Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel, Date of authorisation: 18/02/2015, Revision: 15, Status: Authorised
Clopidogrel ratiopharm is a blood-thinning medicine used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel ratiopharm can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Clopidogrel ratiopharm 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 ratiopharm 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), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up); the medicine should be given with aspirin (another medicine that prevents blood clots). Clopidogrel ratiopharm 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.
Clopidogrel ratiopharm can also be used to prevent problems caused by blood clots in adults 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.
Clopidogrel ratiopharm is a ‘generic medicine’. This means that Clopidogrel ratiopharm is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.
Clopidogrel ratiopharm contains the active substance clopidogrel.
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