Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2025 to 31 October 2025 (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: 2025-11-21
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_202506344EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/6344


21.11.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2025 to 31 October 2025
         


(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/2025/6344)







—



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




17.10.2025


Winlevi


Clascoterone







Cassiopea S.p.A.




Via Cristoforo Colombo 1, 20045 Lainate, Milano, Italia






EU/1/25/1927


Cream


D10AX06


21.10.2025














—



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




1.10.2025


Adasuve







Ferrer Internacional S.A.




Gran Via Carlos III 94, 08028 Barcelona, España






EU/1/13/823


9.10.2025




1.10.2025


Celsentri







ViiV Healthcare BV




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






EU/1/07/418


2.10.2025




1.10.2025


Nuvaxovid







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/21/1618


2.10.2025




1.10.2025


Prevenar 20







Pfizer Europe MA EEIG




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






EU/1/21/1612


2.10.2025




1.10.2025


Tivicay







ViiV Healthcare BV




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






EU/1/13/892


2.10.2025




1.10.2025


Viramune







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/055


2.10.2025




2.10.2025


BIMERVAX







Hipra Human Health, S.L.U.




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






EU/1/22/1709


6.10.2025




9.10.2025


Simponi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/09/546


10.10.2025




9.10.2025


Tofidence







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/24/1825


13.10.2025




13.10.2025


Amyvid







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/12/805


14.10.2025




13.10.2025


Ibandronic Acid Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/642


14.10.2025




13.10.2025


Juluca







ViiV Healthcare B.V.




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






EU/1/18/1282


14.10.2025




13.10.2025


Keppra







UCB Pharma S.A.




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






EU/1/00/146


14.10.2025




13.10.2025


Lacosamide Adroiq







Extrovis EU Kft.




Raktarvarosi Ut 9, Torokbalint, 2045, Magyarország






EU/1/23/1732


21.10.2025




17.10.2025


Enzalutamide Viatris







Viatris Limited




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






EU/1/24/1842


22.10.2025




17.10.2025


Voriconazole Accord







Accord Healthcare S.L.U.




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






EU/1/13/835


20.10.2025




20.10.2025


Effentora







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/441


23.10.2025




20.10.2025


Mycophenolate mofetil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/439


27.10.2025




20.10.2025


Myfenax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/438


27.10.2025




20.10.2025


Quofenix







A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.




Via Sette Santi 3, 50131 Florence, Italia






EU/1/19/1393


23.10.2025




20.10.2025


Tezspire







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1677


21.10.2025




20.10.2025


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


21.10.2025




20.10.2025


Tyverb







Novartis Europharm Limited




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






EU/1/07/440


21.10.2025




20.10.2025


Zyprexa Velotab







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/99/125


24.10.2025




21.10.2025


Ganfort







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/06/340


21.10.2025




24.10.2025


Alecensa







Roche Registration GmbH




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






EU/1/16/1169


27.10.2025




24.10.2025


Brukinsa







BeOne Medicines Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/21/1576


27.10.2025




24.10.2025


Dovprela







Mylan IRE Healthcare Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland






EU/1/20/1437


28.10.2025




24.10.2025


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


27.10.2025




24.10.2025


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


27.10.2025




24.10.2025


Pyzchiva







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1801


27.10.2025




24.10.2025


Spevigo







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/22/1688


28.10.2025




24.10.2025


Tevimbra







BeOne Medicines Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/23/1758


27.10.2025




24.10.2025


Usymro







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/25/1957


30.10.2025




24.10.2025


Verquvo







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/21/1561


27.10.2025




24.10.2025


Zynlonta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/22/1695


27.10.2025




24.10.2025


Zypadhera







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/08/479


28.10.2025




30.10.2025


Kaletra







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/01/172


3.11.2025




30.10.2025


Kirsty







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/20/1506


10.11.2025




30.10.2025


Posaconazole AHCL







Accord Healthcare S.L.U.




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






EU/1/19/1380


3.11.2025














—



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




1.10.2025


PritorPlus







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/215


6.10.2025




17.10.2025


Dengvaxia







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/18/1338


20.10.2025




30.10.2025


NutropinAq







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/00/164


3.11.2025














—



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




24.10.2025


Hemosyvet


Etamsylate







Axience




Tour Essor, 14 Rue Scandicci, 93500 Pantin, France






EU/2/25/352


Solution for injection


Pending


27.10.2025




27.10.2025


Portela


relfovetmab







Zoetis Belgium




Rue Laid Burniat 1, 1348 Ottignies-Louvain-La-Neuve, Belgique






EU/2/25/353


Solution for injection


QN02BG92


29.10.2025














—



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




9.10.2025


OvuGel







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/20/260


10.10.2025




13.10.2025


ArthriCox







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, H62 FH90, Ireland






EU/2/24/323


16.10.2025




24.10.2025


Emevet







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/25/343


27.10.2025




24.10.2025


Meloxidolor







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/13/148


27.10.2025




24.10.2025


Novaquin







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/15/186


29.10.2025




24.10.2025


Osurnia







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/14/170


29.10.2025




24.10.2025


Semintra







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/12/146


28.10.2025




24.10.2025


Zulvac 1+8 Bovis







Zoetis Belgium




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






EU/2/12/139


30.10.2025




24.10.2025


Zulvac 1+8 Ovis







Zoetis Belgium




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






EU/2/11/120


30.10.2025




27.10.2025


BRAVECTO TriUNO







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/24/325


29.10.2025




27.10.2025


EVICTO







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/19/242


28.10.2025




27.10.2025


GUMBOHATCH







Laboratorios Hipra, S.A.




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






EU/2/19/245


30.10.2025




27.10.2025


Zulvac SBV







Zoetis Belgium




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






EU/2/14/178


29.10.2025




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/2025/6344/oj
ISSN 1977-091X (electronic edition)