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Document 52025XC00476
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2024 to 31 December 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2024 to 31 December 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2024 to 31 December 2024 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
PUB/2025/58
OJ C, C/2025/476, 31.1.2025, ELI: http://data.europa.eu/eli/C/2025/476/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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Official Journal |
EN C series |
C/2025/476 |
31.1.2025 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2024 to 31 December 2024
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2) )
(C/2025/476)
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
12.12.2024 |
ABSIMKY |
Ustekinumab |
|
EU/1/24/1880 |
Concentrate for solution for infusion Solution for injection in a pre-filled syringe |
L04AC05 |
13.12.2024 |
||
12.12.2024 |
Eltrombopag Viatris |
eltrombopag |
|
EU/1/24/1869 |
Film-coated tablet |
B02BX05 |
13.12.2024 |
||
12.12.2024 |
IMULDOSA |
ustekinumab |
|
EU/1/24/1872 |
Concentrate for solution for infusion Solution for injection |
L04AC05 |
16.12.2024 |
||
13.12.2024 |
Alhemo |
concizumab |
|
EU/1/24/1881 |
Solution for injection |
B02BX10 |
16.12.2024 |
||
19.12.2024 |
Buprenorphine Neuraxpharm |
buprenorphine |
|
EU/1/24/1809 |
Sublingual film |
N07BC01 |
20.12.2024 |
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
16.12.2024 |
Syfovre |
|
- |
19.12.2024 |
||
19.12.2024 |
Masitinib AB Science |
|
- |
10.1.2025 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
4.12.2024 |
Defitelio |
|
EU/1/13/878 |
5.12.2024 |
||
4.12.2024 |
Hemgenix |
|
EU/1/22/1715 |
10.12.2024 |
||
4.12.2024 |
Hexacima |
|
EU/1/13/828 |
5.12.2024 |
||
4.12.2024 |
Hexyon |
|
EU/1/13/829 |
5.12.2024 |
||
4.12.2024 |
Hyftor |
|
EU/1/23/1723 |
12.12.2024 |
||
4.12.2024 |
Vevizye |
|
EU/1/24/1857 |
5.12.2024 |
||
4.12.2024 |
Xeljanz |
|
EU/1/17/1178 |
6.12.2024 |
||
6.12.2024 |
Cerdelga |
|
EU/1/14/974 |
10.12.2024 |
||
9.12.2024 |
Apretude |
|
EU/1/23/1760 |
10.12.2024 |
||
9.12.2024 |
Feraccru |
|
EU/1/15/1075 |
13.12.2024 |
||
9.12.2024 |
Olanzapine Viatris |
|
EU/1/08/475 |
11.12.2024 |
||
9.12.2024 |
Tegsedi |
|
EU/1/18/1296 |
10.12.2024 |
||
11.12.2024 |
Rivastigmine Sandoz |
|
EU/1/09/599 |
13.12.2024 |
||
12.12.2024 |
Abiraterone Mylan |
|
EU/1/21/1571 |
16.12.2024 |
||
12.12.2024 |
Alimta |
|
EU/1/04/290 |
17.12.2024 |
||
12.12.2024 |
Armisarte |
|
EU/1/15/1063 |
16.12.2024 |
||
12.12.2024 |
BIMERVAX |
|
EU/1/22/1709 |
13.12.2024 |
||
12.12.2024 |
Bridion |
|
EU/1/08/466 |
13.12.2024 |
||
12.12.2024 |
Cinacalcet Accordpharma |
|
EU/1/20/1429 |
13.12.2024 |
||
12.12.2024 |
Dengvaxia |
|
EU/1/18/1338 |
16.12.2024 |
||
12.12.2024 |
Hukyndra |
|
EU/1/21/1589 |
13.12.2024 |
||
12.12.2024 |
Imlygic |
|
EU/1/15/1064 |
13.12.2024 |
||
12.12.2024 |
Keppra |
|
EU/1/00/146 |
16.12.2024 |
||
12.12.2024 |
Kyprolis |
|
EU/1/15/1060 |
13.12.2024 |
||
12.12.2024 |
Nintedanib Accord |
|
EU/1/24/1803 |
13.12.2024 |
||
12.12.2024 |
Opdualag |
|
EU/1/22/1679 |
16.12.2024 |
||
12.12.2024 |
Pemetrexed Accord |
|
EU/1/15/1071 |
16.12.2024 |
||
12.12.2024 |
Prometax |
|
EU/1/98/092 |
18.12.2024 |
||
12.12.2024 |
Refixia |
|
EU/1/17/1193 |
16.12.2024 |
||
12.12.2024 |
