Active Substance: clopidogrel hydrochloride
Common Name: clopidogrel
ATC Code: B01AC04
Marketing Authorisation Holder: Mylan S.A.S.
Active Substance: clopidogrel hydrochloride
Authorisation Date: 2009-09-21
Therapeutic Area: Peripheral Vascular Diseases Stroke Myocardial Infarction
Pharmacotherapeutic Group: Antithrombotic agents
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.
What is Clopidogrel Mylan?
Clopidogrel Mylan is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel Mylan is a ‘generic medicine’. This means that Clopidogrel Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.
What is Clopidogrel Mylan used for?
Clopidogrel Mylan is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel Mylan can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Clopidogrel Mylan can be started between a few days and 35 days after the attack;
- patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Clopidogrel Mylan can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood flow in the arteries).
The medicine can only be obtained with a prescription.
How is Clopidogrel Mylan used?
The standard dose of Clopidogrel Mylan is one 75 mg tablet once a day, taken with or without food.
How does Clopidogrel Mylan work?
The active substance in Clopidogrel Mylan, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
How has Clopidogrel Mylan been studied?
Because Clopidogrel Mylan is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefit and risk of Clopidogrel Mylan?
Because Clopidogrel Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Why has Clopidogrel Mylan been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Mylan has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Clopidogrel Mylan be given marketing authorisation.
Other information about Clopidogrel Mylan
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan to Mylan S.A.S on 21 September 2009.