Clopidogrel Teva (hydrogen sulphate)
Authorised
This medicine is authorised for use in the European Union
clopidogrel
MedicineHumanAuthorised
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).
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.
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.
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).
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.
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.
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.
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.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.
Product information
Latest procedure affecting product information: IB/0059/G
08/02/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 agentsTherapeutic 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.
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