Eptifibatide Accord (eptifibatide)
- Region
- 🇪🇺 EU
- Active substance
- eptifibatide
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Myocardial Infarction
- CHMP opinion
- Thu 19 Nov 2015
- EU approval
- Mon 11 Jan 2016
- Designations
- Generic
- Application
- EMEA/H/C/004104
- ATC
- B01AC16
- Official record
- www.ema.europa.eu
Indication
Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes. Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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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.