Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2025 to 30 September 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: 2025-10-23
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_202505744EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/5744


23.10.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2025 to 30 September 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/2025/5744)







—



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




15.9.2025


Eyluxvi


aflibercept







Biolitec Pharma Limited Zweigniederlassung Jena




Otto-Schott-Str. 15, 07745 Jena, Deutschland






EU/1/25/1972


Solution for injection in a vial


S01LA05


16.9.2025




17.9.2025


Bildyos


denosumab







Henlius Europe GmbH




Sternstraße 67, 40479 Düsseldorf, Deutschland






EU/1/25/1978


Solution for injection


M05BX04


18.9.2025




17.9.2025


Bilprevda


denosumab







Henlius Europe GmbH




Sternstraße 67, 40479 Düsseldorf, Deutschland






EU/1/25/1979


Solution for injection


M05BX04


18.9.2025




17.9.2025


Ekterly


sebetralstat







KalVista Pharmaceuticals (Ireland) Ltd




Magennis Place, Block C, Dublin 2, D02 FK76, Ireland






EU/1/25/1975


Film-coated tablet


B06AC08


18.9.2025




17.9.2025


ROMVIMZA


vimseltinib







Deciphera Pharmaceuticals (Netherlands) B.V.




Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland






EU/1/25/1968


Capsule, hard


L01EX29


24.9.2025




17.9.2025


Tryngolza


olezarsen







Ionis Ireland Limited




Saint James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland






EU/1/25/1969


Solution for injection


Pending


18.9.2025




17.9.2025


Usrenty


ustekinumab







Biosimilar Collaborations Ireland Limited




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






EU/1/25/1973


Concentrate for solution for infusion


L04AC05


26.9.2025




17.9.2025


Voranigo


vorasidenib







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/25/1912


Film-coated tablet


L01XM04


19.9.2025




17.9.2025


Zurzuvae


Zuranolone







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/25/1977


Capsule, hard


N06AX31


18.9.2025




24.9.2025


Kisunla


donanemab







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/25/1926


Concentrate for solution for infusion


N06DX05


29.9.2025




24.9.2025


Macitentan Accord


macitentan







Accord Healthcare S.L.U.




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






EU/1/25/1970


Film-coated tablet


C02KX04


25.9.2025




24.9.2025


Macitentan AccordPharma


macitentan







Accord Healthcare S.L.U.




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






EU/1/25/1971


Film-coated tablet


C02KX04


25.9.2025














—



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




24.9.2025


Elevidys







Roche Registration GmbH




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






-


25.9.2025














—



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




2.9.2025


Bronchitol







Pharmaxis Europe Limited




108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland






EU/1/12/760


4.9.2025




2.9.2025


Edarbi







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/11/734


3.9.2025




2.9.2025


Qoyvolma







Celltrion Healthcare Hungary Kft.




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






EU/1/25/1925


10.9.2025




2.9.2025


Steglujan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1266


3.9.2025




2.9.2025


Tevagrastim







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/08/445


5.9.2025




2.9.2025


Yuflyma







Celltrion Healthcare Hungary Kft.




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






EU/1/20/1513


3.9.2025




8.9.2025


Bexsero







GlaxoSmithKline Vaccines S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/12/812


9.9.2025




8.9.2025


Dectova







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/18/1349


10.9.2025




8.9.2025


ELREXFIO







Pfizer Europe MA EEIG




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






EU/1/23/1770


10.9.2025




8.9.2025


Helicobacter Test INFAI







INFAI GmbH




An der Kohlenbahn 39, D-58135 Hagen, Deutschland






EU/1/97/045


16.9.2025




8.9.2025


Jaypirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1738


12.9.2025




8.9.2025


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


9.9.2025




8.9.2025


Otulfi







Fresenius Kabi Deutschland GmbH




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






EU/1/24/1863


10.9.2025




8.9.2025


Rapamune







Pfizer Europe MA EEIG




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






EU/1/01/171


10.9.2025




8.9.2025


Rukobia







ViiV Healthcare BV




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






EU/1/20/1518


9.9.2025




8.9.2025


Vumerity







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/21/1585


10.9.2025




11.9.2025


Azacitidine Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/23/1777


15.9.2025




11.9.2025


EVUSHELD







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1651


12.9.2025




11.9.2025


Imatinib Accord







Accord Healthcare S.L.U.




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






EU/1/13/845


16.9.2025




11.9.2025


Imraldi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1216


15.9.2025




11.9.2025


Omlyclo







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1817


16.9.2025




11.9.2025


Pioglitazone Accord







Accord Healthcare S.L.U.




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






EU/1/11/722


16.9.2025




11.9.2025


Pregabalin Accord







Accord Healthcare S.L.U.




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






EU/1/15/1027


16.9.2025




11.9.2025


Rivastigmine Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/11/693


12.9.2025




11.9.2025


Segluromet







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1265


12.9.2025




11.9.2025


Steglatro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1267


17.9.2025




11.9.2025


Steqeyma







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1844


12.9.2025




12.9.2025


IXCHIQ







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/24/1828


15.9.2025




15.9.2025


Apexelsin







WhiteOak Pharmaceutical B.V.




