European Commission approves Ronapreve to treat Covid-19
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021
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