EMA — authorised 12 November 2021
- Marketing authorisation holder: CELLTRION HEALTHCARE HUNGARY KFT.
- Status: approved
🇪🇺 Regkirona in European Union
EMA authorised Regkirona on 12 November 2021
Marketing authorisations
EMA — authorised 12 November 2021
- Application: EMEA/H/C/005854
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Regkirona
- 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.
- Status: withdrawn
Regkirona in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Regkirona approved in European Union?
Yes. EMA authorised it on 12 November 2021; EMA authorised it on 12 November 2021.
Who is the marketing authorisation holder for Regkirona in European Union?
CELLTRION HEALTHCARE HUNGARY KFT. holds the EU marketing authorisation.