 DLP was
Lead MS amended
and PRACon 30/04/2024
Rapporteur PSUSA/00010163/202508 Gabriele Maurer Germany NAP
authorised products) PRAC Representative amended
name updated on 23/10/2018
on 28/03/2017

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)

bismuth subcitrate potassium / metronidazole /


10199 24/11/2011 3 years 24/05/2027 22/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010199/202705 Barbara Kovacic Bytyqi Croatia NAP
tetracycline
Entry name amended on
17/10/2017
10203 calcium gluconate / colecalciferol / nicotinic acid Not available* 13 years 20/01/2027 20/04/2027 No 17/10/2017 PSUSA/00010203/202701 NAP
Correction of DLP was done on
08/08/2014
PSUR frequency and DLP updated
10204 calcium levofolinate, calcium folinate 03/04/1982 15 years 03/04/2029 02/07/2029 No 01/12/2014 on 27/07/2022 PSUSA/00010204/202904 NAP
Entry re-introduced on
29/06/2022
10206 cefuroxime sodium (for intracameral use) 18/08/1987 3 years 15/05/2027 13/08/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010206/202705 Maia Uusküla Estonia NAP
DLP was updated on 29/07/2020

DLP was updated on 21/07/2017


10207 chloroquine phosphate / proguanil hydrochloride Not available* 5 years 18/04/2026 17/07/2026 No 27/07/2022 PSUSA/00010207/202604 Ana Sofia Diniz Martins Portugal NAP
Correction of PRAC Rapporteur
PSUR
name frequency updated on
on 28/02/2017
cholic acid (oxosteroid-reductase or hydroxy-steroid
10208 12/09/2013 1 year 12/09/2024 21/11/2024 12/09/2025 21/11/2025 Yes 16/01/2025 17/11/2021
DLP was amended on 30/04/2024 PSUSA/00010208/202409 PSUSA/00010208/202509 Maria Poulianiti Greece CAP
dehydrogenase deficiency indication)
PRAC Rapporteur name was
DLP was updated
amended on 20/10/2021
on 20/12/2016
10209 cilostazol 20/01/1988 3 years 19/01/2026 19/04/2026 Yes 20/09/2023 DLP
Leadamended
DLP was on 20/09/2023
MS updated
and PRAConRapporteur
23/09/2020 PSUSA/00010209/202601 Adam Przybylkowski Poland NAP
name was added on 03/06/2016
DLP was updated on 25/09/2019
colistimethate sodium (all applications except for dry
10210 08/10/1962 13 years 31/12/2026 31/03/2027 No 06/10/2014 PSUSA/00010210/202612 NAP
inhalation powder) Lead MS and PRAC Rapporteur
name updated on 30/04/2019

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

Next DLP was amended on


PRAC representative updated on
25/09/2017
10217 drospirenone / ethinylestradiol 07/03/2000 3 years 06/09/2025 05/12/2025 No 31/01/2024 PSUSA/00010217/202509 Bianca Mulder Netherlands NAP
31/01/2024
PSUR Frequency and DLP
updated and PRAC
10218 elosulfase alfa 14/02/2014 3 years 13/02/2027 14/05/2027 No 20/10/2021 Representative amended on PSUSA/00010218/202702 Rhea Fitzgerald Ireland CAP
28/03/2017

PSUR Frequency and following


10220 ethanol (cutaneous route of administration) Not available* 16 years 15/06/2030 13/09/2030 No 06/10/2015 PSUSA/00010220/203006 NAP
DLP updated and EURD date
amended on 18/11/2016

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

Correction of active substance


PRAC representative updated on
10230 indapamide / perindopril 30/08/2001 5 years 25/11/2026 23/02/2027 No 31/01/2024 name on 23/09/2020 PSUSA/00010230/202611 Carla Torre Portugal NAP
31/01/2024
DLP
PSURwas amended
frequency on 23/10/2024
amended and
iron in any combination with multivitamins and/or
10233 minerals and/or aminoacids (except for combinations 09/05/1969 13 years 03/11/2032 01/02/2033 No 23/10/2024 DLP updated on 03/04/2019 PSUSA/00010233/203211 Gudrun Thengilsdottir Iceland NAP
Active substance name was
with folic acid)
amended
PRACwas on 23/10/2024
Rapporteur
DLP amendedname amended
on 23/10/2024
iron in combination with folic acid and/or multivitamins on 04/07/2018
10234 10/07/1962 13 years 03/11/2032 01/02/2033 No 16/01/2025 PSUSA/00010234/203211 Georgia Gkegka Greece NAP
and/or minerals and/or aminoacids Active substance name was
DLP was updated
amended on 27/03/2018
on 23/10/2024
PSURwas
DLP frequency
amendedand
onDLP
28/03/2017
10235 iron / oral preparations 01/01/1949 10 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00010235/203211 Zane Neikena Latvia NAP
amended on 23/10/2024
PSUR Frequency amended and
DLP updated on 22/09/2016
10239 magnesium sulfate / sodium sulfate / potassium sulfate 05/08/2010 3 years 05/08/2024 03/11/2024 No 30/03/2022 PSUSA/00010239/202408 Jana Lukačišinová Czech Republic NAP
Next DLP was amended on
07/04/2016
PSUR frequency amended and
10242 modafinil 01/09/1994 3 years 31/08/2026 29/11/2026 No 30/04/2024
Nextupdated
DLP wason
updated on
PSUSA/00010242/202608 Martin Huber Germany NAP
DLP 30/04/2024
30/09/2015

Lead MS was added on


22/12/2014
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Classified as internal/staff contractors by the EuropForadvice on submission for Page 62 / 223
DLPs falling before 05/02/2015
#

please consult the List of


substance under Work sharing
scheme and other substance
contained in Nationally
Authorised Products with DLPs
Information included in column
"Are PSURs required for products
referred to in Articles 10(1), 10a,
14, 16a of Directive 2001/83/EC
as amended?" was amended on
18/12/2024

PSUR frequency amended and


DLP updated on 18/12/2024

DLP and PSUR frequency were


updated
PRAC on 02/02/2022
representative was
updated on 01/03/2023
PSUR frequency amended and
10245 olodaterol 18/09/2013 5 years 03/03/2029 01/06/2029 No 20/11/2024 PSUR frequency and DLP were PSUSA/00010245/202903 Bianca Mulder Netherlands NAP
DLP
DLP updated
was on on 20/11/2024
updated, active
updated
DLP was 20/11/2019
updated on 21/12/2022
DLP was updated
substance on 02/03/2022
name amended and
entrywas
DLP split on 02/03/2022
updated on DLP
21/11/2018
10250 propranolol (centrally authorised product) 23/04/2014 5 years 23/04/2029 22/07/2029 Yes 18/12/2024 PSUR
PRAC frequency and
representative was were
added PSUSA/00010250/202904 Monica Martinez Redondo Spain CAP
updated on 18/12/2019
on 22/12/2021
Next DLPupdated
DLP was was updated on
on 19/12/2017
06/03/2019
DLP
LMS was
was updated
added onon 20/11/2019
18/11/2020
10251 propranolol (except for centrally authorised product) 30/06/1965 3 years 30/06/2024 28/09/2024 No 02/03/2022 Next DLP was amended on PSUSA/00010251/202406 Guðrún Stefánsdóttir Iceland NAP
Procedure
DLP was scope amended
updated on on
20/12/2016
DLP
PSUR was on 21/09/2022
updated frequency
submission 21/11/2018
and
26/09/2018
DLP amended on 19/12/2018
representative was
anti-t lymphocyte immunoglobulin for human use, PRAC Representative amended
DLP was updated on 06/06/2018
10252 16/04/1984 3 years 30/06/2024 28/09/2024 No 02/03/2022 Active
updated
on substance name was
on 27/07/2022
28/06/2016 PSUSA/00010252/202406 Maia Uusküla Estonia NAP
rabbit
Name fo entry
amended was amended on
on 07/04/2016
PSUR Frequency amended and
02/07/2014
PRAC
PSUR
DLP representative
Frequency
DLP was updated
updated was and
amended
on 21/09/2022
on 19/12/2017
PSUR frequency
updated and DLP were
on 25/09/2019
10254 siltuximab 23/04/2014 3 years 22/04/2025 21/07/2025 No 21/12/2022 DLP updated
updated
on 03/06/2016
on 04/03/2016
PSUSA/00010254/202504 Gabriele Maurer Germany CAP
PRAC
DLP representative
was was
updated on 23/05/2017
PSUR frequency
Next DLP
updated was
on and DLP
updated
27/07/2022 onwere
'PSUR
updatedFrequency and Next DLP
Next DLPon
27/11/2015. 31/07/2019
was amended on
10256 sodium feredetate Not available* 8 years 01/12/2026 01/03/2027 No 23/10/2024 amended
DLP amended
PRAC on 31/07/2015
on 23/10/2024
representative was PSUSA/00010256/202612 NAP
20/12/2016
DLP
Nextwas
updated updated
DLPonwas on 26/09/2018
amended
25/09/2019 on
'Lead MS was added on
16/06/2015
Next DLP was amended on
22/12/2014
PRAC
PSUR Rapporteur
frequency name
and was
10262 trametinib 29/05/2014 1 year 29/05/2025 07/08/2025 29/05/2026 07/08/2026 No 05/02/2025 03/06/2016
DLP was amended onDLP were
05/02/2025 PSUSA/00010262/202505 PSUSA/00010262/202605 David Olsen Norway CAP
04/07/2018
updated on 31/07/2019
PRAC representative was
Information
Next DLPonwasincluded
updatedin on
column
updated 01/03/2023 23/05/2017
DLP
"Are was
PSURsupdated
27/11/2015. on for
required 31/07/2018
products
10263 umeclidinium 16/04/2014 3 years 17/12/2024 17/03/2025 No 21/09/2022 referred to in Articles 10(1), 10a, PSUSA/00010263/202412 Amelia Cupelli Italy CAP
Correction
Active of active
substance substance
name was
PRAC
14, Rapporteur
Next16a
DLP name
of Directive amended
2001/83/EC
name
amendedandwas
DLP
on
amended on on
was updated
26/04/2017
on
as 04/07/2018
amended?"
16/06/2015 was amended on
23/09/2020
10264 umeclidinium bromide / vilanterol 18/12/2013 3 years 17/12/2024 17/03/2025 No 21/09/2022 18/12/2024 PSUSA/00010264/202412 Amelia Cupelli Italy CAP
PSUR
DLP Frequency
was
The DLP updated
wasand amended
on
corrected and
21/07/2017
on were
Entry
DLP name
updated on next DLP
18/11/2016
PSUR frequency amended and
27/07/2014
amended on 25/09/2017
PSURupdated
DLP Frequency and Next DLP
on 18/12/2024
10266 varicella-zoster immunoglobuline 29/12/1995 5 years 31/12/2024 31/03/2025 No 23/09/2020 Next DLPon
updated was amended on
30/01/2017 PSUSA/00010266/202412 Gabriele Maurer Germany NAP
Lead MS and PRAC Rapporteur
03/06/2016
Reference
PRAC to NAP name
addedwason
name Rapporteur
was added on 28/07/2016
everolimus (indicated for advanced renal cell Next DLP was
30/03/2022
amended amended on
on 22/09/2022
carcinoma, advanced breast cancer, advanced Next DLP was updated on
28/07/2016
10268 03/08/2009 5 years 31/03/2029 29/06/2029 Yes 18/12/2024 Transferred
27/11/2015. from the List of PSUSA/00010268/202903 Martin Huber Germany CAP NAP
neuroendocrine tumors (gastrointestinal, lung, PSUR
DLP frequency
was updated and
on DLP were
30/03/2022
substances under PSUR Work
pancreatic cancers) (NET) Next DLPon
updated was amended on
22/12/2021
Sharing
Next DLPscheme and other
was amended on
04/02/2016
DLP was corrected on 03/06/2020
everolimus (indicated for rejection of transplanted substances
16/06/2015 contained in
10269 08/07/2003 3 years 31/07/2024 29/10/2024 No 30/03/2022 Active substance name was
Nationally Authorised Products PSUSA/00010269/202407 Mari Thorn Sweden NAP
organs) Nextwas
DLPonwas amended on
updated
DLP 03/02/2021
updated on 03/04/2019
with
EURDDLPwassynchronised
amended on
13/07/2015
PSUR frequency and on
DLP were
06/03/2015
06/10/2014
paracetamol / pseudoephedrine hydrochloride / updated
Next
PSUR DLP on 01/03/2023
was
frequency amended
and DLPon were
10270 Not available* 8 years 03/11/2024 01/02/2025 No 05/01/2025 Next DLP was
07/04/2016 amended on
15/11/2017 PSUSA/00010270/202411 Amelia Cupelli Italy NAP
triprolidine hydrochloride amended on 23/10/2024
04/02/2015
DLP was updated on 03/03/2021
DLP was
Lead MS updated
added onon 18/11/2016
01/04/2015
10271 ezetimibe / rosuvastatin 24/07/2014 3 years 24/07/2026 22/10/2026 No 27/03/2024 PSUR frequency amended
DLP was amended on 27/03/2024 and PSUSA/00010271/202607 Barbara Kovacic Bytyqi Croatia NAP
DLP updated
The Next DLPon 06/02/2019
was amended on
05/02/2025
29/10/2015.
PRAC Frequency
PSUR Rapporteurand namenextupdated
DLP
Next DLP was updated on
10272 insulin degludec / liraglutide 18/09/2014 3 years 30/09/2025 29/12/2025 No 06/05/2020 on 19/12/2018
were updated on 02/03/2022 PSUSA/00010272/202509 Bianca Mulder Netherlands CAP
31/05/2023
amendedon
DLP was updated on03/03/2021
31/01/2018
10273 brinzolamide / brimonidine tartrate 18/07/2014 5 years 30/06/2027 28/09/2027 No 01/03/2023 PSUSA/00010273/202706 Eamon O Murchu Ireland CAP
Nextwas
DLP DLPupdated
updatedon
on04/03/2020
30/01/2017

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

Next DLP was updated on


22/09/2016
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the EuropEURD and Next DLP were Page 63 / 223
corrected on 04/03/2016

Next DLP was updated on


30/09/2015

New CAP authorised on


PSUR frequency and DLP were
updated on 25/05/2022
PRAC representative
DLP was was
updatedamended
on 26/05/2021
PSUR frequency and
updated on 27/07/2022
DLP updated on 28/06/2023
DLP was updated on 06/05/2020
PSUR frequency and DLP were
DLP was updated on 29/06/2022
updated on 28/04/2022
DLP was updated on 05/06/2019
Entry name
DLP was amended
updated on
on 30/06/2021
10304 folinic acid, (di)sodium folinate, levomefolic acid 03/04/1982 15 years 03/04/2029 02/07/2029 No 28/02/2018 PSUR frequency PSUSA/00010304/202904 NAP
updatedand
28/02/2018
DLP was on DLP were
06/06/2018
corrected on 26/05/2021
DLP was updated on 01/07/2020
PSUR Frequency amended and
Phenol / halogenated phenols / sodium salicylate / PSURupdated
frequency and DLP were
10305 07/07/1988 13 years 30/06/2027 28/09/2027 No 22/12/2014 on 15/11/2017
DLP was updated on 03/07/2019 PSUSA/00010305/202706 NAP
chloroxylenol / triclosan updated on 28/04/2021
DLP was
PRAC updated on 23/05/2017
Representative and LMS
DLP
PSURwas updatedand
frequency on DLP
06/05/2020
were
10306 sofosbuvir / ledipasvir 10/10/2014 3 years 09/10/2024 07/01/2025 No 25/05/2022 updated on 19/12/2018 PSUSA/00010306/202410 Ana Sofia Diniz Martins Portugal CAP
PSUR frequency and DLP were
updated on 25/05/2022
updated on 29/06/2022
PRAC representative was
DLP was updated on 04/07/2018
updated onof25/09/2019
Correction PRAC Rapporteur
PRAC representative was
10307 aclidinium bromide / formoterol fumarate dihydrate 19/11/2014 3 years 19/11/2025 17/02/2026 No 28/06/2023 name Frequency
PSUR on 28/02/2017
updated
amended and PSUSA/00010307/202511 Adam Przybylkowski Poland CAP
DLP was on 22/12/2021
updated on 30/04/2019
DLP updated on 19/12/2017
PRAC Rapporteur name was
DLP
PRACwas updated name
Rapporteur on 30/06/2021
amended
amended
Next on 20/12/2016
DLP was amended on
10311 dulaglutide 18/09/2014 3 years 18/09/2024 17/12/2024 No 27/07/2022 on 04/07/2018
27/06/2017
PSUSA/00010311/202409 Amelia Cupelli Italy CAP
PRAC representative was
Next DLP was updated on
updated
DLP was on 03/03/2021
updated on 07/05/2018
18/11/2016
Next DLP was amended on
10312 omega-3-acid ethyl esters 12/07/2000 1 year 22/01/2025 02/04/2025 22/01/2026 02/04/2026 No 25/09/2024 20/12/2016
DLP was
DLP
PSURwas amended on01/07/2020
25/09/2024
updatedamended
Frequency on PSUSA/00010312/202501 PSUSA/00010312/202601 Amelia Cupelli Italy NAP
Next DLP was amended on and
DLP updated on 17/10/2017
03/06/2016
Next DLP was amended on
DLP was updated on 03/07/2019
28/06/2016
10313 tilmanocept 19/11/2014 3 years 19/05/2026 17/08/2026 No 31/01/2024 Next DLP
DLP was
Next was
was amended
DLPamended on
on 31/01/2024
updated on PSUSA/00010313/202605 Rugile Pilviniene Lithuania CAP
PSUR frequency amended and
26/04/2017
27/11/2015.
Next DLP was updated on
DLP updated on 19/12/2018
21/12/2015.
Next DLP
PSUR was amended
frequency amended onand
10314 afamelanotide 22/12/2014 2 years 22/06/2025 20/09/2025 No 31/01/2024 DLP was updated
19/10/2016 on 04/07/2018 PSUSA/00010314/202506 Martin Huber Germany CAP
DLP
New updated on 31/01/2024
CAP authorised on
19/11/2014
DLP
Nextwas
DLPupdated on 19/12/2017
was amended on
10315 darunavir / cobicistat 19/11/2014 3 years 18/05/2026 16/08/2026 No 31/01/2024 03/05/2016
DLP was amended on 31/01/2024 PSUSA/00010315/202605 Amelia Cupelli Italy CAP
PRAC Rapporteur name was
amended on 25/09/2017
The Next DLP was amended on
29/10/2015.
10316 ketoconazole (centrally authorised product only) 19/11/2014 3 years 19/11/2024 17/02/2025 Yes 29/06/2022 Next DLP was amended on PSUSA/00010316/202411 Petar Mas Croatia CAP
27/06/2017
New CAP authorised on
Reference
21/11/2014to NAP added on
Next DLP was amended on
23/10/2024
10317 naloxegol 16/09/2014 1 year 15/09/2024 24/11/2024 15/09/2025 24/11/2025 No 23/10/2024
20/12/2016
PSUSA/00010317/202409 PSUSA/00010317/202509 Eamon O Murchu Ireland CAP NAP
DLP was amended on 30/04/2024
PRAC Representative amended
10318 nintedanib (oncology indications) 15/10/2014 3 years 15/10/2025 13/01/2026 No 28/06/2023 on
DLP18/11/2016
was amended on 28/06/2023 PSUSA/00010318/202510 Georgia Gkegka Greece CAP
DLP was updated on 21/12/2022
Next DLP was updated on
28/06/2016
PSURwas
frequency and
10319 nintedanib (respiratory indication) 15/10/2014 6 months 15/10/2024 24/12/2024 15/04/2025 24/06/2025 No 20/11/2024 DLP amended onDLP were
20/11/2024 PSUSA/00010319/202410 PSUSA/00010319/202504 Barbara Kovacic Bytyqi Croatia CAP
updated on 20/11/2019
PRAC representative was
PRAC representative was
corrected
DLP was onon 04/03/2016
updated on 21/11/2018
updated 01/03/2023
10320 nonacog gamma 19/12/2014 3 years 30/06/2026 28/09/2026 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010320/202606 Gabriele Maurer Germany CAP
Next DLPamended
was updated on
on21/12/2022
15/11/2017
DLP was updated on
21/12/2015.
Next DLP
PSUR was updated
frequency and DLPonwere
10321 oestrogens conjugated / bazedoxifene 16/12/2014 3 years 02/04/2025 01/07/2025 No 21/12/2022 Are PSURs required for products PSUSA/00010321/202504 Martin Huber Germany CAP
18/11/2016
updated on 20/11/2019
referred to in Articles 10(1), 10a,
14,
PSUR16a of Directive
Frequency 2001/83/EC
DLP was updatedamended and
on 21/11/2018
as amended?
DLP updated Yes/No"
on was
03/05/2016 Amelia Cupelli Italy
10322 olaparib 16/12/2014 1 year 15/12/2024 23/02/2025 15/12/2025 23/02/2026 No 31/07/2024 was amended on 31/07/2024 PSUSA/00010322/202412 PSUSA/00010322/202512 CAP
amended on 30/09/2015
DLP was updated on 19/12/2017
Next DLP was updated on
New CAP authorised on
27/11/2015.
PSUR Frequency amended and
10323 ramucirumab 21/04/2014 3 years 21/04/2025 20/07/2025 No 21/12/2022 19/11/2014 PSUSA/00010323/202504 Gabriele Maurer Germany CAP
DLP updated on 23/05/2017
New CAP authorised on
16/12/2014
Next DLP was
Information amended
included on
in column
10324 tafluprost / timolol 02/12/2014 3 years 02/12/2026 02/03/2027 No 31/07/2024 20/12/2016
DLP was
"Are PSURsamended
requiredonfor
31/07/2024
products PSUSA/00010324/202612 Martin Huber Germany NAP
referred to in Articles 10(1), 10a,
Next16a
14, DLPofwas amended
Directive on
2001/83/EC
03/06/2016
as amended?" was amended on
10325 yttrium (90Y) citrate 28/10/1985 10 years 27/10/2035 25/01/2036 Yes 23/10/2024 PSUSA/00010325/203510 Amelia Cupelli Italy NAP
23/10/2024
Next DLP was updated on
27/11/2015.
DLP was amended on 23/10/2024
10326 fosfomycin (oral formulation) 27/08/1986 5 years 31/07/2027 29/10/2027 No 19/09/2024 PSUSA/00010326/202707 Zoubida Amimour France NAP
New was
DLP CAP amended
authorised
onon
03/07/2024
19/12/2014.
Next DLP was updated on
10330 salbutamol 31/01/1969 3 years 31/01/2026 01/05/2026 No 18/10/2023 PSUSA/00010330/202601 Melinda Palfi Hungary NAP
18/10/2023

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

DLP was updated on 16/11/2022

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

DLP was updated on 28/03/2017

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

EURD and Next DLP was


amended on 30/09/2015

New CAP authorised on


ex vivo expanded autologous human corneal epithelial PSUR frequency amended and
10352 17/02/2015 1 year 17/02/2025 28/04/2025 17/02/2026 28/04/2026 No 27/03/2024 PSUSA/00010352/202502 PSUSA/00010352/202602 Eamon O Murchu Ireland CAP
cells containing stem cells DLP updated on 27/03/2024

misoprostol (gynaecological indication - labour Marie Louise Schougaard


10353 Not available* 2 years 31/05/2025 29/08/2025 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010353/202505
Christiansen Denmark NAP
induction)

misoprostol (gynaecological indication - termination of Marie Louise Schougaard


10354 Not available* 3 years 31/05/2026 29/08/2026 Yes 31/01/2024 DLP was amended on 31/01/2024 PSUSA/00010354/202605
Christiansen Denmark NAP
pregnancy)

DLP was updated on 16/11/2022


10355 phloroglucinol, phloroglucinol / trimethylphloroglucinol 18/02/1992 3 years 30/09/2024 29/12/2024 No 19/09/2024 PSUSA/00010355/202409 Zoubida Amimour France NAP
PRAC representative was
updated on 17/11/2021
PSUR frequency amended and
10356 safinamide 24/02/2015 5 years 24/02/2028 24/05/2028 No 18/10/2023 PSUSA/00010356/202802 Eamon O Murchu Ireland CAP
DLP updated
PRAC on 18/10/2023
representative was
updated on 30/06/2021
amlodipine / indapamide, amlodipine / indapamide / PRAC representative updated on
10358 23/09/2013 5 years 25/11/2027 23/02/2028 No 31/01/2024 PSUR frequency and DLP were PSUSA/00010358/202711 Bianca Mulder Netherlands NAP
perindopril 31/01/2024
updated on 20/11/2019
Entry re-activated on 19/10/2022
benzoyl peroxide hydrous / potassium DLP was updated on 23/10/2019
10359 03/02/1987 13 years 30/03/2033 28/06/2033 No 19/10/2022 Information included in column PSUSA/00010359/203303 Eamon O'Murchu Ireland NAP
hydroxyquinoline sulphate LMS and PRAC representative
"Are PSURs
werewas
added required for products
on 06/05/2020
DLP updated on 23/10/2018
referred to in Articles 10(1), 10a,
10360 cangrelor 23/03/2015 3 years 23/03/2025 21/06/2025 No 16/11/2022 14, 16a of Directive 2001/83/EC PSUSA/00010360/202503 Amelia Cupelli Italy CAP
PRACCAP
New Rapporteur
authorisedname
on was on
as amended?" was amended
updated on 04/07/2018
01/08/2024
26/07/2023
DLP
DLP was
was amended on
on 15/11/2017
amendedname, 28/06/2023
10361 chlorphenoxamine Not available* 9 years 17/05/2027 15/08/2027 Yes 26/07/2023 Active substance PSUR PSUSA/00010361/202705 Eva Jirsová Czech Republic NAP
frequency and DLP were
PSUR
PSUR Frequency
frequency amended
and and
DLP were
amended
New on 26/07/2023
CAP authorised on
DLP updated
updated on 26/04/2017
on 20/11/2019
19/09/2024
10362 ciclosporin (topical use) 19/03/2015 1 year 19/03/2025 28/05/2025 19/03/2026 28/05/2026 No 15/11/2023
DLP was updated on 06/02/2019
PSUSA/00010362/202503 PSUSA/00010362/202603 Jan Neuhauser Austria CAP
Nextwas
DLP DLPupdated
was amended
on on
21/11/2018
PSUR frequency
DLP was amended amended and
on 15/11/2023
19/10/2016
DLP
PRACupdated on 31/05/2023
representative added on
DLP was amended on 15/11/2017
10364 germanium (68Ge) chloride / gallium (68Ga) chloride 15/09/2014 3 years 15/03/2025 13/06/2025 No 25/09/2024 17/10/2017
Next DLP was amended on PSUSA/00010364/202503 Eva Jirsová Czech Republic CAP NAP
PSUR frequency and DLP were
03/05/2016
PSUR Frequency amended and
updated on 28/04/2021
DLP updated on 23/05/2017
10366 naltrexone / bupropion 26/03/2015 1 year 09/09/2024 18/11/2024 09/09/2025 18/11/2025 No 30/04/2024 New CAP authorised
DLP was onin Martin Huber Germany
DLP was amended
updated on 30/04/2024
06/05/2020 PSUSA/00010366/202409 PSUSA/00010366/202509 CAP
23/03/2015
Next DLP was updated on
18/11/2016
DLP updated on 30/04/2019
PSUR frequency amended and
10368 oritavancin 19/03/2015 1 year 19/03/2025 28/05/2025 19/03/2026 28/05/2026 No 15/11/2023 Nextupdated
DLP authorised
wason
amended PSUSA/00010368/202503 PSUSA/00010368/202603 Adam Przybylkowski Poland CAP
DLP
New CAP on on
15/11/2023
03/05/2016
18/02/2019

10369 tedizolid phosphate 20/06/2014 3 years 20/06/2026 18/09/2026 No 28/02/2024 Lead MS


DLP was
PSUR added on
amended
frequency 29/10/2015.
on 28/02/2024
amended and PSUSA/00010369/202606 Maria del Pilar Rayon Spain CAP
DLP updated on 23/10/2018

tobramycin (nebuliser solution) (centrally authorised PRAC Rapporteur name was


10370 18/03/2015 3 years 18/09/2025 17/12/2025 No 31/05/2023 PSUSA/00010370/202509 Mari Thorn Sweden CAP
product only) amended on 31/07/2018

DLP was updated on 07/05/2018


10372 ceritinib 29/04/2014 3 years 28/10/2025 26/01/2026 No 28/06/2023 DLP was amended on 28/06/2023 PSUSA/00010372/202510 Mari Thorn Sweden CAP
DLP was updated on 17/10/2017

Next DLP was amended on


10373 raltegravir 26/03/2015 2 years 26/09/2025 25/12/2025 No 19/09/2024 26/04/2017 PSUSA/00010373/202509 Zoubida Amimour France CAP

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

lidocaine hydrochloride / phenylephrine hydrochloride / DLP was


PRAC
DLP was amendedname
Rapporteur
updated on26/05/2021
on 31/01/2018
was
10390 02/07/2015 3 years 21/07/2024 19/10/2024 No 16/10/2023 PSUSA/00010390/202407 Karin Erneholm Denmark NAP
tropicamide amended on 18/10/2023
DLP
DLP was
was updated on 21/07/2017
New CAP updated on on
authorised 06/05/2020
22/11/2024
10391 lutetium (177Lu) chloride 19/06/2015 3 years 19/12/2026 19/03/2027 Yes 25/09/2024 Next
PRACDLP was updated
representative on
was PSUSA/00010391/202612 Rhea Fitzgerald Ireland CAP NAP
30/01/2017
updated
DLP was on 25/09/2019
amended on 25/09/2024
Nextwas
DLP DLPupdated
was amended on
on 05/06/2019
10392 macrogol 4000, macrogol 4000 combinations (oral use) 05/05/1995 5 years 31/05/2027 29/08/2027 No 19/09/2024 28/07/2016 PSUSA/00010392/202705 Zoubida Amimour France NAP
PSUR frequency amended and
EURD
DLP and Next
updated on DLP was updated
21/11/2018
10393 netupitant / palonosetron 10/10/2014 3 years 10/10/2024 08/01/2025 No 27/07/2022 on 21/12/2015. PSUSA/00010393/202410 Amelia Cupelli Italy CAP
PSUR frequency
PRAC Rapporteurand DLPamended
name were
New CAPon
updated
on authorised on
01/02/2023
04/07/2018
10/06/2015
PSUR frequency amended and
10394 tasimelteon 03/07/2015 3 years 03/07/2027 01/10/2027 No 05/02/2025 PRACupdated
PSUR Rapporteur
frequency name was
updated and DLP
PSUSA/00010394/202707 Adam Przybylkowski Poland CAP
DLP on 05/02/2025
amended on
amended on 17/10/2017
22/09/2022

tolvaptan (indicated for adults with autosomal PSUR frequency and


10395 27/05/2015 3 years 18/05/2027 16/08/2027 No 05/02/2025 PSUR Frequency
DLP was amended onDLP
amended were
and
05/02/2025 PSUSA/00010395/202705 Amelia Cupelli Italy CAP
dominant polycystic kidney disease (ADPKD)) updated
DLP on 03/02/2021
updated on 23/05/2017

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
#

MS and PRAC Rapporteur


name was added on 19/10/2016

DLP corrected on 04/03/2016


New active substance added on
10398 chlorhexidine / phenol Not available* 13 years 16/03/2028 14/06/2028 No 06/10/2015 PSUSA/00010398/202803 NAP
06/10/2015

betamethasone dipropionate / clotrimazole / PSUR frequency and DLP


10399 02/12/1986 9 years 01/12/2028 01/03/2029 No 31/07/2024 PSUSA/00010399/202812 Petar Mas Croatia NAP
gentamicin amended on 31/07/2024
Correction of DLP on 20/11/2024
10400 tinidazole, nystatin / tinidazole 15/06/1972 10 years 01/12/2034 01/03/2035 No 05/01/2025 PSUSA/00010400/203412 Adam Przybylkowski Poland NAP
PSUR frequency and DLP
amended on 23/10/2024

