Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2025 to 30 April 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: 2025-05-28
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_202502785EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/2785


28.5.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2025 to 30 April 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/2025/2785)


—   

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




4.4.2025


Datroway


Datopotamab deruxtecan







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/25/1915


Powder for concentrate for solution for infusion


L01FX35


8.4.2025




4.4.2025


PAVBLU


Aflibercept







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, A96 F2A8, Ireland






EU/1/25/1909


Solution for injection in a pre-filled syringe
Solution for injection in a vial


S01LA05


7.4.2025




15.4.2025


LEQEMBI


Lecanemab







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/24/1891


Concentrate for solution for infusion


N06DX04


15.4.2025




23.4.2025


Filspari


Sparsentan







Vifor France




100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France






EU/1/23/1788


Film-coated tablet


C09XX01


25.4.2025




23.4.2025


LYNOZYFIC


linvoseltamab







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27, Ireland






EU/1/25/1917


Concentrate for solution for infusion


L01FX


25.4.2025




23.4.2025


Vyjuvek


Beremagene geperpavec







Krystal Biotech Netherlands B.V.




Atrium Gebouw, Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland






EU/1/25/1918


Suspension and gel for gel


D03AX16


24.4.2025




25.4.2025


Trabectedin Accord


trabectedin







Accord Healthcare S.L.U.




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






EU/1/24/1902


Powder for concentrate for solution for infusion


L01CX01


29.4.2025






—   

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




3.4.2025


Ketoconazole Esteve







Esteve Pharmaceuticals S.A.




Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España






EU/1/14/965


4.4.2025




4.4.2025


Briumvi







Neuraxpharm Pharmaceuticals, S.L.




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






EU/1/23/1730


8.4.2025




4.4.2025


Capecitabine Accord







Accord Healthcare S.L.U.




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






EU/1/12/762


7.4.2025




4.4.2025


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/16/1101


7.4.2025




4.4.2025


Ebvallo







Pierre Fabre Medicament




Les Cauquillous, 81500 Lavaur, France






EU/1/22/1700


7.4.2025




4.4.2025


Ecansya







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/12/763


7.4.2025




4.4.2025


Fingolimod Accord







Accord Healthcare S.L.U.




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






EU/1/20/1450


7.4.2025




4.4.2025


Finlee







Novartis Europharm Limited




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






EU/1/23/1767


7.4.2025




4.4.2025


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/20/1468


7.4.2025




4.4.2025


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/12/782


7.4.2025




4.4.2025


Ketoconazole Esteve







Esteve Pharmaceuticals S.A.




Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España






EU/1/14/965


8.4.2025




4.4.2025


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


7.4.2025




4.4.2025


Lenvima







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/15/1002


7.4.2025




4.4.2025


Lysodren







Esteve Pharmaceuticals S.A.




Torre Esteve Passeig Zona Franca 109, 4o 08038 Barcelona, España






EU/1/04/273


8.4.2025




4.4.2025


Ondexxya







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1345


7.4.2025




4.4.2025


RINVOQ







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


7.4.2025




4.4.2025


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


8.4.2025




4.4.2025


Tafinlar







Novartis Europharm Limited




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






EU/1/13/865


7.4.2025




4.4.2025


Waylivra







Akcea Therapeutics Ireland Ltd




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






EU/1/19/1360


7.4.2025




4.4.2025


Xenleta







Venipharm




4 Bureaux De La Colline, 92210 Saint-Cloud, France






EU/1/20/1457


7.4.2025




4.4.2025


Zercepac







Accord Healthcare S.L.U.




