LONDON, UK – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending the approval of a combination tablet that includes clopidogrel and aspirin (Teva Pharma) for individuals at risk for atherothrombotic events who are already taking the two antiplatelet agents[1].
CHMP, a committee that prepares opinions for the EMA on medications for human use, adopted the opinion that the agency grant marketing authorization for the fixed-dose combination this week.
Specifically, it recommends that the combination be made available for adult patients with non-ST-segment-elevation acute coronary syndrome, including patients undergoing PCI. In addition, the combination should be made available for patients with ST-segment-elevation MI eligible for thrombolytic therapy.
On the overall "basis of quality, safety, and efficacy data submitted," CHMP says the positive risk-to-benefit balance favors the approval of the combination tablet. The drug would be available in two doses: clopidogrel 75 mg/aspirin 75 mg and clopidogrel 75 mg/aspirin 100 mg.
Heartwire from Medscape © 2014 Medscape, LLC
Cite this: CHMP Recommends Approval of Clopidogrel/Aspirin Combo - Medscape - Jun 27, 2014.
Comments