Regkirona
Withdrawn
This medicine's authorisation has been withdrawn
regdanvimab
MedicineHumanWithdrawn
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- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Product information
Latest procedure affecting product information:IB/0016
25/08/2023
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Regkirona
- Active substance
- regdanvimab
- International non-proprietary name (INN) or common name
- regdanvimab
- Therapeutic area (MeSH)
- COVID-19 virus infection
- Anatomical therapeutic chemical (ATC) code
- J06BD06
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic 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.
Assessment history
News on Regkirona
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