Clopidogrel Hexal

clopidogrel

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Clopidogrel Hexal?

Clopidogrel Hexal is a medicine that contains the active substance clopidogrel. It is available as white, round tablets (75 mg).

Clopidogrel Hexal is a ‘generic medicine’. This means that Clopidogrel Hexal is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix. 

What is Clopidogrel Hexal used for?

Clopidogrel Hexal is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel Hexal can be given to the following groups of patients:

• patients who have recently had a myocardial infarction (heart attack). Clopidogrel Hexal can be started between a few days and 35 days after the attack;
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Clopidogrel Hexal can be started between seven days and six months after the stroke;
• patients with peripheral arterial disease (problems with blood flow in the arteries);
• patients who have a condition known as ‘acute coronary syndrome’, when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up). Clopidogrel Hexal can be used in patients who are having myocardial infarction with ‘ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment. It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave’ myocardial infarction.

The medicine can only be obtained with a prescription.

How is Clopidogrel Hexal used?

The standard dose of Clopidogrel Hexal is one 75 mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Hexal is used together with aspirin and 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 non-ST segment elevation syndrome).

How does Clopidogrel Hexal work?

The active substance in Clopidogrel Hexal, 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 Hexal been studied?

Because Clopidogrel Hexal 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 benefit and risk of Clopidogrel Hexal?

Because Clopidogrel Hexal 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 Hexal been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Hexal 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 Hexal be given marketing authorisation.

Other information about Clopidogrel Hexal

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Hexal to Acino Pharma GmbH on 28 July 2009.

This EPAR was last updated on 31/03/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

16/09/2010  Clopidogrel Hexal -EMEA/H/C/001139 -A20/0006

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
* Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
* Patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
For further information please refer to section 5.1.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents