Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2026 to 30 June 2026 (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: 2026-07-17
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_202603946EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/3946


17.7.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2026 to 30 June 2026
         


(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/2026/3946)

—   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




4.6.2026


Retsevmo


selpercatinib







Eli Lilly Nederland B.V.




Orteliuslaan 1000, 3528 BD Utrecht, Nederland






EU/1/20/1527


Capsule, hard


L01EX22


5.6.2026




19.6.2026


Cenrifki


tolebrutinib







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/25/2011


Film-coated tablet


L04AA62


22.6.2026




19.6.2026


Palbociclib Viatris


palbociclib







Viatris Limited




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






EU/1/26/2039


Film-coated tablet


L01EF01


22.6.2026




19.6.2026


Redemplo


plozasiran







Arrowhead Pharmaceuticals Ireland Limited




One Spencer Dock, North Wall Quay, Dublin 1, D01 X9R7, Ireland






EU/1/26/2041


Solution for injection


Pending


22.6.2026




19.6.2026


Rexatilux


ranibizumab







Intas Third Party Sales 2005, S.L.




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






EU/1/26/2043


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


S01LA04


25.6.2026




30.6.2026


Itvisma


onasemnogene abeparvovec







Novartis Europharm Limited




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






EU/1/26/2038


Solution for injection


M09AX09


1.7.2026




—   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




12.6.2026


Iloperidone Vanda Pharmaceuticals







Vanda Pharmaceuticals Netherlands B.V.




Basisweg 10, 1043 AP Amsterdam, Nederland






-


18.6.2026




—   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




3.6.2026


Lojuxta







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/13/851


5.6.2026




4.6.2026


Ahzantive







Formycon AG




82152 Martinsried/Planegg, Deutschland






EU/1/24/1888


8.6.2026




4.6.2026


Anzupgo







LEO Pharma A/S




Industriparken 55, DK-2750 Ballerup, Danmark






EU/1/24/1851


8.6.2026




4.6.2026


Cholestagel







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/03/268


9.6.2026




4.6.2026


Enbrel







Pfizer Europe MA EEIG




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






EU/1/99/126


5.6.2026




4.6.2026


JEMPERLI







GlaxoSmithKline Trading Services Limited




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






EU/1/21/1538


9.6.2026




4.6.2026


RINVOQ







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


5.6.2026




4.6.2026


Sarclisa







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/20/1435


5.6.2026




4.6.2026


Zejula







GlaxoSmithKline Trading Services Limited




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






EU/1/17/1235


9.6.2026




8.6.2026


Aucatzyl







Autolus GmbH




Im Schwarzenbach 4, 79576 Weil am Rhein, Deutschland






EU/1/25/1951


9.6.2026




8.6.2026


Pirfenidone Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/22/1707


9.6.2026




11.6.2026


Alkindi







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/17/1260


16.6.2026




11.6.2026


Aripiprazole Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1009


12.6.2026




11.6.2026


Doptelet







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/19/1373


18.6.2026




11.6.2026


Elaprase







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/06/365


15.6.2026




11.6.2026


Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1133


12.6.2026




11.6.2026


Ofev







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/979


30.6.2026




11.6.2026


Qoyvolma







Celltrion Healthcare Hungary Kft.




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






EU/1/25/1925


13.6.2026




11.6.2026


Repaglinide Accord







Accord Healthcare S.L.U.




