Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2025 to 31 January 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: 2025-02-28
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_202501266EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/1266


28.2.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2025 to 31 January 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/2025/1266)

—   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




13.1.2025


Ahzantive


Aflibercept







Klinge Biopharma GmbH




83607 Holzkirchen, Deutschland






EU/1/24/1888


Solution for injection


S01LA05


17.1.2025




13.1.2025


AUGTYRO


repotrectinib







Bristol Myers Squibb Pharma EEIG




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






EU/1/24/1883


Capsule, hard


L01EX28


14.1.2025




13.1.2025


Baiama


Aflibercept







Formycon AG




Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland






EU/1/24/1887


Solution for injection


S01LA05


14.1.2025




13.1.2025


Gohibic


vilobelimab







InflaRx GmbH




Winzerlaer Strasse 2, 07745 Jena, Deutschland






EU/1/24/1884


Concentrate for solution for infusion


L04AJ10


14.1.2025




13.1.2025


SIILTIBCY


rdESAT-6 and rCFP-10







Serum Life Science Europe GmbH




Ahrensburger Strasse 1, 30659 Hannover, Deutschland






EU/1/24/1882


Solution for injection


Pending


17.1.2025




20.1.2025


KAVIGALE


Sipavibart







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1900


Solution for injection or infusion


J06BD09


21.1.2025




20.1.2025


Lazcluze


lazertinib







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/24/1886


Film-coated tablet


L01EB09


21.1.2025




—   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




13.1.2025


Benepali







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/15/1074


20.1.2025




13.1.2025


Benlysta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/11/700


14.1.2025




13.1.2025


Briumvi







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/23/1730


14.1.2025




13.1.2025


Elucirem







Guerbet




15 rue des Vanesses, 93420, Villepinte, France






EU/1/23/1772


16.1.2025




13.1.2025


Fetcroja







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/20/1434


14.1.2025




13.1.2025


Imvanex







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/13/855


20.1.2025




13.1.2025


Jakavi







Novartis Europharm Limited




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






EU/1/12/773


14.1.2025




13.1.2025


Kevzara







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1196


14.1.2025




13.1.2025


Latuda







Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.




Viale Amelia 70, 00181 Roma, Italia






EU/1/14/913


17.1.2025




13.1.2025


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem, België






EU/1/13/869


14.1.2025




13.1.2025


Levitra







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/03/248


14.1.2025




13.1.2025


Lyumjev







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1422


17.1.2025




13.1.2025


Mayzent







Novartis Europharm Limited




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






EU/1/19/1414


14.1.2025




13.1.2025


Nepexto







Biosimilar Collaborations Ireland Limited




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






EU/1/20/1436


15.1.2025




13.1.2025


Neuraceq







Life Molecular Imaging GmbH




Tegeler Strasse 6-7, Wedding, 13353 Berlin, Deutschland






EU/1/13/906


14.1.2025




13.1.2025


Nexium Control







GlaxoSmithKline Dungarvan Limited




Knockbrack, Dungarvan, Co. Waterford, Ireland






EU/1/13/860


14.1.2025




13.1.2025


Nimvastid







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/525


17.1.2025




13.1.2025


Ocrevus







Roche Registration GmbH




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






EU/1/17/1231


14.1.2025




13.1.2025


Qaialdo







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland






EU/1/23/1731


14.1.2025




13.1.2025


REKAMBYS







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1482


14.1.2025




13.1.2025


Renagel







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/99/123


14.1.2025




13.1.2025


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


17.1.2025




13.1.2025


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


14.1.2025




13.1.2025


Sunosi







Atnahs Pharma Netherlands B. V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark






EU/1/19/1408


16.1.2025




13.1.2025


Thyrogen







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/99/122


14.1.2025




13.1.2025


Vaxchora







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/20/1423


20.1.2025




13.1.2025


Viagra







Upjohn EESV




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






EU/1/98/077


22.1.2025




13.1.2025


Vocabria







ViiV Healthcare BV




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






EU/1/20/1481


14.1.2025




15.1.2025


Bemfola







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/13/909


20.1.2025




15.1.2025


Copalia







Novartis Europharm Limited




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






EU/1/06/372


17.1.2025




15.1.2025


Dafiro







Novartis Europharm Limited




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






EU/1/06/371


16.1.2025




15.1.2025


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569


17.1.2025




15.1.2025


JEMPERLI







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1538


16.1.2025




15.1.2025


Tavneos







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/21/1605


17.1.2025




15.1.2025


VPRIV







Takeda Pharmaceuticals International AG Ireland Branch




Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland






EU/1/10/646


16.1.2025




20.1.2025


Blitzima







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/17/1205


24.1.2025




20.1.2025


PritorPlus







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/215


21.1.2025




20.1.2025


ProQuad







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/323


22.1.2025




20.1.2025


Revatio







Upjohn EESV




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






EU/1/05/318


23.1.2025




20.1.2025


Sarclisa







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1435


21.1.2025




20.1.2025


Truxima







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/16/1167


24.1.2025




23.1.2025


BLINCYTO







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1047


24.1.2025




23.1.2025


Bonviva







Atnahs Pharma Netherlands B.V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark






EU/1/03/265


7.2.2025




23.1.2025


Cinacalcet Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/15/1054


24.1.2025




23.1.2025


Copalia HCT







Novartis Europharm Limited




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






EU/1/09/575


24.1.2025




23.1.2025


Dafiro HCT







Novartis Europharm Limited




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






EU/1/09/574


24.1.2025




23.1.2025


Flucelvax Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/18/1326


24.1.2025




23.1.2025


GHRYVELIN







Atnahs Pharma Netherlands B.V.




Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark






EU/1/18/1337


29.1.2025




23.1.2025


Ravicti







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/15/1062


30.1.2025




23.1.2025


Rubraca







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/17/1250


27.1.2025




23.1.2025


Vazkepa







Amarin Pharmaceuticals Ireland Limited




88 Harcourt Street, Dublin 2, D02DK18, Ireland






EU/1/20/1524


27.1.2025




28.1.2025


Bridion







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/466


29.1.2025




28.1.2025


Duloxetine Viatris







Viatris Limited




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






EU/1/15/1010


29.1.2025




28.1.2025


Fymskina







Formycon AG




Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland






EU/1/24/1862


3.2.2025




28.1.2025


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland






EU/1/20/1468


29.1.2025




28.1.2025


Kauliv







Strides Pharma (Cyprus) Ltd.




Themistokli Dervi, 3, Julia House, 1st Floor, 1066, Nicosia, Κύπρος






EU/1/22/1710


30.1.2025




28.1.2025


Lysodren







Esteve RD France SAS




25 Boulevard, Romain Rolland, 92120 Montrouge, France






EU/1/04/273


30.1.2025




28.1.2025


Tyenne







Fresenius Kabi Deutschland GmbH




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






EU/1/23/1754


29.1.2025




30.1.2025


Capecitabine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/761


4.2.2025




30.1.2025


Carmustine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/18/1278


3.2.2025




30.1.2025


Omnitrope







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/06/332


4.2.2025




30.1.2025


Tracleer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/220


31.1.2025




30.1.2025


Vimpat







UCB Pharma S.A.




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






EU/1/08/470


31.1.2025




30.1.2025


Zonisamide Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1093


31.1.2025




30.1.2025


Zonisamide Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1093


31.1.2025




—   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




13.1.2025


Grastofil







Accord Healthcare S.L.U.




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






EU/1/13/877


14.1.2025




20.1.2025


Penbraya







Pfizer Europe MA EEIG




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






EU/1/24/1871


22.1.2025




—   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




23.1.2025


Icthiovac ERM


Inactivated vaccine against yersiniosis in Atlantic salmon







Laboratorios Hipra, S.A.




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






EU/2/24/330


concentrate for dip suspension


QI10AB04


24.1.2025




23.1.2025


Poulvac Procerta HVT-IBD-ND


Marek’s disease, infectious bursal disease and Newcastle disease vaccine (live recombinant)







Zoetis Belgium




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






EU/2/24/324


Concentrate and solvent for suspension for injection


Pending


28.1.2025




—   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




13.1.2025


CircoMax







Zoetis Belgium




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






EU/2/21/281


17.1.2025




13.1.2025


MS-H vaccine







Pharmsure Veterinary Products Europe Limited




4 Fitzwilliam Terrace, Strand Road, Bray, WICKLOW A98 T6H6, Ireland






EU/2/11/126


21.1.2025




13.1.2025


REXXOLIDE







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/20/263


22.1.2025




23.1.2025


Bonqat







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/273


27.1.2025




23.1.2025


Ecoporc SHIGA







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/13/149


24.1.2025




23.1.2025


Librela







Zoetis Belgium




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






EU/2/20/261


24.1.2025




23.1.2025


Pexion







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/12/147


25.1.2025




—   Withdrawal 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)









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




28.1.2025


Neocolipor







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/98/008


30.1.2025




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/2025/1266/oj
ISSN 1977-091X (electronic edition)