PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Clopidogrel Sandoz?
Clopidogrel Sandoz is a medicine that contains the active substance clopidogrel, available as white round tablets (75 mg).
Clopidogrel Sandoz is a "generic medicine". 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, see the questions and answers by clicking here.
What is Clopidogrel Sandoz used for?
Clopidogrel Sandoz is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Sandoz can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel Sandoz 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 an area of the brain). Treatment with Clopidogrel Sandoz 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 Sandoz used?
The standard dose of Clopidogrel Sandoz is one 75 mg tablet once a day, with or without food.
How does Clopidogrel Sandoz work?
The active substance in Clopidogrel Sandoz, clopidogrel, is an inhibitor of platelet aggregation, which means it helps prevent blood clots. Blood coagulation occurs through 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 Sandoz been studied?
Because Clopidogrel Sandoz 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 Sandoz?
Because Clopidogrel Sandoz 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 Sandoz been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Clopidogrel Sandoz has been shown to have comparable quality and to be bioequivalent to Plavix. It is the opinion of the CHMP that, as in the case of Plavix, the benefits outweigh the risks identified. The Committee therefore recommended the granting of a marketing authorization for Clopidogrel Sandoz.
More information on Clopidogrel Sandoz:
On 21 September 2009, the European Commission granted Acino Pharma GmbH a marketing authorization for Clopidogrel Sandoz, valid throughout the European Union.
The full EPAR for Clopidogrel Sandoz 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.
