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.
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\.
Therapeutic Area (MeSH)
ATC Code
J06BD06
ATC Item
N/A
Pharmacotherapeutic Group
Immune sera and immunoglobulins
Active Substance (Summary)
INN / Common Names
EMA Name
Regkirona
Medicine Name
Regkirona
Aliases
N/ANo risk management plan link.
