What is it?

Zylagren is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Zylagren is a ?generic medicine?. This means that Zylagren is similar to a ?reference medicine? already authorised in the European Union (EU) called Plavix. For more information on generic medicines, see the question-and-answer document here.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

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

  • patients who have recently had a myocardial infarction (heart attack). Zylagren 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). Zylagren 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 it used?

The standard dose of Zylagren is one 75 mg tablet once a day, taken with or without food.

How does it work?

The active substance in Zylagren, 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 it been studied?

Because Zylagren 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 benefits has it shown during the studies?

Because Zylagren 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.

What is the risk associated?

Because Zylagren 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 it been approved?

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

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