Clopidogrel BGR (previously Zylagren)

Clopidogrel BGR is a medicine that contains the active substance clopidogrel. It is available astablets (75 mg).

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

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

• patients who have recently had a myocardial infarction (heart attack). Clopidogrel BGR 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 BGR 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.

The standard dose of Clopidogrel BGR is one 75 mg tablet once a day.

The active substance in Clopidogrel BGR, 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.

Because Clopidogrel BGR is a generic medicine, studies in people 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 BGR 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 CHMP concluded that, in accordance with EU requirements, Clopidogrel BGR 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 BGR be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the EU for Zylagren on 21 September 2009. The name of the medicine was changed to Clopidogrel BGR on 14 July 2014.

For more information about treatment with Clopidogrel BGR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.