What is Clopidogrel Mylan?
Clopidogrel Mylan is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel Mylan is a 'generic medicine'. This means that Clopidogrel Mylan 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 Clopidogrel Mylan used for?
Clopidogrel Mylan is used to prevent atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Mylan can be given to the following patient groups:
- patients who have had a recent myocardial infarction (heart attack). Clopidogrel Mylan treatment 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). Clopidogrel Mylan treatment 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 used?
The standard dose of Clopidogrel Mylan is one 75 mg tablet once a day, with or without meals.
How does Clopidogrel Mylan work?
The active substance in Clopidogrel Mylan, clopidogrel, is an inhibitor of platelet aggregation, which means that it helps prevent the formation of blood clots. Blood clotting occurs as a result of the action of special blood cells, platelets, which aggregate. (they stick together). Clopidogrel blocks the clumping of platelets by preventing a substance called ADP from binding to a specific receptor on their surface. This prevents platelets from becoming "sticky", reducing the risk of blood clots forming and helping to prevent another attack. heart disease or stroke.
How has Clopidogrel Mylan been studied?
As Clopidogrel Mylan 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 Clopidogrel Mylan?
Since Clopidogrel Mylan 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 Clopidogrel Mylan been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Mylan has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, it is the view 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 Mylan.
Other information about Clopidogrel Mylan:
On 21 September 2009, the European Commission granted Mylan S.A.S a "Marketing Authorization" for Clopidogrel Mylan, valid throughout the European Union.
For the full version of the Clopidogrel Mylan 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.
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