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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/909073/2011

EMEA/H/C/1189

EPAR summary for the public

Clopidogrel Apotex¹

clopidogrel

This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Apotex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Apotex.

What is Clopidogrel Apotex?

Clopidogrel Apotex is a medicine that contains the active substance clopidogrel. It is available as tablets (75 mg).

Clopidogrel Apotex is a 'generic medicine'. This means that Clopidogrel Apotex is similar to a 'reference medicine' already authorised in the European Union (EU) called Plavix. For more information on generic medicines, see the question-and-answer document here.

What is Clopidogrel Apotex used for?

Clopidogrel Apotex is used to prevent problems caused by blood clots in adults who have:

•    recently had a myocardial infarction (heart attack). Clopidogrel Apotex can be started between a few days and 35 days after the attack;

•    recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Clopidogrel Apotex can be started between seven days and six months after the stroke;

• peripheral arterial disease (problems with blood flow in the arteries);

• a condition known as 'acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots). Acute coronary syndrome is a group of heart problems that

¹ Previously known as Clopidogrel Mylan Pharma.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

include heart attacks and unstable angina (a severe type of chest pain). Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;

• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin. It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.

The medicine can only be obtained with a prescription.

How is Clopidogrel Apotex used?

The standard dose of Clopidogrel Apotex is one 75-mg tablet once a day. In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets. This is then followed by the standard 75-mg dose once a day for at least four weeks (in 'ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or 'non-Q-wave' myocardial infarction). In acute coronary syndrome and atrial fibrillation, Clopidogrel Apotex is used together with aspirin, the dose of which should not be higher than 100 mg.

How does Clopidogrel Apotex work?

The active substance in Clopidogrel Apotex, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming 'sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.

How has Clopidogrel Apotex been studied?

Because Clopidogrel Apotex 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 the active substance in the body.

What are the benefits and risks of Clopidogrel Apotex?

Because Clopidogrel Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Clopidogrel Apotex been approved?

The CHMP concluded that, in accordance with EU requirements, Clopidogrel Apotex has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Clopidogrel Apotex be given marketing authorisation.

Other information about Clopidogrel Apotex:

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan Pharma on 16 October 2009. The name of the medicine was changed to Clopidogrel Apotex on 20 January 2010.

The full EPAR for Clopidogrel Apotex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Clopidogrel Apotex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2011.

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