Efient (prasugrel)
- Region
- 🇪🇺 EU
- Active substance
- prasugrel
- Company
- Substipharm
- Status
- Authorised
- Therapeutic area
- Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction
- CHMP opinion
- Thu 18 Dec 2008
- EU approval
- Tue 24 Feb 2009
- Application
- EMEA/H/C/000984
- ATC
- B01AC22
- Official record
- www.ema.europa.eu
Indication
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Prasugrel Viatris (previously Prasugrel Mylan) Authorised · Viatris Limited
Follow Efient
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.