What is Clopidogrel Apotex?
Clopidogrel Apotex is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel Apotex is a "generic medicine". This means that Clopidogrel Apotex is similar to a 'reference medicine' already authorized in the European Union (EU) called Plavix.
What is Clopidogrel Apotex used for?
Clopidogrel Apotex is used for the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Apotex can be given to the following groups of patients:
• patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel Apotex can be started between a few days and 35 days after the infarction;
• patients who have recently had an ischemic stroke (an attack caused by insufficient blood supply to an area of the brain). Treatment with Clopidogrel Apotex 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 Apotex used?
The standard dose of Clopidogrel Apotex is one 75 mg tablet once a day, with or without food.
How does Clopidogrel Apotex work?
The active substance in Clopidogrel Apotex, clopidogrel, is an inhibitor of platelet aggregation, ie it helps to prevent the formation of 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 a recurrence of heart attacks or strokes.
How has Clopidogrel Apotex been studied?
Because Clopidogrel Apotex 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 Apotex?
Because Clopidogrel Apotex 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 Apotex been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Apotex 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 the granting of a marketing authorization for Clopidogrel Apotex.
More information on Clopidogrel Apotex
On 16 October 2009, the European Commission granted Mylan SAS a marketing authorization valid throughout the European Union for Clopidogrel Mylan Pharma. On 20 January 2010 the name of the medicine was changed to Clopidogrel Apotex. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Clopidogrel Apotex can be found here. For more information about treatment with Clopidogrel Apotex, read the package leaflet (also part of the EPAR). The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 02-2010.
