Ronapreve (casirivimab;imdevimab)
- Region
- 🇪🇺 EU
- Active substance
- casirivimab;imdevimab
- Company
- Roche Registration GmbH
- 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- Withdrawn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/005814
- ATC
- J06BD07
- Official record
- www.ema.europa.eu
Indication
Ronapreve is indicated for:- Treatment of COVID-19 in adults, adolescents and children aged 2 years and older weighing at least 10 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. - Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.Ronapreve should be used in accordance with official recommendations where available and based on information on the activity of casirivimab and imdevimab against presently circulating viral variants.
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.