Clopidogrel Teva Pharma BV

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Clopidogrel Teva Pharma BV?

Clopidogrel Teva Pharma BV It is a medicine that contains the active substance clopidogrel. The medicine is available in pink, capsule-shaped tablets (75 mg).

Clopidogrel Teva Pharma BV It is a "generic medicine". This means that Clopidogrel Teva Pharma BV is similar to a 'reference medicine' already authorized in the European Union (EU) called Plavix.

What is Clopidogrel Teva Pharma BV used for?

Clopidogrel Teva Pharma BV It is used in the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Teva Pharma BV can be given to the following groups of patients:

  • patients who have recently had a myocardial infarction (heart attack). Treatment with Clopidogrel Teva Pharma BV can be started between a few days and 35 days after the heart attack;
  • patients who have recently had an ischemic stroke (attack caused by insufficient blood supply to an area of ​​the brain); treatment with Clopidogrel Teva Pharma BV may start 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", which should be 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 to prevent it obturation). Clopidogrel Teva Pharma BV can be used in patients who have a heart attack with "ST-segment elevation" (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks the treatment may be beneficial. It can also be used in patients who do not have this abnormal ECG reading, 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 Teva Pharma BV used?

The standard dose of Clopidogrel Teva Pharma BV is a 75 mg tablet once a day, with or without food. In acute coronary syndrome, Clopidogrel Teva Pharma BV 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 ST segment elevation) or up to 12 months (in the presence of ST-segmentless elevation syndrome).

Clopidogrel Teva Pharma BV is converted into the active form in the body. For genetic reasons, some individuals may not be able to convert Clopidogrel Teva Pharma BV as effectively as other patients, which may lower the degree of response to the medicine. The most suitable dose for this type of patient has not yet been identified.

How does Clopidogrel Teva Pharma BV work?

The active substance in Clopidogrel Teva Pharma BV, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps prevent blood clots from forming. 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 a recurrence of heart attacks or strokes.

How has Clopidogrel Teva Pharma BV been studied?

Because Clopidogrel Teva Pharma BV is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. Two medicines are considered bioequivalent when they produce the same levels of active ingredient in the body.

What are the benefits and risks of Clopidogrel Teva Pharma BV?

Because Clopidogrel Teva Pharma BV is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are supposed to be the same as the latter.

Why has Clopidogrel Teva Pharma BV been approved?

The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma BV has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP considered that, as in the case of Plavix, the benefits outweighed the identified risks and recommended that they be given marketing authorization.

Further information on Clopidogrel Teva Pharma BV

On June 16, 2011, the European Commission granted Teva Pharma BV a marketing authorization for Clopidogrel Teva Pharma BV, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.

For more information about treatment with Clopidrogrel Teva Pharma BV, read the package leaflet (also part of the EPAR), or contact your doctor or pharmacist.

The full EPAR for the reference medicine can be found on the Agency's website.

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