Kostaive (zapomeran)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- zapomeran
- Company
- Arcturus Therapeutics Europe B.V.
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Wed 12 Feb 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006207
- ATC
- J07BN01
- Official record
- www.ema.europa.eu
Indication
Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
Follow Kostaive
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.