Regkirona (regdanvimab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- regdanvimab
- Company
- Celltrion Healthcare Hungary Kft.
- Status
- Withdrawn
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Fri 12 Nov 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005854
- ATC
- J06BD06
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.