THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency1,
Having regard to the application submitted by AstraZeneca AB on 5 March 2024 with a view to the withdrawal of the marketing authorisation for the medicinal product "Vaxzevria - COVID-19 Vaccine (ChAdOx1-S [recombinant])",
Whereas:
(1) The placing on the market of the medicinal product "Vaxzevria - COVID-19 Vaccine (ChAdOx1-S [recombinant])", which is entered in the Union Register of Medicinal Products under the number EU/1/21/1529 was authorised by Commission Decision C(2021) 698(final) of 29 January 2021.
(2) Following the holder's request, that authorisation should be withdrawn,
HAS ADOPTED THIS DECISION:
Article 1
At the holder's request, the marketing authorisation granted by Decision C(2021) 698(final) of 29 January 2021 for the medicinal product "Vaxzevria - COVID-19 Vaccine (ChAdOx1-S [recombinant])" is withdrawn.
Article 2
The withdrawal referred to in Article 1 shall be applicable with effect from 7 May 2024.
No comments:
Post a Comment