Lagevrio

molnupiravir

Table of contents

Opinion

Update as of 13 March 2023:

The applicant for Lagevrio has requested a re-examination of EMA’s February 2023 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its recommendation and issue a final recommendation.

The European Medicines Agency has recommended the refusal of the marketing authorisation for Lagevrio, a medicine intended for the treatment of COVID-19 in adults.

The Agency issued its opinion on 23 February 2023. The company that applied for authorisation, Merck Sharp & Dohme B.V., may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Name
Lagevrio
Agency product number
EMEA/H/C/005789
International non-proprietary name (INN) or common name
  • molnupiravir
Active substance
  • molnupiravir
Therapeutic area
COVID-19 virus infection
Date opinion adopted
23/02/2023
Company name
Merck Sharp & Dohme B.V. 
Status
Negative
Application type
Initial authorisation

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