Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2025 to 31 March 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: 2025-04-25
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_202501955EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/1955


25.4.2025






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2025 to 31 March 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/2025/1955)

—   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




6.3.2025


Wainzua


eplontersen







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1875


Solution for injection in pre-filled pen


N07XX21


7.3.2025




7.3.2025


Rytelo


imetelstat







Geron Netherlands B.V.




Naritaweg 165, Noord-Holland, 1043 BW Amsterdam, Nederland






EU/1/24/1894


Powder and solvent for concentrate for solution for infusion


L01XX80


11.3.2025




24.3.2025


CAPVAXIVE


Pneumococcal polysaccharide conjugate vaccine (21-valent)







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/25/1913


Solution for injection


J07AL02


25.3.2025




28.3.2025


Dyrupeg


Pegfilgrastim







CuraTeQ Biologics s.r.o




Trtinova 260/1, Cakovice, 19600 Prague 9, Česká republika






EU/1/25/1914


Solution for injection


L03AA13


31.3.2025




28.3.2025


Eltrombopag Accord


eltrombopag







Accord Healthcare S.L.U.




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






EU/1/24/1903


Film-coated tablet


B02BX05


1.4.2025




28.3.2025


Tivdak


Tisotumab vedotin







Pfizer Europe MA EEIG




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






EU/1/25/1911


Powder for concentrate for solution for infusion


L01FX23


31.3.2025




—   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




6.3.2025


LIVTENCITY







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/22/1672


7.3.2025




7.3.2025


Gencebok







Gennisium Pharma




Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France






EU/1/20/1465


12.3.2025




7.3.2025


Incellipan







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1807


10.3.2025




7.3.2025


RXULTI







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/18/1294


10.3.2025




7.3.2025


Uplizna







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1602


10.3.2025




10.3.2025


Cejemly







CStone Pharmaceuticals Ireland Limited




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






EU/1/24/1833


11.3.2025




12.3.2025


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


13.3.2025




12.3.2025


Breyanzi







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1631


14.3.2025




12.3.2025


Daxas







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/636


13.3.2025




12.3.2025


Enjaymo







Recordati Rare Diseases




Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France






EU/1/22/1687


14.3.2025




12.3.2025


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


14.3.2025




12.3.2025


Faslodex







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/03/269


13.3.2025




12.3.2025


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


13.3.2025




12.3.2025


Mirapexin







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/051


13.3.2025




12.3.2025


Pandemic influenza vaccine H5N1 AstraZeneca







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1089


13.3.2025




12.3.2025


Relvar Ellipta







GlaxoSmithKline Trading Services Limited




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






EU/1/13/886


17.3.2025




12.3.2025


Revinty Ellipta







GlaxoSmithKline Trading Services Limited




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






EU/1/14/929


17.3.2025




12.3.2025


Venclyxto







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/16/1138


17.3.2025




17.3.2025


BYANNLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1453


19.3.2025




17.3.2025


Scintimun







TELIX INNOVATIONS




Rue de Hermée 255, 4040 Herstal, Belgique






EU/1/09/602


20.3.2025




17.3.2025


Slenyto







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/18/1318


19.3.2025




19.3.2025


Rystiggo







UCB Pharma S.A.




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






EU/1/23/1780


1.4.2025




20.3.2025


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


21.3.2025




20.3.2025


Nexviadyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1579


24.3.2025




20.3.2025


Ximluci







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/22/1691


21.3.2025




24.3.2025


Azacitidine Mylan







Mylan Pharmaceuticals Limited




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






EU/1/20/1426


27.3.2025




24.3.2025


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


26.3.2025




24.3.2025


Fintepla







UCB Pharma S.A.




