What is Clopidogrel MYLAN Pharma?
Clopidogrel MYLAN Pharma is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel MYLAN Pharma is a "generic medicine". This means that Clopidogrel MYLAN Pharma 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 MYLAN Pharma used for?
Clopidogrel MYLAN Pharma is used for the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel MYLAN Pharma can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel MYLAN Pharma 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 Clopidogrel MYLAN Pharma 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 Clopidogrel MYLAN Pharma used?
The standard dose of Clopidogrel MYLAN Pharma is one 75 mg tablet once a day, with or without food.
How does Clopidogrel MYLAN Pharma work?
The active substance in Clopidogrel MYLAN Pharma, 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.
How has Clopidogrel MYLAN Pharma been studied?
Because Clopidogrel MYLAN Pharma 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 MYLAN Pharma?
Because Clopidogrel MYLAN Pharma 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 MYLAN Pharma been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel MYLAN Pharma 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 therefore recommended the granting of a marketing authorization for Clopidogrel MYLAN Pharma.
More information on Clopidogrel Mylan Pharma:
On October 16, 2009, the European Commission granted Mylan SAS a marketing authorization valid throughout the European Union for Clopidogrel MYLAN Pharma.
The full EPAR for Clopidogrel MYLAN Pharma can be found here.
The full EPAR of the reference medicine is also found on the Agency's website .
Last update of this summary: 08-2009.