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






EU/1/20/1456


7.4.2025




10.4.2025


Columvi







Roche Registration GmbH




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






EU/1/23/1742


11.4.2025




10.4.2025


Flucelvax







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1879


11.4.2025




14.4.2025


Arsenic trioxide Mylan







Mylan Ireland Limited




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






EU/1/20/1427


15.4.2025




14.4.2025


Livogiva







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/20/1462


15.4.2025




14.4.2025


Lunsumio







Roche Registration GmbH




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






EU/1/22/1649


15.4.2025




14.4.2025


Oyavas







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/20/1510


16.4.2025




14.4.2025


Xenleta







Venipharm




4 Bureaux De La Colline, 92210 Saint-Cloud, France






EU/1/20/1457


17.4.2025




16.4.2025


Ovaleap







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/13/871


22.4.2025




16.4.2025


Sprycel







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/363


22.4.2025




16.4.2025


Targretin







H.A.C. Pharma




Pericentre 2, 43 Avenue De La Cote De Nacre, Caen, 14000, France






EU/1/01/178


22.4.2025




16.4.2025


Vafseo







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37, 58638 Iserlohn, Deutschland






EU/1/23/1725


23.4.2025




17.4.2025


Alymsys







Mabxience Research SL




C/ Manuel Pombo Angulo 28, 28050 Madrid, España






EU/1/20/1509


22.4.2025




17.4.2025


Enbrel







Pfizer Europe MA EEIG




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






EU/1/99/126


23.4.2025




17.4.2025


Glivec







Novartis Europharm Limited




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






EU/1/01/198


24.4.2025




23.4.2025


Ahzantive







Formycon AG




82152 Martinsried/Planegg, Deutschland






EU/1/24/1888


24.4.2025




23.4.2025


Apixaban Accord







Accord Healthcare S.L.U.




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






EU/1/20/1458


24.4.2025




23.4.2025


AQUMELDI







Proveca Pharma Limited




2 Dublin Landings, North Wall Quay, Dublin 1, Ireland






EU/1/23/1717


24.4.2025




23.4.2025


Insulin aspart Sanofi







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1447


28.4.2025




23.4.2025


Lutathera







Advanced Accelerator Applications




8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France






EU/1/17/1226


28.4.2025




23.4.2025


Lyrica







Upjohn EESV




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






EU/1/04/279


25.4.2025




23.4.2025


MAVENCLAD







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1212


24.4.2025




23.4.2025


Neparvis







Novartis Europharm Limited




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






EU/1/16/1103


28.4.2025




23.4.2025


OPDIVO







Bristol-Myers Squibb Pharma EEIG




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






EU/1/15/1014


24.4.2025




23.4.2025


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


25.4.2025




23.4.2025


Spikevax







MODERNA BIOTECH SPAIN, S.L.




C/ Julián Camarillo no 31, 28037 Madrid, España






EU/1/20/1507


25.4.2025




23.4.2025


TOBI Podhaler







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/10/652


25.4.2025




23.4.2025


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


24.4.2025




23.4.2025


Upstaza







PTC Therapeutics International Limited




70 Sir John Rogerson's Quay, Dublin 2, Ireland






EU/1/22/1653


28.4.2025




25.4.2025


Axumin







Blue Earth Diagnostics Ireland Ltd




6th Floor, 2 Grand Canal Square, Dublin 2, Ireland






EU/1/17/1186


29.4.2025




25.4.2025


Cufence







Univar Solutions B.V.




Schouwburgplein 30, Rotterdam, 3012 CL, Nederland






EU/1/19/1365


30.4.2025




25.4.2025


Cuprior







Orphalan




226 Boulevard Voltaire, 75011 Paris, France






EU/1/17/1199


28.4.2025




25.4.2025


DaTSCAN







GE Healthcare B.V.