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






EU/1/20/1491


27.3.2025




24.3.2025


Rozlytrek







Roche Registration GmbH




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






EU/1/20/1460


25.3.2025




24.3.2025


Xromi







Nova Laboratories Ireland Limited




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






EU/1/19/1366


25.3.2025




24.3.2025


Zeposia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1442


27.3.2025




28.3.2025


Abrysvo







Pfizer Europe MA EEIG




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






EU/1/23/1752


31.3.2025




28.3.2025


Capecitabine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/12/802


31.3.2025




28.3.2025


Daurismo







Pfizer Europe MA EEIG




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






EU/1/20/1451


31.3.2025




28.3.2025


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/691


1.4.2025




28.3.2025


Entyvio







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/14/923


31.3.2025




28.3.2025


Evrenzo







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1574


2.4.2025




28.3.2025


Fluenz







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1816


1.4.2025




28.3.2025


IXCHIQ







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/24/1828


31.3.2025




28.3.2025


Jaypirca







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/23/1738


31.3.2025




28.3.2025


Jinarc







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/15/1000


4.4.2025




28.3.2025


LOQTORZI







Topalliance Biosciences Europe Limited




Ground Floor, Two Dockland Central, Guild Street, I.f.s.c., Dublin 1, Co. Dublin, D01 K2C5, Ireland






EU/1/24/1853


31.3.2025




28.3.2025


Mvabea







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1445


31.3.2025




28.3.2025


Nivestim







Pfizer Europe MA EEIG




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






EU/1/10/631


1.4.2025




28.3.2025


PHELINUN







ADIENNE S.r.l.S.U.




Via Galileo Galilei 19, 20867 Caponago (MB), Italia






EU/1/20/1487


2.4.2025




28.3.2025


Raxone







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/15/1020


2.4.2025




28.3.2025


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


1.4.2025




28.3.2025


Roclanda







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/20/1502


4.4.2025




28.3.2025


Supemtek Tetra







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1484


4.4.2025




28.3.2025


Taltz







Eli Lilly and Company (Ireland) Limited




Dunderrow, Kinsale, Co. Cork, Ireland






EU/1/15/1085


1.4.2025




28.3.2025


Talzenna







Pfizer Europe MA EEIG




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






EU/1/19/1377


31.3.2025




28.3.2025


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


31.3.2025




28.3.2025


Tevimbra







BeiGene Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland






EU/1/23/1758


2.4.2025




28.3.2025


Translarna







PTC Therapeutics International Limited




Unit 1, 52-55 Sir John Rogerson's Quay, Dublin 2, D02 NA07, Ireland






EU/1/13/902


31.3.2025




28.3.2025


Vyvgart







argenx BV




Industriepark-Zwijnaarde 7, 9052 Gent, België






EU/1/22/1674


31.3.2025




28.3.2025


Xeloda







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/00/163


1.4.2025




28.3.2025


Zabdeno







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1444


1.4.2025




28.3.2025


Zolgensma







Novartis Europharm Limited




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






EU/1/20/1443


1.4.2025




31.3.2025


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


3.4.2025




31.3.2025


FABHALTA







Novartis Europharm Limited




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






EU/1/24/1802


1.4.2025




31.3.2025


Fampridine Accord







Accord Healthcare S.L.U.




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






EU/1/20/1477


1.4.2025




31.3.2025


HETRONIFLY







Accord Healthcare S.L.U.




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






EU/1/24/1870


1.4.2025




31.3.2025


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


1.4.2025




31.3.2025


Sifrol







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/050


1.4.2025




31.3.2025


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


1.4.2025




31.3.2025


Vargatef







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/954


4.4.2025




—   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




6.3.2025


Riarify







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/18/1275


7.3.2025




—   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




28.3.2025


Elmaro


Maropitant citrate monohydrate







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/25/337


Solution for injection


QA04AD90


1.4.2025




28.3.2025


Vectormune HVT-AIV


Avian influenza vaccine (live, recombinant)







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/25/335


Concentrate and solvent for suspension for injection


QI01AD


1.4.2025




—   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




28.3.2025


FORTEKOR PLUS







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/15/185


31.3.2025




28.3.2025


Increxxa







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/20/258


31.3.2025




28.3.2025


ProZinc







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/13/152


1.4.2025




28.3.2025


ReproCyc ParvoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/237


31.3.2025




28.3.2025


Sedadex







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/16/198


1.4.2025




28.3.2025


Sileo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/15/181


31.3.2025




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/2025/1955/oj
ISSN 1977-091X (electronic edition)