On 18 January 2017, the European Commission withdrew the marketing authorisation for Clopidogrel Acino (clopidogrel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Acino AG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Clopidogrel Acino was granted marketing authorisation in the EU on 28 July 2009 for prevention of atherothrombotic events. The marketing authorisation was initially valid for a 5\-year period. It was then granted unlimited validity in 2014\. Clopidogrel Acino is a generic medicine of Plavix. There are other generic medicinal products of Plavix authorised and marketed in the EU. The European Public Assessment Report (EPAR) for Clopidogrel Acino is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Therapeutic Indication
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: * 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 * 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 * Patients suffering from acute coronary syndrome.
Therapeutic Area (MeSH)
ATC Code
B01AC04
ATC Item
N/A
Pharmacotherapeutic Group
Antithrombotic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Clopidogrel Acino
Medicine Name
Clopidogrel Acino
Aliases
N/ANo risk management plan link.
