European CHMP recommends approval of remdesivir (Veklury)

The license is for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.

SPS commentary:

In a related press release, The European Medicines Agency (EMA) state remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.


European Medicines Agency

Resource links:

Press release