Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2026 to 30 April 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: 2026-06-25
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








C_202603348EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/3348


25.6.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2026 to 30 April 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/2026/3348)

—   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




27.4.2026


Dazparda


insulin aspart







Gan & Lee Pharmaceuticals Europe GmbH




Prinzenallee 11a, 40549 Düsseldorf, Deutschland






EU/1/26/2029


Solution for injection


A10AB05


13.5.2026




—   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




10.2.2026


Nexavar







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/06/342


11.3.2026




23.2.2026


Sialanar







Proveca Pharma Limited




2 Dublin Landings, North Wall Quay, Dublin 1, Ireland






EU/1/16/1135


16.3.2026




26.3.2026


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


15.4.2026




27.4.2026


Osenvelt







Celltrion Healthcare Hungary Kft.




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






EU/1/24/1904


13.5.2026




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/2026/3348/oj
ISSN 1977-091X (electronic edition)