Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2025 to 31 December 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: 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_202601043EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/1043


27.2.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2025 to 31 December 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/2026/1043)







—



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




30.1.2025


Celsunax







Pinax Pharma GmbH




Lausitz, Mühlenweg 5, 04924 Bad Liebenwerda, Deutschland






EU/1/21/1560


13.2.2025




16.4.2025


Kostaive







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/24/1873


17.4.2025




22.5.2025


PHELINUN







ADIENNE S.r.l.S.U.




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






EU/1/20/1487


23.5.2025




26.5.2025


Exforge







Novartis Europharm Limited




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






EU/1/06/370


27.5.2025




26.5.2025


Vyepti







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/21/1599


27.5.2025




26.5.2025


Zeffix







GlaxoSmithKline Trading Services Limited




12 River Walk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland






EU/1/99/114


11.6.2025




28.7.2025


AGAMREE







Santhera Pharmaceuticals (Deutschland) GmbH




Marie-Curie Straße 8, 79539 Lörrach, Deutschland






EU/1/23/1776


13.8.2025




17.9.2025


Besremi







AOP Orphan Pharmaceuticals GmbH




Leopold-Ungar-Platz 2, 1190 Wien, Österreich






EU/1/18/1352


24.9.2025




17.9.2025


ELZONRIS







Stemline Therapeutics B.V.




Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland






EU/1/20/1504


19.9.2025




24.9.2025


Zometa







Phoenix Labs Unlimited Company




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






EU/1/01/176


16.10.2025




24.10.2025


CABOMETYX







Ipsen Pharma




70 rue Balard, 75015 Paris, France






EU/1/16/1136


28.10.2025




25.11.2025


INTEGRILIN







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/99/109


26.11.2025




19.12.2025


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1222


6.1.2026




19.12.2025


Uptravi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/15/1083


22.12.2025














—



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




30.1.2025


Celsunax







Pinax Pharma GmbH




Lausitz, Mühlenweg 5, 04924 Bad Liebenwerda, Deutschland






EU/1/21/1560


13.2.2025




26.11.2025


INTEGRILIN







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/99/109


1.12.2025














—



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




30.7.2025


BioBhyo


Swine dysentery vaccine (inactivated)







Aquilón CyL S.L.




Facultad de Veterinaria, Campus de Vegazana s/n, 24007 León, España






EU/2/25/348


Emulsion for injection


QI09AB


8.8.2025














—



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




30.10.2025


Chanhold







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/19/236


3.11.2025




27.11.2025


Vectormune HVT-AIV







Ceva Santé Animale




8 rue de Logrono, 33500 Libourne, France






EU/2/25/335


2.12.2025




18.12.2025


MS-H vaccine







Pharmsure Veterinary Products Europe Limited




4 Fitzwilliam Terrace, Strand Road, Bray, WICKLOW A98 T6H6, Ireland






EU/2/11/126


23.1.2026




19.12.2025


MHYOSPHERE PCV ID







Laboratorios Hipra, S.A.




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






EU/2/20/259


30.12.2025








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/2026/1043/oj
ISSN 1977-091X (electronic edition)