What is Zopya?
Zopya is a medicine that contains the active substance clopidogrel that 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, please see the questions and answers by clicking here.
What is Zopya used for?
Zopya is indicated for the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Zopya can be given to the following patient groups:
- patients who have had a recent myocardial infarction (heart attack). Treatment with Zopya can be started between a few days and 35 days after the heart attack;
- patients with recent ischemic stroke (attack caused by insufficient blood supply to one 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 meals.
How does Zopya work?
The active substance in Zopya, clopidogrel, is an inhibitor of platelet aggregation, meaning it helps prevent the formation of blood clots. Blood clotting occurs as a result of the action of special blood cells, platelets, which aggregate ( stick to each other). Clopidogrel blocks the clumping of platelets 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 attack. heart disease or stroke.
How has Zopya been studied?
Since Zopya is a generic medicine, the studies have been limited to evidence designed to show that the medicine 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 are the benefits and risks of Zopya?
Because Zopya is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed to be the same as the reference medicine.
Why has Zopya been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that according to EU requirements, 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 risks identified. The Committee recommended that Zopya be given marketing authorization.
Other information about Zopya:
On 21 September 2009, the European Commission granted Norpharm Regulatory Services Ltd a "Marketing Authorization" for Zopya, valid throughout the European Union.
For the full version of Zopya's EPAR, click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 07-2009.
The information on Zopya - clopidogrel published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
