The European Medicines Agency (EMA) has announced that it has started the evaluation of an application submitted by Pfizer Europe for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir).
The application concerns the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19.
According to the announcement, the benefits and risks of Paxlovid will be assessed under a reduced timeline and the EMA’s opinion could be issued within weeks, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation.
Source: Cyprus News Agency