Clopidogrel Teva (hydrogen sulphate)

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.

The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets. This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).

The active substance in Clopidogrel Teva, 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.

Clopidogrel Teva is a medicine that contains the active substance clopidogrel. It is available as pink tablets (75 mg).

Clopidogrel Teva is a ‘generic medicine’. This means that Clopidogrel Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.

Clopidogrel Teva is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel Teva can be given to the following groups of patients:

• patients who have recently had a myocardial infarction (heart attack). Clopidogrel Teva 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 Teva can be started between seven days and six months after the stroke;
• patients with peripheral arterial disease (problems with blood flow in the arteries);
• patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up). Clopidogrel Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation’ (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment. It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or ‘non-Q-wave’ myocardial infarction.

The medicine can only be obtained with a prescription.

Because Clopidogrel Teva 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.

Because Clopidogrel Teva 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.

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Teva 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 Teva be given marketing authorisation.