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

LMS and PRAC representative


10402 phenylephrine (ophthalmic formulations) 01/01/1940 5 years 01/01/2025 01/04/2025 No 23/09/2020 were added on 31/07/2019 PSUSA/00010402/202501 Eva Jirsová Czech Republic NAP

Procedure number was corrected


on 18/11/2016
10403 pembrolizumab 04/09/2014 1 year 03/09/2024 12/11/2024 03/09/2025 12/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010403/202409 PSUSA/00010403/202509 Bianca Mulder Netherlands CAP

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

Lead MS and PRAC Rapporteur


10405 evolocumab 17/07/2015 3 years 17/07/2026 15/10/2026 No 27/03/2024 DLP was
name amended
added on 27/03/2024
on 03/04/2019 PSUSA/00010405/202607 Kimmo Jaakkola Finland CAP

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

PRAC Representative updated on


PSUR frequency amended and
10409 panobinostat 23/02/2015 3 years 22/08/2026 20/11/2026 No 16/01/2025 26/09/2018 PSUSA/00010409/202608 Georgia Gkegka Greece CAP
DLP updated on 27/03/2024
DLP was updated on 27/03/2018
human alfa1-proteinase inhibitor (centrally authorised
10410 20/08/2015 5 years 20/08/2027 18/11/2027 No 03/05/2023 PSUSA/00010410/202708 Monica Martinez Redondo Spain CAP
product) PSUR Frequency amended and
DLP updated on 17/10/2017

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

Next DLP was updated on


22/09/2016
10412 idebenone (centrally authorised products) 08/09/2015 1 year 08/09/2024 17/11/2024 08/09/2025 17/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010412/202409 PSUSA/00010412/202509 Amelia Cupelli Italy CAP
PRAC Representative amended
PSUR frequency and DLP were
on 28/06/2016
10413 guanfacine 17/09/2015 3 years 17/03/2027 15/06/2027 No 20/11/2024 updated
DLP was on 03/06/2020
amended on 20/11/2024 PSUSA/00010413/202703 Maria del Pilar Rayon Spain CAP
Entry name amended on
LMS and PRAC representatives
03/05/2016
were added on 31/07/2019
10414 1-propanol / 2-propanol / lactic acid 07/09/1981 10 years 07/09/2029 06/12/2029 No 03/06/2020 New was
CAP updated
was authorised on PSUSA/00010414/202909 Adam Przybylkowski Poland NAP
DLP on 27/03/2018
Procedure
20/08/2015number was corrected
DLP and PSUR frequency
on 18/11/2016
PSUR frequency and DLP were
were
Lead MS and22/09/2021
updated PRAC Rapporteur
10415 demeclocycline / triamcinolone Not available* 13 years 13/07/2030 11/10/2030 No 27/11/2015 updated on
on 23/10/2019 PSUSA/00010415/203007 Eva Jirsová Czech Republic NAP
name was added on 20/12/2016
New substance added on
DLP was
MS updated
27/11/2015
Lead and PRAConRapporteur
23/09/2020
New active substance added on
name added on 31/07/2018
27/11/2015
DLP was updated on 25/09/2019
10416 ethanol / orthophenylphenol 05/02/1997 10 years 05/02/2029 06/05/2029 No 23/10/2019 PRAC Representative amended PSUSA/00010416/202902 Jana Lukačišinová Czech Republic NAP
on 21/12/2022
Active substance name was
Next DLP, on
amended PSUR frequency, Lead
20/12/2016
MS and
PSUR PRAC Rapporteur name
PRAC Rapporteur updatedwere
frequency and DLP on
10417 octenidine dihydrochloride / 1-propanol / 2-propanol 30/01/1987 10 years 30/01/2034 30/04/2034 No 15/11/2023 were amended
updated
New on 06/03/2019
on substance
active 28/04/2022 added on
PSUSA/00010417/203401 Barbara Kovacic Bytyqi Croatia NAP
15/11/2023
PRAC representative was
27/11/2015
was active
DLP and
updated updated
on on 26/09/2018
substance
01/03/2023 name
10419 phenylephrine / ketorolac 28/07/2015 3 years 28/01/2027 28/04/2027 No 22/09/2021 were updated on 28/04/2021 PSUSA/00010419/202701 Jan Neuhauser Austria CAP
DLP and
DLP was PSUR
updated on 28/02/2018
frequency were
DLP was on
updated updated to 01/04/2020
02/03/2022
Next DLP was amended on
PSUR frequency amended and
10421 asfotase alfa 03/07/2015 3 years 03/07/2026 01/10/2026 No 28/02/2024 25/09/2017
DLP was updated 03/04/2019
on 03/03/2021 PSUSA/00010421/202607 Eamon O Murchu Ireland CAP
DLP updated on 28/02/2024
Active substance name was
Next DLP
PSUR was
Frequency
frequency
amended amended
and DLPonand
amended
on 05/06/2024
28/02/2017
updated
DLP on 26/09/2018
updated on 06/03/2019
10422 sebelipase alfa 28/08/2015 3 years 28/08/2024 26/11/2024 No 28/04/2022 PSUSA/00010422/202408 Mari Thorn Sweden CAP
Information included in column
Next
DLP
"Are DLP
PRACwas was
Rapporteur
updated
PSURs updated
requiredname
on DLP on
was
07/05/2018
for products
PSUR frequency and were
22/09/2016
amendedto
referred onin31/07/2018
Articles 10(1), 10a,
updated on 28/04/2022
10423 alirocumab 24/07/2015 3 years 24/07/2024 22/10/2024 No 02/03/2022 European
14, 16a of Union reference
Directive date
2001/83/EC PSUSA/00010423/202407 Gabriele Maurer Germany CAP
glucose (apart from glucose1- phosphate), glucose in New
DLP
and CAP
was
Next was
updated
DLP
as amended?", authorised
were on
PSUR on on
27/03/2018
amended
frequency
DLP was updated on 28/04/2021
combination with calcium chloride and/or sodium 28/07/2015
19/12/2017
and DLP were amended on
chloride and/or magnesium chloride and/or sodium DLP
DLP was
was updated
updated on
26/07/2023 on 17/10/2017
06/05/2020
10424 22/03/1971 10 years 02/09/2034 01/12/2034 Yes 05/06/2024 DLP was updated
amendedon on01/02/2023
15/11/2017
PSUSA/00010424/203409 none NAP
citrate and/or potassium chloride and/or sodium
acetate (intravenous or parenteral use except DLP was
Active
PSUR updatedand
substance
frequency on DLP
28/03/2017
name, PSUR
were
haemodialysis, hemodiafiltration) PRAC Representative
Next DLP
frequency
updated onwas
and amended
DLP were
23/10/2019 name
on was
10425 inosine pranobex 01/08/1978 5 years 01/08/2028 30/10/2028 No 27/03/2024 Next DLPamended
corrected
26/04/2017
amended
DLP was was amended
29/07/2020
on 03/05/2023 on
on 27/03/2024 PSUSA/00010425/202808 Irina Sandu Romania NAP
19/10/2016
DLP was updated on 30/04/2019
Correction
Next DLP
Active of the
was
substance PSUR
name frequency
amended on
was
New DLP
and CAPon
19/10/2016
amended
DLP was authorised on on
on04/03/2020
23/10/2018
updated 23/10/2018
10426 isavuconazole 06/09/2015 3 years 06/09/2024 05/12/2024 No 28/04/2022 28/08/2015 PSUSA/00010426/202409 Adam Przybylkowski Poland CAP
DLP was
New was
DLP updated
CAP updated
was
active on 07/05/2018
05/02/2020
authorised
substance
on on on
added
23/09/2015.
21/12/2015
10427 linagliptin, linagliptin / metformin 24/08/2011 3 years 02/05/2027 31/07/2027 No 05/02/2025 Active
DLP substance
was updated name
amended on was
on17/10/2017
05/02/2025 PSUSA/00010427/202705 Bianca Mulder Netherlands CAP NAP
amended on 05/06/2019
New active
Next DLP was substances
amendedadded on to
the
DLP entry on 31/07/2018
was updated
26/04/2017 on 06/02/2019
10428 sterculia, frangula / sterculia 01/12/1955 10 years 28/02/2034 29/05/2034 No 31/07/2018 PSUSA/00010428/203402 Guðrún Stefánsdóttir Iceland NAP
New
Next Active
PRAC Substance
Representative
DLP was amended was
on added
updated on
on 21/12/2015.
26/09/2018
19/10/2016
10429 levofloxacin (Inhalation use) 26/03/2015 3 years 26/05/2025 24/08/2025 No 01/02/2023 PSUSA/00010429/202505 Maria del Pilar Rayon Spain CAP
DLP
New was
CAP amended on 31/01/2018
was authorised on
06/09/2015
PSUR Frequency amended and
PRACwas
DLP Rapporteur name was
10430 phenylephrine / tropicamide Not available* 5 years 08/11/2025 06/02/2026 No 16/10/2023 next DLP updated
updated on
on 30/06/2021
27/06/2017 PSUSA/00010430/202511 Karin Erneholm Denmark NAP
amended
PSUR on 18/10/2023
frequency and DLP were
PRACDLP
Next representative
updated on on and
01/07/2020
updated LMS
30/01/2017
were added on 01/04/2020
10431 amlodipine / atorvastatin / perindopril 31/07/2015 5 years 22/10/2025 20/01/2026 No 30/06/2021 Lead DLP
Next MS and
andPRAC
PRACRapporteur
Rapporteur PSUSA/00010431/202510 Jana Lukačišinová Czech Republic NAP
DLP
name
name was updated
amended
updated onon
on 07/05/2018
19/12/2018
03/06/2016
DLP was updated on 30/03/2022
New
Nameactive
Next
PSUR DLP substance
was
frequency amended
and added
DLP on on
were
10432 timolol (systemic use) 06/12/1990 5 years 13/10/2024 11/01/2025 No 01/07/2020 of the
04/02/2016
entry was amended PSUSA/00010432/202410 Jana Lukačišinová Czech Republic NAP
27/06/2017
Active
updatedsubstance name was
on 29/06/2022
on 04/03/2016
amended on 02/03/2022
PRAC
DLP representative
was
Next DLP updated
DLP was on
was updated was added
30/06/2021
amendedon on
anti-T lymphocyte immunoglobulin for human use, Next
10433 17/11/1981 5 years 16/11/2027 14/02/2028 No 26/07/2023 on 03/05/2016
PRAC representative was
04/02/2016 PSUSA/00010433/202711 Zane Neikena Latvia NAP
horse 26/07/2023
updated
DLP was on 23/09/2020
updated on 03/06/2020
New
New active
CAP was substance
authorisedadded
on on
amlodipine/rosuvastatin, 04/02/2016
Active
DLP substance
was
26/03/2015updated name was
on 05/06/2019
10434 29/07/2015 3 years 29/07/2024 27/10/2024 No 30/03/2022 PSUSA/00010434/202407 Melinda Palfi Hungary NAP
amlodipine/perindopril/rosuvastatin amended on 05/02/2020
PSUR frequency amended and
was updated
DLP updated on 03/04/2019
on 21/11/2018
10435 idarucizumab 16/10/2015 3 years 15/10/2024 13/01/2025 No 29/06/2022 PSUSA/00010435/202410 Bianca Mulder Netherlands CAP
PRACwas
DLP Representative and Lead
updated on 06/06/2018
MS were added on 19/12/2017
DLP was amended on 15/11/2017
10438 sacubitril / valsartan 07/07/2015 1 year 31/07/2024 09/10/2024 31/07/2025 09/10/2025 No 27/03/2024 DLP
New was amended
active on 27/03/2024
substance added on PSUSA/00010438/202407 PSUSA/00010438/202507 Karin Erneholm Denmark CAP
04/02/2016
DLP was updated on 23/05/2017

Next DLP was updated on


18/11/2016
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Classified as internal/staff contractors by the EuropNewCAP authorised on Page 66 / 223
16/10/2015
#
DLP was updated on 30/03/2022

Next DLP was amended on


26/04/2017

EURD and DLP were amended on


10439 timolol (eye preparations) 01/12/1981 5 years 31/07/2026 29/10/2026 No 30/03/2022 07/04/2016 PSUSA/00010439/202607 Martin Huber Germany NAP

Active substance name was


estradiol (except cream/balm/emulsion for application amended
PRAC on 04/02/2016
representative updated on
10440 01/01/1946 5 years 31/08/2026 29/11/2026 No 31/01/2024 PSUSA/00010440/202608 Bianca Mulder Netherlands NAP
in female genital area) 31/01/2024
Lead MS and PRAC Rapporteur
estradiol, estradiol /prednisolone (only name updated on 04/02/2016
10441 cream/balm/emulsion for application in the female Not available* 3 years 24/04/2026 23/07/2026 Yes 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010441/202604 Rugile Pilviniene Lithuania NAP
genital area)

levonorgestrel / ethinylestradiol, ethinylestradiol PSUR frequency amended and


10442 29/01/2015 5 years 13/01/2029 13/04/2029 No 25/09/2024 PSUSA/00010442/202901 Zoubida Amimour France NAP
(combination pack) DLP updated on 25/09/2024

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

PSUR frequency amended and


10448 carfilzomib 20/07/2012 3 years 19/07/2026 17/10/2026 No 28/02/2024 PRAC representative was PSUSA/00010448/202607 Barbara Kovacic Bytyqi Croatia CAP
DLP updated on 28/02/2024
updated on 27/07/2022

cobicistat / elvitegravir / emtricitabine / tenofovir DLP and PSUR frequency were


10449 05/11/2015 1 year 04/11/2024 13/01/2025 04/11/2025 13/01/2026 No 03/07/2024 DLP was amended on 03/07/2024 PSUSA/00010449/202411 PSUSA/00010449/202511 Amelia Cupelli Italy CAP
alafenamide updated on 22/09/2021

DLP was updated on 23/09/2020


10450 cobimetinib 24/08/2015 3 years 23/08/2026 21/11/2026 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010450/202608 Bianca Mulder Netherlands CAP
DLP and PRAC representative
were updated on 25/09/2019
10451 efmoroctocog alfa 06/06/2014 1 year 05/06/2025 14/08/2025 05/06/2026 14/08/2026 No 05/02/2025 DLP was
DLP was amended
updated onon05/04/2023
05/02/2025 PSUSA/00010451/202506 PSUSA/00010451/202606 Sonja Hrabcik Austria CAP
DLP and PRAC Representative
updated
DLP was on 04/07/2018
corrected on 01/04/2020

10454 glycerol phenylbutyrate 01/02/2013 3 years 31/01/2027 01/05/2027 No 27/07/2022 European


PSUR Union reference
frequency date
and DLP were PSUSA/00010454/202701 Amelia Cupelli Italy CAP
and Nexton
updated DLP were updated on
04/03/2020
07/05/2018
10455 lumacaftor / ivacaftor 19/11/2015 1 year 19/05/2025 28/07/2025 19/05/2026 28/07/2026 No 05/02/2025 Nextwas
DLP DLP,amended
Lead MSonand PRAC
05/02/2025 PSUSA/00010455/202505 PSUSA/00010455/202605 Eamon O Murchu Ireland CAP
PSUR frequency
Rapporteur nameamended and
were amended
DLP06/03/2019
on updated on 31/01/2018
Correction of DLP on 05/06/2024
10456 mepolizumab 02/12/2015 1 year 23/09/2024 02/12/2024 23/09/2025 02/12/2025 No 30/04/2024 Next
PSURDLP was amended
frequency amendedonand PSUSA/00010456/202409 PSUSA/00010456/202509 Gabriele Maurer Germany CAP
PSUR frequency amended and
27/06/2017
DLP updated on 31/07/2018
DLP updated on 30/04/2024
Nextwas
DLP DLPupdated
was amended on
on 28/02/2018
10457 pegaspargase (centrally authorised product) 14/01/2016 3 years 14/07/2025 12/10/2025 No 05/04/2023 30/01/2017 PSUSA/00010457/202507 Mari Thorn Sweden CAP
Next DLP was amended on
New CAP authorised on
25/09/2017
PSUR frequency amended and
27/11/2015
10458 susoctocog alfa 11/11/2015 3 years 11/11/2025 09/02/2026 No 28/06/2023 PSUSA/00010458/202511 Gabriele Maurer Germany CAP
DLP updated on 28/06/2023
PRAC Representative amended
on 28/03/2017
PSUR frequency amended and
10459 talimogene laherparepvec 27/10/2015 3 years 26/10/2026 24/01/2027 No 05/06/2024 Nextupdated
DLP wason amended on PSUSA/00010459/202610 Gabriele Maurer Germany CAP
DLP 05/06/2024
28/02/2017
PRAC Rapporteur name was
amended on 26/07/2023
10460 blinatumomab 03/12/2014 3 years 02/12/2025 02/03/2026 No 26/07/2023 Entry name was amended on PSUSA/00010460/202512 Jana Lukacisinova Czech Republic CAP
03/06/2016
Next DLP was updated on
PRAC representative was
26/07/2023
updated
PRAC
New CAP
PARC on
was22/12/2021
Representative updated
authorised
representative was on on
PRAC Rapporteur name was
10461 diclofenac / omeprazole Not available* 5 years 30/09/2026 29/12/2026 No 16/10/2023 16/11/2022
14/01/2016
updated on PSUSA/00010461/202609 Karin Erneholm Denmark NAP
amended on19/10/2022
18/10/2023
DLP was updated on 30/06/2021
PSUR frequency and DLP
PRAC representative was were
PRAC representative
updated 02/03/2022
on 27/07/2022 and LMS
10462 bisoprolol / perindopril 09/11/2015 5 years 22/10/2025 20/01/2026 No 30/06/2021 PSUSA/00010462/202510 Anna Mareková Slovakia NAP
were added on 01/04/2020
Nextwas
DLP DLPupdated
was updated on
on 02/03/2022
European Union reference date
06/03/2019
10463 fosinopril, fosinopril / hydrochlorothiazide 03/07/1990 5 years 02/07/2026 30/09/2026 No 02/03/2022 updated
PRAC on 07/05/2018
representative was PSUSA/00010463/202607 Maria del Pilar Rayon Spain NAP
PRAC Representative
updated on 25/09/2019 updated on
New entry added on 04/03/2016
26/09/2018
Next DLP and Information
10464 thiocolchicoside, paracetamol / thiocolchicoside 04/07/1956 3 years 04/07/2024 02/10/2024 No 19/10/2022
New merged entryname
added on
PSUSA/00010464/202407 Amelia Cupelli Italy NAP
included
Active in column
substance "Are was
PSURs
07/04/2016
required
amended for
onproducts
28/02/2024referred to
allergen for therapy: Dactylis Glomerata L., Phleum in Articles 10(1), 10a, 14, 16a of
10465 Pratense L., Anthoxanthum Odoratum L., Lolium 10/08/2004 3 years 24/12/2025 24/03/2026 No 28/02/2024 Next DLP
Directive
Active was amended
2001/83/EC
substance name on
aswas PSUSA/00010465/202512 Gabriele Maurer Germany NAP
Perenne L., Poa Pratensis L. (sublingual tablet) 07/04/2016
amended?"
amended onwere amended on
20/12/2023
allergen for diagnostic: grass pollen, tree pollen, house 06/03/2019
dust mites, moulds, weed pollen, vertebrates, animal DLP amended
PRAC on 20/09/2023
Rapporteur name was
10466 26/06/1983 10 years 31/10/2026 29/01/2027 No 16/10/2023 Lead MS and PRAC Rapporteur PSUSA/00010466/202610 Karin Erneholm Denmark NAP
epithelia (except for hymenoptera venoms) single or amended on 18/10/2023
mixes, positive and negative controls PRAC Representative
name added on 15/11/2017 updated on
16/11/2022
cinchocaine hydrochloride / prednisolone caproate,
PSUR frequency
New merged amended
active and
substance
10467 cinchocaine hydrochloride / fluocortolone caproate / Not available* 9 years 03/11/2029 01/02/2030 No 28/08/2024 PSUSA/00010467/202911 NAP
addedupdated
DLP was on 28/08/2024
onupdated on 21/09/2022
07/04/2016
fluocortolone pivalate
DLP was updated on 25/09/2019
10468 dexketoprofen / tramadol 07/01/2016 3 years 07/01/2025 07/04/2025 No 21/09/2022 PSUSA/00010468/202501 Monica Martinez Redondo Spain NAP
PRAC Representative and Lead
Member state assigned on
diphtheria / tetanus / pertussis (acellular, component) /
04/07/2018
Next DLP was updated on
10469 hepatitis B (rDNA) / poliomyelitis (inactivated) / 15/02/2016 3 years 15/02/2026 16/05/2026 No 18/10/2023 PSUSA/00010469/202602 Gabriele Maurer Germany CAP
18/10/2023
PSUR frequency amended and
haemophilus type b conjugate vaccine (adsorbed)
New updated
DLP active
was substance
updated added on
on 16/11/2022
on 05/04/2023
07/04/2016
PSUR frequency amended and
10472 osimertinib 13/11/2015 3 years 12/11/2026 10/02/2027 No 31/07/2024 DLP was
PRAC updated on 20/11/2019
representative was PSUSA/00010472/202611 Bianca Mulder Netherlands CAP
DLP updated on 31/07/2024
updated on 26/05/2021
PRAC frequency
PSUR Representative andwere
and DLP Lead
MS were
DLP added
was on
updated updatedonon
26/09/2018
01/04/2020
16/11/2022
10473 varicella vaccine (live) 17/10/1994 3 years 16/03/2025 14/06/2025 No 16/11/2022 PSUSA/00010473/202503 Jean-Michel Dogné Belgium NAP
Next DLP
PRAC was amended
Representative
Rapporteur name on
updated
was on
28/02/2017
26/09/2018
amended on 22/09/2022
10474 meloxicam 08/05/1995 5 years 09/07/2027 07/10/2027 No 05/04/2023 PSUSA/00010474/202707 Tiphaine Vaillant France NAP
New
PRACactive substance
Rapporteur
DLP was updated nameadded on
updated
on 01/04/2020
07/04/2016
on 21/07/2017
allergen for therapy: Phleum Pratense (oromucosal
PRAC Rapporteur name was
10475 use, product authorised via mutually recognition 14/03/2006 5 years 13/03/2027 11/06/2027 No 16/11/2022
DLP was updated on 28/03/2017
PSUSA/00010475/202703 Mari Thorn Sweden NAP
amended on 31/07/2018
procedure)
Leadwas
DLP MS updated
and PRAConRapporteur
28/03/2017
Next
nameDLP
waswas updated on
10476 ferric maltol 18/02/2016 3 years 18/02/2027 19/05/2027 No 18/10/2023 added on 28/07/2016 PSUSA/00010476/202702 Adam Przybylkowski Poland CAP
18/10/2023
Lead MS and PRAC Rapporteur
New active
name substance
was added added on
on 28/07/2016
07/04/2016
New active substance added on
10477 diflucortolone valerate / chlorquinaldol Not available* 13 years 30/09/2027 29/12/2027 No 07/04/2016 New active substance added on PSUSA/00010477/202709 NAP
07/04/2016
07/04/2016

New active substance added on


10478 diflucortolone valerate / salicylic acid Not available* 13 years 04/04/2027 03/07/2027 No 07/04/2016 PSUSA/00010478/202704 NAP
07/04/2016

dexamethasone (centrally authorised product PSUR frequency amended and


10480 16/03/2016 3 years 16/09/2026 15/12/2026 No 05/06/2024 PSUSA/00010480/202609 Tiphaine Vaillant France CAP
indicated in symptomatic multiple myeloma) DLP updated on 05/06/2024

© 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

DLP was updated on 03/02/2021

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

PRAC Representative and LMS


updated
Next DLPon 19/12/2018
was updated on
10486 tauroselcholic [75Se] acid 25/06/1991 5 years 31/01/2028 30/04/2028 No 18/10/2023 PSUSA/00010486/202801 Melinda Palfi Hungary NAP
18/10/2023
DLP was updated on 04/07/2018

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

DLP was updated on 21/07/2017


PSUR frequency amended and
10489 olodaterol / tiotropium 20/05/2015 5 years 19/05/2029 17/08/2029 No 05/02/2025 Lead MS and on
PRAC Rapporteur PSUSA/00010489/202905 Bianca Mulder Netherlands NAP
DLP updated 05/02/2025
name was added on 28/07/2016

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

PSUR frequency amended and


10492 azithromycin (ocular use formulations) Not available* 5 years 30/04/2028 29/07/2028 No 31/01/2024 PSUSA/00010492/202804 Kimmo Jaakkola Finland NAP
DLP updated on 31/01/2024

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

10497 albutrepenonacog alfa 26/01/2016 3 years 26/01/2027 26/04/2027 No 25/09/2024 PSUR


Lead frequency
MS
DLP was amendedand
and PRAC onDLP were
Rapporteur
25/09/2024 PSUSA/00010497/202701 Bianca Mulder Netherlands CAP
updated
name wasonadded
27/07/2022
on 20/12/2016

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

DLP was updated on 03/07/2019


10500 elotuzumab 30/11/2015 3 years 29/11/2024 27/02/2025 No 27/07/2022 PSUSA/00010500/202411 Gabriele Maurer Germany CAP
DLP was updated on 06/02/2019

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

Next DLP was amended on


10503 selexipag 21/12/2015 3 years 20/12/2026 20/03/2027 No 25/09/2024 DLP was amended on 25/09/2024
30/01/2017 PSUSA/00010503/202612 Zoubida Amimour France CAP

New CAP authorised on


ascorbic acid / rutoside, ascorbic acid / rutoside / PSUR frequency amended and
11/05/2016
10504 Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 PSUSA/00010504/202512 Adam Przybylkowski Poland NAP
alfatocopherol DLP updated on 31/07/2024

autologous CD34+ enriched cell fraction that contains


PSUR frequency amended and
10505 CD34+ cells transduced with retroviral vector that 26/05/2016 3 years 25/11/2025 23/02/2026 No 26/07/2023 PSUSA/00010505/202511 Liana Martirosyan Netherlands CAP
DLP updated on 26/07/2023
encodes for the human ADA cDNA sequence

Next DLP was updated on


10506 dutasteride, dutasteride / tamsulosine 20/11/2001 5 years 19/11/2027 17/02/2028 No 26/07/2023 PSUSA/00010506/202711 Melinda Palfi Hungary NAP
26/07/2023
PSUR frequency and DLP were
updated on 28/04/2021
10507 migalastat 26/05/2016 3 years 26/05/2027 24/08/2027 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010507/202705 Mari Thorn Sweden CAP
PRAC representative was
updated on 31/03/2021
10508 metronidazole / neomycin / nystatin 02/05/1997 5 years 02/09/2025 01/12/2025 No 15/01/2025 PSUSA/00010508/202509 Tiphaine Vaillant France NAP
DLP was updated on 06/06/2018

Lead MS and PRAC Rapporteur


PSUR frequency and DLP
10509 pyridoxine / thiamine, arginine / pyridoxine / thiamine Not available* 9 years 03/05/2032 01/08/2032 No 23/10/2024 name was added on 28/02/2017 PSUSA/00010509/203205 Gudrun Thengilsdottir Iceland NAP
amended on 23/10/2024
New entry added on 28/06/2016
PRAC Rapporteur updated on
10510 beta-alanine 23/09/1991 3 years 23/01/2026 23/04/2026 No 15/11/2023 PSUSA/00010510/202601 Barbara Kovacic Bytyqi Croatia NAP
15/11/2023

PRAC representative updated on


10511 budesonide / salmeterol 23/07/2015 3 years 23/07/2024 21/10/2024 No 31/01/2024 PSUSA/00010511/202407 Bianca Mulder Netherlands NAP
31/01/2024

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

Next DLP was amended on


PSUR
Activefrequency
substanceand DLPcorrected
name were
PRAC representative
updated was
on 01/02/2023
on 02/02/2022
updated on 01/03/2023
DLP was
PSUR updatedand
frequency on DLP
02/02/2022
were
PSUR frequency and DLP were
updated on 25/09/2019
amended
DLP on 20/10/2021
was updated on 03/02/2021
Entry name, PSUR frequency
DLP was updated 21/10/2020
10521 technetium (99mTc) edda / hynic-octreotide 03/06/2016 15 years 02/06/2032 31/08/2032 Yes 25/09/2019 amended and DLPon 05/02/2020
updated on PSUSA/00010521/203206 Adam Przybylkowski Poland NAP
31/01/2018
DLP
PSURwas updatedand
frequency on DLP
25/09/2019
were
updated
Lead MS on
and31/07/2019
PRAC Rapporteur
10523 reslizumab 16/08/2016 3 years 16/02/2027 17/05/2027 No 20/10/2021 PSUR frequency amended and
name was added on 26/04/2017
PSUSA/00010523/202702 Gabriele Maurer Germany CAP
updated
DLP was on 03/04/2019
updated on 06/02/2019
New active substance added on
DLP 26/09/2018
was updated on 31/07/2018
10524 sofosbuvir / velpatasvir 28/06/2016 3 years 27/06/2025 25/09/2025 No 01/02/2023 20/12/2016 PSUSA/00010524/202506 Ana Sofia Diniz Martins Portugal CAP
updated on
DLP was amended on27/03/2018
31/01/2018

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 amended and Marie Louise Schougaard


10544 palbociclib 03/02/2015 3 years 02/08/2026 31/10/2026 No 27/03/2024 PSUSA/00010544/202608
Christiansen Denmark CAP
DLP updated on 27/03/2024

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

alfa-tocopherol / vaccinium myrtillus anthocyanosides, PSUR frequency amended and


10547 Not available* 9 years 03/03/2029 01/06/2029 No 28/08/2024 PSUSA/00010547/202903 Maia Uusküla Estonia NAP
betacarotene / vaccinium myrtillus anthocyanosides DLP updated on 28/08/2024

PRAC Rapporteur name was


10549 morphine, morphine / cyclizine 14/04/1969 5 years 14/10/2027 12/01/2028 No 16/10/2023 PSUSA/00010549/202710 Karin Erneholm Denmark NAP
amended on 18/10/2023
DLP was updated on 19/10/2022

