What is Clopidogrel DURA?
Clopidogrel DURA is a medicine containing the active substance clopidogrel, available as round pink tablets (75 mg).
Clopidogrel DURA is a "generic medicine", which means that Clopidogrel DURA is similar to a "reference medicine" 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 Clopidogrel DURA used for?
Clopidogrel DURA is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel DURA can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). treatment with Clopidogrel DURA can start in the period between a few days and 35 days after the infarction;
- patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain). Treatment with Clopidogrel DURA may begin between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood circulation in the arteries).
The medicine can only be obtained with a prescription.
How is Clopidogrel DURA used?
The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, with or without food.
How does Clopidogrel DURA work?
The active substance in Clopidogrel DURA, clopidogrel, is an inhibitor of platelet aggregation, meaning 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 performed on Clopidogrel DURA?
Because Clopidogrel DURA 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 Clopidogrel DURA?
Because Clopidogrel DURA 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 Clopidogrel DURA been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Clopidogrel DURA 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 recommended the granting of a marketing authorization for Clopidogrel DURA.
Further information on Clopidogrel DURA
The European Commission issued a marketing authorization valid throughout the European Union for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
The full EPAR for Clopidogrel DURA can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 07-2009.