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






EU/1/11/743


12.6.2026




11.6.2026


Repaglinide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/530


12.6.2026




11.6.2026


RINVOQ







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


12.6.2026




11.6.2026


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


22.6.2026




11.6.2026


Voxzogo







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/21/1577


22.6.2026




12.6.2026


Alkindi







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/17/1260


16.6.2026




12.6.2026


Dazublys







CuraTeQ Biologics (Malta) Limited




Vault 14 Level 2, Valletta Waterfront, Floriana, FRN 1914, Malta






EU/1/25/1949


19.6.2026




12.6.2026


Dyrupeg







CuraTeQ Biologics (Malta) Limited




Vault 14 Level 2, Valletta Waterfront, Floriana, FRN 1914, Malta






EU/1/25/1914


19.6.2026




12.6.2026


Faslodex







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/03/269


15.6.2026




12.6.2026


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


15.6.2026




12.6.2026


Rezzayo







Mundipharma GmbH




De-Saint-Exupery-Strasse 10, 60549 Frankfurt Am Main, Deutschland






EU/1/23/1775


15.6.2026




12.6.2026


Rozlytrek







Roche Registration GmbH




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






EU/1/20/1460


15.6.2026




12.6.2026


TALVEY







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/23/1748


15.6.2026




12.6.2026


TECVAYLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1675


15.6.2026




12.6.2026


Xbryk







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/24/1889


17.6.2026




12.6.2026


Xigduo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/900


15.6.2026




12.6.2026


Zefylti







CuraTeQ Biologics (Malta) Limited




Vault 14 Level 2, Valletta Waterfront, Floriana, FRN 1914, Malta






EU/1/24/1899


19.6.2026




19.6.2026


Alunbrig







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/18/1264


23.6.2026




19.6.2026


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


22.6.2026




19.6.2026


Columvi







Roche Registration GmbH




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






EU/1/23/1742


22.6.2026




19.6.2026


Constella







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/12/801


22.6.2026




19.6.2026


Fluenz







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1816


22.6.2026




19.6.2026


Gardasil 9







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1007


22.6.2026




19.6.2026


Gotenfia







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/25/2009


23.6.2026




19.6.2026


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


22.6.2026




19.6.2026


Icandra







Novartis Europharm Limited




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






EU/1/08/484


22.6.2026




19.6.2026


Inaqovi







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/23/1756


23.6.2026




19.6.2026


Kesimpta







Novartis Europharm Limited




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






EU/1/21/1532


22.6.2026




19.6.2026


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


22.6.2026




19.6.2026


Maviret







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/17/1213


22.6.2026




19.6.2026


Memantine Mylan







Mylan Pharmaceuticals Limited




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






EU/1/13/827


22.6.2026




19.6.2026


Mysimba







Orexigen Therapeutics Ireland Limited




9-10 Fenian Street, Dublin 2, D02 RX24, Ireland






EU/1/14/988


22.6.2026




19.6.2026


Ngenla







Pfizer Europe MA EEIG




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






EU/1/21/1617


22.6.2026




19.6.2026


Ontozry







Angelini Pharma S.p.A




Viale Amelia 70, 00181 Rome, Italia






EU/1/21/1530


22.6.2026




19.6.2026


Opzelura







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/23/1726


23.6.2026




19.6.2026


Padcev







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1615


22.6.2026




19.6.2026


Palynziq







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/19/1362


29.6.2026




19.6.2026


Poteligeo







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/18/1335


23.6.2026




19.6.2026


QUVIVIQ







Idorsia Pharmaceuticals Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland






EU/1/22/1638


3.7.2026




19.6.2026


Rezdiffra







Madrigal Pharmaceuticals EU Limited




1 Castlewood Avenue, Dublin, D06 H685, Ireland






EU/1/25/1962


22.6.2026




19.6.2026


Rixathon







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1185


22.6.2026




19.6.2026


Rizmoic







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/18/1291


2.7.2026




19.6.2026


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


22.6.2026




19.6.2026


Spherox







CO.DON GmbH




Deutscher Platz 5d, 04103 Leipzig, Deutschland






EU/1/17/1181


30.6.2026




19.6.2026


Vipdomet







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/13/843


23.6.2026




19.6.2026


Zessly







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1280


23.6.2026




19.6.2026


Zomarist







Novartis Europharm Limited




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






EU/1/08/483


22.6.2026




22.6.2026


Trodelvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/21/1592


23.6.2026




25.6.2026


ADVATE







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/03/271


26.6.2026




25.6.2026


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/691


26.6.2026




25.6.2026


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


26.6.2026




25.6.2026


Erbitux







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/04/281


26.6.2026




25.6.2026


Eucreas







Novartis Europharm Limited




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






EU/1/07/425


26.6.2026




25.6.2026


Eydenzelt







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1895


30.6.2026




25.6.2026


Lokelma







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1173


26.6.2026




25.6.2026


Olanzapine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/427


26.6.2026




25.6.2026


Rimmyrah







QILU PHARMA SPAIN S.L.




Paseo de la Castellana 40, planta 8, 28046 Madrid, España






EU/1/23/1779


26.6.2026




25.6.2026


Sugammadex Mylan







Mylan Pharmaceuticals Limited




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






EU/1/21/1583


26.6.2026




25.6.2026


Teysuno







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/11/669


29.6.2026




25.6.2026


Trimbow







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/17/1208


26.6.2026




25.6.2026


Truqap







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/24/1820


26.6.2026




25.6.2026


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


30.6.2026




25.6.2026


Zoledronic acid Accord







Accord Healthcare S.L.U.




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






EU/1/13/834


26.6.2026




26.6.2026


Levetiracetam Actavis







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/11/713


29.6.2026




26.6.2026


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


29.6.2026




26.6.2026


Tresiba







Novo Nordisk A/S




Novo Alle 1, 2880 Bagsvaerd, Danmark






EU/1/12/807


4.7.2026




—   Modification 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




19.6.2026


Hetlioz







Vanda Pharmaceuticals Netherlands B.V.




Basisweg 10, 1043 AP Amsterdam, Nederland






EU/1/15/1008


23.6.2026




—   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




12.6.2026


Qoyvolma







Celltrion Healthcare Hungary Kft.




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






EU/1/25/1925


16.6.2026




—   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




5.6.2026


CLYNAV







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/16/197


8.6.2026




5.6.2026


Solensia







Zoetis Belgium SA




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






EU/2/20/269


10.6.2026




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/2026/3946/oj
ISSN 1977-091X (electronic edition)