De Rondom 8, 5612 AP, Eindhoven, Nederland






EU/1/00/135


28.4.2025




25.4.2025


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


30.4.2025




25.4.2025


Fabrazyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/01/188


29.4.2025




25.4.2025


IBRANCE







Pfizer Europe MA EEIG




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






EU/1/16/1147


28.4.2025




25.4.2025


Intuniv







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/15/1040


28.4.2025




25.4.2025


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


28.4.2025




25.4.2025


Mixtard







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/231


29.4.2025




25.4.2025


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/15/1059


28.4.2025




25.4.2025


PREVYMIS







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/17/1245


29.4.2025




25.4.2025


Ryzneuta







Evive Biotechnology Ireland LTD




20 Kildare Street, Dublin 2, D02 T3V7, Ireland






EU/1/24/1793


2.5.2025




25.4.2025


SCENESSE







Clinuvel Europe Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/14/969


30.4.2025




25.4.2025


SOTYKTU







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1718


30.4.2025




25.4.2025


VANFLYTA







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/23/1768


29.4.2025






—   

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




10.4.2025


Zostavax







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/341


11.4.2025




14.4.2025


Arsenic trioxide Mylan







Mylan Ireland Limited




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






EU/1/20/1427


15.4.2025




14.4.2025


Regkirona







Celltrion Healthcare Hungary Kft.




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






EU/1/21/1597


16.4.2025






—   

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




2.4.2025


Omeprazole TriviumVet


omeprazole







TriviumVet DAC




Unit 1N, Block 1A, Cleaboy Business Park, Old Kilmeaden Road, Waterford, X91 DEC4, Ireland






EU/2/25/336


Gastro-resistant capsule, hard


QA02BC01


3.4.2025




23.4.2025


HEPIZOVAC


Epizootic haemorrhagic disease vaccine (inactivated)







CZ Vaccines S.A.U.




A Relva s/n – Torneiros 36410 O Porriño Pontevedra, España






EU/2/25/341


Suspension for injection


QI02AA


25.4.2025




23.4.2025


PRAZIVETIN


Praziquantel







VETHELLAS S.A.




51, 31rst AUGOUSTOU STREET, 412 21 LARISSA, Ελλάδα






EU/2/25/340


Premix for medicated feeding stuff


QP52AA01


28.4.2025




23.4.2025


Prevestrus vet


finrozole







Vetcare Oy




P.O. Box 99, 24101 Salo, Suomi






EU/2/25/338


Film-coated tablet


QG03XX90


25.4.2025




25.4.2025


Nobilis Multriva IBm+ND+EDS


Infectious Bronchitis, Newcastle disease and Egg Drop Syndrome virus vaccine (inactivated)







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/25/339


Emulsion for injection


QI01AA13


28.4.2025






—   

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




2.4.2025


Cardalis







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/12/142


7.4.2025




2.4.2025


Clevor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/17/222


4.4.2025




2.4.2025


Coxatab







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/22/286


4.4.2025




2.4.2025


Hydrocortisone aceponate Ecuphar







Ecuphar NV




Legeweg 157-i, 8020 Oostkamp, België






EU/2/18/230


7.4.2025




2.4.2025


Porcilis ColiClos







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/141


3.4.2025




2.4.2025


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


3.4.2025




2.4.2025


Simparica Trio







Zoetis Belgium




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






EU/2/19/243


3.4.2025




10.4.2025


Innovax-ND-H5







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/24/315


11.4.2025




14.4.2025


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/07/079


16.4.2025




23.4.2025


Eluracat







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/23/297


25.4.2025




23.4.2025


Osurnia







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/14/170


29.4.2025




23.4.2025


Quadrisol







GROVET B.V.




Centurionbaan 140, 3769 AV Soesterberg,Nederland






EU/2/97/005


28.4.2025




23.4.2025


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/07/078


25.4.2025




23.4.2025


Suvaxyn PRRS MLV







Zoetis Belgium




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






EU/2/17/215


28.4.2025




23.4.2025


Veraflox







Elanco Animal Health GmbH




Alfred-Nobel-Str. 50, 40789 Monheim, Deutschland






EU/2/10/107


25.4.2025






—   

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




10.4.2025


Pirsue







Zoetis Belgium




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






EU/2/00/027


14.4.2025





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/2025/2785/oj
ISSN 1977-091X (electronic edition)