Teleportboulevard 130, Amsterdam, 1043 EJ, Nederland






EU/1/24/1835


18.9.2025




15.9.2025


AUBAGIO







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/13/838


16.9.2025




15.9.2025


JEMPERLI







GlaxoSmithKline Trading Services Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland






EU/1/21/1538


16.9.2025




15.9.2025


mRESVIA







MODERNA BIOTECH SPAIN, S.L.




C/ Julián Camarillo no 31, 28037 Madrid, España






EU/1/24/1849


16.9.2025




15.9.2025


Ogluo







Strongbridge Dublin Limited




25 North Wall Quay, Dublin 1, Co. Dublin, D01 H104, Ireland






EU/1/20/1523


17.9.2025




15.9.2025


Ratiograstim







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/08/444


16.9.2025




15.9.2025


Rybelsus







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/20/1430


16.9.2025




15.9.2025


Skyclarys







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/23/1786


16.9.2025




15.9.2025


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


16.9.2025




15.9.2025


Zoely







Theramex Ireland Limited




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






EU/1/11/690


18.9.2025




15.9.2025


Zyprexa







CHEPLAPHARM Registration GmbH




Weiler Straße 5e, 79540 Lörrach, Deutschland






EU/1/96/022


17.9.2025




17.9.2025


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


18.9.2025




17.9.2025


Cejemly







CStone Pharmaceuticals Ireland Limited




117-126 Sheriff Street Upper Dublin 1, D01 YC43, Ireland






EU/1/24/1833


18.9.2025




17.9.2025


Efmody







Neurocrine Netherlands B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/21/1549


29.9.2025




17.9.2025


Epidyolex







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland






EU/1/19/1389


22.9.2025




17.9.2025


Ervebo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


18.9.2025




17.9.2025


Evrenzo







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1574


3.10.2025




17.9.2025


Idacio







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1356


18.9.2025




17.9.2025


Jayempi







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/21/1557


18.9.2025




17.9.2025


Kentera







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/03/270


18.9.2025




17.9.2025


Klisyri







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/21/1558


22.9.2025




17.9.2025


Lenalidomide Accord







Accord Healthcare S.L.U.




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






EU/1/18/1316


18.9.2025




17.9.2025


Loargys







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/23/1774


18.9.2025




17.9.2025


Minjuvi







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1570


18.9.2025




17.9.2025


Orkambi







Vertex Pharmaceuticals (Ireland) Limited




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






EU/1/15/1059


18.9.2025




17.9.2025


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1251


18.9.2025




17.9.2025


Padcev







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1615


18.9.2025




17.9.2025


Tevimbra







BeOne Medicines Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/23/1758


18.9.2025




17.9.2025


TUKYSA







Pfizer Europe MA EEIG




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






EU/1/20/1526


18.9.2025




19.9.2025


BIMERVAX







Hipra Human Health, S.L.U.




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






EU/1/22/1709


22.9.2025




22.9.2025


Hepcludex







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1446


23.9.2025




22.9.2025


Kinzalkomb







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/214


24.9.2025




22.9.2025


Phesgo







Roche Registration GmbH




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






EU/1/20/1497


23.9.2025




24.9.2025


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


25.9.2025




24.9.2025


Dovprela







Mylan IRE Healthcare Limited




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






EU/1/20/1437


29.9.2025




24.9.2025


Gliolan







photonamic GmbH & Co. KG




Eggerstedter Weg 12, 25421 Pinneberg, Deutschland






EU/1/07/413


25.9.2025




24.9.2025


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


25.9.2025




24.9.2025


Imatinib Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/808


25.9.2025




24.9.2025


Lytenava







Outlook Therapeutics Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/24/1798


25.9.2025




24.9.2025


Onivyde pegylated liposomal







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/16/1130


29.9.2025




24.9.2025


Opfolda







Amicus Therapeutics Europe Limited




Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland






EU/1/23/1737


26.9.2025




24.9.2025


PritorPlus







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/215


2.10.2025




24.9.2025


Spikevax







MODERNA BIOTECH SPAIN, S.L.




C/ Julián Camarillo no 31, 28037 Madrid, España






EU/1/20/1507


25.9.2025




24.9.2025


Vyndaqel







Pfizer Europe MA EEIG




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






EU/1/11/717


26.9.2025




29.9.2025


Orphacol







THERAVIA




16 Rue Montrosier, 92200 Neuilly-sur-Seine, France






EU/1/13/870


16.10.2025




29.9.2025


Stayveer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/832


30.9.2025




29.9.2025


Striascan







CIS bio international




RN 306 – Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France






EU/1/19/1372


1.10.2025




29.9.2025


Tracleer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/220


30.9.2025




30.9.2025


LEQEMBI







Eisai GmbH




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






EU/1/24/1891


30.9.2025














—



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




11.9.2025


EVUSHELD







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1651


12.9.2025




26.9.2025


Kinzalkomb







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/214


29.9.2025




29.9.2025


Tybost







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/872


30.9.2025








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/2025/5744/oj
ISSN 1977-091X (electronic edition)