Rivastigmine HEXAL |
|
EU/1/09/589 |
13.12.2024 |
||
12.12.2024 |
Sevelamer carbonate Winthrop |
|
EU/1/14/952 |
16.12.2024 |
||
12.12.2024 |
Skytrofa |
|
EU/1/21/1607 |
13.12.2024 |
||
12.12.2024 |
Spravato |
|
EU/1/19/1410 |
16.12.2024 |
||
12.12.2024 |
Tepkinly |
|
EU/1/23/1759 |
16.12.2024 |
||
12.12.2024 |
Tibsovo |
|
EU/1/23/1728 |
13.12.2024 |
||
12.12.2024 |
Toujeo |
|
EU/1/00/133 |
16.12.2024 |
||
12.12.2024 |
Valdoxan |
|
EU/1/08/499 |
16.12.2024 |
||
12.12.2024 |
Vocabria |
|
EU/1/20/1481 |
16.12.2024 |
||
12.12.2024 |
Vueway |
|
EU/1/23/1773 |
13.12.2024 |
||
12.12.2024 |
Zykadia |
|
EU/1/15/999 |
17.12.2024 |
||
13.12.2024 |
CellCept |
|
EU/1/96/005 |
16.12.2024 |
||
13.12.2024 |
Evkeeza |
|
EU/1/21/1551 |
16.12.2024 |
||
13.12.2024 |
Teriflunomide Viatris |
|
EU/1/22/1698 |
16.12.2024 |
||
13.12.2024 |
Trepulmix |
|
EU/1/19/1419 |
17.12.2024 |
||
16.12.2024 |
Gilenya |
|
EU/1/11/677 |
17.12.2024 |
||
19.12.2024 |
Azacitidine Accord |
|
EU/1/19/1413 |
20.12.2024 |
||
19.12.2024 |
Cinacalcet Viatris |
|
EU/1/15/1054 |
20.12.2024 |
||
19.12.2024 |
Erbitux |
|
EU/1/04/281 |
20.12.2024 |
||
19.12.2024 |
Erelzi |
|
EU/1/17/1195 |
7.1.2025 |
||
19.12.2024 |
Exelon |
|
EU/1/98/066 |
7.1.2025 |
||
19.12.2024 |
Fluad Tetra |
|
EU/1/20/1433 |
20.12.2024 |
||
19.12.2024 |
Libmyris |
|
EU/1/21/1590 |
20.12.2024 |
||
19.12.2024 |
LIBTAYO |
|
EU/1/19/1376 |
20.12.2024 |
||
19.12.2024 |
Litak |
|
EU/1/04/275 |
20.12.2024 |
||
19.12.2024 |
Lyrica |
|
EU/1/04/279 |
7.1.2025 |
||
19.12.2024 |
Omvoh |
|
EU/1/23/1736 |
20.12.2024 |
||
19.12.2024 |
OPDIVO |
|
EU/1/15/1014 |
20.12.2024 |
||
19.12.2024 |
Palforzia |
|
EU/1/20/1495 |
20.12.2024 |
||
19.12.2024 |
Pemetrexed Fresenius Kabi |
|
EU/1/16/1115 |
20.12.2024 |
||
19.12.2024 |
Relistor |
|
EU/1/08/463 |
7.1.2025 |
||
19.12.2024 |
Renvela |
|
EU/1/09/521 |
20.12.2024 |
||
19.12.2024 |
Rivaroxaban Viatris |
|
EU/1/21/1588 |
20.12.2024 |
||
19.12.2024 |
Rivastigmine 1 A Pharma |
|
EU/1/09/585 |
23.12.2024 |
||
19.12.2024 |
Rybrevant |
|
EU/1/21/1594 |
20.12.2024 |
||
19.12.2024 |
Sitagliptin/Metformin hydrochloride Mylan |
|
EU/1/21/1619 |
20.12.2024 |
||
19.12.2024 |
TAGRISSO |
|
EU/1/16/1086 |
20.12.2024 |
||
19.12.2024 |
Trazimera |
|
EU/1/18/1295 |
20.12.2024 |
||
19.12.2024 |
Vabysmo |
|
EU/1/22/1683 |
20.12.2024 |
||
19.12.2024 |
Vidaza |
|
EU/1/08/488 |
20.12.2024 |
||
19.12.2024 |
YERVOY |
|
EU/1/11/698 |
20.12.2024 |
— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
13.12.2024 |
Alofisel |
|
EU/1/17/1261 |
13.12.2024 |
— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
19.12.2024 |
Carprofen Orion |
carprofen |
|
EU/2/24/328 |
Chewable tablet Solution for injection |
QM01AE91 |
20.12.2024 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
||
19.12.2024 |
Daxocox |
|
EU/2/21/270 |
28.12.2024 |
||
19.12.2024 |
Equisolon |
|
EU/2/14/161 |
23.12.2024 |
||
19.12.2024 |
Locatim |
|
EU/2/99/011 |
20.12.2024 |
||
19.12.2024 |
Simparica Trio |
|
EU/2/19/243 |
20.12.2024 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
European Medicines Agency |
Domenico Scarlattilaan 6 |
1083 HS Amsterdam |
NETHERLANDS |
(1) OJ L 136, 30.4.2004, p. 1, ELI: https://data.europa.eu/eli/reg/2004/726/oj.
(2) OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.
ELI: http://data.europa.eu/eli/C/2025/476/oj
ISSN 1977-091X (electronic edition)