What is Clopidogrel Qualimed?
Clopidogrel Qualimed is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel Qualimed is a "generic medicine", which means that Clopidogrel Qualimed 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 Qualimed used for?
Clopidogrel Qualimed is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Qualimed can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Clopidogrel Qualimed treatment 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 Qualimed can start 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 Qualimed used?
The standard dose of Clopidogrel Qualimed is one 75 mg tablet once a day, with or without food.
How does Clopidogrel Qualimed work?
The active substance in Clopidogrel Qualimed, 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.
How has Clopidogrel Qualimed been studied?
Because Clopidogrel Qualimed 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 Clopidogrel Qualimed?
Because Clopidogrel Qualimed 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 Qualimed been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Qualimed 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 Qualimed.
More information on Clopidogrel Qualimed:
On 23 September 2009, the European Commission granted Qualimed a marketing authorization for Clopidogrel Qualimed, valid throughout the European Union.
The full EPAR for Clopidogrel Qualimed can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 07-2009.