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

DLP was updated on 06/02/2019


10556 venetoclax 05/12/2016 3 years 04/12/2024 04/03/2025 No 27/07/2022 PSUSA/00010556/202412 Eva Jirsová Czech Republic CAP
PRAC Representative and LMS
carbasalate calcium / metoclopramide, lysine updated on 19/12/2018
10557 acetylsalicylic acid / metoclopramide, paracetamol / 16/07/1981 15 years 16/07/2027 14/10/2027 No 30/01/2017 New entry added on 30/01/2017 PSUSA/00010557/202707 NAP
metoclopramide DLP was updated on 04/07/2018
PSUR frequency and DLP were
DLP was on
updated amended on 31/01/2018
01/03/2023
10558 cidofovir 23/04/1997 3 years 10/06/2027 08/09/2027 Yes 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010558/202706 Rugile Pilviniene Lithuania NAP
PRAC Rapporteur
PRAC Representative
nameamended
was
on 28/03/2017
amended on 28/04/2022
10559 lonoctocog alfa 04/01/2017 1 year 03/01/2025 14/03/2025 03/01/2026 14/03/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010559/202501 PSUSA/00010559/202601 Sonja Hrabcik Austria CAP
New CAP
PRAC authorised
Rapporteur on was
name
05/12/2016
amended on 21/11/2018
Marie Louise Schougaard
10561 sulfamethizole 15/06/1955 10 years 15/06/2032 13/09/2032 Yes 01/03/2023 PSUSA/00010561/203206
Christiansen Denmark NAP
DLP was updated on 28/02/2018
calcium glycerophosphate / magnesium gluconate,
Lead MS and PRAC Rapporteur
calcium glycerophosphate / manganese PSUR frequency and DLP
10563 14/09/1959 11 years 03/05/2039 01/08/2039 No 23/10/2024 name was added on 26/04/2017 PSUSA/00010563/203905 NAP
glycerophosphate / potassium glycerophosphate / amended on 23/10/2024
sodium glycerophosphate / thiamine Entryentry
nameadded
amended on
New on 30/01/2017
19/12/2017
10564 cetrimide, cetyltrimethylammonium naproxenate 07/12/1976 15 years 28/02/2030 29/05/2030 No 19/12/2017 PRACwas
Rapporteur PSUSA/00010564/203002 NAP
DLP updated name updated
on 02/02/2022
New
DLP active
was substance
updated
on 05/11/2018 added on
on 02/02/2022
amino acid combinations / glucose / triglyceride
28/02/2017
combinations (e.g. olive oil, soya bean oil, fish oil)/ PRAC representative and LMS
10565 Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 PRAC representative was PSUSA/00010565/202606 Melinda Palfi Hungary NAP
with or without electrolytes/ mineral compounds (i.v. were added on 23/09/2020
updated on 28/07/2021
application) - except the combination with procedure
number 00010190 (drug Numeta) New active substance added on
PRACwas
DLP representative was
updated on 21/09/2022
amino acid combinations/ glucose/ with or without 28/02/2017
10566 Not available* 5 years 03/06/2026 01/09/2026 No 02/02/2022 updated on 28/04/2021 PSUSA/00010566/202606 Polona Golmajer Slovenia NAP
electrolytes / mineral compounds (i.v. application)
DLP was updated on 25/09/2019
PRAC representative and LMS
Camellia sinensis, Leaf, Dry extract refined (derived were added on 23/09/2020
PRAC Representative and Lead
10569 31/08/2009 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00010569/202412 Adam Przybylkowski Poland NAP
from Camellia sinensis, L. O.KUNTZE) (topical use) Member state assigned on
New active substance added on
04/07/2018
28/02/2017
PRAC representative updated on
10570 landiolol 03/08/2016 3 years 02/02/2026 03/05/2026 No 31/01/2024 New active substance added on PSUSA/00010570/202602 Bianca Mulder Netherlands NAP
31/01/2024
28/02/2017

© 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

PSUR frequency amended and


10595 nusinersen 30/05/2017 3 years 30/05/2027 28/08/2027 No 05/02/2025 PSUSA/00010595/202705 Karin Bolin Sweden CAP
DLP updated on 05/02/2025

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

DLP was updated on 06/06/2018


lactobacillus all subspecies and combinations of PRAC Representative updated on
10598 14/07/1954 10 years 13/07/2024 11/10/2024 No 06/06/2018 PSUSA/00010598/202407 Martin Huber Germany NAP
subspecies New was
DLP active substance
amended
16/11/2022 added on
on 03/05/2023
27/06/2017
Leadwas
DLP MS updated
and PRAConRapporteur
28/04/2022
10599 choline alfoscerate 27/07/1987 8 years 30/08/2030 28/11/2030 No 03/05/2023 name added on 29/06/2022 PSUSA/00010599/203008 Rugile Pilviniene Lithuania NAP
Correction of active substance
New active
name substance added on
on 30/03/2022
deproteinised hemoderivative of calf blood,
27/06/2017
10600 deproteinised hemoderivative of calf blood / macrogol 03/01/1957 8 years 31/03/2031 29/06/2031 No 20/12/2023 DLP was amended on 20/12/2023 PSUSA/00010600/203103 Jana Lukačišinová Czech Republic NAP
PRAC Representative updated on
400
26/09/2018

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

DLP was updated on 04/07/2018


DLP and PSUR frequency
10609 sarilumab 12/01/2017 3 years 12/01/2026 12/04/2026 No 20/09/2023 PSUSA/00010609/202601 Monica Martinez Redondo Spain CAP
amended on
European 20/09/2023
Union reference date
was amended on 19/12/2017

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

PSUR frequency and DLP were


updated on 05/06/2019
DLP and PSUR frequency were
10613 sodium oxybate (intravenous use) 13/06/1961 3 years 12/10/2024 21/12/2024 Yes 25/05/2022 DLP was on
updated updated on 06/06/2018
02/03/2022 PSUSA/00010613/202410 Ana Sofia Diniz Martins Portugal NAP

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

PRAC representative was


10628 gentamicin (implant) 28/02/1973 5 years 31/03/2027 29/06/2027 No 21/12/2022 updated on 27/07/2022 PSUSA/00010628/202703 Amelia Cupelli Italy NAP

LMS and PRAC representative


were active
New addedsubstance
on 20/10/2021
added on
10629 hamamelis water Not available* 13 years 01/01/2040 31/03/2040 No 25/09/2017 PSUSA/00010629/204001 NAP
25/09/2017
New active substance added on
25/09/2017
spheroids of human autologous matrix-associated
10630 10/07/2017 1 year 09/07/2024 17/09/2024 09/07/2025 17/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010630/202407 PSUSA/00010630/202507 Gabriele Maurer Germany CAP
chondrocytes DLP was updated on 21/09/2022

DLP was udpated on 25/09/2019


10631 testosterone (all formulations apart from topical use) 01/07/1978 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00010631/202412 Maia Uusküla Estonia NAP
New active substance added on
08/09/2017 following merge of
entries
PSUR frequency and DLP
10632 zinc oxide, zinc oxide/calamine Not available* 9 years 03/11/2032 01/02/2033 No 23/10/2024 PSUSA/00010632/203211 Martin Huber Germany NAP
amended on 23/10/2024

Next DLP was updated on Marie Louise Schougaard


10633 ribociclib 13/03/2017 1 year 12/03/2025 21/05/2025 12/03/2026 21/05/2026 No 18/10/2023 PSUSA/00010633/202503 PSUSA/00010633/202603
Christiansen Denmark CAP
18/10/2023
PSUR frequency and DLP were
updated on 19/10/2022

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

DLP was updated on 21/10/2020


PSUR frequency amended and
10635 avelumab 23/03/2017 3 years 22/03/2026 20/06/2026 No 15/11/2023 PRAC representative updated PSUSA/00010635/202603 Karin Erneholm Denmark CAP
DLP updated
PSUR frequency and DLP wereon
on 15/11/2023
21/12/2022
updated on 01/04/2020

10636 tivozanib 24/08/2017 3 years 23/02/2025 24/05/2025 No 19/10/2022 PSUR frequency


DLP was updatedand
on DLP were
25/09/2019 PSUSA/00010636/202502 Rugile Pilviniene Lithuania CAP
updated on 29/06/2022
DLP was updated on 03/04/2019
DLP was updated on 30/06/2021
10637 trientine 05/09/2017 2 years 05/09/2025 04/12/2025 No 30/04/2024 DLP was amended on 30/04/2024
PRAC Rapporteur name was
PSUSA/00010637/202509 Ana Sofia Diniz Martins Portugal CAP NAP
PSUR frequency
amended and DLP were
on 06/03/2019
updated 03/06/2020
10638 midostaurin 28/04/2017 3 years 27/10/2024 05/01/2025 No 29/06/2022 DLP was updated on 26/09/2018 PSUSA/00010638/202410 Carla Torre Portugal CAP
DLP was updated on 18/12/2019
New CAP authorised on
DLP was updated on 05/06/2019
24/08/2017
Next DLP was updated on
10639 telotristat 28/02/2017 3 years 27/02/2027 28/05/2027 No 18/10/2023 PSUSA/00010639/202702 Adam Przybylkowski Poland CAP
18/10/2023
DLP was updated on 23/10/2018
benzalkonium chloride / isopropyl myristate / paraffin Next DLP corrected on
PSUR frequency amended and
10640 liquid, benzalkonium chloride / chlorhexidine / Not available* 8 years 01/12/2025 01/03/2026 No 31/07/2024 15/11/2017 PSUSA/00010640/202512 Rhea Fitzgerald Ireland NAP
DLP updated on 31/07/2024
isopropyl myristate / paraffin liquid
New CAP authorised on
10641 eucalyptus oil Not available* 13 years 01/01/2030 01/04/2030 No 17/10/2017 18/09/2017
New entry added on 17/10/2017 PSUSA/00010641/203001 NAP

PSUR frequency amended and


10643 lutetium (177Lu) oxodotreotide 26/09/2017 3 years 19/12/2025 19/03/2026 No 26/07/2023 PSUSA/00010643/202512 Adam Przybylkowski Poland CAP
DLP updated
PSUR on 26/07/2023
frequency and DLP were
updated on 28/04/2022

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

DLP was updated on 06/05/2020


10645 dupilumab 28/03/2017 1 year 28/03/2025 06/06/2025 28/03/2026 06/06/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010645/202503 PSUSA/00010645/202603 Kimmo Jaakkola Finland CAP
PSUR frequency amended on
20/11/2019
darunavir / cobicistat / emtricitabine / tenofovir
10646 21/09/2017 3 years 20/09/2024 19/12/2024 No 28/04/2022 DLP was updated on 23/10/2019 PSUSA/00010646/202409 Ana Sofia Diniz Martins Portugal CAP
alafenamide
DLP was updated on 30/04/2019
10647 dimethyl fumarate (psoriasis) 23/06/2017 2 years 23/03/2025 21/06/2025 No 15/11/2023 DLP was amended on 15/11/2023
Lead
PSUSA/00010647/202503 Mari Thorn Sweden CAP
PSUR MS and PRAC
frequency andRapporteur
DLP were
name updated
updated on 23/10/2018
on 21/12/2022
triglyceride combinations (e.g. olive oil, soya bean oil,
PRAC Rapporteur
updated updated on
10648 fish oil)/ with or without mineral 06/02/2014 5 years 03/06/2026 01/09/2026 No 15/11/2023 DLP was
PRAC on 23/10/2018
representative updated on PSUSA/00010648/202606 Petar Mas Croatia NAP
15/11/2023
compounds/electrolytes (i.v. application) 16/11/2022
New CAP authorised on
ibuprofen, ibuprofen lysine (not indicated in ductus 21/09/2017
Next DLP was
Correction updated
of DLP on
on 27/07/2022
10649 19/02/1969 3 years 18/02/2026 19/05/2026 No 18/10/2023 PSUSA/00010649/202602 John Joseph Borg Malta NAP
arteriosus), ibuprofen / caffeine 18/10/2023
DLP was updated on 16/11/2022
DLP was updated on 03/02/2021
PRAC Representative amended
10650 clodronic acid, clodronic acid / lidocaine 13/02/1985 5 years 28/02/2027 29/05/2027 Yes 16/11/2022 on 28/04/2022
PSUR frequency and DLP were PSUSA/00010650/202702 Jean-Michel Dogné Belgium NAP
updated on 01/07/2020
New entry added following
merge
DLP wasonupdated
15/11/2017
on 05/02/2020
10651 ozenoxacin 19/05/2017 3 years 18/05/2025 16/08/2025 No 21/12/2022 PSUSA/00010651/202505 Monica Martinez Redondo Spain NAP
PSUR frequency and DLP was
amended on 06/02/2019

PSUR frequency amended and


DLP updated on 21/11/2018
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 71 / 223
PRAC Representative updated on
26/09/2018

PRAC Representative and Lead


MS were added on 07/05/2018
10652 guselkumab 13/07/2017 1 year 12/07/2024 20/09/2024 12/07/2025 20/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010652/202407 PSUSA/00010652/202507 Gabriele Maurer Germany 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

PSUR frequency amended and


10654 padeliporfin 10/11/2017 3 years 09/11/2025 07/02/2026 No 28/06/2023 PSUSA/00010654/202511 Maia Uusküla Estonia CAP
DLP updated on 28/06/2023

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

PRAC representative and LMS


10656 methohexital 24/01/1977 5 years 01/01/2027 01/04/2027 No 21/09/2022 PSUSA/00010656/202701 Liana Martirosyan Netherlands NAP
were added on 26/05/2021
methyl salicylate, New entry added on 19/17/2017
10657 menthol
naloxone/ (for
methyl
use salicylate,
in non-medical settings) 06/06/2016 2 years 09/05/2026 07/08/2026 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010657/202605 Liana Martirosyan Netherlands CAP NAP
menthol / methyl salicylate / camphor, PSUR frequency and DLP were
methyl salicylate/ camphor, methyl salicylate / updated on 29/06/2022
menthol / camphor / tocopherol,
PRAC representative updated on
10658 methyl salicylate / camphor / menthol / turpentine 23/06/1989 5 years 20/04/2027 19/07/2027 No 31/01/2024 DLP was updated on 30/06/2021 PSUSA/00010658/202704 Carla Torre Portugal NAP
31/01/2024
(essence, oil),
methyl salicylate / menthol / camphor / hydroxyethyl DLP was updated on 01/07/2020
salicylate,
10659 inotuzumab ozogamicin
methyl salicylate / menthol / camphor / hydroxyethyl
29/06/2017 1 year 28/12/2024 08/03/2025 28/12/2025 08/03/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010659/202412 PSUSA/00010659/202512 Gabriele Maurer Germany CAP
PSUR frequency and next DLP
salicylate / benzyl nicotinate were corrected on 01/04/2020

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 was updated on 05/06/2019


PSUR frequency amended and
10661 benralizumab 14/11/2017 3 years 13/11/2025 11/02/2026 No 28/06/2023
was updated on 19/12/2018
PSUSA/00010661/202511 David Olsen Norway CAP
DLP updated on 28/06/2023

Lead MS and PRAC Rapporteur


10662 ocrelizumab 28/03/2017 3 years 27/03/2027 25/06/2027 No 20/11/2024 name added
DLP was on 21/11/2018
amended on 20/11/2024 PSUSA/00010662/202703 Gabriele Maurer Germany CAP

New CAP authorised on


08/01/2018
10663 rurioctocog alfa pegol 13/11/2018 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/00010663/202411 PSUSA/00010663/202511 Bianca Mulder Netherlands CAP

budesonide (for centrally authorised products


10664 08/01/2018 1 year 07/07/2024 15/09/2024 07/07/2025 15/09/2025 No 28/02/2024 DLP was amended on 28/02/2024 PSUSA/00010664/202407 PSUSA/00010664/202507 Zane Neikena Latvia CAP
indicated for eosinophilic esophagitis only) Correction of DLP on 26/07/2023

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

DLP was updated on 20/10/2021


10669 burosumab 19/02/2018 1 year 18/02/2025 29/04/2025 18/02/2026 29/04/2026 No 05/04/2023 PSUSA/00010669/202502 PSUSA/00010669/202602 Gabriele Maurer Germany CAP
PSUR frequency and DLP were
updated on 31/03/2021
PRAC Rapporteur name was
10670 opium 01/10/1986 3 years 30/09/2024 29/12/2024 Yes 16/10/2023 PSUSA/00010670/202409 Karin Erneholm Denmark NAP
amended on 18/10/2023
DLP was updated on 21/10/2020

DLP was updated on 01/04/2020


10671 semaglutide 05/12/2017 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/00010671/202505 PSUSA/00010671/202605 Mari Thorn Sweden CAP
DLP was updated on 25/09/2019

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

New CAP authorised on


19/02/2018
10673 sitagliptin, metformin hydrochloride / sitagliptin 21/03/2007 3 years 03/08/2026 01/11/2026 No 30/04/2024 PSUR frequency
DLP was amendedand
onDLP were
30/04/2024 PSUSA/00010673/202608 Bianca Mulder Netherlands CAP NAP
updated on 16/11/2022

DLP was updated on 17/11/2021


hydrocortisone (centrally authorised products for PSUR frequency amended and
10674 09/02/2018 3 years 08/08/2026 06/11/2026 No 27/03/2024 PSUSA/00010674/202608 Karin Bolin Sweden CAP
adrenal insufficiency, paediatric use only) DLP updated on 27/03/2024
PSUR frequency and DLP were
updated on 18/11/2020
10675 sodium zirconium cyclosilicate 22/03/2018 3 years 21/03/2025 19/06/2025 No 16/11/2022 PSUSA/00010675/202503 Terhi Lehtinen Finland CAP
DLP was updated on 06/05/2020

DLP was updated on 23/10/2019


10677 velmanase alfa 23/03/2018 1 year 22/03/2025 31/05/2025 22/03/2026 31/05/2026 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010677/202503 PSUSA/00010677/202603 Jan Neuhauser Austria CAP
DLP was updated on 30/04/2019
PRAC representative was
New CAP authorised
updated on
10678 herpes zoster vaccine (recombinant, adjuvanted) 13/10/2017 1 year 12/10/2024 21/12/2024 12/10/2025 21/12/2025 No 05/06/2024 DLP was on 17/11/2021
amended
22/03/2018 on 05/06/2024 PSUSA/00010678/202410 PSUSA/00010678/202510 Sonja Hrabcik Austria CAP
DLP was updated on 30/06/2021

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

New active substance added on


10686 enterococcus faecium 27/07/1955 10 years 26/07/2026 24/10/2026 No 06/06/2018 PSUR frequency and DLP were PSUSA/00010686/202607 NAP
06/06/2018
corrected on 01/03/2023

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

DLP was updated on 02/02/2022


10689 dolutegravir / rilpivirine 16/05/2018 2 years 15/05/2025 13/08/2025 No 19/09/2024 PSUSA/00010689/202505 Zoubida Amimour France CAP
DLP was updated on 03/02/2021

PSUR frequency and DLP were


10690 glibenclamide (for centrally authorised products only) 24/05/2018 3 years 23/05/2025 21/08/2025 No 01/03/2023 PSUSA/00010690/202505 Maria del Pilar Rayon Spain CAP
updated on 01/07/2020

DLP was updated on 05/02/2020


New combination of active
10691 heparin / zinc sulphate 30/11/1998 12 years 29/11/2027 27/02/2028 No 31/07/2018 DLP was updated PSUSA/00010691/202711 NAP
substances addedon
on21/09/2022
31/07/2018
DLP was updated on 03/07/2019
allergen for therapy: Ambrosia Artemisiifolia (302) PSUR frequency and DLP were
PRAC Representative
updated updated on
10693 (sublingual use, products authorised via decentralised 10/04/2014 3 years 09/04/2027 08/07/2027 No 18/12/2024 DLP was on 30/03/2022
amended
26/09/2018 on 18/12/2024 PSUSA/00010693/202704 Gabriele Maurer Germany NAP
procedure)”
PSUR frequency and DLP were
New CAPon
updated authorised on
22/09/2021
PSUR frequency amended and
10694 rucaparib 19/12/2016 2 years 19/12/2025 19/03/2026 No 31/07/2024 24/05/2018 PSUSA/00010694/202512 Mari Thorn Sweden CAP
DLP updated on 31/07/2024
DLP was updated on 31/03/2021

DLP was updated on 23/09/2020


10695 bictegravir / emtricitabine / tenofovir alafenamide 07/02/2018 3 years 06/02/2025 07/05/2025 No 21/09/2022 PSUSA/00010695/202502 Liana Martirosyan Netherlands CAP
PRAC representative and DLP
were updated on 04/03/2020

DLP was updated on 25/09/2019


© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the EuropNextDLP was updated on Page 72 / 223
06/03/2019

New CAP authorised on


07/02/2018
PRAC representative was
updated on 27/07/2022

DLP was updated on 02/03/2022

PRAC Rapporteur name was


amended on 02/02/2022

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 and DLP were


10698 brexpiprazole 10/07/2015 3 years 09/07/2024 07/10/2024 No 27/07/2022 updated on 03/03/2021 PSUSA/00010698/202407 Miroslava Gocova Slovakia CAP

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

DLP was updated on 25/09/2019


10703 axicabtagene ciloleucel 18/10/2017 1 year 17/10/2024 26/12/2024 17/10/2025 26/12/2025 No 05/06/2024 DLP was amended on 05/06/2024 PSUSA/00010703/202410 PSUSA/00010703/202510 Karin Erneholm Denmark CAP
New CAP authorised on
23/08/2018
PSUR frequency amended and
10706 sodium fluoride (18F) 14/11/1994 5 years 13/11/2027 11/02/2028 Yes 26/07/2023 PSUSA/00010706/202711 Kimmo Jaakkola Finland NAP
DLP updated on 26/07/2023

PRAC Rapporteur updated on


10707 soybean phospholipids (oral use) 02/10/1957 5 years 01/10/2026 30/12/2026 No 15/11/2023 DLP was amended on 23/08/2023 PSUSA/00010707/202610 Petar Mas Croatia NAP
15/11/2023
DLP updated on 02/02/2022
10708 fluorocholine (18F) 02/04/2010 3 years 01/04/2026 30/06/2026 No 23/08/2023 PSUSA/00010708/202604 Eva Jirsová Czech Republic NAP
LMS and PRAC representative
were added on 25/09/2019
PSUR frequency amended and
10709 vestronidase alfa 15/11/2017 3 years 14/11/2026 12/02/2027 No 03/07/2024 New entry added on 26/09/2018 PSUSA/00010709/202611 Maria del Pilar Rayon Spain CAP
DLP updated on 03/07/2024

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

PSUR frequency amended and


10712 neratinib 17/07/2017 3 years 16/07/2026 14/10/2026 No 28/02/2024 PSUSA/00010712/202607 Bianca Mulder Netherlands CAP
DLP updated on 28/02/2024

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

PSUR frequency amended and


10714 vonicog alfa 08/12/2015 3 years 31/12/2026 31/03/2027 No 31/07/2024 PSUSA/00010714/202612 Mari Thorn Sweden CAP
DLP updated on 31/07/2024

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

New active substance added on


10716 Symphytum officinale L., radix (comfrey root) 07/01/1966 13 years 31/12/2027 30/03/2028 No 23/10/2018 PSUSA/00010716/202712 NAP
23/10/2018

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

PSUR frequency amended and


10725 interferon beta-1a (intramuscular use) 13/03/1997 5 years 03/05/2029 01/08/2029 No 05/02/2025 PSUSA/00010725/202905 Maria del Pilar Rayon Spain CAP
DLP updated on 05/02/2025
PSUR frequency and DLP were
updated on 02/02/2022
10726 interferon beta-1a (subcutaneous use) 04/05/1998 5 years 03/05/2026 01/08/2026 No 02/02/2022 PSUSA/00010726/202605 Mari Thorn Sweden CAP
New entry added on 19/12/18

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

DLP was updated on 28/04/2022


PSUR frequency amended and
10728 brigatinib 28/04/2017 3 years 27/04/2026 26/07/2026 No 20/12/2023 PSUSA/00010728/202604 Carla Torre Portugal CAP
DLP updated on 20/12/2023
DLP was updated on 28/04/2021

PSUR frequency and DLP were


10729 doravirine 30/08/2018 3 years 29/08/2025 27/11/2025 No 05/04/2023 PSUR frequency amended and PSUSA/00010729/202508 Ana Sofia Diniz Martins Portugal CAP
updated on 21/10/2020
DLP updated on 05/04/2023
DLP was updated on 01/04/2020
10730 tezacaftor / ivacaftor 12/02/2018 1 year 11/02/2025 22/04/2025 11/02/2026 22/04/2026 No 25/09/2024 DLP was amended
DLP was updated on
on28/04/2022
25/09/2024 PSUSA/00010730/202502 PSUSA/00010730/202602 Eamon O Murchu Ireland CAP
DLP was updated on 23/10/2019
DLP was updated on 28/04/2021
New CAP authorised on
10731 doravirine / lamivudine / tenofovir disoproxil 30/08/2018 3 years 29/08/2025 27/11/2025 No 05/04/2023 PSUR frequency and DLP were
22/11/2018 PSUSA/00010731/202508 Ana Sofia Diniz Martins Portugal CAP
updated on 21/10/2020

DLP was updated on 01/04/2020


10732 damoctocog alfa pegol 29/08/2018 2 years 28/08/2025 26/11/2025 No 30/04/2024 DLP was amended on 30/04/2024 PSUSA/00010732/202508 Bianca Mulder Netherlands CAP
DLP was updated on 23/10/2019
PSUR
DLP frequency
New was updatedamended
on on and
27/07/2022
10733 galcanezumab 27/09/2018 3 years 27/09/2026 26/12/2026 No 30/04/2024 Next CAP
DLP authorised
wason
updated 22/11/18
on PSUSA/00010733/202609 Terhi Lehtinen Finland CAP
DLP updated 30/04/2024
28/06/2023
PSUR frequency amended and
DLP updated on 12/07/2019
10734 ceftobiprole 20/11/2013 3 years 19/11/2024 17/02/2025 No 27/07/2022 PRAC representative was PSUSA/00010734/202411 Mari Thorn Sweden NAP
updated on 28/07/2021
Lead MS and PRAC Rapporteur
name added on 03/04/2019
PRAC representative was
10735 valsartan / rosuvastatin 12/10/2016 3 years 11/10/2025 09/01/2026 No 28/06/2023 updated on 28/04/2021
New entry added on 19/12/18
PSUSA/00010735/202510 Polona Golmajer Slovenia NAP

DLP was updated on 03/06/2020

Lead MS and PRAC Rapporteur


name added on 03/04/2019
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Classified as internal/staff contractors by the EuropNew Page 73 / 223
#

entry added on 19/12/18


activated attapulgite mormoiron,
10736 30/03/1956 10 years 31/12/2026 31/03/2027 No 19/12/2018 New entry added on 19/12/18 PSUSA/00010736/202612 NAP
activated attapulgite / aluminium / pectin
New CAP authorised on
15/11/2024
influenza vaccine (surface antigen, inactivated,
10737 12/12/2018 1 year 15/03/2025 24/05/2025 15/03/2026 24/05/2026 No 18/10/2023 PSUSA/00010737/202503 PSUSA/00010737/202603 Gabriele Maurer Germany CAP
prepared in cell cultures)
Next DLP was updated on
18/10/2023
Next DLP was updated on
10738 mexiletine (centrally authorised products only) 18/12/2018 3 years 17/12/2025 17/03/2026 No 26/07/2023 PSUSA/00010738/202512 Eva Jirsová Czech Republic CAP
26/07/2023

PSUR frequency amended and


10739 glycopyrronium bromide / formoterol 25/04/2016 3 years 24/04/2026 23/07/2026 No 20/12/2023 PSUSA/00010739/202604 Jan Neuhauser Austria CAP
dengue tetravalent vaccine (live, attenuated) DLP updated on 20/12/2023
[Chimeric yellow fever dengue virus serotype 1 (live,
attenuated) / Chimeric yellow fever dengue virus
PSUR frequency amended and
10740 serotype 2 (live, attenuated) / Chimeric yellow fever 08/12/2015 3 years 07/12/2025 07/03/2026 No 26/07/2023 PSUSA/00010740/202512 Sonja Hrabcik Austria CAP
DLP updated on 26/07/2023
dengue virus serotype 3 (live, attenuated) / Chimeric
yellow fever dengue virus serotype 4 (live,
attenuated)] PSUR frequency amended and Marie Louise Schougaard
10741 mogamulizumab 30/03/2012 3 years 29/03/2026 27/06/2026 No 15/11/2023 PSUSA/00010741/202603
Christiansen Denmark CAP
DLP updated on 15/11/2023

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

PSUR frequency amended and


10743 lanadelumab 23/08/2018 3 years 22/08/2026 20/11/2026 No 27/03/2024 PSUSA/00010743/202608 Terhi Lehtinen Finland CAP
DLP updated on 27/03/2024

DLP was updated on 21/09/2022


New entry introduced on
10744 2-propanol, 2-propanol / benzalkonium 03/12/1982 10 years 02/12/2029 02/03/2030 No 06/03/2019 PSUSA/00010744/202912 NAP
06/03/2019
Correction of DLP on 30/03/2022

PSUR frequency and DLP were


10745 apalutamide 14/02/2018 1 year 13/02/2025 24/04/2025 13/02/2026 24/04/2026 No 25/09/2024 DLP was on
updated amended on 25/09/2024
02/03/2022 PSUSA/00010745/202502 PSUSA/00010745/202602 Tiphaine Vaillant France CAP

DLP was updated on 22/09/2021


10746 macimorelin 11/01/2019 3 years 10/01/2025 10/04/2025 No 21/09/2022 PSUSA/00010746/202501 Liana Martirosyan Netherlands CAP
DLP and PRAC representative
were updated on 03/03/2021
calcium dobesilate / lidocaine, 'calcium dobesilate / PSUR frequency and DLP
10747 30/12/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 DLP was updated on 23/09/2020 PSUSA/00010747/203503 NAP
dexamethasone / lidocaine amended on 23/10/2024
DLP was updated on 05/02/2020
PRAC Rapporteur updated on
10748 octenidine 18/07/2018 5 years 17/07/2025 15/10/2025 No 15/11/2023 New CAP Authorised on PSUSA/00010748/202507 Petar Mas Croatia NAP
15/11/2023
11/01/2019

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

New entry introduced on


10750 magnesium / pyridoxine 24/07/1991 13 years 23/07/2026 21/10/2026 No 06/03/2019 PSUSA/00010750/202607 NAP
06/03/2019

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

PSUR frequency and DLP


10754 amidotrizoic acid and combination 05/03/1956 11 years 01/12/2036 01/03/2037 No 23/10/2024 PSUSA/00010754/203612 Karin Erneholm Denmark NAP
amended on 23/10/2024

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 updated on 25/05/2022


PSUR frequency amended and
10756 ropeginterferon alfa-2b 15/02/2019 3 years 14/02/2026 15/05/2026 No 18/10/2023 PSUSA/00010756/202602 Carla Torre Portugal CAP
DLP updated on 18/10/2023
DLP was updated on 17/11/2021

PSUR frequency and DLP were


10757 dacomitinib 27/09/2018 2 years 26/09/2024 25/12/2024 No 03/05/2023 PSUSA/00010757/202409 Bianca Mulder Netherlands CAP
updated on 26/05/2021

DLP was updated on 18/11/2020


PSUR frequency
PRAC Rapporteuramended
name wasand
10758 fremanezumab 14/09/2018 3 years 13/09/2026 12/12/2026 No 30/04/2024 PSUSA/00010758/202609 Terhi Lehtinen Finland CAP
DLP updated
amended on 30/04/2024
on 26/07/2023
DLP was updated on 06/05/2020
DLP
New was
CAP amended on 03/05/2023
authorised
10759 infliximab 16/11/2000 3 years 23/08/2025 21/11/2025 No 03/05/2023 PSUR frequency and on
DLP were PSUSA/00010759/202508 Karin Bolin Sweden CAP
02/04/2019
updated
DLP was on 01/02/2023
updated on 06/05/2020
DLP
New was updated
entry on 02/02/2022
due to merge added
10760 lorlatinib 21/09/2018 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
on 30/04/2019
PSUSA/00010760/202409 PSUSA/00010760/202503 Barbara Kovacic Bytyqi Croatia CAP
PSUR frequency and DLP were
updated on 30/06/2021
10761 pegvaliase 24/05/2018 3 years 23/05/2025 21/08/2025 No 01/02/2023 PSUSA/00010761/202505 Rhea Fitzgerald Ireland CAP
DLP was updated on 03/02/2021

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

PSUR frequency amended and


10767 levofloxacin (intravenous and oral use) 01/10/1993 3 years 01/10/2026 30/12/2026 No 05/06/2024 PSUSA/00010767/202610 Martin Huber Germany NAP
DLP updated
PRAC on 05/06/2024
representative was
updated on 01/03/2023

