Kavigale (sipavibart)
- Region
- 🇪🇺 EU
- Active substance
- sipavibart
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Mon 20 Jan 2025
- Application
- EMEA/H/C/006291
- ATC
- J06BD09
- Official record
- www.ema.europa.eu
Indication
Kavigale is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments.Kavigale should be used in accordance with official recommendations where available and based on information on the activity of sipavibart against presently circulating viral variants (see sections 4.4 and 5.1).
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.