Clopidogrel HCS
Authorised
This medicine is authorised for use in the European Union
clopidogrel
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Clopidogrel HCS. 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 HCS.
Clopidogrel HCS is a blood-thinning medicine that contains the active substance clopidogrel. It is available as tablets (75 mg).
Clopidogrel HCS is a ‘generic medicine’. This means that Clopidogrel HCS is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.
Clopidogrel HCS is used in adults to prevent problems caused by blood clots. Clopidogrel HCS can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Clopidogrel HCS 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 HCS 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 with acute coronary syndrome (a condition in which blood supply to the heart is reduced), 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 HCS can be used in patients who are having a heart attack 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 have had a ‘non-Q-wave’ myocardial infarction.
- patients with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin. It is used in patients who have at least one risk factor for 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.
The standard dose of Clopidogrel HCS is one 75-mg tablet once a day. In acute coronary syndrome, treatment generally starts with a loading dose of four 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 HCS is used together with aspirin, the dose of which should not be higher than 100 mg.
The active substance in Clopidogrel HCS, 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 HCS is a generic medicine, studies in people 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 HCS is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine’s.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel HCS 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 HCS be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel HCS on 28 October 2010.
For more information about treatment with Clopidogrel HCS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0023
03/05/2018
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 HCS
- Active substance
- clopidogrel (as hydrochloride)
- International non-proprietary name (INN) or common name
- clopidogrel
- Therapeutic area (MeSH)
- Peripheral Vascular Diseases
- Acute Coronary Syndrome
- 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.
For further information please refer to section 5.1.
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