Basic Information
Regkirona
Regulatory Information
EMEA/H/C/005854
November 12, 2021
November 11, 2021
9
April 24, 2025
Company Information
Hungary
1062 Budapest Váci út 1-3. WestEnd Office Building B torony
Celltrion Healthcare Hungary Kft
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Overview Summary
On 14 April 2025, the European Commission withdrew the marketing authorisation for Regkirona (regdanvimab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Celltrion Healthcare Hungary Kft., which notified the European Commission of its decision to permanently discontinue the marketing of Regkirona for commercial reasons. Regkirona was granted marketing authorisation in the EU on 12 November 2021 for the treatment of COVID-19. The marketing authorisation was initially valid for a 5-year period.