Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2025 to 31 August 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: 2025-09-19
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_202505097EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/5097


19.9.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2025 to 31 August 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/2025/5097)







—



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




11.8.2025


Vivlipeg


pegfilgrastim







Biosimilar Collaborations Ireland Limited




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






EU/1/25/1967


Solution for injection


L03AA13


1.9.2025




14.8.2025


Eiyzey


aflibercept







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19, 83-200 Starogard Gdański, Polska






EU/1/25/1963


Solution for injection


S01LA05


19.8.2025




14.8.2025


Ogsiveo


nirogacestat







SpringWorks Therapeutics Ireland Limited




Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland






EU/1/25/1932


Film-coated tablet


L01XX81


18.8.2025




14.8.2025


Usymro


ustekinumab







ELC Group s.r.o.




Pobrezni 394/12, Karlin, 186 00 Praha 8, Česká republika






EU/1/25/1957


Concentrate for solution for infusion
Solution for injection
Solution for injection in a pre-filled syringe


L04AC05


26.8.2025




14.8.2025


Vgenfli


aflibercept







Zakłady Farmaceutyczne POLPHARMA S.A.




ul. Pelplińska 19, 83-200 Starogard Gdański, Polska






EU/1/25/1961


Solution for injection


S01LA05


19.8.2025




18.8.2025


Afiveg


aflibercept







STADA Arzneimittel AG




Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland






EU/1/25/1965


Solution for injection


S01LA05


22.8.2025




18.8.2025


MYNZEPLI


aflibercept







Advanz Pharma Limited




Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland






EU/1/25/1964


Solution for injection


S01LA05


20.8.2025




18.8.2025


Rezdiffra


Resmetirom







Madrigal Pharmaceuticals EU Limited




1 Castlewood Avenue, Dublin, D06 H685, Ireland






EU/1/25/1962


Film-coated tablet


A05BA11


19.8.2025




19.8.2025


Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris


emtricitabine / rilpivirine / tenofovir alafenamide







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/25/1966


Film-coated tablet


J05AR19


21.8.2025




21.8.2025


Imreplys


sargramostim







Partner Therapeutics Ltd.




28-32 Pembroke Street Upper, Dublin 2, D02NT28, Ireland






EU/1/25/1924


Powder for solution for injection


L03AA09


8.9.2025




22.8.2025


Nintedanib Viatris


nintedanib







Viatris Limited




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






EU/1/25/1959


Capsule, soft


L01E09


25.8.2025




25.8.2025


Yeytuo


lenacapavir







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/25/1976


Film-coated tablet
Solution for injection


J05AX31


25.8.2025




25.8.2025


Zemcelpro


dorocubicel / allogeneic umbilical cord-derived CD34- cells, non-expanded







Cordex Biologics International Limited




5th Floor, Block E, Iveagh Court, Harcourt Road, Dublin, Ireland






EU/1/25/1960


Dispersion for infusion


B05AX04


26.8.2025














—



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




21.8.2025


Kinselby







4SC AG




Fraunhoferstraße 22, 82152 Planegg-Martinsried, Deutschland






-


28.8.2025














—



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




4.8.2025


Beyfortus







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/22/1689


9.8.2025




4.8.2025


Bortezomib Hospira







Pfizer Europe MA EEIG




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






EU/1/16/1114


5.8.2025




4.8.2025


Clopidogrel Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/08/465


5.8.2025




4.8.2025


IMJUDO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1713


5.8.2025




4.8.2025


INCRELEX







Esteve Pharmaceuticals S.A.




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






EU/1/07/402


5.8.2025




4.8.2025


Nplate







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/08/497


5.8.2025




4.8.2025


Nyvepria







Pfizer Europe MA EEIG




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






EU/1/20/1486


5.8.2025




4.8.2025


Oxlumo







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1496


5.8.2025




4.8.2025


Sitagliptin/Metformin hydrochloride Accord







Accord Healthcare S.L.U.




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






EU/1/22/1661


5.8.2025




4.8.2025


Skilarence







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/17/1201


19.8.2025




4.8.2025


Symkevi







Vertex Pharmaceuticals (Ireland) Limited




Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland






EU/1/18/1306


13.8.2025




4.8.2025


Tenkasi







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/989


5.8.2025




4.8.2025


Yorvipath







Ascendis Pharma Bone Diseases A/S




Tuborg Boulevard 12, DK-2900 Hellerup, Danmark






EU/1/23/1766


6.8.2025




6.8.2025


Fampyra







Merz Therapeutics GmbH




Eckenheimer Landstraße 100, 60318 Frankfurt Am Main, Deutschland






EU/1/11/699


8.8.2025




6.8.2025


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem, België






EU/1/13/869


11.8.2025




6.8.2025


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem, België






EU/1/13/869


11.8.2025




6.8.2025


Luveris







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/00/155


7.8.2025




6.8.2025


Rivaroxaban Accord







Accord Healthcare S.L.U.




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






EU/1/20/1488


7.8.2025




6.8.2025


Ruconest







Pharming Group N.V.




