Basic Information
Zyllt
Regulatory Information
EMEA/H/C/001058
September 28, 2009
18
February 29, 2024
Company Information
Slovenia
KRKA d.d., Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto
KRKA, d.d., Novo mesto
Drug Classification
Active Ingredients
Active Substances Detail
clopidogrel (as hydrogen sulfate)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Prevention 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.
Overview Summary
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).