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.
|Agency product number||
|International non-proprietary name (INN) or common name||
COVID-19 virus infection
|Date opinion adopted||