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

DLP was updated on 22/09/2021


10771 anthrax vaccine 06/01/1994 3 years 31/12/2024 31/03/2025 No 21/09/2022 PSUSA/00010771/202412 Gabriele Maurer Germany NAP
DLP was
Lead MS updated
and PRACon 29/07/2020
reperesentative were updated on
10772 metergoline 15/01/1990 5 years 31/08/2028 29/11/2028 No 03/07/2019 Lead MS and PRAC Rapporteur
21/12/2022 PSUSA/00010772/202808 Amelia Cupelli Italy NAP
name added on 04/03/2020
New entry added on 03/07/2019
amlodipine besilate / ramipril, amlodipine / New entry added on 03/07/2019
10774 hydrochlorothiazide / ramipril, 31/03/2012 3 years 31/03/2027 29/06/2027 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010774/202703 Jan Neuhauser Austria NAP
hydrochlorothiazide/ramipril

Entry name updated on


10775 ursodeoxycholic acid, tauroursodeoxycholic acid 27/11/1979 10 years 30/11/2026 28/02/2027 No 03/07/2019 PSUSA/00010775/202611 John Joseph Borg Malta NAP
03/07/2019

PSUR frequency and DLP


10776 pramocaine, hydrocortisone / pramocaine 12/12/1965 11 years 02/12/2039 01/03/2040 No 23/10/2024 PSUSA/00010776/203912 NAP
amended on 23/10/2024

PSUR frequency amended and


10777 treosulfan (for centrally authorised product) 20/06/2019 3 years 19/06/2026 17/09/2026 No 31/01/2024 PSUSA/00010777/202606 Julia Pallos Hungary CAP
DLP updated on 31/01/2024

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 74 / 223
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

DLP was updated on 25/05/2022


PSUR frequency amended and
10779 avatrombopag 21/05/2018 3 years 20/05/2027 18/08/2027 No 05/02/2025 PSUSA/00010779/202705 Monica Martinez Redondo Spain CAP
DLP updated on 05/02/2025
PSUR frequency corrected on
30/03/2022
10780 cemiplimab 28/09/2018 2 years 27/09/2024 26/12/2024 No 03/05/2023 PSUSA/00010780/202409 Bianca Mulder Netherlands CAP
DLP was updated on 17/11/2021

PSUR frequency and DLP were


10781 talazoparib 16/10/2018 1 year 15/10/2024 24/12/2024 15/10/2025 24/12/2025 No 05/06/2024 updated
DLP was on 26/05/2021
amended on 05/06/2024 PSUSA/00010781/202410 PSUSA/00010781/202510 Carla Torre Portugal CAP

DLP was updated on 18/11/2020


PSUR frequency amended and
10782 turoctocog alfa pegol 20/06/2019 3 years 19/06/2027 17/09/2027 No 05/02/2025 was updated on 06/05/2020 PSUSA/00010782/202706 Gabriele Maurer Germany CAP
DLP updated on 05/02/2025

New CAP authorised on


10783 adalimumab 08/09/2003 3 years 31/12/2025 31/03/2026 No 20/09/2023 28/06/2019
DLP amended on 20/09/2023 PSUSA/00010783/202512 Karin Bolin Sweden CAP

ertugliflozin / metformin, ertugliflozin / sitagliptin,


10784 19/12/2017 2 years 18/12/2025 18/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010784/202512 Bianca Mulder Netherlands CAP
ertugliflozin

PSUR frequency amended and


10785 angiotensin II 21/12/2017 2 years 20/12/2025 20/03/2026 No 31/07/2024 PSUSA/00010785/202512 Bianca Mulder Netherlands CAP
DLP updated on 31/07/2024

PSUR frequency amended and


10786 l-lysine hydrochloride / l-arginine hydrochloride 25/07/2019 3 years 24/07/2026 22/10/2026 Yes 28/02/2024 PSUSA/00010786/202607 Adam Przybylkowski Poland CAP
DLP updated on 28/02/2024

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

technetium (99mtc) 3,3-diphosphono-1,2-


10789 31/01/1995 15 years 30/01/2032 29/04/2032 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010789/203201 NAP
propanedicarboxylic acid PSUR frequency and DLP were
updated on 28/04/2022

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

New entry added on 25/09/2019


10792 cod-liver oil (oral and parental use) Not available* 15 years 01/01/2034 01/04/2034 Yes 25/09/2019 New entry added on 25/09/2019 PSUSA/00010792/203401 NAP

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

PSUR frequency amended and


10795 etanercept 03/02/2000 5 years 02/02/2028 02/05/2028 No 18/10/2023 PSUSA/00010795/202802 Monica Martinez Redondo Spain CAP
DLP updated on 18/10/2023

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

PSUR frequency amended and


10798 cannabidiol (for centrally authorised products only) 25/06/2018 3 years 24/06/2027 22/09/2027 No 05/02/2025 PSUSA/00010798/202706 Ana Sofia Diniz Martins Portugal CAP
DLP updated on 05/02/2025

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

copper chloride dihydrate / manganese chloride


PSUR frequency and DLP
10803 tetrahydrate / potassium iodide / sodium fluoride / 05/02/1993 8 years 03/08/2025 01/11/2025 No 31/07/2024 PSUSA/00010803/202508 Rugile Pilviniene Lithuania NAP
amended on 31/07/2024
sodium selenite anhydrous / zinc chloride

PSUR frequency and DLP


10805 docusate, docusate/sorbitol 01/01/1976 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00010805/203503 Zoubida Amimour France NAP
amended on 23/10/2024

Active substance amended on


thiamine / riboflavin/ pyridoxine / ascorbic acid / PSUR frequency amended and
10806 rubidium (82Rb) chloride 22/11/2016 3 years 31/10/2026 29/01/2027 No 05/06/2024 28/04/2022 PSUSA/00010806/202610 Martin Huber Germany NAP
nicotinamide/ glucose, thiamine /riboflavin / pyridoxine DLP updated on 05/06/2024
/ ascorbic acid / nicotinamide, ascorbic acid / biotin /
Entry name was amended on
cyanocobalamin / folic acid / nicotinamide /
03/06/2020
10807 pantothenic acid / pyridoxine hydrochloride / 27/09/1968 10 years 27/09/2027 26/12/2027 No 28/04/2022 PSUSA/00010807/202709 NAP
riboflavin / thiamine, riboflavin / thiamine / calcium DLP was updated on 16/11/2022
EURD ID corrected on 05/02/2020
folinate / cyanocobalamin / nicotinamide, calcium
pantothenate / nicotinamide / pyridoxine / riboflavin / EURD ID corrected on 05/02/2020
10808 erythromycin (systemic use)
thiamine
11/03/1954 3 years 11/03/2025 09/06/2025 No 16/11/2022 New entry following merge on PSUSA/00010808/202503 Eamon O'Murchu Ireland NAP
20/11/2019
New entry due to splitting of
entries on 20/11/2019
10809 erythromycin (topical use) 11/03/1954 5 years 11/03/2029 09/06/2029 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00010809/202903 Eamon O'Murchu Ireland NAP

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

valine / histidine / isoleucine / leucine / lysine /


10811 methionine / phenylalanine / threonine / tyrosine / 19/04/1991 10 years 01/08/2028 30/10/2028 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010811/202808 NAP
tryptophan
Active substance name was
sodium thiosulfate (except centrally authorised amended on 28/06/2023
10812 11/11/2003 10 years 30/09/2027 29/12/2027 No 28/06/2023 PSUSA/00010812/202709 none NAP
products)
New entry added on 05/02/2020

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

lactic acid/oxalic acid / nitric acid / cupric nitrate/


10816 27/09/1985 10 years 26/09/2029 25/12/2029 No 05/02/2020 New entry added on 05/02/2020 PSUSA/00010816/202909 NAP
acetic acid

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

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 75 / 223
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

PSUR frequency amended and


10820 osilodrostat 09/01/2020 3 years 08/01/2027 08/04/2027 No 25/09/2024 PSUSA/00010820/202701 Maria del Pilar Rayon Spain CAP
DLP updated on 25/09/2024

PSUR frequency amended and


10822 delafloxacin 19/06/2017 2 years 18/06/2026 16/09/2026 No 05/02/2025 PSUSA/00010822/202606 Petar Mas Croatia CAP
DLP updated on 05/02/2025

PSUR frequency amended and


10823 upadacitinib 16/08/2019 1 year 15/08/2024 24/10/2024 15/08/2025 24/10/2025 No 25/09/2024 PSUSA/00010823/202408 PSUSA/00010823/202508 Petar Mas Croatia CAP
DLP updated on 25/09/2024

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

Next DLP was updated on


10825 esketamine (for centrally authorised product only) 05/03/2019 3 years 04/03/2027 02/06/2027 No 18/10/2023 PSUSA/00010825/202703 Terhi Lehtinen Finland CAP
18/10/2023

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

DLP was updated on 01/02/2023


10827 levonorgestrel (for emergency contraception only) 09/05/1990 3 years 08/05/2025 06/08/2025 No 01/02/2023 PSUSA/00010827/202505 Martin Huber Germany NAP
New entry due to split on
05/02/2020
levonorgestrel (all indications except emergency PSUR frequency amended and
10828 09/05/1990 3 years 08/05/2026 06/08/2026 No 31/01/2024 PSUSA/00010828/202605 Martin Huber Germany NAP
contraception) DLP updated on 31/01/2024

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

recombinant vesicular stomatitis virus - zaire


10834 11/11/2019 1 year 10/05/2025 19/07/2025 10/05/2026 19/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010834/202505 PSUSA/00010834/202605 Liana Martirosyan Netherlands CAP
ebolavirus vaccine (live)
allergen products for treatment: grass pollen, tree
pollen, house dust mites, moulds, weed pollen,
10835 29/06/1984 8 years 31/07/2027 29/10/2027 No 01/04/2020 New entry added on 01/04/2020 PSUSA/00010835/202707 NAP
vertebrates, animal epithelia (except for hymenoptera
venoms) single or mixes (subcutaneous use)
New entry due to split on
10836 human serum albumin (medical dilution) 25/11/1980 15 years 02/07/2035 30/09/2035 No 01/04/2020 PSUSA/00010836/203507 NAP
01/04/2020

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

DLP was updated on 05/04/2023


10840 remdesivir (Veklury) 07/05/2020 1 year 06/05/2025 15/07/2025 06/05/2026 15/07/2026 No 18/12/2024 DLP was amended on 18/12/2024 PSUSA/00010840/202505 PSUSA/00010840/202605 Eva Jirsová Czech Republic CAP
PSUR frequency and DLP were
updated on 19/10/2022

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

DLP was updated on 20/10/2021


10843 darolutamide 30/07/2019 1 year 30/07/2024 08/10/2024 30/07/2025 08/10/2025 No 25/09/2024 DLP was amended on 25/09/2024
DLP was updated on 31/03/2021
PSUSA/00010843/202407 PSUSA/00010843/202507 Jan Neuhauser Austria CAP

New CAPs authorised on


PSUR frequency amended and
10844 dronabinol/cannabidiol 15/04/2005 5 years 14/04/2028 13/07/2028 No 20/12/2023 01/04/2020 and 27/03/2020 PSUSA/00010844/202804 Liana Martirosyan Netherlands NAP
DLP updated on 20/12/2023
calcium carbonate / sodium alginate / sodium PSUR frequency amended and
bicarbonate, sodium alginate / sodium bicarbonate, PSUR frequency
DLP updated and DLP
on 31/05/2023
10845 05/09/1975 10 years 03/03/2035 01/06/2035 No 23/10/2024 PSUSA/00010845/203503 Jan Neuhauser Austria NAP
sodium alginate/ potassium hydrogen carbonate, amended on 23/10/2024
sodium alginate/magnesium alginate DLP was updated on 29/06/2022

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

lidocaine hydrochloride / neomycin sulfate / polymyxin LSM and PRAC representative


b, lidocaine hydrochloride monohydrate / addedfrequency
PSUR on 23/09/2020
and DLP
10847 Not available* 8 years 03/11/2026 01/02/2027 No 23/10/2024 PSUSA/00010847/202611 Zoubida Amimour France NAP
fludrocortisone acetate / neomycin sulfate / polymyxin amended on 23/10/2024
b New entry added on 03/06/2020

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

PSUR frequency amended and


10851 isatuximab 02/03/2020 2 years 01/03/2025 30/05/2025 No 18/10/2023 PSUSA/00010851/202503 Monica Martinez Redondo Spain CAP
DLP updated on 18/10/2023

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

PRAC representative and LMS


10854 dexamethasone / netilmicin 08/04/2006 5 years 08/04/2026 07/07/2026 No 22/12/2021 PSUSA/00010854/202604 Martin Huber Germany NAP
were added on 23/09/2020
hydrocortisone (systemic formulations except for
products indicated in adrenal insufficiency in a New entry added on 29/07/2020
10855 modified release tablet formulation and except for 05/08/1952 5 years 31/08/2024 29/11/2024 No 29/07/2020 New entry added on 29/07/2020 PSUSA/00010855/202408 Barbara Kovacic Bytyqi Croatia NAP
centrally authorised products for adrenal insufficiency,
paediatric use only)
hydrocortisone (all formulations apart from systemic
10856 05/08/1952 5 years 31/08/2024 29/11/2024 No 29/07/2020 New entry added on 29/07/2020 PSUSA/00010856/202408 Barbara Kovacic Bytyqi Croatia NAP
use)

ebola vaccine (Ad26.ZEBOV-GP [recombinant], MVA-


10857 27/09/2019 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/00010857/202409 PSUSA/00010857/202509 Jean-Michel Dogné Belgium CAP
BN-Filo [recombinant])

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 76 / 223
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

DLP was amended on 23/10/2024


10873 bulevirtide 31/07/2020 1 year 30/07/2025 08/10/2025 30/07/2026 08/10/2026 No 23/10/2024 PSUSA/00010873/202507 PSUSA/00010873/202607 Adam Przybylkowski Poland CAP
DLP was amended on 25/09/2024

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

DLP was updated on 02/02/2022


10881 levofloxacin/dexamethasone (ocular use) 13/06/2020 3 years 12/06/2025 10/09/2025 No 01/02/2023 PSUSA/00010881/202506 Amelia Cupelli Italy NAP
PRAC representative was
updated on 30/06/2021
10882 amikacin (centrally authorised product only) 28/09/2018 1 year 27/09/2024 06/12/2024 27/09/2025 06/12/2025 No 30/04/2024 DLP was amended on 30/04/2024
PRAC representative and LMS
PSUSA/00010882/202409 PSUSA/00010882/202509 Jean-Michel Dogné Belgium CAP
were added on 03/02/2021
PRAC representative updated on
10883 carvedilol / ivabradine 25/04/2005 3 years 25/04/2025 24/07/2025 No 31/01/2024 New entry added on 18/11/2020 PSUSA/00010883/202504 Bianca Mulder Netherlands NAP
31/01/2024

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

quadrivalent influenza vaccine (recombinant, prepared


10886 16/01/2013 1 year 15/01/2025 26/03/2025 15/01/2026 26/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010886/202501 PSUSA/00010886/202601 Zoubida Amimour France CAP
in cell culture)

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

Next DLP was updated on


10895 baloxavir marboxil 23/02/2018 1 year 22/02/2025 03/05/2025 22/02/2026 03/05/2026 No 18/10/2023 PSUSA/00010895/202502 PSUSA/00010895/202602 Sonja Hrabcik Austria CAP
18/10/2023
PSUR frequency amended and
DLP updated on 28/08/2024
10896 tagraxofusp 21/12/2018 2 years 20/12/2025 20/03/2026 No 28/08/2024 PSUSA/00010896/202512 Bianca Mulder Netherlands CAP
DLP was amended on 31/07/2024
elasomeran (Spikevax), elasomeran / imelasomeran
(Spikevax bivalent Original/Omicron BA.1), elasomeran PSUR frequency amended and Marie Louise Schougaard
10897 18/12/2020 1 year 17/12/2024 25/02/2025 17/12/2025 25/02/2026 No 31/07/2024 PSUSA/00010897/202412 PSUSA/00010897/202512
Christiansen Denmark CAP
/ davesomeran (Spikevax bivalent Original/Omicron DLP updated on 31/07/2024
BA.4-5), andusomeran
tozinameran (Spikevax XBB.1.5)
(COMIRNATY),
tozinameran/riltozinameran (COMIRNATY
PSUR frequency amended and
10898 Original/Omicron BA.1), tozinameran/famtozinameran 19/12/2020 1 year 18/12/2024 26/02/2025 18/12/2025 26/02/2026 No 31/07/2024 PSUSA/00010898/202412 PSUSA/00010898/202512 Liana Martirosyan Netherlands CAP
DLP updated on 31/07/2024
(COMIRNATY Original/Omicron BA.4-5), raxtozinameran
(COMIRNATY Omicron XBB.1.5)
10899 atidarsagene autotemcel 17/12/2020 1 year 16/12/2024 24/02/2025 16/12/2025 24/02/2026 No 31/07/2024 DLP was amended on 31/07/2024 PSUSA/00010899/202412 PSUSA/00010899/202512 Gabriele Maurer Germany CAP

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# 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

defatted powder of Arachis hypogaea L., semen


10902 31/01/2020 1 year 30/01/2025 10/04/2025 30/01/2026 10/04/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010902/202501 PSUSA/00010902/202601 Terhi Lehtinen Finland CAP
(peanuts)

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

formoterol fumarate dihydrate / glycopyrronium


10908 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/00010908/202412 PSUSA/00010908/202506 Jan Neuhauser Austria CAP
bromide / budesonide

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

PSUR frequency amended and


10911 fostemsavir 04/02/2021 3 years 03/02/2027 04/05/2027 No 25/09/2024 PSUSA/00010911/202702 Liana Martirosyan Netherlands CAP
DLP updated on 25/09/2024

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

PSUR frequency amended and


10924 remimazolam 23/01/2020 1 year 22/07/2024 30/09/2024 22/07/2025 30/09/2025 No 25/09/2024 PSUSA/00010924/202407 PSUSA/00010924/202507 Eamon O Murchu Ireland CAP
DLP updated on 25/09/2024

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

salmeterol / fluticasone propionate (for centrally


10928 27/01/2017 1 year 27/01/2025 07/04/2025 27/01/2026 07/04/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010928/202501 PSUSA/00010928/202601 Amelia Cupelli Italy CAP
authorised products)

Next DLP was updated on


10929 trifarotene 04/10/2019 2 years 03/10/2024 01/01/2025 No 29/06/2022 PSUSA/00010929/202410 Karin Bolin Sweden NAP
31/05/2023

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

New active substance added on


10933 lidocaine (topical use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 30/06/2021 following split of PSUSA/00010933/202809 NAP
previous entry
New active substance added on
10934 lidocaine (systemic use) 01/10/1948 8 years 30/09/2028 29/12/2028 No 30/06/2021 30/06/2021 following split of PSUSA/00010934/202809 NAP
previous entry

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

PSUR frequency amended and


10937 tralokinumab 17/06/2021 1 year 16/12/2024 24/02/2025 16/12/2025 24/02/2026 No 05/02/2025 PSUSA/00010937/202412 PSUSA/00010937/202512 Kimmo Jaakkola Finland CAP
DLP updated on 05/02/2025

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

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
# Classified as internal/staff contractors by the Europ Page 78 / 223
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

New CAP authorised on


19/09/2024
10949 odevixibat 16/07/2021 6 months 15/07/2024 23/09/2024 15/01/2025 26/03/2025 No 25/09/2024 PSUSA/00010949/202407 PSUSA/00010949/202501 Adam Przybylkowski Poland CAP
DLP was amended on 25/09/2024
Correction of DLP on 23/10/2024
10950 vericiguat 19/01/2021 1 year 18/01/2025 29/03/2025 18/01/2026 29/03/2026 No 25/09/2024 PSUSA/00010950/202501 PSUSA/00010950/202601 Kimmo Jaakkola Finland CAP
PSUR frequency amended and
DLP updated on 25/09/2024

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

PSUR frequency amended and


DLP updated on 05/02/2025
10955 roxadustat 17/12/2018 1 year 16/12/2024 24/02/2025 16/12/2025 24/02/2026 No 05/02/2025 PSUSA/00010955/202412 PSUSA/00010955/202512 Anna Mareková Slovakia CAP
DLP was amended on 31/07/2024

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

PSUR frequency amended and


10957 mometasone furoate/olopatadine 26/04/2021 3 years 25/04/2026 24/07/2026 No 20/12/2023 PSUSA/00010957/202604 Mari Thorn Sweden NAP
DLP updated on 20/12/2023

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

PSUR frequency amended and


DLP updated on 18/12/2024
10959 sacituzumab govitecan 22/04/2020 3 years 21/04/2025 20/07/2025 No 18/12/2024 PSUSA/00010959/202504 Bianca Mulder Netherlands CAP
DLP was amended on 20/12/2023

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

PSUR frequency amended and


10964 regdanvimab (Regkirona) 05/02/2021 3 years 04/02/2027 05/05/2027 No 25/09/2024 PRAC representative was PSUSA/00010964/202702 Amelia Cupelli Italy CAP
DLP updated on 25/09/2024
updated on 19/10/2022

PRAC representative was


10965 dexamethasone / tobramycin (systemic formulations) Not available* 5 years 31/03/2026 29/06/2026 No 19/10/2022 PSUSA/00010965/202603 Amelia Cupelli Italy NAP
updated on 27/07/2022
Correction of PSUR frequency
New entry due to splitting of
and Next DLP on 03/07/2024
10966 eptinezumab 21/02/2020 1 year 20/02/2025 01/05/2025 20/02/2026 01/05/2026 No 03/07/2024 entries on 22/12/2021 PSUSA/00010966/202502 PSUSA/00010966/202602 Liana Martirosyan Netherlands CAP
DLP was amended on 27/03/2024

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

PSUR frequency amended and


10968 glucarpidase 17/01/2012 1 year 16/07/2024 24/09/2024 16/07/2025 24/09/2025 No 25/09/2024 PSUSA/00010968/202407 PSUSA/00010968/202507 Martin Huber Germany CAP
DLP updated on 25/09/2024

PSUR frequency amended and


10969 lonapegsomatropin 25/08/2021 1 year 25/08/2024 03/11/2024 25/08/2025 03/11/2025 No 30/04/2024 PSUSA/00010969/202408 PSUSA/00010969/202508 Martin Huber Germany CAP
DLP updated on 30/04/2024

Marie Louise Schougaard


10970 sotorasib 28/05/2021 6 months 27/11/2024 05/02/2025 27/05/2025 05/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010970/202411 PSUSA/00010970/202505
Christiansen Denmark 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

PSUR frequency amended and


sars-cov-2, spike protein, recombinant, expressed in
DLP updated on 05/02/2025
10972 sf9 cells derived from spodoptera frugiperda 20/12/2021 1 year 19/12/2024 27/02/2025 19/12/2025 27/02/2026 No 05/02/2025 PSUSA/00010972/202412 PSUSA/00010972/202512 Gabriele Maurer Germany CAP
(Nuvaxovid, Nuvaxovid XBB1.5)
DLP was amended on 31/07/2024

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

pneumococcal polysaccharide conjugate vaccine (15


10975 16/07/2021 1 year 15/01/2025 26/03/2025 15/01/2026 26/03/2026 No 25/09/2024 DLP was amended on 25/09/2024 PSUSA/00010975/202501 PSUSA/00010975/202601 Gabriele Maurer Germany CAP
valent, adsorbed)

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

PSUR frequency amended and


DLP updated on 05/02/2025
10977 amivantamab 21/05/2021 1 year 20/11/2024 29/01/2025 20/11/2025 29/01/2026 No 05/02/2025 PSUSA/00010977/202411 PSUSA/00010977/202511 Gabriele Maurer Germany CAP
DLP was amended on 03/07/2024

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

pneumococcal polysaccharide conjugate vaccine (20-


10981 08/06/2021 6 months 07/12/2024 15/02/2025 07/06/2025 16/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00010981/202412 PSUSA/00010981/202506 Jean-Michel Dogné Belgium CAP
valent, adsorbed)
Correction of DLP on 03/07/2024
10982 somatrogon 26/10/2021 1 year 26/10/2024 04/01/2025 26/10/2025 04/01/2026 No 05/06/2024 PSUSA/00010982/202410 PSUSA/00010982/202510 Liana Martirosyan Netherlands CAP
PSUR frequency amended and
DLP updated on 05/06/2024

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

Next DLP was updated on


10986 sodium citrate (extracorporeal use) 22/10/1990 8 years 31/01/2031 01/05/2031 Yes 18/10/2023 PSUSA/00010986/203101 Polona Golmajer Slovenia NAP
18/10/2023

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

ascorbic acid / magnesium aspartate / leucine L /


10988 09/11/2007 5 years 28/10/2024 26/01/2025 No 28/04/2022 PSUSA/00010988/202410 Guðrún Stefánsdóttir Iceland NAP
lysine L / phenylalanine L / valine L

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

PSUR frequency amended and


10991 tebentafusp 25/01/2022 1 year 24/07/2024 02/10/2024 24/07/2025 02/10/2025 No 25/09/2024 PSUSA/00010991/202407 PSUSA/00010991/202507 Bianca Mulder Netherlands CAP
DLP updated on 25/09/2024

Correction of DLP on 05/02/2025


10992 tixagevimab / cilgavimab (Evusheld) 14/11/2021 1 year 13/11/2024 22/01/2025 13/11/2025 22/01/2026 No 03/07/2024 PSUSA/00010992/202411 PSUSA/00010992/202511 Kimmo Jaakkola Finland CAP
DLP was amended on 03/07/2024

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

PSUR frequency amended and


10995 difelikefalin 23/08/2021 1 year 22/08/2024 31/10/2024 22/08/2025 31/10/2025 No 30/04/2024 PSUSA/00010995/202408 PSUSA/00010995/202508 Mari Thorn Sweden CAP
DLP updated on 27/03/2024
PSUR frequency amended and
DLP updated on 05/02/2025
10996 inebilizumab 11/06/2020 1 year 10/12/2024 18/02/2025 10/12/2025 18/02/2026 No 05/02/2025 PSUSA/00010996/202412 PSUSA/00010996/202512 Amelia Cupelli Italy CAP
DLP was amended on 31/07/2024
PSUR frequency amended and
10997 rimegepant 27/02/2021 1 year 26/02/2025 07/05/2025 26/02/2026 07/05/2026 No 30/04/2024 PSUSA/00010997/202502 PSUSA/00010997/202602 Karin Erneholm Denmark CAP
DLP updated on 30/04/2024

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

PSUR frequency amended and


DLP updated on 05/02/2025
11004 eladocagene exuparvovec 18/07/2022 1 year 16/12/2024 24/02/2025 16/12/2025 24/02/2026 No 05/02/2025 PSUSA/00011004/202412 PSUSA/00011004/202512 Gabriele Maurer Germany CAP
DLP was amended on 31/07/2024

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

budesonide (for centrally authorised products


Marie Louise Schougaard
11007 indicated for primary immunoglobulin A nephropathy 15/12/2021 6 months 14/12/2024 22/02/2025 14/06/2025 23/08/2025 No 05/02/2025 DLP was amended on 05/02/2025 PSUSA/00011007/202412 PSUSA/00011007/202506
Christiansen Denmark CAP
only)

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

PSUR frequency amended and


11011 lasmiditan 11/10/2019 1 year 11/10/2024 20/12/2024 11/10/2025 20/12/2025 No 20/11/2024 PSUSA/00011011/202410 PSUSA/00011011/202510 Anna Mareková Slovakia CAP
DLP updated on 20/11/2024

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

PSUR frequency amended and


DLP updated on 05/02/2025
11014 efgartigimod alfa 17/12/2021 1 year 16/12/2024 24/02/2025 16/12/2025 24/02/2026 No 05/02/2025 PSUSA/00011014/202412 PSUSA/00011014/202512 Rhea Fitzgerald Ireland CAP
DLP was amended on 31/07/2024
PSUR frequency amended and
DLP updated on 05/02/2025
11015 tezepelumab 17/12/2021 1 year 16/12/2024 24/02/2025 16/12/2025 24/02/2026 No 05/02/2025 PSUSA/00011015/202412 PSUSA/00011015/202512 Eva Jirsová Czech Republic CAP
DLP was amended on 31/07/2024

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

PSUR frequency amended and


DLP updated on 05/02/2025
11028 tabelecleucel 16/12/2022 1 year 15/12/2024 23/02/2025 15/12/2025 23/02/2026 No 05/02/2025 PSUSA/00011028/202412 PSUSA/00011028/202512 Amelia Cupelli Italy CAP
DLP was amended on 31/07/2024

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

COVID-19 Vaccine (recombinant, adjuvanted)


11045 30/03/2023 6 months 29/09/2024 08/12/2024 29/03/2025 07/06/2025 No 20/11/2024 DLP was amended on 20/11/2024 PSUSA/00011045/202409 PSUSA/00011045/202503 Zane Neikena Latvia CAP
(Bimervax)

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

Marie Louise Schougaard


11048 ivosidenib 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/00011048/202411 PSUSA/00011048/202505
Christiansen Denmark 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

New CAP authorised on


11053 Insulin icodec 21/05/2024 6 months 20/11/2024 29/01/2025 20/05/2025 29/07/2025 No 05/06/2024 PSUSA/00011053/202411 PSUSA/00011053/202505 Sonja Hrabcik Austria CAP
21/05/2024

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

New CAP authorised on


11055 aztreonam / avibactam 22/04/2024 6 months 21/10/2024 30/12/2024 21/04/2025 30/06/2025 No 05/06/2024 PSUSA/00011055/202410 PSUSA/00011055/202504 Lina Seibokiene Lithuania CAP
22/04/2024

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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

New CAP authorised on


11059 retifanlimab 22/03/2023 6 months 21/09/2024 30/11/2024 21/03/2025 30/05/2025 No 05/06/2024 PSUSA/00011059/202409 PSUSA/00011059/202503 Gabriele Maurer Germany CAP
19/04/2024

New CAP authorised on


11060 sparsentan 17/02/2023 6 months 16/08/2024 25/10/2024 16/02/2025 27/04/2025 No 05/06/2024 PSUSA/00011060/202408 PSUSA/00011060/202502 Martin Huber Germany CAP
19/04/2024
EURD and DLP updated on
25/09/2024
11061 capivasertib 16/11/2023 6 months 15/11/2024 24/01/2025 15/05/2025 24/07/2025 No 25/09/2024 PSUSA/00011061/202411 PSUSA/00011061/202505 Sonja Hrabcik Austria CAP
New CAP authorised on
17/06/2024
Correction of DLP on 31/07/2024
11062 efanesoctocog alfa 22/02/2023 6 months 22/08/2024 31/10/2024 22/02/2025 03/05/2025 No 31/07/2024 PSUSA/00011062/202408 PSUSA/00011062/202502 Amelia Cupelli Italy CAP
New CAP authorised on
17/06/2024
Reference to NAP added on
18/12/2024
11063 dantrolene sodium, hemiheptahydrate 29/05/2024 6 months 28/11/2024 06/02/2025 28/05/2025 06/08/2025 No 18/12/2024 PSUSA/00011063/202411 PSUSA/00011063/202505 Liana Martirosyan Netherlands CAP NAP
New CAP authorised on
29/05/2024
New CAP authorised on
11064 tofersen 25/04/2023 6 months 24/10/2024 02/01/2025 24/04/2025 03/07/2025 No 02/07/2024 PSUSA/00011064/202410 PSUSA/00011064/202504 Kimmo Jaakkola Finland CAP
29/05/2024

New CAP authorised on


11065 bevacizumab gamma 27/05/2024 6 months 26/11/2024 04/02/2025 26/05/2025 04/08/2025 No 02/07/2024 PSUSA/00011065/202411 PSUSA/00011065/202505 Karin Erneholm Denmark CAP
27/05/2024

New CAP authorised on


11066 dopamine hydrochloride 27/05/2024 6 months 26/11/2024 04/02/2025 26/05/2025 04/08/2025 No 02/07/2024 PSUSA/00011066/202411 PSUSA/00011066/202505 Maia Uusküla Estonia CAP
27/05/2024