Darwinweg 24, 2333 CR Leiden, Nederland






EU/1/10/641


7.8.2025




6.8.2025


Wezenla







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/24/1823


7.8.2025




11.8.2025


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/99/118


22.8.2025




11.8.2025


Eksunbi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1858


12.8.2025




11.8.2025


TALVEY







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/23/1748


12.8.2025




11.8.2025


TECVAYLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


12.8.2025




11.8.2025


Xaluprine







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/11/727


12.8.2025




14.8.2025


Brukinsa







BeOne Medicines Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/21/1576


20.8.2025




14.8.2025


Emselex







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/04/294


19.8.2025




14.8.2025


Invega







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/07/395


19.8.2025




14.8.2025


Leflunomide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/10/637


20.8.2025




14.8.2025


OBIZUR







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/15/1035


18.8.2025




14.8.2025


Pyzchiva







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1801


19.8.2025




14.8.2025


REKAMBYS







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1482


19.8.2025




14.8.2025


Roclanda







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/20/1502


26.8.2025




14.8.2025


Spevigo







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/22/1688


18.8.2025




14.8.2025


TRIXEO AEROSPHERE







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1498


18.8.2025




14.8.2025


Vocabria







ViiV Healthcare BV




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






EU/1/20/1481


19.8.2025




14.8.2025


Zinforo







Pfizer Ireland Pharmaceuticals Unlimited Company




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/12/785


18.8.2025




18.8.2025


Arexvy







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/23/1740


19.8.2025




18.8.2025


Herceptin







Roche Registration GmbH




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






EU/1/00/145


19.8.2025




18.8.2025


Neupro







UCB Pharma S.A.




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






EU/1/05/331


19.8.2025




21.8.2025


Diacomit







Biocodex




22 rue des Aqueducs, 94250 Gentilly, France






EU/1/06/367


22.8.2025




21.8.2025


Imnovid







Bristol Myers Squibb Pharma EEIG




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






EU/1/13/850


25.8.2025




21.8.2025


Lenalidomide Mylan







Mylan Pharmaceuticals Limited




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






EU/1/20/1490


22.8.2025




21.8.2025


Ondexxya







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1345


22.8.2025




21.8.2025


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


22.8.2025




21.8.2025


Tevimbra







BeOne Medicines Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/23/1758


25.8.2025




22.8.2025


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


26.8.2025




22.8.2025


Alhemo







Novo Nordisk A/S




Novo Alle 1, 2880 Bagsvaerd, Danmark






EU/1/24/1881


25.8.2025




22.8.2025


Baqsimi







Amphastar France Pharmaceuticals




Usine Saint Charles, Eragny Sur Epte, 60590 France






EU/1/19/1406


25.8.2025




22.8.2025


Clopidogrel Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/08/465


26.8.2025




22.8.2025


Invokana







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/884


25.8.2025




22.8.2025


Omvoh







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1736


26.8.2025




22.8.2025


Roctavian







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/22/1668


25.8.2025




22.8.2025


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/901


25.8.2025




22.8.2025


Sugammadex Adroiq







Extrovis EU Ltd.




Pátriárka utca 14., 2000, Szentendre, Magyarország






EU/1/23/1733


25.8.2025




22.8.2025


Taltz







Eli Lilly and Company (Ireland) Limited




Dunderrow, Kinsale, Co. Cork, Ireland






EU/1/15/1085


25.8.2025




28.8.2025


Accofil







Accord Healthcare S.L.U.




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






EU/1/14/946


29.8.2025




28.8.2025


Enspryng







Roche Registration GmbH




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






EU/1/21/1559


29.8.2025




28.8.2025


Livmarli







Mirum Pharmaceuticals International B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland






EU/1/22/1704


2.9.2025




28.8.2025


Moventig







Grünenthal GmbH




Zieglerstraße 6, 52078, Aachen, Deutschland






EU/1/14/962


29.8.2025














—



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




6.8.2025


Bortezomib Hospira







Pfizer Europe MA EEIG




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






EU/1/16/1114


7.8.2025




11.8.2025


Biopoin







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/09/565


12.8.2025




11.8.2025


Olanzapine Apotex







Apotex Europe B.V.




Baarnsche Dijk 1, 3741 LN Baarn, Nederland






EU/1/10/635


9.9.2025




11.8.2025


Stocrin







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/111


12.8.2025




18.8.2025


Eksunbi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1858


20.8.2025














—



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




28.8.2025


CEVAC REOMUNE


avian reovirus vaccine (inactivated)


FILAVIE
20, la Corbière ROUSSAY, 49450 SEVREMOINE, France


EU/2/25/334


Emulsion for injection


QI01AA04


29.8.2025














—



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




21.8.2025


Nobivac L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/143


22.8.2025




21.8.2025


Nobivac LoVo L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/23/304


22.8.2025




28.8.2025


DIVENCE IBR Marker Live







Laboratorios Hipra, S.A.




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






EU/2/24/318


29.8.2025




28.8.2025


Eluracat







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/23/297


29.8.2025




28.8.2025


Neptra







Elanco Animal Health GmbH




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






EU/2/19/246


29.8.2025




28.8.2025


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


29.8.2025




28.8.2025


Syvazul BTV 3







Laboratorios Syva S.A




C/Marqués de la Ensenada16, 28004 Madrid, España






EU/2/24/332


29.8.2025




28.8.2025


Zulvac 8 Ovis







Zoetis Belgium




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






EU/2/09/104


29.8.2025














—



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): 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




6.8.2025


Poulvac E. coli







Zoetis Belgium




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






EU/2/12/140


11.8.2025














—



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




4.8.2025


Econor







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/98/010


6.8.2025




21.8.2025


MiPet Easecto







Zoetis Belgium




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






EU/2/17/220


25.8.2025








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/2025/5097/oj
ISSN 1977-091X (electronic edition)