Mary Wilson
Well-known member
Ronapreve and Regkirona are now authorised in the EU. This follows the granting of marketing authorisations for these products by the European Commission on 12 November 2021.
News 11/11/2021
EMA’s human medicines committee (CHMP) has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19.
The Committee recommended authorising Ronapreve for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. The company that applied for authorisation of Ronapreve was Roche Registration GmbH.
With regard to Regkirona, the Committee recommended authorising the medicine for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.
https://www.ema.europa.eu/en/news/c...thorisation-two-monoclonal-antibody-medicines
News 11/11/2021
EMA’s human medicines committee (CHMP) has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19.
The Committee recommended authorising Ronapreve for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. The company that applied for authorisation of Ronapreve was Roche Registration GmbH.
With regard to Regkirona, the Committee recommended authorising the medicine for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.
https://www.ema.europa.eu/en/news/c...thorisation-two-monoclonal-antibody-medicines