Clopidogrel Krka d.d. (previously Zopya)
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 Krka d.d. 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 Krka d.d.
Clopidogrel Krka d.d. is a medicine that contains the active substance clopidogrel. It is available as pink, round tablets (75 mg).
Clopidogrel Krka d.d. is a ‘generic medicine’. This means that Clopidogrel Krka d.d. is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Plavix.
Clopidogrel Krka d.d. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Clopidogrel Krka d.d. can be given to the following groups of patients:
- patients who have recently had a myocardial infarction (heart attack). Clopidogrel Krka d.d. 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 Krka d.d. can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (problems with blood flow in the arteries).
The medicine can only be obtained with a prescription.
The standard dose of Clopidogrel Krka d.d. is one 75 mg tablet once a day, taken with or without food.
The active substance in Clopidogrel Krka d.d., 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 Krka d.d. 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 Krka d.d. 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 CHMP concluded that, in accordance with EU requirements, Clopidogrel Krka d.d. 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 Krka d.d. be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the EU for Zopya on 21 September 2009. The name of the medicine was changed to Clopidogrel Krka d.d. on 18 May 2011.
For more information about treatment with Clopidogrel Krka d.d., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0036/G
09/02/2024
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 Krka d.d. (previously Zopya)
- Active substance
- clopidogrel (as hydrochloride)
- International non-proprietary name (INN) or common name
- clopidogrel
- Therapeutic area (MeSH)
- Peripheral Vascular Diseases
- Stroke
- Myocardial Infarction
- Anatomical therapeutic chemical (ATC) code
- B01AC03
Therapeutic indication
Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) 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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