EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19

EMA

4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19. 

The applicant is Celltrion Healthcare Hungary.

Read EMA press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier , COVID-19