New CAP authorised on


11067 aprocitentan 19/03/2024 6 months 18/09/2024 27/11/2024 18/03/2025 27/05/2025 No 31/07/2024 PSUSA/00011067/202409 PSUSA/00011067/202503 Maria del Pilar Rayon Spain CAP
27/06/2024

New CAP authorised on


11068 vibegron 21/09/2018 6 months 20/09/2024 29/11/2024 20/03/2025 29/05/2025 No 31/07/2024 PSUSA/00011068/202409 PSUSA/00011068/202503 Jan Neuhauser Austria CAP
27/06/2024

New CAP authorised on


11069 fruquintinib 04/09/2018 6 months 03/09/2024 12/11/2024 03/03/2025 12/05/2025 No 31/07/2024 PSUSA/00011069/202409 PSUSA/00011069/202503 Bianca Mulder Netherlands CAP
20/06/2024

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

New CAP authorised on


11071 crovalimab 06/02/2024 6 months 05/02/2025 16/04/2025 05/08/2025 14/10/2025 No 25/09/2024 PSUSA/00011071/202502 PSUSA/00011071/202508 Bianca Mulder Netherlands CAP
22/08/2024

New CAP authorised on


11072 erdafitinib 12/04/2019 6 months 11/10/2024 20/12/2024 11/04/2025 20/06/2025 No 25/09/2024 PSUSA/00011072/202410 PSUSA/00011072/202504 Bianca Mulder Netherlands CAP
22/08/2024
DLP was amended on 23/10/2024
11073 flortaucipir (18F) 28/05/2020 6 months 28/11/2024 06/02/2025 28/05/2025 06/08/2025 No 23/10/2024 PSUSA/00011073/202411 PSUSA/00011073/202505 Adam Przybylkowski Poland CAP
New CAP authorised on
22/08/2024
New CAP authorised on
11074 odronextamab 22/08/2024 6 months 21/02/2025 02/05/2025 21/08/2025 30/10/2025 No 25/09/2024 PSUSA/00011074/202502 PSUSA/00011074/202508 Jana Lukačišinová Czech Republic CAP
22/08/2024
DLP amended on 20/11/2024

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

DLP was amended on 23/10/2024


11077 rADAMTS13 09/08/2024 6 months 08/11/2024 17/01/2025 08/05/2025 17/07/2025 No 23/10/2024 PSUSA/00011077/202411 PSUSA/00011077/202505 Maia Uusküla Estonia CAP
New CAP authorised on
01/08/2024
EURD updated on 05/02/2025
11078 dasiglucagon 22/03/2021 6 months 23/01/2025 03/04/2025 23/07/2025 01/10/2025 No 05/02/2025 PSUSA/00011078/202501 PSUSA/00011078/202507 Zane Neikena Latvia CAP
New CAP authorised on
24/07/2024
New CAP authorised on Marie Louise Schougaard
11079 fidanacogene elaparvovec 27/12/2023 6 months 26/12/2024 06/03/2025 26/06/2025 04/09/2025 No 25/09/2024 PSUSA/00011079/202412 PSUSA/00011079/202506
Christiansen Denmark CAP
24/07/2024

New CAP authorised on


11080 sugemalimab 20/12/2021 6 months 19/12/2024 27/02/2025 19/06/2025 28/08/2025 No 25/09/2024 PSUSA/00011080/202412 PSUSA/00011080/202506 Petar Mas Croatia CAP
24/07/2024
Correction of EURD date and DLP
on 05/02/2025
11081 epinephrine (for nasal use) 09/08/2024 6 months 08/02/2025 19/04/2025 08/08/2025 17/10/2025 No 05/02/2025 PSUSA/00011081/202502 PSUSA/00011081/202508 Terhi Lehtinen Finland CAP
New CAP authorised on
22/08/2024
New CAP authorised on
11082 polihexanide 22/08/2024 6 months 21/02/2025 02/05/2025 21/08/2025 30/10/2025 No 25/09/2024 PSUSA/00011082/202502 PSUSA/00011082/202508 Adam Przybylkowski Poland CAP
22/08/2024

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

New CAP authorised on


11092 elafibranor 10/06/2024 6 months 09/12/2024 17/02/2025 09/06/2025 18/08/2025 No 23/10/2024 PSUSA/00011092/202412 PSUSA/00011092/202506 Rugile Pilviniene Lithuania 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

New CAP authorised on


11103 vilobelimab 04/04/2023 6 months 03/04/2025 12/06/2025 03/10/2025 12/12/2025 No 05/02/2025 PSUSA/00011103/202504 PSUSA/00011103/202510 Liana Martirosyan Netherlands CAP
13/01/2025

New CAP authorised on


11104 rdESAT-6 / rCFP-10 09/05/2022 6 months 08/05/2025 17/07/2025 08/11/2025 17/01/2026 No 05/02/2025 PSUSA/00011104/202505 PSUSA/00011104/202511 Sonja Hrabcik Austria CAP
13/01/2025

New CAP authorised on Marie Louise Schougaard


11105 concizumab 10/03/2023 6 months 09/03/2025 18/05/2025 09/09/2025 18/11/2025 No 05/02/2025 PSUSA/00011105/202503 PSUSA/00011105/202509
Christiansen Denmark CAP
13/12/2024

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

PSUR frequency amended and


107812 netarsudil 18/12/2017 2 years 17/06/2025 15/09/2025 No 31/01/2024 PSUSA/00107812/202506 Maria del Pilar Rayon Spain CAP
DLP updated on 31/01/2024

© 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

azacitidine (oral formulations)

chlortalidone / metoprolol

dextromethorphan hydrobromide / mepyramine maleate

dextromethorphan hydrobromide / guaifenesin / mepyramine maleate

dextromethorphan hydrobromide / guaifenesin / mepyramine maleate /


phenylephrine hydrochloride

magnesium oxide

pixantrone

pralsetinib

acetylsalicylic acid / calcium carbonate

amitriptyline hydrochloride / chlordiazepoxide

ascorbic acid / dextromethorphan / paracetamol / pseudoephedrine

alum / benzalkonium chloride

benzalkonium chloride / dimethicone

benzalkonium chloride / dimethicone / hydrocortisone / nystatin

benzalkonium chloride / hexylresorcinol

# Classified as internal/staff contractors by the European Medicines Agency


benzalkonium chloride / lidocaine

benzalkonium chloride / tolnaftate

chlorhexidine / neomycin

chlorocresol combinations

acetylsalicylic acid / ascorbic acid / caffeine / chlorphenamine maleate

cinchocaine hydrochloride / esculin / framycetin sulfate / hydrocortisone


acetate

clopamide / pindolol

clopamide / reserpine

codeine polysulfonate / phenyltoloxamine polysulfonate

dextromethorphan / paracetamol

dextromethorphan hydrobromide / paracetamol / pseudoephedrine


hydrochloride

caffeine / codeine phosphate / doxylamine succinate / paracetamol

guaifenesin / pseudoephedrine

measles vaccine (live attenuated)

menadiol

miglitol

neomycin sulfate / polymyxin b sulfate

orphenadrine

acetylsalicylic acid / caffeine / codeine / paracetamol

# Classified as internal/staff contractors by the European Medicines Agency


caffeine / codeine / paracetamol

quinidine / verapamil hydrochloride

acetylsalicylic acid / citric acid / sodium hydrogen carbonate

ketoprofen / sucralfate

zaleplon

acetylsalicylic acid / codeine phosphate / paracetamol

dihydrocodeine / paracetamol

ferrimanitol ovoalbumin

neomycin sulphate / polymyxin b sulfate / prednisolone acetate

calcium folinate / iron succinyl-protein complex

macrogol 3350 combinations (oral use)

dasabuvir, ombitasvir / paritaprevir / ritonavir

dibromotyrosine

dihydroxyaluminum sodium carbonate

hydrocortisone / oxytetracycline

hydrocortisone acetate / oxytetracycline hydrochloride / polymyxin b

sodium citrate / sodium lauryl sulfoacetate

dibromotyrosine / thiamazole

magnesium citrate / magnesium lactate

# Classified as internal/staff contractors by the European Medicines Agency


ulipristal acetate (treatment of moderate to severe symptoms of uterine
fibroids)

obiltoxaximab

COVID-19 vaccine (Ad26.COV2-S [recombinant]) (JCOVDEN)

ethambutol / isoniazid / pyrazinamide / rifampicine

amifostine

clemastine / dexamethasone

azidamfenicol

benzalkonium chloride / benzyl alcohol / chlorhexedine

benzododecinium / polysorbate 80, benzododecinium

beractant

chloroxylenol / edetic acid / triclosan

eberconazole

fluocortolone

lofexidine

talinolol

tiopronin

lamivudine / tenofovir disoproxil

citric acid / potassium / sodium

dexamethasone / neomycin

# Classified as internal/staff contractors by the European Medicines Agency


dexamethasone acetate / hydroxyethyl salicylate / salicylamide

piretanide

proguanil

tazarotene

dexamethasone sodium / framycetin sulfate

caffeine / chlorphenamine maleate / paracetamol

acetylsalicylic acid / ascorbic acid / chlorphenamine maleate /


phenylephrine hydrochloride

biclotymol / chlorphenamine maleate / phenylephrine hydrochloride

chlorphenamine / paracetamol / phenylephrine

chlorphenamine maleate / codeine phosphate / pseudoephedrine


hydrochloride

acetic acid glacial / dexamethasone / neomycin

mephenesin

mephenesin / methyl nicotinate

naloxone / tilidine

glucose anhydrous / nikethamide

chlorphenamine / phenylephrine

pirenzepine

propantheline

acetylsalicylic acid / ascorbic acid / chlorphenamine / colae semen

# Classified as internal/staff contractors by the European Medicines Agency


caffeine / chlorphenamine / paracetamol / phenylephrine

belantamab mafodotin

COVID-19 Vaccine (ChAdOx1-S [recombinant]) (Vaxzevria)

benzathine benzylpenicillin, benzathine benzylpenicillin / lidocaine

cetylpyridinium / menthol

ciprofloxacin hydrochloride / dexamethasone acetate

homatropine

lauromacrogol / lidocaine / matricariae tinctura

mezlocillin

orciprenaline

procaine benzylpenicillin

sulfogaiacol

codeine phosphate / sulfogaiacol

SARS-CoV-2, B.1.351 variant, prefusion Spike delta TM protein,


recombinant

ascorbic acid / caffeine citrate / chlorphenamine maleate /


dextromethorphan hydrobromide / paracetamol

chlorphenamine maleate / diphenhydramine hydrochloride /


phenylephrine hydrochloride

chlortalidone / clonidine hydrochloride

calcium pantothenate / cystine / keratin / p-aminobenzoic acid /


thiamine / yeast

demoxytocin

# Classified as internal/staff contractors by the European Medicines Agency


diclofenamide

pandemic influenza vaccine (H5N1) (whole virion, Vero cell derived,


inactivated)

dichlorobenzyl alcohol / sodium benzoate

dextropropoxyphene hydrochloride

benzododecinium bromide

chorionic gonadotrophin

dihydralazine

dihydralazine / hydrochlorothiazide / reserpine

dimethoxanate

framycetin sulfate / lidocaine hydrochloride / salicylates / triamcinolone


acetonide

hydralazine hydrochloride / hydrochlorothiazide / metoprolol tartrate

chlortalidone / hydralazine hydrochloride / oxprenolol hydrochloride

hydralazine hydrochloride / propranolol hydrochloride

polyvinyl alcohol / povidone

reteplase

copper (64Cu) chloride

estradiol / medroxyprogesterone acetate

ornithine

perazine

# Classified as internal/staff contractors by the European Medicines Agency


thiethylperazine

trifluoperazine

caffeine / indomethacin / proclorperazine maleate

acetylsalicylic acid / dipyridamole

abciximab

acrivastine / pseudoephedrine

altretamine

aluminium hydroxide gel / calcium carbonate

amiloride

amiloride / bumetanide

amiloride / chlortalidone

amiloride / hydrochlorthiazide

amiloride / hydrochlorthiazide / timolol

amitriptyline hydrochloride / medazepam

bacitracin / neomycin

bacitracin / hydrocortisone / neomycin

bacitracin zinc / cystein / glycine / neomycin sulfate / threonine

bacitracin zinc / neomycin sulfate / polymyxin b sulfate

bisacodyl combinations

# Classified as internal/staff contractors by the European Medicines Agency


canrenone

chloroxine

colecalciferol

cyanamide

caffeine / cyclizine / ergotamine

dimemorfan

efavirenz / emtricitabine / tenofovir

ergocalciferol

lomefloxacin

neostigmine

nilvadipine

pneumococcal polysaccharide conjugate vaccine (adsorbed) - 7


valent

quazepam

cinchonidine / cinchonine / quinidine / quinine

saquinavir

bacitracin / polymyxine

calcium / ergocalciferol

bupivacaine/meloxicam

chlorphenamine maleate / pholcodine

# Classified as internal/staff contractors by the European Medicines Agency


paracetamol / pholcodine / pseudoephedrine

pholcodine / biclotymol / chlorphenamine maleate

SARS-CoV-2 virus, strain wuhan hCoV-19/Italy/INMI1-isl/2020,


inactivated (Valneva)

dimenhydrinate

hydrochlorothiazide / propranolol / triamterene

metildigoxin

nitrofurantoin / pyridoxine hydrochloride

pancreatic enzymes, pancreatic extracts, pancreatin (except for


the centrally authorised product)

pancreatin / simeticone

dimethicone / pancreatin

selenite sodium

hydrochlorothiazide / triamterene / verapamil hydrochloride

xipamide

crizanlizumab

iodohippurate sodium (123i)

elivaldogene autotemcel

naphazoline nitrate / prednisolone

dextromethorphan hydrobromide / quinidine sulfate

neridronic acid

# Classified as internal/staff contractors by the European Medicines Agency


penfluridol

chlorphenoxamine

acrivastine / pseudoephedrine

pholcodine

rufloxacin

risperidone (centrally authorised products only)

iodohippurate sodium (123i)

betamethasone / diprophylline / guaifenesin

ioxaglic acid

lysine acetylsalicylate

lidocaine / norepinephrine

sodium benzoate / grindelia tincture / polygala syrup

calcium chloride / glucose monohydrate / magnesium chloride


hexahydrate

piretanide

peppermint oil

nilvadipine

sulbactam

xenon

indinavir

# Classified as internal/staff contractors by the European Medicines Agency


metformin / saxagliptin

telbivudine

telithromycin

ibalizumab

equine tetanus immunoglobulin

adefovir

peginterferon alpha-2b

botulinum toxin type b

aminotridecane adipate

strontium [89sr] chloride

atenolol / nifedipine

diphtheria / tetanus / pertussis (acellular, component) /


haemophilus type b conjugate vaccine (adsorbed)

leuprorelin (except for depot formulations)

hydrochlorothiazide / moexipril

halofantrine

ertugliflozin

ceftibuten

interferon alpha-2a

calcium chloride / glucose / magnesium chloride hexahydrate /


sodium chloride / sodium hydrogen carbonate

# Classified as internal/staff contractors by the European Medicines Agency


cloxazolam

sotagliflozin

nateglinide

moxetumomab pasudotox

cefodizime

benzalkonium chloride (incl ocular)

sodium aurothiomalate

calcium pantothenate / nicotinamide / pyridoxine / riboflavin /


thiamine

dicobalt edetate

betibeglogene autotemcel

flubendazole

oxatomide

pergolide

lesinurad

naltrexone

crisaborole

didanosine

fenoterol (obsteric indications)

influenza vaccine (split virion, inactivated, prepared in cell


cultures)

# Classified as internal/staff contractors by the European Medicines Agency


benzoyl peroxide hydrous / potassium hydroxyquinoline sulphate
allogeneic T cells genetically modified with a retroviral vector
encoding for a truncated form of the human low affinity nerve
growth factor receptor (ΔLNGFR) and the herpes simplex I virus
thymidine kinase (HSV-TK Mut2)
allopurinol / lesinurad

cinoxacin

enoxacin

fluocinolone acetonide / framycetin

fluocinolone acetonide / ketocaine hydrochloride

interferon alpha-2b

erythromycin / isotretinoin, isotretinoin (topical formulations)

nalidixic acid

pipemidic acid

dihydroergocryptine

dihydroergotoxine

ispaghula husk, ispaghula husk/ ispaghula seed, ispaghula


husk/ispaghula seed/senna Tinnervelly pod, psyllium, psyllium
husk, psyllium seed

senna glycosides standardised 60%

eluxadoline

necitumumab

lidocaine

collagenase clostridium histolyticum (treatment of Dupuytren’s


contracture and treatment of Peyronie’s disease)

# Classified as internal/staff contractors by the European Medicines Agency


methionine

meningococcal group a and c polysaccharide vaccine

benzathine benzylpenicillin / procaine benzylpenicillin

furosemide / ramipril

cholic acid (CTX, AMACR or cholesterol 7α-hydroxylase deficiency


indication)

meningococcal group a, c, w135, y polysaccharide vaccine

alendronate / alfacalcidol

peramivir

alitretinoin (cutaneous use)

oxytocin

indoramin

quizartinib

fluticasone / salmeterol (for centrally authorised products)

ivabradine

carvedilol / ivabradine

strontium ranelate

benzocain / neomycin sulfate

stavudine

iron (parenteral preparations, except for iron dextran)

# Classified as internal/staff contractors by the European Medicines Agency


ingenol mebutate

hydrocortisone (except for products indicated in adrenal


insufficiency in a modified release tablet formulation)

rubella vaccine (live, attenuated)

technetium (99mtc) tiatide

rolapitant

rimexolone

ferric citrate coordination complex

chlorpropamide

lidocaine hydrochloride monohydrate / fludrocortisone acetate /


neomycin sulfate / polymyxin b

lidocaine / paraformaldehyde

lidocaine / pentosan polysulfate sodium / triamcinolone,


lidocaine / triamcinolone

lidocaine hydrochloride / neomycin sulfate / polymyxin b

pheniramine maleate / tetryzoline hydrochloride

ergocalciferol / retinol acetate

a-tocopherol / ergocalciferol / phytomenadion / retinol palmitate

calcium carbonate / sodium alginate / sodium bicarbonate

sodium alginate / sodium bicarbonate

sulfanilamide

adenosine 5' triphosphate / disodium salt

# Classified as internal/staff contractors by the European Medicines Agency


125i-human serum albumin

acetyldigoxin combinations

adenosine / cytochrome c / nicotinamide / sodium succinate /


sorbitol

adenosine 5' triphosphate / disodium salt / glycine

alpha amylase / bacitracin

alpha chymotrypsin

aluminium / calcium / sodium

aminocaproic acid / esculina / hesperidina metil chalcona /


menadiona / menadione sodium bisulfite

amylsalicylate / levomenthol / methylnicotinate

anatoxin staphylococcal native mixed alpha / beta and delta

benzalkonium chloride / oxymetazoline

benzylnicotinate / hydroxyethyl salicylate

dihydroergocristine / esculinum / rutoside

dihydroergocristine mesilate / raubasine

caffeine / dihydroergotamine / propyphenazone

dihydroergotoxin / hydrochlorothiazide / reserpine

anthracene glycosides / glycosides hidroxiantracénicos / iodine

lidocaine / matricariae extract

potassium / sodium / triclosan

# Classified as internal/staff contractors by the European Medicines Agency


codeine
ascorbic acid phosphate
/ calcium / promethazine /hydrochloride
hydrogenphosphate calcium panthotenate
/ colecalciferol / cyanocobalamin / folic acid / nicotinamide /
pyridoxine hydrochloride / retinol / riboflavine / thiamin nitrate,
ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide /
pyridoxine / retinol / riboflavin / thiamine hydrochloride, ascorbic
acid / colecalciferol / dexpanthenol / nicotinamide / pyridoxine /
retinol / riboflavin
a-tocopheryl / thiamine
acetate / retinol acetate

pyridoxine hydrochloride / retinol acetate / tocopheryl acetate

a-tocoferol acetate / aurantii aetheroleum / citri aetheroleum /


retinol palmitate / terpineol

sacarose / trioxymethylene

saccharomyces cerevisiae / sodium sulfate

sulfabenzamide / sulfacetamide / sulfathiazole

pyrimethamine / sulfalene

aminopropylone / sulodexide

sulphur / triclosan

oxydation product / terebenthin essential oil

calcium carbonate / magnesium carbonate / sodium bicarbonate

allethrin (isomers and mixtures of isomers) / piperonyl butoxide

cibenzoline

formaldehyde

pristinamycin

guanosine / inosine / miconazole nitrate / vitamin f

levonorgestrel

# Classified as internal/staff contractors by the European Medicines Agency


nilvadipine

phentermine

charcoal activated / sodium thiosulphate

androstanolone

acetyldigoxin

allobarbital / aminophenazone

allopurinol / benzbromarone

ambucetamide

amiloride / hydrochlorthiazide / methyldopa

aminaftone

amlodipine / benazepril

amoxicillin / metronidazole

amoxicillin trihydrate / clarithromycin / lansoprazole

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

azepentacene polysulfonate sodium

bacitracin / neomycin / prednisolone

# Classified as internal/staff contractors by the European Medicines Agency


benfotiamine / biotin / cyanocobalamin / pantothenic acid /
pyridoxine / retinol

benfotiamine / cyanocobalamin

benfotiamine / cyanocobalamin / pyridoxine

benfotiamine / caffeine / codeine / paracetamol / propyphenazone

benfotiamine / pyridoxine

benidipine

benzalkonium chloride / chloroxylenol / disodium edetate

benzatropine

benzonatate

brompheniramine maleate / codeine phosphate / guaifenesin

buclizine hydrochloride / cyanocobalamin / lysine hydrochloride /


pyridoxine hydrochloride / tryptophan

bupranolol

buprenorphine hydrochloride / salicylic acid

butalbital / paracetamol

butalbital / caffeine / paracetamol

butalbital / caffeine / codeine phosphate / paracetamol

butenafine

butriptyline

cafedrine

# Classified as internal/staff contractors by the European Medicines Agency


calamine

calcium / magnesium / phosphorus

cannabidiol (except for centrally authorised product)

carbenicillin

carbimide

carbinoxamine maleate / phenylephrine hydrochloride

carmellose (except for eye preparation)

adenine / benfotiamine / carnitine orotate / fructose / nicotinamide


/ pantothenic acid / potassium orotate / pyridoxine / riboflavin /
xanthine

cefcapene

cefpiramide

cefsulodin

cefteram

ceftezole

cefapirin

cerivastatin

benzoyl peroxide / cetylpyridinium chloride

chlormadinone / estradiol

chlornitrofenol

chlorobutanol / levomenthol / pine oils / terpineol / thymol

# Classified as internal/staff contractors by the European Medicines Agency


chlorothiazide

chloroxylenol / disodium edetate

chlorphenamine maleate / hydrocodone bitartrate / phenylephrine


hydrochloride

chlorphenamine maleate / hydrocodone polistirex

chlorphenamine maleate / paracetamol / phenylephrine


hydrochloride / phenyltoloxamine citrate

chlorproethazine

chlortetracycline / demeclocycline / tetracycline

chlorxylenol / cinchocaine

chlorzoxazone / paracetamol

cilastatin

bismuth subgallate / cinchocaine hydrochloride / oxidised cellulose


calcium salt

clofibrate

clorazepate / pyridoxine

codeine / creosote

codeine / diphenhydramine

codeine / ephedrine hydrochloride / guaifenesin

codeine polysulfonate / guaifenesin / phenyltoloxamine

codeine polysulfonate / guaifenesin / phenyltoloxamine / thyme

codeine polysulfonate resin

# Classified as internal/staff contractors by the European Medicines Agency


cyanocobalamin / folic acid / nicotinamide / pantothenic acid /
pyridoxine hydrochloride / riboflavin / thiamine nitrate

cyproheptadine hydrochloride / dimethylaminoethanol


acetylglutamate / metoclopramide hydrochloride

dantrone / poloxamer

delavirdine

dexbudesonide

dexetimide

dextranomer

dextromethorphan hydrobromide / phenylpropanolamine


hydrochloride

dextromethorphan hydrobromide / guaifenesin / pseudoephedrine


hydrochloride

dextromethorphan hydrobromide / guaifenesin / paracetamol /


pseudoephedrine hydrochloride

chlorphenamine / dextromethorphan hydrochloride /


phenylephrine hydrochloride

dibenzepine

diclofenac / gentamicin

diclofenac / tobramycin

diclofenac sodium / lidocaine

dipivefrine

dipivefrine hydrochloride / guanethidine

docusate

doxercalciferol

# Classified as internal/staff contractors by the European Medicines Agency


erythromycin

ethambutol / isoniazid

ethambutol / isoniazid / rifampicine

etoperidone

etynodiol / mestranol

fenbufen

fendiline

flurithromycin

guaifenesin / hydrocodone

guaifenesin / pentoxyverine

hyaluronate zinc

hydrochlorothiazide / methyldopa

hydrochlorothiazide / reserpine / triamterene

hydrocodone

homatropine methylbromide / hydrocodone bitartrate

hydrocodone bitartrate / ibuprofen

hydrocodone bitartrate / paracetamol

guaifenesin / hydrocodone bitartrate / phenylephrine


hydrochloride

hydrocodone bitartrate / phenyltoloxamine citrate

# Classified as internal/staff contractors by the European Medicines Agency


escherichia coli / hydrocortisone acetate

atropine / hydromorphone

calcium oxide / ichthammol / potassium aluminium sulfate /


salicylic acid / sodium perborate

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 / methylene blue

methenamine / phenazopyridine

acetylsalicylic acid / methocarbamol

methyl diethylacetylsalicylate

methylprednisolone acetate / neomycin sulfate

metipamide

metizoline

metronidazole / minocycline / nystatine

mitiglinide

# Classified as internal/staff contractors by the European Medicines Agency


mofebutazone

morphine sulfate / naltrexone hydrochloride

nafcillin

naloxone hydrochloride / pentazocine hydrochloride

neomycin / phenylephrine / polymyxin b

norfenefrine

nystatin / triamcinolone

oxiglutatione

parethoxycaine

pentosan polyester / phenylephrine

pentoxyverine hydrogen citrate / terpine hydrate

phenazone / tetracaine

oxytetracycline / phenazopyridine hydrochloride / sulfamethizole

phendimetrazine

glibenclamide / phenformin hydrochloride

guaifenesin / phenylephrine hydrochloride

isoprenaline / phenylephrine hydrochloride

phenylephrine hydrochloride / promethazine hydrochloride

phenylsalicylate

# Classified as internal/staff contractors by the European Medicines Agency


paracetamol / phenyltoloxamine citrate

phosphorus (32p) sodium phosphate / sodium carbonate

betaxolol / pilocarpine

poliovirus type 1 (oral, live, attenuated) vaccine

poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine


(oral, live, attenuated)

poliovirus type 2 (oral, live, attenuated) vaccine

poliovirus type 3 (oral, live, attenuated) vaccine

pranlukast

prenoxdiazine

progabide

quinaprilat

rebamipide

reserpine

rofecoxib

rokitamycin

rosoxacin

sermorelin

streptodornase

tegaserod

# Classified as internal/staff contractors by the European Medicines Agency


thenoate sodium

teprenone

terconazole

terguride

thyroglobulin

tiotixene

tolazamide

tolmetin

vidarabine

boceprevir

carbidopa / levodopa (for centrally authorised product)

olaratumab

enoxaparin (biosimilars)

enoxaparin (except for biosimilars)

poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine

F(ab’)2 fragments of equine antirabies immunoglobulin

fenspiride

benzathine phenoxymethylpenicillin

daclatasvir

# Classified as internal/staff contractors by the European Medicines Agency


dihydroergotamine / etilefrine

etanercept (except for biosimilars)

ertugliflozin / metformin

ertugliflozin / sitagliptin

etanercept (biosimilars)

zafirlukast

adalimumab (biosimilars)

adalimumab (except for biosimilars)

ursodeoxycholic acid

pramocaine

amlodipine besilate / ramipril

chenodeoxycholic acid (for gallstone dissolution)

dasabuvir

hydrochlorothiazide / ramipril

hydrocortisone acetate / pramocaine hydrochloride

malathion / permethrin / piperonyl butoxide

ombitasvir / paritaprevir / ritonavir

tauroursodeoxycholic acid

antithrombin alpha

# Classified as internal/staff contractors by the European Medicines Agency


ethinylestradiol / gestodene (transdermal application)

levofloxacin (except for the centrally authorised product)

ofatumumab

acetylcysteine / tuaminoheptane

colchicine / dicycloverine hydrochloride

colchicine / probenecid

dicycloverine hydrochloride / metochalcone / procaine


hydrochloride

aluminium oxide hydrated / dicycloverine hydrochloride /


magnesium oxide light / simeticone

fluorometholone / tetryzoline

fluorometholone / urea

retapamulin

infliximab (biosimilars)

infliximab (except for biosimilars)

lubiprostone

amidotrizoic acid

aluminium salicylate / sulfaguanidine

amfetamine aspartate / amfetamine sulfate / dexamfetamine


saccharate / dexamfetamine sulfate

biodastase / dehydrocholic acid / lipase / papain / procaine


hydrochloride

calcium / dexamethasone / lidocaine

# Classified as internal/staff contractors by the European Medicines Agency


calcium / lidocaine

calcium carbonate / simeticone

calcium dobesilate / dexamethasone / lidocaine

calcium dobesilate / lidocaine

pegaptanib

ibuprofen / isopropyl myristate

lysine amidotrizoate / sodium amidotrizoate

meglumine amidotrizoate / sodium amidotrizoate

metaxalone

metoxybutropate

pipobroman

polycarbophil

acetylsalicylic acid / magnesium hydroxide

albiglutide

amrinone

calcium pantothenate / dimeticone / magnesium


polygalacturonate

chloramphenicol / medroxyprogesterone / tetryzoline

chloramphenicol / methyluracil

choline magnesium trisalicylate

# Classified as internal/staff contractors by the European Medicines Agency


coprecipitate of aluminium hydroxide / magnesium carbonate

cromoglicate sodium / tetryzoline hydrochloride

dienestrol

diphenhydramine hydrochloride / naphazoline hydrochloride /


neomycin sulfate

estradiol / gestodene

estrogen / methyltestosterone

estrone sodium sulfate

ethinylestradiol / etynodiol

ethinylestradiol / lynestrenol

ethinylestradiol / norgestrel

fluorometholone / gentamicin

fluorometholone / miconazole nitrate / neomycin sulfate

fluorometholone acetate / tobramycin

heptaminol

magnesium peroxide

mebhydroline

medroxyprogesterone acetate / tetryzoline hydrochloride

metipranolol

metipranolol hydrochloride / pilocarpine hydrochloride

# Classified as internal/staff contractors by the European Medicines Agency


oxamniquine

oxandrolone

oxymetholone

pegademase

pimethixene

polyestradiol

polythiazide

polythiazide / reserpine

pramocaine hydrochloride / zinc sulfate

prednisolone acetate / sulfacetamide sodium

sodium bicarbonate / sodium citrate / sodium fluoride

sodium bromide

ribavirin (aerosol application)

fentanyl (transdermal system - centrally authorised product)

aluminium lactate / benzydamine

bacitracin / colistimethate sodium / hydrocortisone acetate

cobamamide / cyproheptadine

copper acetate / lactic acid / salicylic acid

olpadronic acid

# Classified as internal/staff contractors by the European Medicines Agency


ticarcillin

amyl nitrite

chloramphenicol / collagenase

chlorcyclizine hydrochloride / cinnarizine

cilnidipine

clemastine fumarate / phenylpropanolamine hydrochloride

clocinizine / phenylpropanolamine hydrochloride

co-danthrusate

desipramine

eptotermin alpha

fructose

ibacitabine

influenza vaccine (split virion, inactivated) (centrally authorised


products only)

