Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2026 to 31 January 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: 2026-02-27
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_202601044EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/1044


27.2.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2026 to 31 January 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/2026/1044)







—



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




8.1.2026


Austedo


deutetrabenazine







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/25/1956


Prolonged-release tablet


N07XX16


9.1.2026




8.1.2026


GalenVita


germanium (68Ge) chloride / gallium (68Ga) chloride







Curium Romania SRL




Pantelimon, Str. Gradinarilor, nr.1, Ilfov, România






EU/1/25/2004


Radionuclide generator.


V09X


9.1.2026




8.1.2026


Osqay


denosumab







Theramex Ireland Limited




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






EU/1/25/1997


Solution for injection in a pre-filled syringe


M05BX04


9.1.2026




8.1.2026


Teduglutide Viatris


teduglutide







Viatris Limited




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






EU/1/25/2005


Powder and solvent for solution for injection


A16AX08


12.1.2026




8.1.2026


Teizeild


Teplizumab







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/25/1998


Concentrate for solution for infusion


A10XX01


9.1.2026




9.1.2026


Enzalutamide Accordpharma


Enzalutamide







Accord Healthcare S.L.U.




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






EU/1/25/1990


Film-coated tablet


L02BB04


12.1.2026




9.1.2026


Inluriyo


Imlunestrant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/25/2003


Film-coated tablet


Pending


13.1.2026




9.1.2026


Ondibta


Insulin glargine







Gan & Lee Pharmaceuticals Europe GmbH




Prinzenallee 11a, 40549 Düsseldorf, Deutschland






EU/1/25/2000


solution for injection in a cartridge


A10AE04


12.1.2026




9.1.2026


VacPertagen


Pertussis vaccine (recombinant, acellular, component, adsorbed)







BioNet Europe




41 Quai Fulchiron, 69005 Lyon, France






EU/1/25/1999


Suspension for injection


J07AJ02


19.1.2026




9.1.2026


Waskyra


etuvetidigene autotemcel







Fondazione Telethon ETS




Via Varese 16/B, 00185 Roma, Italia






EU/1/25/1996


Dispersion for infusion


Pending


12.1.2026




19.1.2026


Aqneursa


levacetylleucine







IntraBio Ireland Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland






EU/1/25/1928


Granules for oral suspension


N07XX


20.1.2026




19.1.2026


Dawnzera


Donidalorsen







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/25/2001


Solution for injection in pre-filled pen


Pending


20.1.2026














—



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




8.1.2026


Abevmy







Biosimilar Collaborations Ireland Limited




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






EU/1/20/1515


19.1.2026




8.1.2026


Envarsus







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/935


14.1.2026




8.1.2026


Evrysdi







Roche Registration GmbH




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






EU/1/21/1531


9.1.2026




8.1.2026


Gardasil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/357


9.1.2026




8.1.2026


Isturisa







Recordati Rare Diseases




Tour Hekla, 52 Avenue Du General De Gaulle, 92800 Puteaux, France






EU/1/19/1407


13.1.2026




8.1.2026


Nemluvio







Galderma International




La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France






EU/1/24/1901


9.1.2026




8.1.2026


Onureg







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1556


9.1.2026




8.1.2026


Sibnayal







ADVICENNE




262, rue du Faubourg Saint Honoré 75008 Paris, France






EU/1/20/1517


9.1.2026




8.1.2026


Signifor







Recordati Rare Diseases




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






EU/1/12/753


9.1.2026




8.1.2026


Trumenba







Pfizer Europe MA EEIG




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






EU/1/17/1187


9.1.2026




8.1.2026


Tyruko







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/23/1745


9.1.2026




8.1.2026


WELIREG







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/24/1893


9.1.2026




8.1.2026


Winrevair







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/24/1850


9.1.2026




8.1.2026


Xenpozyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/22/1659


9.1.2026




9.1.2026


ADZYNMA







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/24/1837


12.1.2026




9.1.2026


Drovelis







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1547


15.1.2026




9.1.2026


Effentora







Phoenix Labs Unlimited Company




Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland






EU/1/08/441


12.1.2026




9.1.2026


Efmody







Neurocrine Netherlands B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/21/1549


14.1.2026




9.1.2026


GONAL-f







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/95/001


13.1.2026




9.1.2026


Kesimpta







Novartis Europharm Limited




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






EU/1/21/1532


12.1.2026




9.1.2026


Koselugo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1552


12.1.2026




9.1.2026


Potactasol







Actavis Group PTC ehf.




Dalshraun 1, 220 Hafnarfjörður, Íceland






EU/1/10/660


12.1.2026




9.1.2026


Spinraza







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/17/1188


13.1.2026




9.1.2026


Tepkinly







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1759


12.1.2026




9.1.2026


Tovanor Breezhaler







Novartis Europharm Limited




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






EU/1/12/790


12.1.2026




9.1.2026


ZYNYZ







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/24/1800


12.1.2026




13.1.2026


Otezla







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/14/981


20.1.2026




15.1.2026


ASPAVELI







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/21/1595


16.1.2026




15.1.2026


Eylea







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/12/797


16.1.2026




15.1.2026


IMULDOSA







Accord Healthcare S.L.U.




