In the European Union, regdanvimab is indicated for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.[4]
In March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of data on regdanvimab.[9][10] In October 2021, the EMA started evaluating an application for marketing authorization for the monoclonal antibody regdanvimab (Regkirona) 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.[11] The applicant is Celltrion Healthcare Hungary Kft.[11] The European Medicines Agency (EMA) concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adults who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.[8]
In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorization in the European Union for regdanvimab (Regkirona) for the treatment of COVID-19.[12][13] The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft.[13] Regdanvimab was approved for medical use in the European Union in November 2021.[4][5]
^"AusPAR: Regdanvimab". Therapeutic Goods Administration (TGA). 7 December 2021. Archived from the original on 5 January 2022. Retrieved 4 January 2022.
^ abcdefg"Regkirona EPAR". European Medicines Agency. 10 November 2021. Archived from the original on 12 November 2021. Retrieved 12 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ abc"Regkirona". Union Register of medicinal products. 12 November 2021. Archived from the original on 24 April 2022. Retrieved 24 April 2022.
Viruses
COVID-19