acebutolol / mefruside

acebutolol / nifedipine

acepromazine / aceprometazine / clorazepate dipotassium

acetylsalicylic acid / carisoprodol

actinoquinol / oxedrine tartrate

activated attapulgite / attapulgite / morphine hydrochloride

# Classified as internal/staff contractors by the European Medicines Agency


aluminium hydroxide / attapulgite / kaolin / pectin

amineptine

amylocaine hydrochloride / dodeclonium bromide

avobenzone / ensulizole / octisalate

azintamide / hyoscine

benzalkonium chloride / furazolidone

bile-dispert / pancreatin

bretylium

broxaterol

buformin

butorphanol

buzepide metiodide / haloperidol

caffeine / carisoprodol / diclofenac sodium / paracetamol

calcium pidolate

camostat

carisoprodol

carisoprodol / paracetamol

carmofur

carmoisine

# Classified as internal/staff contractors by the European Medicines Agency


carmoisine / paracetamol

centella extract / hydrocortisone acetate / neomycine

cetylpyridinium / dequalinium chloride

cevimeline

chymopapain

cinnarizine / heptaminol acefylline

corticotropin

cyanocobalamin / hydroxocobalamin

cyclandelate

d,l-1-(p-hydroxyphenyl)-propylamine hydroiodide / muramidase


hydrochloride / thonzylamine hydrochloride

dalfopristin / quinupristin

denileukin diftitox

deslanoside

dextromoramide

dimefline

diphemanil

dipivefrine hydrochloride / pilocarpine hydrochloride

dipotassium clorazepate / gabob / pyridoxine hydrochloride

diprophylline / oxidation product / terebenthin essential oil

# Classified as internal/staff contractors by the European Medicines Agency


diprophylline / proxyphylline / theophylline

disodium inosinate

dixyrazine

domiphen

drofenine / propyphenazone

dronabinol

eledoisin

embramine

emetine

epervudine

equilin sulfate sodium / estrone sodium sulfate

estropipate

eszopiclone

ethylmorphine hydrochloride / indometacin

etofylline / hexobendine

etretinate

fluocortin

framycetin sulfate / oxedrine / polymyxin b sulphate

fursultiamine / riboflavin

# Classified as internal/staff contractors by the European Medicines Agency


gastric mucin

glibornuride

gramicidin / neomycin

gramicidin s / framycetin sulfate / polymyxin b sulfate

ibudilast

iopanoic acid

edrophonium

prenoxdiazine

propacetamol

proscillaridin

quinfamide

resorcinol / sulphur

sibutramine

sivelestat

sodium aurothiosulfate

sodium bromebrate

sodium medronate / stannous fluoride

sodium pidolate

stannous fluoride

# Classified as internal/staff contractors by the European Medicines Agency


sulesomab

tedisamil

tinidazole / tioconazole

ascorbic acid / macrogol 3350 / potassium chloride / sodium


ascorbate / sodium chloride / sodium sulphate

hydroxocobalamin (except for products for chemical poisoning)

macrogol 3350 / potassium chloride / sodium bicarbonate / sodium


chloride

macrogol 3350 / potassium chloride / sodium sulphate anhydrous /


sodium chloride / sodium hydrogen carbonate

retigabine

sodium fluoride

amylocaine hydrochloride / sodium benzoate

catalase

catalase / neomycin

cellulase

cetalkonium / lidocaine

chlorquinaldol / hydrocortisone butyrate

cicletanine

clofoctol

desoxycortone acetate

dimecrotate magnesium

# Classified as internal/staff contractors by the European Medicines Agency


eperisone

ephedrine hydrochloride / naphazoline nitrate

ethionamide

fenoldopam

fluoride sodium / strontium acetate hemihydrate

gramicidin / naphazoline / neomycin / phenylephrine

halcinonide

hydroxocobalamin / pyridoxine / thiamine

ibopamine

metixene

naphazoline nitrate / thonzylamine hydrochloride

procaterol

rociverine

takadiastase

alitretinoin

rabbit anti-human T-lymphocyte immunoglobulin (powder for


solution for infusion)

acetylaminonitropropoxybenzene

acetylleucine

aconitine / histamine disalicylate

# Classified as internal/staff contractors by the European Medicines Agency


acriflavinium chloride / menthol / resorcinol

algeldrate, algeldrate / magnesium hydroxide

alibendole

altizide

amezinium

amilomer

aminoglutethimide

aminohippurate

aminotridecane undecylenate

ampicillin / flucloxacillin

azulenolum

barbexaclone

benexate

benorilate

bopindolol

buclizine

cadralazine

calcium carbonate / magnesium carbonate

cortivazol

# Classified as internal/staff contractors by the European Medicines Agency


detajmium

ditazole

flavodate

glycol salicylate / methyl nicotinate

idrocilamide

iotrolan

lidoflazine

limaprost

linsidomine

mabuprofen

matrix-applied characterised autologous cultured chondrocytes

mitoguazone

nimorazole

nitrogen

nonivamide

oxilofrine

oxitropium

oxymetazoline hydrochloride / prednisolone sodium phosphate

pemoline

# Classified as internal/staff contractors by the European Medicines Agency


pipazetate

pipotiazine

pitofenone

ramelteon

stanozolol

thioproperazine

triclabendazole

trimethobenzamide

tropatepine

troxipide

tulobuterol

unoprostone

valethamate

vasopressin

viloxazine

viminol

voglibose

vorinostat

xantinol nicotinate

# Classified as internal/staff contractors by the European Medicines Agency


zalcitabine

simeprevir

flupirtine

acetylsalicylic acid / ibuprofen

benzathine benzylpenicillin / lidocaine hydrochloride

cefonicid / lidocaine hydrochloride

cetylpyridinium chloride / dichlorobenzyl alcohol / lidocaine


hydrochloride

indometacin / methocarbamol

lidocaine hydrochloride / metacresol / paraformaldehyde

lidocaine hydrochloride / phenylbutazone

lidocaine hydrochloride / phenylephrine hydrochloride / sodium


propionate

lidocaine hydrochloride / piperacillin sodium

lidocaine hydrochloride / tolperisone hydrochloride

pheniramine

acediasulfone

acediasulfone / cinchocaine / dihydroxymethyl carbamide

alfoscerate olamine

aloxiprin

benzethonium chloride

# Classified as internal/staff contractors by the European Medicines Agency


benzfetamine

calcium phosphate / cyanocobalamin / cyproheptadine


hydrochloride

coal tar, distilled coal tar

coal tar / menthol

coconut oil / distilled coal tar / salicylic acid, coal tar solution /
salicylic acid / sulfur

cholecalciferol concentrate / sodium fluoride

colchicine / opium / tiemonium

delapril

distilled coal tar / lecithin

mebutizide

reviparin

trilostane

abarelix

peramivir

prasterone

tiemonium

telavancin

ipecacuanha / potassium sulfoguaiacolate / promethazine

nesiritide

# Classified as internal/staff contractors by the European Medicines Agency


aceclidine

ammonium chloride / dextromethorphan hydrobromide /


diphenhydramine hydrochloride / pseudoephedrine hydrochloride

benzocaine / chlorobutanol

caffeine / propyphenazone

calcium carbonate / vitamin d / zinc

chlorphenamine maleate / hyoscine methobromide /


pseudoephedrine hydrochloride

cimetidine / sodium alginate

cineole / codeine phosphate

cineole / thymol

clorprenaline / codeine / pseudoephedrine

colistimethate sodium / erythromycin lactobionate

daclizumab

caffeine (apnea, centrally authorised product only)

estradiol (17-beta) / trimegestone

lactobacillus acidophilus

metformin hydrochloride / sitagliptin

sitagliptin

triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/
with or without mineral compounds/electrolytes (i.v. application)

acetylsalicylic acid / pseudoephedrine hydrochloride

# Classified as internal/staff contractors by the European Medicines Agency


pseudoephedrine

a-tocopherol / ascorbic acid / cupric oxide / sodium selenate /


vitamin a / zinc oxide

boric acid / guaiazulen / ichthammol / zinc oxide

brompheniramine / pseudoephedrine

calcium levomefolate / mecobalamin / pyridoxal phosphate

carbethopendecinium bromide / ephedrine hydrochloride

carbinoxamine maleate / pseudoephedrine hydrochloride

cefdinir

clocortolone hexanoate / clocortolone pivalate

estradiol / norgestimate

glaucine hydrobromide / pseudoephedrine hydrochloride

insulin porcine

iotalamic acid

lisuride

loperamide

loperamide hydrochloride / simeticone

macrogol 3350 / potassium chloride / sodium chloride / sodium


bicarbonate / potassium sulfate

chlorphenesin
adenosine / allopurinol / glutathione / lactobionic acid / magnesium
sulphate / poly (0-2-hydroxyethyl) starch (pentafraction) /
potassium dihydrogen phosphate / potassium hydroxide / raffinose
/ sodium hydroxide

# Classified as internal/staff contractors by the European Medicines Agency


azoximer bromide

brompheniramine

dolasetron

ketanserin

methyl salicylate / levomenthol

methyl salicylate / levomenthol / DL-camphor

catumaxomab

desirudin

alipogene tiparvovec

gadoversetamide

influenza vaccine (surface antigen, inactivated, prepared in cell


cultures)

influenza vaccine (surface antigen, inactivated, virosome)

mestranol / norethisterone

hepatitis A vaccine (inactivated, virosome)

dihydroergocristine

bemetizide / triamterene

ebastine / pseudoephedrine

fish oil / olive oil / soybean oil / triglycerides medium-chain

clodronic acid

# Classified as internal/staff contractors by the European Medicines Agency


ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)

vorapaxar

roxatidine

tiludronic acid

eucalyptol

tropisetron

calcium chloride dihydrate / lactic acid / magnesium chloride


hexahydrate / sodium chloride / sodium hydrogen carbonate

benzalkonium chloride / isopropyl myristate / paraffin liquid

pancreas powder (centrally authorised product only)

buflomedil

influenza vaccine (H1N1)ν (split virion, inactivated, adjuvanted)

alcium chloride dihydrate / magnesium chloride hexahydrate /


malic acid / sodium acetate trihydrate / sodium chloride /
potassium chloride

bismuth subnitrate / lidocaine / zinc oxide

cefminox

chondroitin

chondroitin / glucosamine

D-camphor / hydroxyethyl salicylate / levomenthol / methyl


salicylate

dornase alpha / fibrinolysin

fructose / glycerin

# Classified as internal/staff contractors by the European Medicines Agency


glycerine

hexamidine / tetravacaine

icodextrin

methysergide

testosterone undecanoate (injection)

testosterone (all formulations apart from topical use and


testosterone undecanoate injection)

tetrazepam

zinc oxide

caffeine / ephedrine sulfate / promethazine hydrochloride

sodium oxybate

acetic acid / calcium chloride / glucose anhydrous / magnesium


chloride / potassium chloride / sodium chloride
acetic acid glacial / calcium chloride dihydrate / glucose
monohydrate / magnesium chloride hexahydrate / potassium
chloride / sodium chloride / sodium dihydrogen phosphate
dihydrate / sodium hydrogen carbonate
acetylsalicylic acid / pravastatin

arsenic trioxide / ephedrine hydrochloride / lidocaine

benzocaine / chlorhexidine

benzocaine / chlorhexidine / tyrothricin

calcium chloride / glucose / potassium chloride / sodium chlorid /


sodium lactate / sodium saccharin

chlorhexidine gluconate / oxybuprocaine hydrochloride

chlorhexidine gluconate / tetracaine hydrochloride

# Classified as internal/staff contractors by the European Medicines Agency


chondroitin sulphate sodium / sodium hyaluronate

fexofenadine combinations

glucosamine / lidocaine

human albumin solution

human plasma proteins with not less than 96% albumin

mangafodipir

methyl salicylate bp / octafonium chloride / phenol / zinc oxide

lactobacillus rhamnosus

lactobacillus acidophilus

lactobacillus fermentum / lactobacillus rhamnosus / lactobacillus


salivarius / lactobacillus vaginalis

guaifenesin / salbutamol sulfate

hydrochlorothiazide / irbesartan

irbesartan

propiomazine

sulfametrole / trimethoprim, sulfadiazine trimethoprim

palifermin

hetastarch / sodium chloride

elvitegravir

co-trimoxazole

# Classified as internal/staff contractors by the European Medicines Agency


bendroflumethiazide / hydralazine / propanolol

clarithromycin / lansoprazole / tinidazole

amyleine / chlorhexidine

bacitracin / chlorhexidine

bendroflumethiazide

benzalkonium chloride / chlorhexidine dihydrochloride / isopropyl


myristate / paraffin liquid

collagen

collagenase clostridium histolyticum (all indications except for


treatment of Dupuytren’s contracture and Peyronie’s disease)

characterised viable autologous cartilage cells expanded ex vivo


expressing specific marker proteins

benzylnicotine / camphora / dimethyl sulphate / turpentine oil

dinutuximab

budesonide / formoterol (apart from centrally authorised products)

budesonide / formoterol (only centrally authorised products)

chlorhexidine / hydrocortisone

chlorhexidine / sodium fluoride

chlorhexidine / tolnaftate

chlorhexidine hydrochloride / hydrocortisone acetate / nystatin

chlorhexidine hydrochloride / nystatin

mycobacterium bovis

# Classified as internal/staff contractors by the European Medicines Agency


dextromethorphan hydrobromide / salbutamol sulfate

oagulation factor ii / human coagulation factor ix / human


coagulation factor vii / human coagulation factor x / protein c

calcium carbonate / etidronate disodium

chelidonium majus L., herba

cyanocobalamin / dexamethasone / lidocaine hydrochloride /


thiamine

dehydrocholic acid / homatropine / papaverine

ferucarbotran

fusafungine

rimantadine

nicotinic acid

oxedrine

oxybuprocaine hydrochloride / tetracaine hydrochloride

penamecillin

phenolphthalein

poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine

sulfamethoxazole

aluminium oxide / hydrated / magnesium hydroxide / oxetacaine

antazoline phosphate / naphazoline hydrochloride / zinc sulfate

biclotymol / cineole / pholcodine

# Classified as internal/staff contractors by the European Medicines Agency


charcoal activated / magnesium hydroxide

chlorhexidine gluconate / oxedrine tartrate

chlorhexidine hydrochloride / phenobarbital / valerian extract

enterococcus faecalis / escherichia coli / klebsiella pneumoniae /


morganella morganii / proteus mirabilis

ethanolic extracts of camellia sinensis (L.) kuntze, non


fermentatum folium

influenza vaccine (H1N1)ν (split virion, inactivated)

meprobamate

mercaptamine

oxetacaine

influenza vaccine (H1N1)ν (whole virion, inactivated, prepared in


cell culture)

nitrous oxide

naphazoline hydrochloride / pheniramine maleate

naphazoline

methotrexate (for centrally authorised product)

calcium glycerophosphate / magnesium gluconate

carbasalate calcium / metoclopramide

enoxaparin

lysine acetylsalicylic acid / metoclopramide

sulfametrole / trimethoprim

# Classified as internal/staff contractors by the European Medicines Agency


phenothrin / piperonyl butoxide

betamethasone sodium phosphate / framycetin sulfate

sulpiride

mycophenolate mofetil

mycophenolic acid (apart from mycophenolate mofetil)

morphine

ascorbic acid / calcium

benzalkonium chloride / cetrimide

betacarotene / vaccinium myrtillus anthocyanosides

factor x / human coagulation factor ix / human coagulation factor


vii / protein c / protein s / prothrombin

ferumoxsil (siloxane coated superparamagnetic ironoxide)

itopride

olanzapine

olanzapine pamoate

coconut oil / distilled coal tar / salicylic acid

diazepam / sulpiride

urea

lisinopril

pegloticase

# Classified as internal/staff contractors by the European Medicines Agency


hydrochlorothiazide / lisinopril

telaprevir

acidic acid / nitric acid / oxolinic acid / zinc nitrate

ajmaline

ammonium chloride / diphenhydramine hydrochloride

borax / calcium carbonate / cholecalciferol / copper oxide /


magnesium oxide / manganese sulfate / zinc oxide
calcium levulinate / cetylpyridinium chloride / diphenhydramine
hydrochloride / essential sage oil / panthenol / phenylephrine
hydrochloride

cineole / gaiacol / pholcodine

codeine phosphate / ibuprofen / paracetamol

hypericin

lidocaine / zinc oxide

nicotinic acid / simvastatin

tegafur / uracil

dequalinium

dequalinium chloride / lidocaine

diphenhydramine

diphenhydramine hydrochloride / levomenthol

levobunolol

magnesium / potassium / sodium / water for injection

# Classified as internal/staff contractors by the European Medicines Agency


spirapril

dutasteride / tamsulosin hydrochloride

sodium molybdate [99mo] / sodium pertechnetate [99mtc]

pyridoxin / thiamine

dutasteride

ascorbic acid / rutoside

artemether / lumefantrin (dispersible tablet)

delapril / manidipine

calcium chloride / icodextrin / magnesium chloride / sodium


chloride / sodium lactate

azithromycin

ambroxol / doxycycline

ascorbic acid / cyanocobalamin / ergocalciferol / nicotinamide /


pyridoxine / retinol / riboflavin / thiamine hydrochloride

bromhexine / oxymetazoline

citric acid / epoetin alpha / human albumin / sodium chloride /


sodium citrate

histrelin

human coagulation factor xiii / human fibrinogen

influenza vaccine (H1N1)ν (surface antigens, inactivated,


adjuvanted)

influenza vaccine (H1N1)ν (surface antigens, inactivated, prepared


in cell cultures, adjuvanted)

lansoprazole / metronidazole / tetracycline

# Classified as internal/staff contractors by the European Medicines Agency


leucocytes dialysate

selenomethionine (75Se)

thrombin

almagate

erythromycin / isotretinoin

isotretinoin

dextromethorphan hydrobromide / quinidine sulfate (treatment of


pseudobulbar affect (PBA))

fosinopril

fosinopril / hydrochlorothiazide

thiocolchicoside

paracetamol / thiocolchicoside

metopimazine

estradiol

terfenadine

parathyroid hormone (rdna)

dienogest / estradiol

alfatradiol

almitrine

betamethasone / dexchlorpheniramine maleate

# Classified as internal/staff contractors by the European Medicines Agency


butizide / spironolactone

calcium chloride dihydrate / glucose / potassium chloride / sodium


chloride

calcium chloride dihydrate / glucose monohydrate

calcium chloride dihydrate / glucose monohydrate / sodium


chloride

calcium chloride dihydrate / potassium chloride / sodium chloride

chlortalidone / spironolactone

'dexbrompheniramine / pseudoephedrine

dexchlorpheniramine / guaiafenesin / pseudoephedrine

dexchlorpheniramine / pseudoephedrine

galactose

glucose

glucose / potassium chloride

glucose / potassium chloride / sodium chloride / sodium citrate

glucose / sodium chloride

linagliptin

linagliptin / metformin

dibrompropamidine

trapidil

empagliflozin

# Classified as internal/staff contractors by the European Medicines Agency


tacrolimus (systemic formulations) - for CAP Envarsus

tocopherol / tretinoin

tioconazole

phenylephrine

nystatin / tinidazole

tinidazole

beclometasone dipropionate / formoterol fumarate

calcium carbonate / colecalciferol

calcium phosphate / colecalciferol

macrogol 4000

'macrogol 4000 and combinations

macrogol 4000 / potassium chloride / sodium bicarbonate / sodium


chloride / sodium sulfate anhydrous

rosiglitazone

valsartan

hydrochlorothiazide / valsartan

budipine

cidofovir

ferumoxytol

floctafenine

# Classified as internal/staff contractors by the European Medicines Agency


human fibrinogen / human thrombin (all pharmaceutical dose
forms except for sealant matrix)

raltegravir

amitriptyline

amitriptylinoxide

amitriptyline / amitriptylinoxide

colestilan

bacterial lysate

allergen diagnostics: all prick and provocation tests of all species;


intracutan tests (allergens)

allergen products for treatment: epithelia and feathers, single or


mixes (parenteral preparations) native

allergen products for treatment: grass and cereal pollen, single or


mixes (oral preparations, solid forms) native

allergen products for treatment: grass and cereal pollen, single or


mixes (parenteral preparations) allergoid

allergen products for treatment: grass and cereal pollen, single or


mixes (parenteral preparations) native

allergen products for treatment: insects venoms (parenteral


preparations) native

allergen products for treatment: mites, single or mixes (oral


presentation- liquid and semi-solid forms) native

allergen products for treatment: mites, single or mixes (parenteral


preparations) allergoid

allergen products for treatment: mites, single or mixes (parenteral


preparations) native

allergen products for treatment: moulds, single or mixes


(parenteral preparations) native

allergen products for treatment: tree pollen, single or mixes (oral


presentation – liquid and semi-solid forms) native

allergen products for treatment: tree pollen, single or mixes


(parenteral preparations) allergoid

# Classified as internal/staff contractors by the European Medicines Agency


allergen products for treatment: tree pollen, single or mixes
(parenteral preparations) native

allergen products for treatment: weed pollen, single or mixes (oral


presentation – liquid) native

allergen products for treatment: weed pollen, single or mixes


(parenteral preparations) allergoid

allergen products for treatment: weed pollen, single or mixes


(parenteral preparations) native

allergens from vertebrates, single or mixes (parenteral


presentations) native
products used in connection with allergen diagnostics: products for
positive and negative control for allergy prick tests and negative
control for allergy provocation tests; diluents (no active substance)
for prick test and treatment products; positive and negative
control for intracutan tests
guanfacine

dimethyl fumarate / ethyl fumarate calcium / ethyl fumarate


magnesium / ethyl fumarate zinc
autologous peripheral-blood mononuclear cells activated with
prostatic acid phosphatase granulocyte-macrophage colony-
stimulating factor (sipuleucel-T)

amlodipine / indapamide

amlodipine / indapamide / perindopril

budipine

adrafinil

human fibrinogen / human thrombin (sealant matrix)

phloroglucinol / trimethylphloroglucinol

phloroglucinol

niaprazine

misoprostol (gynaecological indication)

mazindol

# Classified as internal/staff contractors by the European Medicines Agency


human spongiosa

human fascia lata collagen

ferumoxtran-10 (superparamagnetic ironoxide)

ferumoxides

chlorphenamine / dexchlorpheniramine / pseudoephedrine

carmustine

caffeine / dexchlorpheniramine / dextromethorphan

atorvastatin (paediatric indication)

atorvastatin (adult indication)

aprotinin / human fibrinogen / thrombin (calcium chloride)

aprotinin / fibrinogen / fibronectin / human coagulation factor XIII /


plasma protein fraction / plasminogen / thrombin

aprotinin / calcium chloride / human factor xiii / human fibrinogen /


human thrombin

codergocrine mesilate

ibuprofen lysine

ibuprofen

sodium bicarbonate

diclofenac (ophtalmic formulations)

diclofenac (cutaneous formulations)

amlodipine / valsartan

# Classified as internal/staff contractors by the European Medicines Agency


amlodipine / hydrochlorothiazide / valsartan

aluminium / calcium or aluminium / magnesium

acidic acid / nitric acid / oxalic acid / zinc nitrate

pegaspargase

crisantaspase (erwinia L-asparaginase)

cilazapril / hydrochlorothiazide

bromhexine / ephedrine

anise oil / bromhexine / fennel oil / levomenthol

ambroxol hydrochloride / theophylline

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

caffeine / opium / paracetamol

hydroxyzine

doripenem

camphor / eucalyptus oil / menthol / thymol / turpentine oil

camphor / eucalyptus oil / menthol / turpentine oil

camphor / menthol

camphor / ichtamol

# Classified as internal/staff contractors by the European Medicines Agency


sodium salt of gamma-hydroxybutyric acid

bendroflumethiazide / spironolactone

nelfinavir

chlorazepate

cetylpyridinium chloride / muramidase hydrochloride

calcium pantothenate / dl-methionine / l-cystine / pa / pyridoxine


hcl / thiamine hcl

benztropine mesylate

benfotiamine / calcium hydrogen phosphate dihydrate /


magnesium estearate

benfotiamine / calcium hydrogen phosphate dihydrate /


cyanocobalamin / magnesium estearate / pyridoxine

ammonium salt / glycine / glycyrrhizic acid / l-station sun cysteine


hydrochloride hydrate

aluminium hydroxide dried / magnesium hydroxide / simeticone

benzalkonium chloride / potassium alum

sodium ferrous citrate

sodium ferric gluconate complex

iron / sodium feredetate

folic acid / iron

ferrous sulphate / folic acid

ferrous sulfate / serine

ferrous sulfate

# Classified as internal/staff contractors by the European Medicines Agency


ferrous salts

ferrous lactate

ferrous glycine sulfate

ferrous gluconate

ferrous fumarate

ferrous aspartate

ferric polymaltose / folic acid

ferric hydroxide sucrose complex

dextriferron

cyanocobalamin / ferrous sulfate / folic acid

cyanocobalamin / dl-serine / ferrous sulfate / folic acid

copper gluconate / ferrous gluconate / manganese gluconate


chromium trichloride hexahydrate / copper chloride dihydrate /
ferric chloride hexahydrate / manganese chloride tetrahydrate /
potassium iodide / sodium fluoride / sodium molybdate dihydrate /
sodium
calcium selenite / water/ copper
panthotenate for injection / zinc chloride
/ d /l-methionine / faex medicinalis /
iron / l-cystine / milium semen extract / paraaminobenzoic acid /
pyridoxine hydrochloride / thiamine hydrochloride / triticum germs
extract / zinc
calcium folinate / iron protein succinylate

ascorbic acid / ferrous sulfate


ascorbic acid / calcium hydrogenphosphate / calcium panthotenate
/ colecalciferol / copper sulfate / cyanocobalamin / ferrous
fumarate / folic acid / magnesium lactate / manganese sulfate /
nicotinamide
ascorbic acid // pyridoxine
betacarotene hydrochloride / retinol / riboflavine /
/ biotine / calcium
sodium molybdenate/ /colecalciferol
hydrogenphosphate thiamin nitrate / tocopherol
/ copper sulfateacetate
/ / zinc
sulfate
cyanocobalamin / ferrous sulfate / folic acid / ginseng radix extract
/ magnesium oxide / manganese sulfate / nicotinamide /
pyridoxine
ascorbic acidhydrochloride / riboflavine / sodium
/ calcium hydrogenphosphate selenate
/ calcium / thiamin
lactate /
nitrate / tocopherol alpha dl acetate / zinc sulfate
calcium panthotenate / colecalciferol / cyanocobalamin / ferrous
fumarate / folic acid / nicotinamide / pyridoxine hydrochloride /
retinol palmitate / riboflavine / thiamin nitrate / tocoferol acetate

# Classified as internal/staff contractors by the European Medicines Agency


ascorbic acid / calcium fluoride / calcium hydrogenphosphate /
calcium panthotenate / copper sulfate / cyanocobalamin / deanol
hydrogentartrate / ergocalciferol / ferrous sulfate / ginseng radix
extract / lecithine / magnesium sulfate / manganese sulfate /
nicotinamide / potassium sulfate / pyridoxine hydrochloride /
ammonium molybdate
retinol palmitate tetrahydrate
/ riboflavine / chromium
/ rutoside trichloride
/ soy lecithine / thiamine
hexahydrate / cobaltalpha
nitrate / tocopherol gluconate / copper
dl acetate gluconate
/ zinc oxide / ferrous
gluconate / manganese gluconate / sodium fluoride / sodium
iodide / sodium selenite / zinc gluconate
valpromide

divalproex sodium

valproic acid

alphatocopherol / ascorbic acid / betacarotene / cyanocobalamin /


extractum ginseng / ferrous fumarate / nicotinamide / pyridoxine
hydrochloride / thiamine mononitrate

methotrimeprazine

diacethyl-midecamycin

aliskiren / amlodipine / hydrochlorothiazide

anti-human t-lymphocyte immunoglobulin from rabbits

desvenlafaxine

diphtheria / tetanus / pertussis (whole cell) and hepatitis B(Rdna)


(Hbv) vaccine (adsorbed)

iobitridol

prepandemic influenza vaccine (H5N1) (split virion, inactivated,


adjuvanted)

docosahexaenoic acid / eicosapentanoic acid

human albumin solution

laropiprant / nicotinic acid

metformin hydrochloride / rosiglitazone

rilonacept

# Classified as internal/staff contractors by the European Medicines Agency


tetrofosmin

articaine hydrochloride / ephedrine

alogliptin / metformin

porfimer

flupirtine

clarithromycin

doconexent / eicosapentaenoic acid / omega-3 acid ethyl esters

testosterone enantate injection

carbamoylphenoxyacetic acid / theophylline

cilostazol

quinine combinations

defibrotide

diphtheria / tetanus / pertussis (acellular, component) / hepatitis b


(rdna) / poliomyelitis (inactivated) vaccines (adsorbed)

alemtuzumab

chlorhexidine gluconate / tixocortol pivalate

aloe barbadensis miller / aloe ferox miller, folium

aloe barbadensis miller / aloe ferox miller, folium

arctostaphylos uva-ursi (L.) spreng., folium

capsicum annuum L. var. minimum (Miller) heiser, fructus

# Classified as internal/staff contractors by the European Medicines Agency


cassia senna L.; cassia angustifolia vahl, fructus // cassia senna L.;
cassia angustifolia vahl, folium
cephaelis ipecacuanha (brot.) a. rich.; cephaelis acuminata
karsten, radix

echinacea pallida (nutt.) nutt.; echinacea purpurea (L.) moench;


echinacea angustifolia dc, radix // echinacea purpurea (L.)
moench, herba

eucalyptus globulus labill., aetheroleum

ginkgo biloba L., folium

glycyrrhiza glabra L.; glycyrrhiza inflata bat.; glycyrrhiza uralensis


fisch., radix

melaleuca alternifolia (maiden and betche) cheel, aetheroleum


melaleuca viridiflora, (melaleuca quinquenervia)
Broad-leaved paperbark,
aetheroleum

mentha x piperita l., aetheroleum

pinus sylvestris L., aetheroleum

plantago ovata forssk., semen

plantago ovata forssk., seminis tegumentum

rhamnus purshianus dc, cortex

rheum palmatum L.; rheum officinale baillon, radix

serenoa repens (bartram) small (sabal serrulata (michaux) nichols,


fructus

symphytum officinale L.
radix

thymus vulgaris L.; thymus zygis loefl. ex L., aetheroleum

valeriana officinalis L., radix

xysmalobium undulatum L.
Aiton f. var. undulatatum, radix

# Classified as internal/staff contractors by the European Medicines Agency


paracetamol (IV formulation)

cyproterone / ethinylestradiol

gentamicin / zyrconium

amcinonide / neomycin

ascorbic acid / cetylpyridinium

deltamethrin

human plasma protease C1 inhibitor

doxylamine

almitrine dimesilate / raubasine

amylase / lipase / protease

grepafloxacin hydrochloride

# Classified as internal/staff contractors by the European Medicines Agency


Month
Comments
removed

Entry (EURD ID 2595) deleted as there is a duplicate entry EURD ID:


Jan-25
1688 "quinidine, hydroquinidine"

Entry deleted as the marketing authorisation for Ocaliva is revoked by


Jan-25
the Commission Implementing Decision of 30 August

Entry deleted as Alofisel (CAP) is withdrawn Jan-25

Entry (EURD ID: 10935) deleted due to merge with EURD ID: 274 Jan-25

Entry removed as only authorised in 1 MS Dec-24

Entry deleted as there are no products in Art 57 Dec-24

Entry deleted as there are no products in Art 57 Dec-24

Entry deleted as there are no products in Art 57 Dec-24

Entry deleted due to merge (See EURD ID: 1929) Dec-24

Entry deleted as Pixuvri (CAP) withdrawn Nov-24

Entry deleted as Gavreto (CAP) withdrawn Nov-24

Entry deleted as there are no products in Art 57 Oct-24

Entry deleted due to merge (See EURD ID: 661) Oct-24

Entry deleted due to merge (See EURD ID: 2307) Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry deleted due to merge (See EURD ID: 332) Oct-24

