This is a summary of the European public assessment report (EPAR) for Clopidogrel HCS. 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 HCS.
Therapeutic Indication
### 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 7 days until less than 6 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 (VKA) 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
clopidogrel
Pharmacotherapeutic Group
Antithrombotic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| clopidogrel (as hydrochloride) | N/A | clopidogrel (as hydrochloride) |
EMA Name
Clopidogrel HCS
Medicine Name
Clopidogrel HCS
Aliases
N/ANo risk management plan link.
