Clopidogrel Teva (hydrogen sulphate)

Authorised

This medicine is authorised for use in the European Union

clopidogrel

Overview

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 Teva?

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

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

What is Clopidogrel Teva used for?

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

• patients who have recently had a myocardial infarction (heart attack). Clopidogrel Teva 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 Teva 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 Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation’ (an abnormal reading on the ECG or electrocardiogram) 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 ‘non-Q-wave’ myocardial infarction.

The medicine can only be obtained with a prescription.

How is Clopidogrel Teva used?

The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food. In acute coronary syndrome, Clopidogrel Teva 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 Teva work?

The active substance in Clopidogrel Teva, 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 Teva been studied?

Because Clopidogrel Teva 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 Teva?

Because Clopidogrel Teva 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 Teva been approved?

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

Other information about Clopidogrel Teva

The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.

Clopidogrel Teva (hydrogen sulphate) : EPAR - Summary for the public

Product information

Clopidogrel Teva (hydrogen sulphate) : EPAR - Product Information

Clopidogrel Teva (hydrogen sulphate) : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel Teva (hydrogen sulphate)
• Active substance:
  clopidogrel (as hydrogen sulfate)
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Acute Coronary Syndrome
  • Peripheral Vascular Diseases
  • Myocardial Infarction
  • Stroke
• Anatomical therapeutic chemical (ATC) code:
  B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:

• Adult 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.
• Adult 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.
• Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
  In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Authorisation details

• EMA product number:
  EMEA/H/C/001053
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva Pharma B.V.

  TEVA Pharma B.V.; Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Opinion adopted:
  29/05/2009
• Marketing authorisation issued:
  27/07/2009
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Clopidogrel Teva (hydrogen sulphate) : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Clopidogrel Teva (hydrogen sulphate) : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Clopidogrel Teva

Reference Number: EMEA/CHMP/305809/2009