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted due to merge (See EURD ID 2307) Oct-24

Entry deleted due to merge (See EURD ID 2307) Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted due to merge (See EURD ID: 1580) Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry deleted due to merge (See EURD ID: 2400) Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted due to merge (See EURD ID: 2224) Oct-24

Entry deleted due to merge (See EURD ID: 2312) Oct-24

# Classified as internal/staff contractors by the European Medicines Agency


Entry deleted due to merge (See EURD ID: 448) Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry deleted due to merge (See EURD ID: 241) Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted due to merge (See EURD ID: 448) Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry removed as only authorised in 1 MS Oct-24

Entry deleted as there are no products in Art 57 Oct-24

Entry deleted due to merge (See EURD ID 10234) Oct-24

Entry deleted due to merge (See EURD ID: 1924) Oct-24

Entry deleted as Exviera & Viekirax (CAPs) withdrawn on 25/09/2024 Oct-24

Entry deleted as there are no products in Art 57 Sep-24

Entry deleted due to merge (see EURD ID: 1098) Sep-24

Entry deleted due to merge (see EURD ID: 2262) Sep-24

Entry deleted due to merge (see EURD ID: 2262) Sep-24

Entry deleted due to merge (see EURD ID: 2735) Sep-24

Entry deleted as there are no products in Art 57 Sep-24

Entry deleted dut to merge (see EURD ID 1928) Sep-24

# Classified as internal/staff contractors by the European Medicines Agency


Entry deleted as CAP (Esmya) withdrawn on 18/07/2024
Sep-24

Entry deleted as CAP (NYXTHRACIS) withdrawn on 02/08/2024


Sep-24

Entry deleted as CAP (JCOVDEN) withdrawn on 26/07/2024


Sep-24

Entry deleted as there are no products in Art 57 Jul-24

Entry deleted as there are no products in Art 57 Jul-24

Entry removed as only authorised in 1 MS Jul-24

Entry removed as only authorised in 1 MS Jun-24

Entry removed as only authorised in 1 MS Jun-24

Entry removed as only authorised in 1 MS Jun-24

Entry removed as only authorised in 1 MS Jun-24

Entry deleted as there are no products in Art 57 Jun-24

Entry removed as only authorised in 1 MS Jun-24

Entry deleted as there are no products in Art 57 Jun-24

Entry deleted as there are no products in Art 57 Jun-24

Entry deleted as there are no products in Art 57 Jun-24

Entry removed as only authorised in 1 MS Jun-24

Entry removed as only authorised in 1 MS Jun-24

Entry deleted as there are no products in Art 57 May-24

Entry deleted due to merge (See EURD ID: 977) May-24

# Classified as internal/staff contractors by the European Medicines Agency


Entry deleted as there are no products in Art 57 May-24

Entry deleted due to merge (See EURD ID: 2434) May-24

Entry deleted as there are no products in Art 57 May-24

Entry deleted as there are no products in Art 57 May-24

Entry removed as only authorised in 1 MS May-24

Entry removed as only authorised in 1 MS Apr-24

Entry deleted as there are no products in Art 57 Apr-24

Entry deleted as there are no products in Art 57 Apr-24

Entry deleted due to merge (See EURD ID: 693) Apr-24

Entry deleted as there are no products in Art 57 Apr-24

Entry removed as only authorised in 1 MS Apr-24

Entry deleted as there are no products in Art 57 Apr-24

Entry deleted as there are no products in Art 57 Apr-24

Entry removed as only authorised in 1 MS Apr-24

Entry removed as only authorised in 1 MS Apr-24

Entry deleted due to merge (See EURD ID: 710) Apr-24

Entry removed as only authorised in 1 MS Apr-24

Entry removed as only authorised in 1 MS Apr-24

Entry deleted as there are no products in Art 57 Apr-24

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Apr-24

Entry deleted as Blenrep (CAP) expired Apr-24

Entry deleted as Vaxzevria (CAP) withdrawn Apr-24

Entry deleted due to merge with EURD ID: 383 Mar-24

Entry deleted as there are no products in Art 57 Mar-24

Entry deleted as already covered under EURD ID: 10012 Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry deleted as there are no products in Art 57 Mar-24

Entry deleted as there are no products in Art 57 Mar-24

Entry deleted due to merge with EURD ID: 383 Mar-24

Entry deleted due to merge with EURD ID: 10542 Mar-24

Entry deleted due to merge with EURD ID: 10542 Mar-24

Entry deleted as Vidprevtyn Beta (CAP) withdrawn on 11 March 2024 Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry deleted as there are no products in Art 57 Mar-24

Entry removed as only authorised in 1 MS Mar-24

# Classified as internal/staff contractors by the European Medicines Agency


Entry deleted as there are no products in Art 57 Mar-24

Entry deleted as there are no products in Art 57 Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry removed as only authorised in 1 MS Mar-24

Entry deleted due to merge with EURD ID: 369 Feb-24

Entry deleted due to merge with EURD ID: 736 Feb-24

Entry deleted due to merge with EURD ID: 1646 Feb-24

Entry deleted as there are no products in Art 57 Feb-24

Entry deleted as there are no products in Art 57 Feb-24

Entry deleted as there are no products in Art 57 Feb-24

Entry deleted as there are no products in Art 57 Feb-24

Entry deleted as there are no products in Art 57 Feb-24

Entry deleted as there are no products in Art 57 Feb-24

Entry 2477 deleted due to merge with EURD ID: 2475 Feb-24

Entry deleted as Rapilysin (CAP) withdrawn on 26 Jan 2024 Feb-24

Entry deleted as Cuprymina (CAP) withdrawn on 25 Jan 2024 Feb-24

Jan-24
Entry deleted due to merge with EURD ID: 582

Entry deleted due to merge with EURD ID: 10187 Jan-24

Jan-24
Entry deleted due to merge with EURD ID: 2426 & 2536

# Classified as internal/staff contractors by the European Medicines Agency


Jan-24
Entry deleted due to merge with EURD ID: 2426 & 2536

Jan-24
Entry deleted due to merge with EURD ID: 2426 & 2536

Entry removed as no products identified in Art 57 Jan-24

Entry removed as only authorised in 1 MS Jan-24

Entry removed as no products identified in Art 57 Dec-23

Deletion of entry due to merge with EURD ID 54 Dec-23

Entry removed as only authorised in 1 MS Dec-23

Entry removed as no products identified in Art 57 Dec-23

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 removed as only authorised in 1 MS Dec-23

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 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 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 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 with EURD ID: 416 Dec-23

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Dec-23

Entry removed as only authorised in 1 MS Dec-23

Entry deleted due to merge entries EURD ID: 862, 1249 and 9089
Dec-23
with entry EURD ID: 10386

Entry removed as no products identified in Art 57 Dec-23

Entry removed as only authorised in 1 MS Dec-23

Entry removed as no products identified in Art 57 Dec-23

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

Entry removed as only authorised in 1 MS Dec-23

Entry deleted due to merge with EURD ID: 1557 Dec-23

Entry removed as only authorised in 1 MS Dec-23

Dec-23
Entry removed as Prevenar (CAP) surrendered

Entry removed as no products identified in Art 57 Dec-23

Entry removed as only authorised in 1 MS Dec-23

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

Entry removed dueastoZynrelef


referral 107i/1521 adopted Nov-23
Entry removed (CAP) withdrawn onin Dec 2022:
05.10.23
CMDh AR conclusions: The Committee, as a consequence, considers
that the benefit-risk balance of pholcodine-containing medicinal
products is not favourable. Nov-23
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the
Committee recommends the revocation of the marketing
authorisations for pholcodine-containing medicinal products.

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed due to referral 107i/1521 adopted in Dec 2022:
CMDh AR conclusions: The Committee, as a consequence, considers
that the benefit-risk balance of pholcodine-containing medicinal
Entry removed due products is not
to referral favourable.
107i/1521 adopted in Dec 2022: Nov-23
Therefore,
CMDh pursuant The
AR conclusions: to Article 116 of as
Committee, Directive 2001/83/EC,
a consequence, the
considers
Committee recommends the revocation of the marketing
that the benefit-risk balance of pholcodine-containing medicinal
authorisations forproducts
pholcodine-containing medicinal products.
is not favourable. Nov-23
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the
Committee recommends the revocation of the marketing
Entry removed as
authorisations forCOVID-19 Vaccine (inactivated,
pholcodine-containing adjuvanted)
medicinal products. Nov-23
Valneva was withdrawn on 12.10.23

Entry removed due to merge (See EURD ID: 1088) Oct-23

Entry removed due to merge (See EURD ID: 1644) Oct-23

Entry removed due to merge (See EURD ID: 1065) Oct-23

Entry removed due to merge (See EURD ID: 2174) Oct-23

Entry removed due to merge (See EURD ID: 2705) Oct-23

Entry removed due to merge (See EURD ID: 2705) Oct-23

Entry removed due to merge (See EURD ID: 2705) Oct-23

Entry removed due to merge (See EURD ID: 2690) Oct-23

Entry removed due to merge (See EURD ID: 3107) Oct-23

Entry removed due to merge (See EURD ID: 3133) Oct-23

Oct-23
Entry for deletion as Adakveo (CAP) is revoked

Entry removed as no products identified in Art 57 Sep-23

Sep-23
Entry for deletion as Skysona (CAP) is withdrawn

Entry removed as only authorised in 1 MS Aug-23

Entry removed as no products identified in Art 57 Aug-23

Entry removed as no products identified in Art 57 Aug-23

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Aug-23

Entry removed as only authorised in 1 MS Aug-23

Entry removed due to merge with EURD ID 54 “Acrivastine,


Jul-23
acrivastine / pseudoephedrine”

Entry removed due to products' revocation (following Referral


Jul-23
procedure)

Entry removed as only authorised in 1 MS Jul-23

Entry removed due to merge with EURD ID: 2649 Jul-23

Entry removed as no products identified in Art 57 Jun-23

Entry removed as only authorised in 1 MS Jun-23

Entry removed as no products identified in Art 57 Jun-23

Entry removed due to merge with EURD ID: 39 (acetylsalicylic acid) Jun-23

Entry removed as only authorised in 1 MS Jun-23

Entry removed as only authorised in 1 MS Jun-23

Entry removed due to merge (see EURD ID: 10424) Apr-23

Entry removed due to merge (see EURD ID: 2434) Apr-23

Entry removed as no longer fulfils requirements for inclusion in EURD


Apr-23
list

Entry removed as only authorised in 1 MS Mar-23

Entry removed as only authorised in 1 MS Mar-23

Entry removed as only authorised in 1 MS Mar-23

Entry removed as Crixivan (CAP) was withdrawn Jan-23

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed due to merge with EURD ID: 2685 (saxagliptin) Jan-23

Entry removed as Sebivo (CAP) was withdrawn Jan-23

Entry removed as Ketek (CAP) was withdrawn Jan-23

Entry removed as Trogarzo (CAP) was withdrawn Jan-23

Entry removed as no products identified in Art 57 Jan-23

Entry removed as Hepsera (CAP) was withdrawn Dec-22

Entry removed as PegIntron & ViraferonPeg (CAP) were withdrawn Dec-22

Entry removed as NeuroBloc (CAP) was withdrawn Dec-22

Entry removed as no products identified in Art 57 Nov-22

Entry removed as only authorised in 1 MS Nov-22

Entry removed as only authorised in 1 MS Nov-22

Entry removed as no products identified in Art 57 Oct-22

Entry removed as only authorised in 1 MS Oct-22

Entry removed as only authorised in 1 MS Oct-22

Entry removed as no products identified in Art 57 Sep-22

Entry ID removed due to merge (see entry ID: 10784) Sep-22

Entry removed as only authorised in 1 MS Jul-22

Entry removed as only authorised in 1 MS Jul-22

Entry removed as no products identified in Art 57 (Products


Jul-22
covered/moved to EURD ID: 2724)

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Jul-22

Entry removed as Zynquista (CAP) was withdrawn Jun-22

Entry removed as Starlix (CAP) was withdrawn May-22

Entry removed as Lumoxiti (CAP) was withdrawn May-22

Entry removed as only authorised in 1 MS May-22

Entry removed due to merge. See EURD ID: 10987 Apr-22

Entry removed as no products identified in Art 57 Apr-22

Entry removed due to merge. See EURD ID: 10807 Apr-22

Entry removed as only authorised in 1 MS Apr-22

Entry removed as Zynteglo (CAP) was withdrawn Apr-22

Entry removed as only authorised in 1 MS Mar-22

Entry removed as only authorised in 1 MS Mar-22

Entry removed as only authorised in 1 MS Mar-22

Entry removed as Zurampic (CAP) was withdrawn Mar-22

Entry removed as only authorised in 1 MS Feb-22

Entry removed as Staquis (CAP) was withdrawn Feb-22

Entry removed as no products identified in Art 57 Jan-22

Entry removed as only authorised in 1 MS Jan-22

Entry removed as no products identified in Art 57 Jan-22

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Jan-22

Entry removed as Zalmoxis (CAP) was withdrawn Jan-22

Entry removed as no products identified in Art 57 Jan-22

Entry removed as only authorised in 1 MS Dec-21

Entry removed as no products identified in Art 57 Dec-21

Entry ID removed due to merge (see entry ID: 1952) Dec-21

Entry ID removed due to merge (see entry ID: 1952) Dec-21

Entry removed as IntronA (CAP) was withdrawn Dec-21

Entry removed as only authorised in 1 MS Dec-21

Entry removed as no products identified in Art 57 Dec-21

Entry removed as no products identified in Art 57 Dec-21

Entry removed as no products identified in Art 57 Oct-21

Entry removed as only authorised in 1 MS Oct-21

Entry removed as GPAG outcome adopted by PRAC Oct-21

Entry removed as GPAG outcome adopted by PRAC Oct-21

Entry removed due to Truberzi (CAP) surrendered Aug-21

Entry removed due to Portrazza (CAP) expiry of MA Jul-21

Entry removed due to split (see entry ID: 10933 and 10934) Jun-21

Entry removed due to Xiapex (CAP) withdrawal Jun-21

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS May-21

Entry removed as only authorised in 1 MS May-21

Entry removed as only products authorised under WEU May-21

Entry removed as only authorised in 1 MS Apr-21

Entry removed as Kolbam was withdrawn Mar-21

Entry removed as no products identified in Art 57 Mar-21

Entry removed as only authorised in 1 MS Mar-21

Entry removed as Alpivab was withdrawn Mar-21

Entry removed as Panretin was withdrawn Feb-21

Entry removed due to split (see entry ID: 10913 and 10914) Feb-21

Entry removed as only authorised in 1 MS Jan-21

Entry removed as no products identified in Art 57 Jan-21

Entry removed as product no longer authrorised Jan-21

Entry ID removed due to merge (see entry ID: 10883) Dec-20

Entry ID removed due to merge (see entry ID: 10883) Dec-20

Entry removed as Protelos and Osseor were withdrawn in April 2020 Nov-20

Entry removed as only authorised in 1 MS Oct-20

Entry removed as Zerit was withdrawn in June 2020 Sep-20

Entry removed due to split (see entry ID: 10864, 10865, 10866 and
Sep-20
10867)

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as product no longer authrorised Jul-20

Entry removed due to split (See entries ID: 10855, 10856) Jul-20

Entry removed as only authorised in 1 MS Jun-20

Entry removed as no products identified in Art 57 Jun-20

Entry removed as Varuby was withdrawn in Jan 2020 Jun-20

Entry removed as no products identified in Art 57 May-20

Entry removed as product no longer authrorised May-20

Entry removed as no products identified in Art 57 May-20

Entry removed due to merge (See entry ID: 10847) May-20

Entry removed as no products identified in Art 57 May-20

Entry removed as no products identified in Art 57 May-20

Entry removed due to merge (See entry ID: 10847) May-20

Entry removed as only authorised in 1 MS May-20

Entry removed as no products identified in Art 57 May-20

Entry removed as no products identified in Art 57 May-20

Entry removed due to merge (See entry ID: 10845) May-20

Entry removed due to merge (See entry ID: 10845) May-20

Entry removed as no products identified in Art 57 May-20

Entry removed as only authorised in 1 MS Apr-20

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as only authorised in 1 MS Mar-20

Entry removed as only authorised in 1 MS Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as only authorised in 1 MS Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed due to merge (See entry ID: 10838) Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Mar-20

Entry removed as only authorised in 1 MS Mar-20

Entry removed as only authorised in 1 MS Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as only authorised in 1 MS Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed as no products identified in Art 57 Mar-20

Entry removed due to merge (See entry ID: 10837) Mar-20

Entry removed as only authorised in 1 MS Mar-20

Entry removed as only authorised in 1 MS Feb-20

Entry removed as only authorised in 1 MS Feb-20

Entry removed as only authorised in 1 MS Feb-20

Entry removed due to merge (See entry ID: 10425) Jan-20

Entry removed due to split (See entry ID: 107831 and 107832) Jan-20

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as it no longer fulfills the criteria for remaining on the
Jan-20
list

Entry removed as it no longer fulfills the criteria for remaining on the


Jan-20
list

Entry removed due to merge (See entry ID: 107816) Jan-20

Entry removed as only authorised in 1 MS Dec-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed due to merge (See entry ID: 107808) Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry deleted due to merge (see Entry ID: 107808) Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry deleted due to merge (See Entry ID: 107806) Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed due to split (See entry ID: 10808 and 10809) Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as it no longer fulfills the criteria for remaining on the


Nov-19
list

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as only authorised in 1 MS Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry deleted due to merge (see Entry ID: 107802) Nov-19

Entry deleted due to merge (see Entry ID: 107802) Nov-19

Entry deleted due to merge (see Entry ID: 107802) Nov-19

Entry deleted due to merge (see Entry ID: 107802) Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry removed as no products identified in Art 57 Nov-19

Entry for removal: Victrelis (CAP) surrendered. No other products in


Nov-19
Art 57.

Entry deleted as Numient (CAP) surrendered Nov-19

Entry deleted as Lartruvo (CAP) revoked following Referral in July


Nov-19
2019

Entry deleted due to merge (see Entry ID: 107810) Nov-19

Entry deleted due to merge (see Entry ID: 107810) Nov-19

Entry deleted due to merge (see Entry ID: 107802) Nov-19

Entry to be removed: produtcts authorised in only 1 MS Sep-19

Entry to be removed as no products identified in Art 57 Sep-19

Entry deleted as medicinal products containing ‘benzathine


phenoxymethylpenicillin’ are covered by the Sep-19
‘phenoxymethylpenicillin’ entry

Entry to be removed due to MA expiry Sep-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed as no products identified in Art 57 Sep-19

Entry deleted due to merge Sep-19

Entry deleted due to merge Sep-19

Entry deleted due to merge Sep-19

Entry deleted due to merge Sep-19

Entry to be removed as no products identified in Art 57 Sep-19

Entry deleted due to merge Jul-19

Entry deleted due to merge Jul-19

Entry to be removed as no products identified in Art 57 Jun-19

Entry deleted due to merge Jun-19

Entry deleted due to merge Jun-19

Entry deleted due to merge Jun-19

Entry deleted due to merge Jun-19

Entry deleted due to merge Jun-19

Entry deleted due to merge Jun-19

Entry to be removed as no products identified in Art 57 Jun-19

Entry deleted due to merge Jun-19

Entry deleted due to merge Jun-19

Entry to be removed due to MA withdrawal May-19

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed from the EURD list since products containing this
May-19
active substance are authorised only in one MS

Entry deleted due to merge May-19

Entry to be removed due to MA withdrawal May-19

Entry deleted due to merge Apr-19

GPAG outcome adopted by PRAC April 2019 entry removed Apr-19

GPAG outcome adopted by PRAC April 2019 entry removed Apr-19

GPAG outcome adopted by PRAC April 2019 entry removed Apr-19

GPAG outcome adopted by PRAC April 2019 entry removed Apr-19

GPAG outcome adopted by PRAC April 2019 entry removed Apr-19

GPAG outcome adopted by PRAC April 2019 entry removed Apr-19

Entry removed due to withdrawal of CAP (only authorisation) Apr-19

Entry merged with 'infliximab (except biosimilars). New entry named


Apr-19
"Infliximab".

Entry merged with 'infliximab (biosimilars). New entry named


Apr-19
"Infliximab".

Entry removed: no products in the procedure Apr-19

Entry to be removed because covered by "amidotrizoic acid and


Feb-19
combination"

Entry removed since no products have been identified containing this


Feb-19
combination of active substances

Entry removed since no products have been identified containing this


Feb-19
combination of active substances

Entry removed since no products have been identified containing this


Feb-19
combination of active substances

Entry to be removed: duplicate of "calcium dobesilate /


Feb-19
dexamethasone / lidocaine"

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed: duplicate of "calcium dobesilate / lidocaine" Feb-19

Entry removed since no products have been identified containing this


Feb-19
combination of active substances

Entry removed because merged with "calcium dobesilate / lidocaine" Feb-19

Entry removed because merged with "calcium dobesilate /


Feb-19
dexamethasone / lidocaine"

Entry to be removed due to MA withdrawal Feb-19

Entry removed since no products have been identified containing this


Feb-19
combination of active substances

Entry removed because covered by "amidotrizoic acid and


Feb-19
combination"

Entry removed because covered by "amidotrizoic acid and


Feb-19
combination"

Entry removed since no products have been identified containing this


Feb-19
active substance

Entry removed since no products have been identified containing this


Feb-19
active substance

Entry removed from the EURD list since product containing this active
Feb-19
substance is authorised only in one MS

Entry removed since no products have been identified containing this


Feb-19
combination of active substances

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS

Entry removed since no products have been identified containing this


Jan-19
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed because covered by "antacids: combinations or
monocomponents of aluminium / calcium / magnesium / potassium / Jan-19
sodium salts"
Entry removed since no products have been identified containing this
Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed since no products have been identified containing this
Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed from the EURD list since products containing this
Jan-19
active substance are authorised only in one MS

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

Entry removed since no products have been identified containing this


Jan-19
active substance

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 since no products have been identified containing this


Nov-18
active substance

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 since no products have been identified containing this


Nov-18
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed from the EURD list since products containing this
Nov-18
active substance are authorised only in one MS

Entry removed since no products have been identified containing this


Oct-18
active substance

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 since no products have been identified containing this


Oct-18
active substance

Entry removed since no products have been identified containing this


Oct-18
active substance

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 since no products have been identified containing this


Oct-18
active substance

Entry removed since no products have been identified containing this


Oct-18
active substance

Entry removed since no products have been identified containing this


Oct-18
active substance

Entry removed from the EURD list since products containing this
Oct-18
active substance are authorised only in one MS

The marketing authorisation has expired on 1 July 2018. Oct-18

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed since no products have been identified containing this
Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed since no products have been identified containing this
Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed since no products have been identified containing this
Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed since no products have been identified containing this
Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry removed since no products have been identified containing this
Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry removed since no products have been identified containing this


Sep-18
active substance

Entry was merged with "macrogol 3350 combinations (oral use)",


Sep-18
therefore it had to be deleted from the list

Entry was merged with "cobamamide"ID 838 due to the similarity in


Sep-18
therapeutical indication, therefore it had to be deleted from the list

Entry was merged with "macrogol 3350 combinations (oral use)",


Sep-18
therefore
Entry was merged with it had to be3350
"macrogol deleted from thechloride
/ potassium list / sodium
bicarbonate / sodium chloride ; ascorbic acid / macrogol 3350 /
potassium chloride / sodium ascorbate / sodium chloride / sodium
Sep-18
sulphate"
in new entry "macrogol 3350 combinations (oral use)", therefore it
had to be deleted from the list
Entry removed due to product withdrawal on 19 July 2018 Sep-18

Entry removed because this substance is covered by the general


Sep-18
"fluoride" entry

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

# Classified as internal/staff contractors by the European Medicines Agency


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 since no products have been identified


Jul-18
containing this combination of active substances

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this combination of active substances.
Removal from EURD list; Entry: "antacids: combinations or
monocomponents of aluminium / calcium / magnesium / potassium / Jul-18
sodium salts" to be followed (PSUSA/00000500)
Entry to be removed since no products have been identified
Jul-18
containing this active substance

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 since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

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 products in one MS
Jul-18
identified containing this combination of active substances.

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance
Removal from EURD list; Entry: "antacids: combinations or
monocomponents of aluminium / calcium / magnesium / potassium / Jul-18
sodium salts" to be followed (PSUSA/00000500)
Entry to be removed from the EURD list since only one product in one
Jul-18
MS identified containing this active substance.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no products have been identified
Jul-18
containing this active substance

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 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 since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

The marketing authorisation has expired on 1 July 2018, therefore


Jul-18
this entry is deleted.

Entry to be removed since no products have been identified


Jul-18
containing this active substance

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 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 products in one MS
Jul-18
identified containing this combination of active substances.

Entry to be removed since no products have been identified


Jul-18
containing this active substance

# Classified as internal/staff contractors by the European Medicines Agency


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 since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

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 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 since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

Entry to be removed since no products have been identified


Jul-18
containing this active substance

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 products in one MS
Jul-18
identified containing this combination of active substances.

Entry to be removed since no products have been identified


Jul-18
containing this active substance

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 products in one MS
Jul-18
identified containing this combination of active substances.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no products have been identified
Jul-18
containing this active substance

Product was withdrawn on 05/03/2018, therefore entry is deleted Jun-18

Marketing authorisations for flupirtine containing priducts have been


revoked with the CMDh position dated 21 March 2018, therefore Jun-18
entry to be removed
Entry to be removed since no products have been identified
Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


Jun-18
containing this combination of active substances

Entry to be removed since no products have been identified


May-18
containing this active substance

Entry to be removed since no products have been identified


May-18
containing this active substance

Entry to be removed since no products have been identified


May-18
containing this active substance

Entry to be removed since no products have been identified


May-18
containing this active substance

Entry to be removed since no products have been identified


May-18
containing this active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no products have been identified
May-18
containing this active substance

Entry to be removed since no products have been identified


May-18
Removalcontaining
from EURDthis listcombination of active
following merge. substances
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,
Removal from coal
EURD tar / menthol,
list followingcoal
merge.tar solution / salicylic
Entry: "coal acid /
tar, distilled
benzalkonium
coal chloride
tar, distilled coal tar solution / polyoxyethylene
/ lecithin, 4 lauryl
coconut oil / distilled ether
coal tar //
polyoxyethylene 23 lauryl
salicylic acid, coal ether" /to
tar solution be followed
salicylic acid /(PSUSA/00010684)
sulfur, coal tar /
May-18
salicylic acid,
Removal from coal
EURD tar / menthol,
list followingcoal
merge.tar solution / salicylic
Entry: "coal acid /
tar, distilled
coal tar, distilled coal tar / lecithin, coconut oil / distilled coal tar //
benzalkonium chloride solution / polyoxyethylene 4 lauryl ether
polyoxyethylene 23 lauryl
salicylic acid, coal ether" /to
tar solution be followed
salicylic acid /(PSUSA/00010684)
sulfur, coal tar /
May-18
salicylic acid, coal tar / menthol, coal tar solution / salicylic acid /
benzalkonium chloride solution / polyoxyethylene 4 lauryl ether /
polyoxyethylene
Entry to be removed 23 from
laurylthe ether"
EURD tolist
be since
followed
only(PSUSA/00010684)
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
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 since no products have been identified


May-18
containing this active substance

Entry to be removed since no products have been identified


May-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Products currently authorised only in PL, therefore entry is deleted Apr-18

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Product was withdrawn on 23/03/2018, therefore entry is deleted Apr-18

Products currently authorised only in NL and as generic, therefore


Apr-18
entry is deleted

Entry to be removed since no products have been identified


Apr-18
containing this active substance

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no products have been identified
Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Products currently authorised only in ES and under WEU, therefore


Apr-18
entry is deleted

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Product currently authorised only in FR, therefore entry is deleted Apr-18

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry to be removed since no products have been identified


Apr-18
containing this active substance

Entry should be removed as the Marketing Authorisation has been


Apr-18
withdrawn on 27 March 2018

Removal from EURD list; Entry: "caffeine (apnea)" to be followed


Mar-18
(PSUSA/0000482)

Entry to be removed since no products have been identified


Mar-18
containing this active substance combination

Removal from EURD list; Entry: "lactobacillus all subspecies and


Mar-18
combinations of subspecies" to be followed (PSUSA/00010598)
Removal from EURD list following merge. Entry: "sitagliptin,
metformin hydrochloride / sitagliptin" to be followed Mar-18
(PSUSA/00010673)
Removal from EURD list following merge. Entry: "sitagliptin,
metformin hydrochloride / sitagliptin" to be followed Mar-18
(PSUSA/00010673)
Removal from EURD list; Entry: "triglyceride combinations (e.g. olive
oil, soya bean oil, fish oil)/ with or without mineral
Mar-18
compounds/electrolytes (i.v. application) to be followed
(PSUSA/00010648)
Entry was merged with "pseudoephedrine" and "acetylsalicylic acid /
pseudoephedrine hydrochloride" entries, therefore it had to be Feb-18
deleted from the list

# Classified as internal/staff contractors by the European Medicines Agency


MERGED with "pseudoephedrine" and "acetylsalicylic acid /
pseudoephedrine hydrochloride" in a new entry, therefore entry is Feb-18
deleted
Entry to be removed since no products have been identified
Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Products currently authorised only in UK and under WEU, therefore


Feb-18
entry is deleted

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Product authorised in 1 MS (FR), therefore should be deleted Feb-18

MERGED with "loperamide hydrochloride/simeticon" in a new entry,


Feb-18
therefore entry is deleted

MERGED with "loperamide" in a new entry, therefore entry is deleted Feb-18

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-18
containing this active substance combination.

Entry to be removed from the EURD list since only one product in one
Jan-18
MS identified containing this combination of active substances.

# Classified as internal/staff contractors by the European Medicines Agency


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.

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 should be removed as the Marketing Authorisation was


Dec-17
withdrawn on 29/07/2014.

Entry should be removed as the marketing authorisation expired on


Dec-17
25/10/2017. No additional PSURs are required to be submitted.

Entry should be removed as the marketing authorisation has expired


Dec-17
on has expired on 23/07/2017.

Entry should be removed as the marketing authorisation has expired


Dec-17
on has expired on 01/06/2017.

Entry should be removed as no products are currently authorised in


Dec-17
EU with this active substance.

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 as there are currently no


Dec-17
products authorised in the EU

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)

# Classified as internal/staff contractors by the European Medicines Agency


Removal from EURD list following merge: Entry: "ibuprofen, ibuprofen
lysine (not indicated in ductus arteriosus), ibuprofen / caffeine" to be Nov-17
followed (PSUSA/00010649)

Product withdrawn, therefore entry should be removed. Nov-17

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 "eucalyptol" is deleted as there a no products authorised in Art


Oct-17
57. New entry "eucalyptus oil" is created as per MAH request
Only 1 valid generic product identified in ES. Products in FR expired
due to sunset clause, products in other MSs are withdrawn. Therefore Oct-17
entry is deleted.
All Products currently authorised in EU are authorised under WEU,
Oct-17
therefore entry is deleted
The entry will be merged with 'benzalkonium chloride /
chlorhexidine / isopropyl myristate / paraffin liquid' therfore the Oct-17
current entry is deleted
Product withdrawn on 27 July 2017, therefore entry should be
Oct-17
removed.

Entry removed, as only 2 generic products identified in Art. 57 DB. No


Oct-17
submissions have been received.

Entry removed, as this medicine is withdrawn from use in the


Oct-17
European Union
Removal from EURD list following merge: Entry: "calcium chloride
dihydrate / magnesium chloride hexahydrate / malic acid / sodium
acetate trihydrate / sodium chloride / potassium chloride, calcium Sep-17
chloride dihydrate / sodium chloride / sodium lactate / potassium
chloride" to be followed (PSUSA/00010622)
Removal from EURD list following merge: Entry: "bismuth / lidocaine /
Sep-17
zinc oxide, lidocaine / zinc oxide" to be followed (PSUSA/00010621)

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: Entries to be followed:


Sep-17
PSUSA/00010625 or PSUSA/00010626 accordingly

Removal from EURD list following merge: Entries to be followed


Sep-17
PSUSA/00010625 or PSUSA/00010626 accordingly

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 since no products have been identified


Sep-17
containing this active substance combination.

Entry to be removed since no products have been identified


Sep-17
containing this active substance combination.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed from the EURD list due to duplication with
Sep-17
"glycerol" entry.

Entry to be removed since no products have been identified


Sep-17
containing this active substance.

Entry to be removed since no products have been identified


Sep-17
containing this active substance.

Entry to be removed since no products have been identified


Sep-17
containing this active substance.

Removal from EURD list: Entry: "testosterone (all formulations apart


Sep-17
from topical use)" to be followed (PSUSA/00010631)

Removal from EURD list: Entry: "testosterone (all formulations apart


Sep-17
from topical use)" to be followed (PSUSA/00010631)

Entry to be removed from the EURD list following suspension of the


Sep-17
products.

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.

Removal from EURD list: Entry deleted due to merging of sodium


Jul-17
oxybate (oral use) and sodium oxybate (intravenous use)

Entry to be removed since no products have been identified


Jul-17
containing this active substance combination.

Entry to be removed since only 2 WEU products in CZ identified. Jul-17

Entry to be removed since no products have been identified


Jul-17
containing this active substance combination.

Entry to be removed since no products are authorised containing this


Jul-17
active substance combination.

Removal from EURD list: Entry deleted due to merging 'benzocaine /


Jul-17
chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'.

Removal from EURD list: Entry deleted due to merging 'benzocaine /


Jul-17
chlorhexidine' with 'benzocaine / chlorhexidine / tyrothricin'.

Entry to be removed since no products are authorised containing this


Jul-17
active substance combination.
Removal from EURD list: Entry deleted due to merging ‘chlorhexidine
gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine Jul-17
gluconate / tetracaine hydrochloride'.
Removal from EURD list: Entry deleted due to merging ‘chlorhexidine
gluconate / oxybuprocaine hydrochloride’ with ‘chlorhexidine Jul-17
gluconate / tetracaine hydrochloride'.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no products are authorised containing this
Jul-17
active substance combination.

Entry to be removed since no products are authorised containing this


Jul-17
active substance combination.

Entry to be removed since product is only authorised in 1 MS (PL). Jul-17

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 since no products have been identified


Jul-17
containing this active substance combination.

Removal from EURD list: Entry: "lactobacillus all subspecies and


Jun-17
combinations of subspecies" to be followed (PSUSA/00010598)

Removal from EURD list: Entry: "lactobacillus all subspecies and


Jun-17
combinations of subspecies" to be followed (PSUSA/00010598)

Removal from EURD list: Entry: "lactobacillus all subspecies and


Jun-17
combinations of subspecies" to be followed (PSUSA/00010598)

Entry to be removed from the EURD list since only one product in one
Jun-17
MS identified containing this combination of active substances.

Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan,


Jun-17
irbesartan" to be followed (PSUSA/00010601)

Removal from EURD list: Entry: "hydrochlorothiazide / irbesartan,


Jun-17
irbesartan" to be followed (PSUSA/00010601)

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').

Product withdrawn on 03.11.2016, therefore entry is removed. May-17


New entry was created by merging 'sulfametrole / trimethoprim,
sulfadiazine / trimethoprim’ with ‘sulfamethoxazole / trimethoprim
May-17
(co-trimoxazole), therefore entry for “co-trimoxazole” should be
deleted.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since only one product identified in Art. 57 DB in
May-17
one MSs (DE). Entry to be deleted.

Entry to be removed since only one generic product identified in Art.


May-17
57 DB in one MSs (LV).

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.
Removal from EURD list: New entry: "bendroflumethiazide,
bendroflumethiazide / potassium chloride" to be followed Apr-17
(PSUSA/00010583)
Entry to be removed from the EURD list since products in only one MS
Apr-17
identified containing this combination of active substances.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed following withdrawal of marketing authorisation Apr-17

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed following withdrawal of marketing authorisation Apr-17

Removal from EURD list: New entry: "budesonide / formoterol" to be


Apr-17
followed (PSUSA/00010585)

Removal from EURD list: New entry: "budesonide / formoterol" to be


Apr-17
followed (PSUSA/00010585)

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Entry to be removed since no products have been identified


Apr-17
containing this active substance combination.

Removal from EURD list: Entry: "BCG vaccine (freeze-dried)" to be


Apr-17
followed (PSUSA/00000304)

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no products have been identified
Mar-17
containing this fixed dose active substance combination.

Entry to be removed since no products are authorised in EU


Mar-17
containing this fixed dose active substance combination.

Entry to be removed since no products have been identified


Mar-17
containing this fixed dose active substance combination.

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 since no products have been identified


Mar-17
containing this active substance.

Entry to be removed since no products are authorised in EU


Mar-17
containing this active substance.

Entry to be removed as all products containing this active substance


Mar-17
are authorised under Article 10(a).

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 to be removed since no products have been identified


Mar-17
containing this fixed dose active substance combination.

Entry to be removed since no products have been identified


Mar-17
containing this combination of active substances.

Entry to be removed since the combination of active substances is


Feb-17
only authorised in 1 MS

Entry to be removed since no products have been identified


Feb-17
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-17
containing this active substance combination.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since the combination of active substances is
Feb-17
only authorised in 1 MS

Entry to be removed since no products have been identified


Feb-17
containing this active substance combination.

Entry to be removed since no products have been identified


Feb-17
containing this active substance combination.

Entry to be removed since the combination of active substances is


Feb-17
only authorised in 1 MS

Entry to be removed since no products have been identified


Feb-17
containing this active substance combination.

Entry to be removed following withdrawal of marketing authorisation Feb-17

Entry to be removed since the combination of active substances is


Feb-17
only authorised in 1 MS
Removal from EURD list: Entry split to two entries: "mercaptamine
(treatment of nephropathic cystinosis)" to be followed Feb-17
(PSUSA/00010573)
Entry to be removed since no products have been identified
Feb-17
containing this active substance.

Entry removed from the list due to withdrawal of the product. Feb-17

Removal from EURD list: Entry merged with combination of active


substances containing nitrous oxide / oxygen. New entry: "nitrous Feb-17
oxide, nitrous oxide/oxygen" to be followed (PSUSA/00010572)
Entry to be removed since no products have been identified
Feb-17
containing this active substance combination.
Removal from EURD list: Entry merged with combination of active
substances containing naphazoline/zinc sulphate. New entry:
Feb-17
"naphazoline, naphazoline/zinc sulphate" to be followed
(PSUSA/00010571)
Removal from EURD list: This entry was wrongly updated in the
Jan-17
previous version of the EURDlist
Removal from EURD list: Entry merged with an existing entry
“calcium glycerophosphate / magnesium gluconate”, therefore entry Jan-17
for “calcium glycerophosphate / magnesium gluconate” is deleted
Removal from EURD list: Entry merged with with other combination of
Jan-17
active substances containing metoclopramide
Removal from EURD list: Entry split to two entries: one entry only for
biosimilar products and another entry for all products except for Jan-17
biosimilars.
Removal from EURD list: Entry merged with with other combination of
Jan-17
active substances containing metoclopramide

Removal from EURD list: Entry to be removed following merging with


Jan-17
sulfadiazine trimethoprim

# Classified as internal/staff contractors by the European Medicines Agency


Removal from EURD list: Entry to be removed from the EURD list
since no products have been identified containing this active Dec-16
substance combination.
Removal from EURD list: Entry to be removed from the EURD list
since no products have been identified containing this active Dec-16
substance combination.
Removal from EURD list: substance was merged with levosulpiride, in
line with the principles set in the EURDlist introductory cover note. Dec-16
Entry: "levosulpiride, sulpiride" to be followed (PSUSA/00001859)
Removal from the EURD List: New entry "'mycophenolate mofetil,
Dec-16
mycophenolic acid" to be followed (PSUSA/00010550)

Removal from the EURD List: New entry "'mycophenolate mofetil,


Dec-16
mycophenolic acid" to be followed (PSUSA/00010550)

Removal from the EURD List: New entry "morphine, morphine /


Dec-16
cyclizine" to be followed (PSUSA/00010549)
Removal from EURD list: ascorbic acid / calcium / lysine” was merged
with the entry “ascorbic acid / calcium”, therefore the existing entry Dec-16
“ascorbic acid / calcium” should be deleted.
Removal from EURD list: “cetrimide/dimeticone” was merged with an
existing entry “benzalkonium chloride/cetrimide”, therefore entry for Dec-16
“benzalkonium chloride/cetrimide” should be deleted.
Removal from EURD list: New entry: "alpha-tocopherol / vaccinium
myrtillus anthocyanosides, betacarotene / vaccinium myrtillus Dec-16
anthocyanosides" to be followed (PSUSA/00010547)
Removal from EURD list: Entry: “human prothrombin complex" to be
Dec-16
followed (PSUSA/00001638)

Entry to be removed since the active substance is only authorised in


Dec-16
1 MS

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)

Removal from EURD list: merge of lisonopril with lisinopril /


Nov-16
hydrochlorothiazide
Removal from EURD list: the product has not been renewed and
Rapporteur notified us that no more PSUR are expected for this Nov-16
product.

# Classified as internal/staff contractors by the European Medicines Agency


Removal from EURD list: merge of lisonopril with lisinopril /
Nov-16
hydrochlorothiazide
Removal from EURD list: entry to be removed from the EURD List
following PRAC AR in October 2016 and the MAH's wish to not renew Nov-16
the MA
Entry to be removed since no products have been identified
Oct-16
containing this active substance combination.

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 to be removed since no products have been identified


Oct-16
containing this active substance combination.

Entry to be removed since no products have been identified


Oct-16
containing this active substance combination.

Entry to be removed since no products have been identified


Oct-16
containing this active substance combination.
Entry to be removed since no products have been identified
containing this active substance.
Oct-16
Additionally, a duplicate entry "hypericum perforatum L., herba" has
been identified.
Entry to be removed since no products have been identified
Oct-16
containing this active substance combination.

Entry to be removed since no products have been identified


Oct-16
containing this active substance combination.

Entry to be removed since no products have been identified


Oct-16
containing this active substance combination.
Removal from EURD list: new entry "dequalinium, dequalinium /
cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be Oct-16
followed
Removal from EURD list: new entry "dequalinium, dequalinium /
cinchocaine, dequalinium / lidocaine" (PSUSA/00010526) should be Oct-16
followed
Removal from EURD list: new entry "diphenhydramine, ammonium
chloride / diphenhydramine hydrochloride, diphenhydramine
Oct-16
hydrochloride / levomenthol, ammonium chloride / diphenhydramine
hydrochloride
Removal from/ EURD
levomenthol"
list: new(PSUSA/00010527) should ammonium
entry "diphenhydramine, be followed
chloride / diphenhydramine hydrochloride, diphenhydramine
Oct-16
hydrochloride / levomenthol, ammonium chloride / diphenhydramine
hydrochloride / levomenthol" (PSUSA/00010527) should be followed
Removal from EURD list: entry "levobunolol (ophthalmic indication)"
Oct-16
(PSUSA/00010109) should be followed

Entry to be removed since no products have been identified


Jul-16
containing this active substance combination.

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed from the EURD list since only one product
Jul-16
authorised in 1 MS has been identified.

Entry removed due to merging the entries for dutasteride and


Jun-16
dutasteride/tamsulosine

Entry removed due to it being duplicate to entry 'technetium (99mTc)


Jun-16
pertechnetate'

Entry removed from the EURD List following the merging with another
Jun-16
combination of active substances

Entry removed due to merging the entries for dutasteride and


Jun-16
dutasteride/tamsulosine

This product is only authorised in France under Article 8(3) of


Jun-16
Directive 2001/83/EC, therefore it should be removed from the list

Product authorised only in 1 Member State, therefore it should be


Jun-16
removed from the list

Removal from EURD


Entry removed andlist: new with
merged entry3'delapril / manidipine,ofdelapril
other combinations active / May-16
indapamide' (PSUSA/00010496)
substances for peritonealshould be followed.
dialysis.
New entry: 'calcium chloride / glucose / magnesium chloride / sodium
chloride / sodium lactate, calcium chloride / glucose / magnesium
May-16
chloride / sodium chloride / sodium lactate/ sodium bicarbonate,
calcium chloride / amino acids blend / magnesium chloride / sodium
Removal
chloride from EURD
/ sodium list: calcium
lactate, new entries “azithromycin
chloride / icodextrin (systemic use
/ magnesium
formulations)”(PSUSA/00010491/) and azithromycin
chloride / sodium chloride / sodium lactate’ to be followed (ocular use May-16
formulations)” (PSUSA/00010492) should be followed.
This entry should be removed from the EURD List since this
Entry to be of
combination removed since products
active substance identified
is already in Art.
covered by 57
theare only
following Apr-16
authorised in 1 MS (DE)
entry:
'ascorbic acid / calcium hydrogenphosphate / calcium panthotenate /
colecalciferol / cyanocobalamin / folic acid / nicotinamide / pyridoxine
Apr-16
hydrochloride / retinol / riboflavine / thiamin nitrate, ascorbic acid /
cyanocobalamin / ergocalciferol / nicotinamide / pyridoxine / retinol /
riboflavin
Entry to be / thiamine
removedhydrochloride,
since productsascorbic
identified acid / colecalciferol
in Art. 57 are only/
dexpanthenol / nicotinamide Apr-16
authorised/ in pyridoxine
1 MS (HU) / retinol / riboflavin /
thiamine
Entry to be removed since no products containing this particular
Apr-16
combination have been identified in the Article 57 database
Entry to be removed from the EURD list as no products containing the
active substance histrelin have been identified in article 57. In
Apr-16
addition, no submissions were received during the reconcilliation
process for PSUSA/00001611/201511
Entry to be removed since no authorised products were identified in
Apr-16
Article 57

Entry to be removed following withdrawal of marketing authorisation


Apr-16
for CAP Focetria on 11/02/2016

Entry to be removed since only the product Celtura (authorised in DE)


Apr-16
was identified in Article 57

Entry to be removed since no authorised products were identified in


Apr-16
Article 57

# Classified as internal/staff contractors by the European Medicines Agency


Entry to be removed since no authorised products were identified in
Apr-16
Article 57

Entry to be removed since no authorised products were identified in


Apr-16
Article 57
Entry to be removed since no products were identified in Article 57
referencing “thrombin” as standalone active substance, apart from 2 Apr-16
products containing bovine thrombin (only authorised in PL))
Removal from EURD List: only authorised in one Member State (ES).
Therefore the active substance almagate should be removed from the Apr-16
EURDlist.
Removal from EURD list: new entries “erythromycin / isotretinoin,
isotretinoin (topical formulations)”(PSUSA/00010487/) and
Apr-16
“isotretinoin (oral formulations)” (PSUSA/00010488) should be
Removal from EURD list: newfollowed.
entries “erythromycin / isotretinoin,
isotretinoin (topical formulations)”(PSUSA/00010487/) and
Apr-16
“isotretinoin (oral formulations)” (PSUSA/00010488) should be
followed.
CAP Nuedexta no longer authorised. MA has been withdrawn on
Mar-16
02/03/2016

Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16

Entry "fosinopril, fosinopril / hydrochlorothiazide" should be followed Mar-16

Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be


Mar-16
followed

Entry "thiocolchicoside, paracetamol / thiocolchicoside" should be


Mar-16
followed

Not authorised in EEA or in more than 1 Member state. Mar-16


The estradiol entry has been split into the following 2 new entries:
-estradiol (without cream/balm/emulsion for application in the female
genital area) Feb-16
-estradiol, estradiol / prednisolone (only cream/balm/emulsion for
application in the female genital area)
Not authorised in EEA or in more than 1 Member state. Feb-16

CAP Preotact no longer authorised. MA has been withdrawn on


Feb-16
16/05/2014.
Entry dienogest / estradiol split into 2 new entries with a different
scope based on the different indication. The 2 new entries to be
followed are: Feb-16
dienogest / estradiol (HRT indication)
dienogest / estradiol (contraception indication)
Not authorised in EEA or in more than 1 Member state Jan-16

Not authorised in EEA or in more than 1 Member state Dec-15

Not authorised in EEA or in more than 1 Member state Dec-15

# Classified as internal/staff contractors by the European Medicines Agency


Not authorised in EEA or in more than 1 Member state Dec-15
Entry "glucose (apart from glucose1- phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous
Entry or parenteral
"glucose (apart use)" should
from glucose1- be followed.
phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous
Entry or parenteral
"glucose (apart use)" should
from glucose1- be followed.
phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous
Entry or parenteral
"glucose (apart use)" should
from glucose1- be followed.
phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous or parenteral use)" should be followed.
Not authorised in EEA or in more than 1 Member state Dec-15

Not authorised in EEA or in more than 1 Member state Dec-15

Not authorised in EEA or in more than 1 Member state Dec-15

Not authorised in EEA or in more than 1 Member state Dec-15

Not authorised in EEA or in more than 1 Member state Dec-15


Entry "glucose (apart from glucose1- phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous
Entry or parenteral
"glucose (apart use)" should
from glucose1- be followed.
phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous
Entry or parenteral
"glucose (apart use)" should
from glucose1- be followed.
phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous
Entry or parenteral
"glucose (apart use)" should
from glucose1- be followed.
phosphate) / glucose in
combination with calcium chloride and/or sodium chloride and/or
Dec-15
magnesium chloride and/or sodium citrate and/or potassium chloride
(intravenous or parenteral use)" should be followed.
Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15

Entry "linagliptin, linagliptin / metformin" should be followed. Dec-15

Entry "dibrompropamidine , propamidine" should be followed. Nov-15

Not authorised in EEA or in more than 1 Member state Nov-15

Entry "empagliflozin, empagliflozin / metformin" should be followed. Nov-15

# Classified as internal/staff contractors by the European Medicines Agency


Entry "tacrolimus (systemic formulations)" should be followed. Nov-15

Not authorised in EEA or in more than 1 Member state Oct-15

Entry "tioconazole, tioconazole / hydrocortisone" should be followed. Oct-15

Entry divided according to indication. Entry "phenylephrine (IV, nasal


or oral formulations )" or "phenylephrine (ophthalmic formulations)" Oct-15
should be followed.

Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15

Entry "tinidazole / nystatin, tinidazole" should be followed Oct-15

Entry "beclometasone / formoterol (inhalative application)" should be


Sep-15
followed

Entry "calcium salts / colecalciferol" should be followed Sep-15

Entry "calcium salts / colecalciferol" should be followed Sep-15

Entry "macrogol 4000 and combinations (systemic use)" to be


Sep-15
followed

Entry "macrogol 4000 and combinations (systemic use)" to be


Sep-15
followed

Entry "macrogol 4000 and combinations (systemic use)" to be


Sep-15
followed

Not authorised in EEA or in more than 1 Member state Sep-15

Entry "valsartan, hydrochlorothiazide / valsartan" to be followed Sep-15

Entry "valsartan,/ hydrochlorothiazide / valsartan" to be followed Sep-15

Not authorised in EEA or in more than 1 Member state Jul-15

Not authorised in EEA or in more than 1 Member state Jul-15

Not authorised in EEA or in more than 1 Member state Jul-15

Not authorised in EEA or in more than 1 Member state Jul-15

# Classified as internal/staff contractors by the European Medicines Agency


Entry "human fibrinogen / human thrombin" should be followed Jul-15

Entry "raltegravir, lamivudine / raltegravir " should be followed Jul-15

Entry "amitriptyline, amitriptyline / amitriptylinoxide,


Jun-15
amitriptylinoxide" should be followed

Entry "amitriptyline, amitriptyline / amitriptylinoxide,


Jun-15
amitriptylinoxide" should be followed

Entry "amitriptyline, amitriptyline / amitriptylinoxide,


Jun-15
amitriptylinoxide" should be followed

Not authorised in EEA or in more than 1 Member state Jun-15

Entry “bacterial lysates” removed and more specific entries are


Jun-15
introduced
Allergen group entry is temporarily removed from the EURD list. For
more details regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
document_listing/document_listing_000353.jsp

# Classified as internal/staff contractors by the European Medicines Agency


Allergen group entry is temporarily removed from the EURD list. For
more details regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
Allergen group entry is temporarily removed from the EURD list. For
more detailsdocument_listing/document_listing_000353.jsp
regarding this decision please refer to the PRAC minutes
(May 2015 - Item 12.10.4.) May-15
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/
document_listing/document_listing_000353.jsp
Not authorised in EEA or in more than 1 Member state May-15

Not authorised in EEA or in more than 1 Member state May-15

Not authorised in EEA or in more than 1 Member state May-15

Entry "'amlodipine / indapamide, amlodipine / indapamide /


May-15
perindopril" should be followed

Entry "'amlodipine / indapamide, amlodipine / indapamide /


May-15
perindopril" should be followed

Not authorised in EEA or in more than 1 Member state May-15

Not authorised in EEA or in more than 1 Member state May-15

Entry "human fibrinogen / human thrombin" should be followed Apr-15

Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should


Apr-15
be followed

Entry "phloroglucinol, phloroglucinol / trimethylphloroglucinol" should


Apr-15
be followed

Not authorised in EEA or in more than 1 Member state Apr-15

Entries "misoprostol (gynaecological indication - labor induction)" and


"misoprostol (gynaecological indication - termination of pregnancy)" Apr-15
should be followed accordingly

Not authorised in EEA or in more than 1 Member state Apr-15

# Classified as internal/staff contractors by the European Medicines Agency


Not authorised in EEA or in more than 1 Member state Apr-15

Not authorised in EEA or in more than 1 Member state Apr-15

Not authorised in EEA or in more than 1 Member state Apr-15

Not authorised in EEA or in more than 1 Member state Apr-15

Not authorised in EEA or in more than 1 Member state Apr-15

Entries "carmustine (powder and solvent for solution for infusion)"


Apr-15
and "carmustine (implant)" should be followed accordingly

Not authorised in EEA or in more than 1 Member state Apr-15

Entry "atorvastatin" should be followed Apr-15

Entry "atorvastatin" should be followed Apr-15


Entry "aprotinin / calcium chloride / human factor xiii / human
fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin /
human coagulation factor XIII / plasma protein fraction / Apr-15
plasminogen / thrombin,
Entry "aprotinin aprotinin
/ calcium chloride/ human
/ humanfibrinogen
factor xiii//thrombin
human
(calcium
fibrinogen / human chloride)"
thrombin, should /be
aprotinin followed/ fibronectin /
fibrinogen
human coagulation factor XIII / plasma protein fraction / Apr-15
plasminogen / thrombin,
Entry "aprotinin aprotinin
/ calcium chloride/ human
/ humanfibrinogen
factor xiii//thrombin
human
(calcium chloride)" should be followed
fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin /
human coagulation factor XIII / plasma protein fraction / Apr-15
plasminogen / thrombin, aprotinin / human fibrinogen / thrombin
(calcium chloride)" should be followed
Entry "dihydroergotoxine" should be followed Mar-15

Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)"


Mar-15
should be followed

Entry "ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus)"


Mar-15
should be followed

Entry "'sodium hydrogen carbonate" should be followed Mar-15

Entry "diclofenac (topical formulations)" should be followed Mar-15

Entry "diclofenac (topical formulations)" should be followed Mar-15

Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide,


Mar-15
valsartan" should be followed

# Classified as internal/staff contractors by the European Medicines Agency


Entry "'amlodipine / valsartan, amlodipine / hydrochlorothiazide,
Mar-15
valsartan" should be followed

Not authorised in EEA or in more than 1 Member state Feb-15

Not authorised in EEA or in more than 1 Member state Feb-15

Entry "asparaginase" should be followed Jan-15

Entry "asparaginase" should be followed Jan-15

Entry "'cilazapril, cilazapril / hydrochlorothiazide" should be followed Jan-15

Not authorised in EEA or in more than 1 Member state Jan-15

Not authorised in EEA or in more than 1 Member state Jan-15

Not authorised in EEA or in more than 1 Member state Jan-15

Entry "'canagliflozin, canagliflozin / metformin" should be followed Dec-14

Entry "'amino acid combinations (only combinations of pure amino


acids or combination of amino acids with mineral Dec-14
compounds/electrolytes, i.v. application)" should be followed

Entry "'vildagliptin, metformin / vildagliptin" should be followed Nov-14

Not authorised in EEA or in more than 1 Member state Nov-14

Entry removed as duplicate to "hydroxyzine chloride / hydroxyzine


Nov-14
pamoate and all fixed combination, hydroxyzine"

Not authorised in EEA or in more than 1 Member state Nov-14

Entry "'camphor, camphor and other terpene derivates" should be


Nov-14
followed

Entry "'camphor, camphor and other terpene derivates" should be


Nov-14
followed

Entry "'camphor, camphor and other terpene derivates" should be


Nov-14
followed

Entry "'camphor, camphor and other terpene derivates" should be


Nov-14
followed

# Classified as internal/staff contractors by the European Medicines Agency


Entry "sodium oxybate" should be followed Oct-14

Not authorised in EEA or in more than 1 Member state Sep-14

Not authorised in EEA or in more than 1 Member state Sep-14

Entry clorazepate in the EURD list to be followed Sep-14

Entry cetylpyridinium, lysozyme in the EURD list to be followed Sep-14

Not authorised in EEA or in more than 1 Member state Sep-14

Entry benztropine in the EURD list to be followed Sep-14

Entry benfotiamine in the EURD list to be followed Sep-14

Entry benfotiamine, cyanocobalamin, pyridoxine in the EURD list to be


Sep-14
followed

Not authorised in EEA or in more than 1 Member state Sep-14

Entry aluminium oxide, magnesium hydroxide, simeticone in the


Sep-14
EURD list to be followed

Entry alum, benzalkonium chloride in the EURD list to be followed Sep-14

Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron, parenteral preparations in the EURD list to be followed Jul-14

Entry sodium feredetate in the EURD list to be followed Jul-14

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, oral preparations in the EURD list to be followed Jul-14

# Classified as internal/staff contractors by the European Medicines Agency


Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron, oral preparations in the EURD list to be followed Jul-14

Entry iron in combination with folic acid and other substances in the
Jul-14
EURD list to be followed

Entry iron, parenteral preparations in the EURD list to be followed Jul-14

Entry iron, parenteral preparations in the EURD list to be followed Jul-14

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

# Classified as internal/staff contractors by the European Medicines Agency


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) in the EURD list to be
followed one or more of the following:
Entry iron in any combination including
multivitamins, minerals, aminoacids, herbal extracts, lecithine
Jul-14
(except for combinations with folic acid) in the EURD list to be
followed
Entry valproic acid / sodium valproate / valproate pivoxil / valproate
semisodium / valpriomide / valproate bismuth / calcium valproate / Jul-14
valproate magnesium in the EURD list to be followed
Entry valproic acid / sodium valproate / valproate pivoxil / valproate
semisodium / valpriomide / valproate bismuth / calcium valproate / Jul-14
valproate magnesium in the EURD list to be followed
Entry valproic acid / sodium valproate / valproate pivoxil / valproate
semisodium / valpriomide / valproate bismuth / calcium valproate / Jul-14
valproate magnesium in the 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) in the EURD list to be
followed
Entry levomepromazine in the EURD list to be followed May-14

Entry midecamycin acetate in the EURD list to be followed May-14

Not authorised in EEA or in more than 1 Member state Feb-14

Moved temporarily to the “List of substances under PSUR Work


Sharing scheme and other substances contained in Nationally Feb-14
Authorised Products with DLP synchronised”

Not authorised in EEA or in more than 1 Member state Feb-14

Not authorised in EEA or in more than 1 Member state Feb-14

Moved temporarily to the “List of substances under PSUR Work


Sharing scheme and other substances contained in Nationally Feb-14
Authorised Products with DLP synchronised”
Merged entry with pandemic influenza vaccine (H5N1) (split virion,
Feb-14
inactivated, adjuvanted)

Entry omega-3-acid-ethyl esters in the PSUR WS List to be followed Feb-14

Moved temporarily to the “List of substances under PSUR Work


Sharing scheme and other substances contained in Nationally Feb-14
Authorised Products with DLP synchronised”

Not authorised in EEA or in more than 1 Member state Feb-14

Not authorised in EEA or in more than 1 Member state Feb-14

Not authorised in EEA or in more than 1 Member state Feb-14

# Classified as internal/staff contractors by the European Medicines Agency


Merged entry with technetium (99mTc) tetrofosmin Feb-14

Not authorised in EEA or in more than 1 Member state Jan-14

Included in shared entry "alogliptin, alogliptin / metformin, alogliptin /


Jan-14
pioglitazone"
Moved temporarily to the “List of substances under PSUR Work
Sharing scheme and other substances contained in Nationally Jan-14
Authorised Products with DLP synchronised”
Moved temporarily to the “List of substances under PSUR Work
Sharing scheme and other substances contained in Nationally Nov-13
Authorised Products with DLP synchronised”
Moved temporarily to the “List of substances under PSUR Work
Sharing scheme and other substances contained in Nationally Oct-13
Authorised Products with DLP synchronised”
Replaced with "omega-3-acid-ethyl esters" which is placed
temporarily in the “List of substances under PSUR Work Sharing
Oct-13
scheme and other substances contained in Nationally Authorised
Products with DLP synchronised”
Replaced with "testosterone (all formulations apart from transdermal
Oct-13
application and testosterone undecylate injection)"

Not authorised in EEA or in more than 1 Member state Sep-13

Moved temporarily to the “List of substances under PSUR Work


Sharing scheme and other substances contained in Nationally Sep-13
Authorised Products with DLP synchronised”
Entry too general, specific combinations will be specified in the EURD
Sep-13
List if those are authorised in EEA or in more than 1 Member state.

Not authorised in EEA or in more than 1 Member state Jul-13

Not authorised in EEA or in more than 1 Member state Jul-13

Not authorised in EEA or in more than 1 Member state Jul-13

Moved temporarily to the “List of substances under PSUR Work


Sharing scheme and other substances contained in Nationally Jul-13
Authorised Products with DLP synchronised”
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs

# Classified as internal/staff contractors by the European Medicines Agency


Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs
Products which do not fall in the scope of Article 10(1), 10a, 16, 14a
of Directive 2001/83/EC as amended should follow national May-13
requirements for the submission of PSURs

# Classified as internal/staff contractors by the European Medicines Agency


Moved temporarily to the “List of substances under PSUR Work May-13
Sharing scheme and other substances contained in Nationally
Authorised Products with DLP synchronised”
Moved temporarily to the “List of substances under PSUR Work May-13
Sharing scheme and other substances contained in Nationally
Authorised Products with DLP synchronised”

Not authorised in EEA or in more than 1 Member state Apr-13

Not authorised in EEA or in more than 1 Member state Apr-13

Not authorised in EEA or in more than 1 Member state Apr-13

Not authorised in EEA or in more than 1 Member state Apr-13

Moved temporarily to the “List of substances under PSUR Work Apr-13


Sharing scheme and other substances contained in Nationally
Authorised Products with DLP synchronised”
Moved temporarily to the “List of substances under PSUR Work Apr-13
Sharing scheme and other substances contained in Nationally
Authorised Products with DLP synchronised”

Not authorised in EEA or in more than 1 Member state Feb-13

Please refer to entry: pancreatic enzymes / pancreatic extracts /


Jan-13
pancreatin

Not authorised in EEA or in more than 1 Member state Dec-12

# Classified as internal/staff contractors by the European Medicines Agency

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