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Marketing Authorization about Paxlovid

Marketing Authorization about Paxlovid

by Claire Deroissart -
Number of replies: 1

Dear Ms Idiart, 

I'm writing regarding Market Access field about paxlovlid. Could you please send us guidelines concerning clinical trials that we have to do to obtain the authorization ?

What are the recommendations for COVID treatment? Can you tell me how many people should be included in clinical trials ? 

Please find attached the plan of clinical trials made by the company. 

Best regards. 

Claire Deroissart 




In reply to Claire Deroissart

Re: Marketing Authorization about Paxlovid

by Lucine Idiart -
Dear MS Deroissart,

Concerning COVID treatment market authorization, you have to subscribe on centralized procedure. So, you have to respond to European recommandations.

Please find attached the guidelines concerning clinical trials and European recommandations. You should find all answers in those documents.
Don't hesitate to mail me again if you have other questions.

Best Regards.
Lucine Idiart