Vazkepa (icosapent ethyl)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- icosapent ethyl
- Company
- Recordati Industria Chimica e Farmaceutica S.p.A.
- Status
- Authorised
- Therapeutic area
- Dyslipidemias
- CHMP opinion
- Thu 28 Jan 2021
- EU approval
- Fri 26 Mar 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005398
- ATC
- C10AX
- Official record
- www.ema.europa.eu
Indication
Indicated to reduce cardiovascular risk as an adjunct to statin therapy.
Regulatory milestones
No milestones recorded in the last year.
Follow Vazkepa
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.