What is Clopidogrel Krka?
Clopidogrel Krka is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel Krka is a "generic medicine". This means that Clopidogrel Krka 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 Krka used for?
Clopidogrel Krka is used in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Krka can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel Krka may start between a few days and 35 days after the infarction;
- patients with recent ischemic stroke (attack caused by insufficient blood supply to an area of the brain). Treatment with Clopidogrel Krka may 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 Krka used?
The standard dose of Clopidogrel Krka is one 75 mg tablet once a day, with or without food.
How does Clopidogrel Krka work?
The active substance in Clopidogrel Krka, 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 Krka been studied?
Because Clopidogrel Krka 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 risks and benefits of Clopidogrel Krka?
Because Clopidogrel Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as the latter.
Why has Clopidogrel Krka been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Krka 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 Krka.
More information on Clopidogrel Krka:
On 23 September 2009, the European Commission granted Krka, dd, Novo mesto a marketing authorization for Clopidogrel Krka, valid throughout the European Union.
The full EPAR for Clopidogrel Krka 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.
