PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Clopidogrel 1A Pharma?
Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel, available as white round tablets (75 mg).
Clopidogrel 1A Pharma 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 1A Pharma used for?
Clopidogrel 1A Pharma is indicated in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel 1A Pharma can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel 1A Pharma 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 1A Pharma can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood circulation 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 1A Pharma can 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 1A Pharma used?
The standard dose of Clopidogrel 1A Pharma is a 75 mg tablet once a day, with or without food. In acute coronary syndrome, Clopidogrel 1A Pharma 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 Clopidogrel 1A Pharma works.
The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation, meaning 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 1A Pharma been studied?
Because Clopidogrel 1A Pharma 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 1A Pharma?
Because Clopidogrel 1A Pharma 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 1A Pharma been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Clopidogrel 1A Pharma 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 1A Pharma.
More information on Clopidogrel 1A Pharma:
On 28 July 2009 the European Commission granted Acino Pharma GmbH a marketing authorization for Clopidogrel 1A Pharma, valid throughout the European Union.
The full EPAR for Clopidogrel 1A Pharma can be found here.
Last update of this summary: 06-2009.
