drugs

Grepid - clopidogrel

What is Grepid?

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

Grepid is a "generic medicine". This means that it is similar to a "reference drug", already authorized in the European Union (EU), called Plavix. For more information on generic medicines, see the questions and answers by clicking here.

What is Grepid used for?

Grepid is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Grepid can be given to the following groups of patients:

  1. patients who have recently had a myocardial infarction (heart attack); Grepid treatment can be started in the period between a few days and 35 days after the heart attack;
  2. patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of ​​the brain); Grepid treatment can be started between seven days and six months after the stroke;
  3. patients with peripheral arterial disease (problems with blood circulation in the arteries).

The medicine can only be obtained with a prescription.

How is Grepid used?

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

How does Grepid work?

The active substance in Grepid, clopidogrel, is an inhibitor of platelet aggregation ie it helps prevent blood clots. Blood coagulation occurs following the action of special blood cells, the platelets, which aggregate (stick together). Clopidogrel blocks platelet aggregation by preventing a substance called ADP from binding to a specific receptor on their surface. This prevents the platelets from becoming "sticky", reducing the risk of blood clots forming and helping to prevent another heart attack or stroke.

What studies have been carried out on Grepid?

Because Grepid is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine Plavix. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.

What are the benefits and risks of Grepid?

Because Grepid is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.

Why has Grepid been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Grepid has been shown to have comparable quality and to be bioequivalent to Plavix. It is the opinion of the CHMP that, as in the case of Plavix, the benefits outweigh the risks identified. The Committee therefore recommended that Grepid be given marketing authorization.

Other information on Grepid:

On 28 July 2009, the European Commission issued a marketing authorization for Grepid, valid throughout the European Union, to Pharmathen SA.

The full EPP for Grepid can be found here.

Last update of this summary: 06-2009.