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Image header Agence Europe
Europe Daily Bulletin No. 13109
Contents Publication in full By article 23 / 23
NEWS BRIEFS / Health

EMA recommends that Paxlovid be granted a standard European marketing authorisation

27/01/23 (Agence Europe)Following the meeting of its Committee for Medicinal Products for Human Use (CMPH) on 23-26 January, the European Medicines Agency (EMA) announced on Friday 27 January that it recommended converting the conditional marketing authorisation for Paxlovid, granted on 28 January 2022 by the European Commission (see EUROPE 12879/27), to a standard marketing authorisation. Paxlovid is an orally active antiviral drug composed of nirmatrelvir and ritonavir, developed and marketed by Pfizer for the treatment of Covid-19. Conditional marketing authorisation is an accelerated procedure whereby the EMA recommends the authorisation of a medicinal product, for one year, on a renewable basis, particularly in the context of a public health emergency, ensuring that the benefits of the medicinal product outweigh the risks associated with its use. (EV)

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