Clopidogrel Taw Pharma (previously Clopidogrel Mylan) (clopidogrel)
- Region
- 🇪🇺 EU
- Active substance
- clopidogrel
- Company
- Taw Pharma (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
- CHMP opinion
- Thu 25 Jun 2009
- EU approval
- Mon 21 Sep 2009
- Designations
- Generic
- Application
- EMEA/H/C/001134
- ATC
- B01AC04
- Official record
- www.ema.europa.eu
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. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS) Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. 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.
Regulatory milestones
No milestones recorded in the last year.
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