Prasugrel Viatris (previously Prasugrel Mylan) (prasugrel)
- Region
- 🇪🇺 EU
- Active substance
- prasugrel
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
- EU approval
- Tue 15 May 2018
- Designations
- Generic
- Application
- EMEA/H/C/004644
- ATC
- B01AC22
- Official record
- www.ema.europa.eu
Indication
Prasugrel Viatris, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult 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
- 🇪🇺 Efient Authorised · Substipharm
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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.