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






EU/1/24/1872


16.1.2026




15.1.2026


Mircera







Roche Registration GmbH




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






EU/1/07/400


16.1.2026




15.1.2026


Oyavas







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/20/1510


16.1.2026




15.1.2026


Vazkepa







Amarin Pharmaceuticals Ireland Limited




88 Harcourt Street, Dublin 2, D02DK18, Ireland






EU/1/20/1524


16.1.2026




16.1.2026


Hemgenix







CSL Behring GmbH




D-35041 Marburg, Deutschland






EU/1/22/1715


26.1.2026




19.1.2026


Adjupanrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/578


20.1.2026




19.1.2026


Alymsys







Mabxience Research SL




C/ Manuel Pombo Angulo 28, 28050 Madrid, España






EU/1/20/1509


20.1.2026




19.1.2026


Arexvy







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/23/1740


20.1.2026




19.1.2026


Dovprela







Mylan IRE Healthcare Limited




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






EU/1/20/1437


22.1.2026




19.1.2026


Lydisilka







Estetra SRL




Rue Saint-Georges 5, 4000 Liège, Belgique






EU/1/21/1548


20.1.2026




19.1.2026


Recarbrio







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1420


21.1.2026




19.1.2026


Simponi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/09/546


20.1.2026




19.1.2026


Tacforius







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/17/1244


23.1.2026




19.1.2026


Wakix







Bioprojet Pharma




9 rue Rameau, 75002 Paris, France






EU/1/15/1068


20.1.2026




19.1.2026


Winrevair







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/24/1850


20.1.2026




19.1.2026


Zegalogue







Zealand Pharma A/S




Sydmarken 11, 2860 Soeborg, Danmark






EU/1/24/1829


20.1.2026




22.1.2026


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


26.1.2026




22.1.2026


Elucirem







Guerbet




15 rue des Vanesses, 93420, Villepinte, France






EU/1/23/1772


23.1.2026




22.1.2026


Izba







Novartis Europharm Limited




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






EU/1/13/905


23.1.2026




22.1.2026


Mounjaro







Eli Lilly Nederland B.V.




Orteliuslaan 1000, 3528 BD Utrecht, Nederland






EU/1/22/1685


23.1.2026




22.1.2026


Ocrevus







Roche Registration GmbH




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






EU/1/17/1231


23.1.2026




22.1.2026


Spevigo







LEO Pharma A/S




Industriparken 55, DK-2750 Ballerup, Danmark






EU/1/22/1688


27.1.2026




22.1.2026


Vueway







Bracco Imaging SPA




Via Egidio Folli, 50 20134 Milano, Italia






EU/1/23/1773


29.1.2026




26.1.2026


Litfulo







Pfizer Europe MA EEIG




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






EU/1/23/1755


28.1.2026




30.1.2026


Exjade







Novartis Europharm Limited




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






EU/1/06/356


3.2.2026




30.1.2026


Opatanol







Novartis Europharm Limited




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






EU/1/02/217


2.2.2026




30.1.2026


Piqray







Novartis Europharm Limited




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






EU/1/20/1455


2.2.2026




30.1.2026


Uzpruvo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/23/1784


2.2.2026




30.1.2026


Uzpruvo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/23/1784


2.2.2026




30.1.2026


Yuflyma







Celltrion Healthcare Hungary Kft.




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






EU/1/20/1513


2.2.2026














—



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




8.1.2026


Mulpleo







Shionogi B.V.




Herengracht 464, 1017 CA, Amsterdam, Nederland






EU/1/18/1348


12.1.2026




15.1.2026


Lumark







IDB Holland B.V.




Weverstraat 17, 5111 PV Baarle-Nassau, Nederland






EU/1/15/1013


21.1.2026




30.1.2026


Ogluo







Strongbridge Dublin Limited




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






EU/1/20/1523


2.2.2026














—



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




22.1.2026


Varenzin


molidustat







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/25/358


Oral suspension


QB03XA09


26.1.2026




26.1.2026


Firocoxib CP-Pharma


firocoxib







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/25/359


Chewable tablet


QM01AH90


28.1.2026




29.1.2026


Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.


Epizootic haemorrhagic disease vaccine (recombinant protein)







Laboratorios Syva S.A.




Calle Marqués de la Ensenada, 16, 28004 Madrid, España






EU/2/25/360


Emulsion for injection


QI02AA


30.1.2026














—



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




8.1.2026


Senvelgo







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/23/305


9.1.2026




22.1.2026


Dexdomitor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/02/033


23.1.2026




22.1.2026


Felpreva







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/21/277


23.1.2026








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/2026/1044/oj
ISSN 1977-091X (electronic edition)