do-me/EUR-LEX huggingface dataset:
Summary of European Union decisions on marketing authorisations in respect of medicinal products on 12 November 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 136, 30.4.2004, p. 1.)) 2021/C 458 I/01
Date: 2021-11-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: coronavirus disease, drug surveillance, market approval, marketing standard, medicinal product








CI2021458EN.01000101.xml










13.11.2021   


EN


Official Journal of the European Union


CI 458/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products on 12 November 2021


(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2021/C 458 I/01)






—



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




12.11.2021


Regkirona


regdanvimab







Celltrion Healthcare Hungary Kft.




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






EU/1/21/1597


Concentrate for solution for infusion


Pending


12.11.2021




12.11.2021


Ronapreve


casirivimab / imdevimab







Roche Registration GmbH




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






EU/1/21/1601


Solution for injection / infusion


Pending


12.11.2021








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.