What is Clopidogrel ratiopharm GmbH?
Clopidogrel ratiopharm GmbH is a medicine that contains the active substance clopidogrel available as white round tablets (75 mg).
Clopidogrel ratiopharm GmbH is a "generic medicine". This means that Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH used for?
Clopidogrel ratiopharm GmbH is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel ratiopharm GmbH can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack); treatment with Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (blood circulation problem in the arteries);
- patients suffering from a disorder known as "acute coronary syndrome", to which the medicine is administered with aspirin (another medicine to prevent the formation of clots), including patients who have been implanted with a stent (a small tube inserted into an artery for prevent clogging). Clopidogrel ratiopharm GmbH may be used in patients who undergo a myocardial attack with "ST-segment elevation" (an abnormal reading on the electrocardiogram or ECG) when the doctor believes the treatment can be beneficial. It can also be used in patients who do not have this abnormal reading in the ECG, when suffering from unstable angina (a severe form of chest pain) or myocardial infarction without Q waves.
The medicine can only be obtained with a prescription.
How is Clopidogrel ratiopharm GmbH used?
The standard dose of Clopidogrel ratiopharm GmbH is one 75 mg tablet once a day, with or without food. In acute coronary syndrome, Clopidogrel ratiopharm GmbH is used together with aspirin and treatment generally begins with a loading dose of four 75 mg tablets. This dose is then followed by the standard dose of 75 mg once a day for at least four weeks (in myocardial infarction with elevation of the ST segment) or up to 12 months (in the presence of a syndrome without elevation of the ST segment).
How does Clopidogrel ratiopharm GmbH work?
The active substance in Clopidogrel ratiopharm GmbH, clopidogrel, is an inhibitor of platelet aggregation ie 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. In this way, it 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 ratiopharm GmbH been studied?
Because Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH?
Because Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH.
More information on Clopidogrel ratiopharm GmbH:
On 28 July 2009, the European Commission granted Acino Pharma GmbH a marketing authorization for Clopidogrel ratiopharm GmbH, valid throughout the European Union.
The full EPAR for Clopidogrel ratiopharm GmbH can be found here.
Last update of this summary: 06-2009.
