What is Zopya?
Zopya is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Zopya is a "generic drug". This means that it 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 Zopya used for?
Zopya is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Zopya can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Zopya can be started in the period between a few days and 35 days after the heart attack;
- patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain). Treatment with Zopya can be started 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 Zopya used?
The standard dose of Zopya is one 75 mg tablet once a day, with or without food.
How does Zopya work?
The active substance in Zopya, clopidogrel, is an inhibitor of platelet aggregation, which means 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 Zopya?
Because Zopya 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 active ingredient in the body.
What are the benefits and risks of Zopya?
Because Zopya is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Zopya been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements in the EU, Zopya has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, it is the CHMP's view that, as in the case of Plavix, the benefits outweigh the identified risks. The Committee recommended that Zopya be given marketing authorization.
More information on Zopya:
On September 21, 2009, the European Commission granted Zopya a marketing authorization valid throughout the European Union to Norpharm Regulatory Services Ltd.
For the full EPAR for Zopya, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 07-2009.
