This is a summary of the European public assessment report (EPAR) for Clopidogrel Zentiva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Zentiva.
Therapeutic Indication
*Secondary prevention of atherothrombotic events* Clopidogrel is indicated in: * adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; * adult patients suffering from acute coronary syndrome: + non\-ST\-segment\-elevation acute coronary syndrome (unstable angina or non\-Q\-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); + ST\-segment\-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. *Prevention of atherothrombotic and thromboembolic events in atrial fibrillation* In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin\-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5\.1\.
Therapeutic Area (MeSH)
ATC Code
B01AC04
ATC Item
N/A
Pharmacotherapeutic Group
Antithrombotic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| clopidogrel | N/A | clopidogrel |
EMA Name
Clopidogrel Zentiva (previously Clopidogrel Winthrop)
Medicine Name
Clopidogrel Zentiva (previously Clopidogrel Winthrop)
Aliases
N/ANo risk management plan link.
