EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19

EMA

23 November 2021 - EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). Lagevrio, which is being developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, is intended for the treatment of COVID-19 in adults.

EMA will assess the benefits and risks of Lagevrio under a reduced timeline and could issue an opinion within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the medicine.

Read EMA press release 

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier , COVID-19