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)
Date: 2025-01-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_202500476EN.000101.fmx.xml












Official Journal of the European Union


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







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






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







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/24/1869


Film-coated tablet


B02BX05


13.12.2024




12.12.2024


IMULDOSA


ustekinumab







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/24/1872


Concentrate for solution for infusion
Solution for injection


L04AC05


16.12.2024




13.12.2024


Alhemo


concizumab







Novo Nordisk A/S




Novo Alle 1, 2880 Bagsvaerd, Danmark






EU/1/24/1881


Solution for injection


B02BX10


16.12.2024




19.12.2024


Buprenorphine Neuraxpharm


buprenorphine







Neuraxpharm Pharmaceuticals, S.L.




Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España






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







Apellis Europe B.V.




Piet Heinkade 55, Amsterdam, Noord-Holland 1019 GM, Nederland






-


19.12.2024




19.12.2024


Masitinib AB Science







AB Science




3 avenue George V, 75008 Paris, France






-


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







Gentium S.r.I.




Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia






EU/1/13/878


5.12.2024




4.12.2024


Hemgenix







CSL Behring GmbH




D-35041 Marburg, Deutschland






EU/1/22/1715


10.12.2024




4.12.2024


Hexacima







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/13/828


5.12.2024




4.12.2024


Hexyon







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/13/829


5.12.2024




4.12.2024


Hyftor







Plusultra pharma GmbH




Fritz-Vomfelde-Str. 36, 40547 Düsseldorf, Deutschland






EU/1/23/1723


12.12.2024




4.12.2024


Vevizye







Laboratoires Thea




12 Rue Louis Bleriot, 63100 Clermont-Ferrand, France






EU/1/24/1857


5.12.2024




4.12.2024


Xeljanz







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/17/1178


6.12.2024




6.12.2024


Cerdelga







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/14/974


10.12.2024




9.12.2024


Apretude







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/23/1760


10.12.2024




9.12.2024


Feraccru







Norgine B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/15/1075


13.12.2024




9.12.2024


Olanzapine Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/08/475


11.12.2024




9.12.2024


Tegsedi







Akcea Therapeutics Ireland Ltd




St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland






EU/1/18/1296


10.12.2024




11.12.2024


Rivastigmine Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/09/599


13.12.2024




12.12.2024


Abiraterone Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/21/1571


16.12.2024




12.12.2024


Alimta







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/04/290


17.12.2024




12.12.2024


Armisarte







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/15/1063


16.12.2024




12.12.2024


BIMERVAX







Hipra Human Health, S.L.U.




Avda. la Selva, 135, 17170 Amer (Girona), España






EU/1/22/1709


13.12.2024




12.12.2024


Bridion







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/466


13.12.2024




12.12.2024


Cinacalcet Accordpharma







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/20/1429


13.12.2024




12.12.2024


Dengvaxia







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/18/1338


16.12.2024




12.12.2024


Hukyndra







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/21/1589


13.12.2024




12.12.2024


Imlygic







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1064


13.12.2024




12.12.2024


Keppra







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/00/146


16.12.2024




12.12.2024


Kyprolis







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1060


13.12.2024




12.12.2024


Nintedanib Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/24/1803


13.12.2024




12.12.2024


Opdualag







Bristol Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland






EU/1/22/1679


16.12.2024




12.12.2024


Pemetrexed Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/15/1071


16.12.2024




12.12.2024


Prometax







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/98/092


18.12.2024




12.12.2024


Refixia







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1193


16.12.2024




12.12.2024


Rivastigmine HEXAL







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/09/589


13.12.2024




12.12.2024


Sevelamer carbonate Winthrop







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/14/952


16.12.2024




12.12.2024


Skytrofa







Ascendis Pharma Endocrinology Division A/S




Tuborg Boulevard 12, 2900 Hellerup, Danmark






EU/1/21/1607


13.12.2024




12.12.2024


Spravato







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/19/1410


16.12.2024




12.12.2024


Tepkinly







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1759


16.12.2024




12.12.2024


Tibsovo







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/23/1728


13.12.2024




12.12.2024


Toujeo







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/133


16.12.2024




12.12.2024


Valdoxan







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/08/499


16.12.2024




12.12.2024


Vocabria







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/20/1481


16.12.2024




12.12.2024


Vueway







Bracco Imaging SPA




Via Egidio Folli, 50 20134 Milano, Italia






EU/1/23/1773


13.12.2024




12.12.2024


Zykadia







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/15/999


17.12.2024




13.12.2024


CellCept







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/96/005


16.12.2024




13.12.2024


Evkeeza







Ultragenyx Germany GmbH




Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland






EU/1/21/1551


16.12.2024




13.12.2024


Teriflunomide Viatris







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/22/1698


16.12.2024




13.12.2024


Trepulmix







SciPharm Sàrl




7, Fausermillen, 6689 Mertert, Luxembourg






EU/1/19/1419


17.12.2024




16.12.2024


Gilenya







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/11/677


17.12.2024




19.12.2024


Azacitidine Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/19/1413


20.12.2024




19.12.2024


Cinacalcet Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/15/1054


20.12.2024




19.12.2024


Erbitux







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/04/281


20.12.2024




19.12.2024


Erelzi







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1195


7.1.2025




19.12.2024


Exelon







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/98/066


7.1.2025




19.12.2024


Fluad Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/20/1433


20.12.2024




19.12.2024


Libmyris







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/21/1590


20.12.2024




19.12.2024


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27, Ireland






EU/1/19/1376


20.12.2024




19.12.2024


Litak







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/04/275


20.12.2024




19.12.2024


Lyrica







Upjohn EESV




Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland






EU/1/04/279


7.1.2025




19.12.2024


Omvoh







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1736


20.12.2024




19.12.2024


OPDIVO







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/15/1014


20.12.2024




19.12.2024


Palforzia







STALLERGENES




6 rue Alexis de Tocqueville, 92160 Antony, France






EU/1/20/1495


20.12.2024




19.12.2024


Pemetrexed Fresenius Kabi







Fresenius Kabi Deutschland GmbH




Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland






EU/1/16/1115


20.12.2024




19.12.2024


Relistor







Bausch Health Ireland Limited




3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland






EU/1/08/463


7.1.2025




19.12.2024


Renvela







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/09/521


20.12.2024




19.12.2024


Rivaroxaban Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/21/1588


20.12.2024




19.12.2024


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Industriestraße 18, 83607 Holzkirchen, Deutschland






EU/1/09/585


23.12.2024




19.12.2024


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


20.12.2024




19.12.2024


Sitagliptin/Metformin hydrochloride Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/21/1619


20.12.2024




19.12.2024


TAGRISSO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1086


20.12.2024




19.12.2024


Trazimera







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/18/1295


20.12.2024




19.12.2024


Vabysmo







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/22/1683


20.12.2024




19.12.2024


Vidaza







Bristol Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland






EU/1/08/488


20.12.2024




19.12.2024


YERVOY







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






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







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






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







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






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







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/21/270


28.12.2024




19.12.2024


Equisolon







Le Vet B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/14/161


23.12.2024




19.12.2024


Locatim







MELCHIOR SANTE ANIMALE




5 Rue Victor Hugo, 69002 Lyon, France






EU/2/99/011


20.12.2024




19.12.2024


Simparica Trio







Zoetis Belgium




rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






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)