Clopidogrel Krka d.d. (previously Zopya)

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clopidogrel

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 17/10/2019

Authorisation details

Product details
Name
Clopidogrel Krka d.d. (previously Zopya)
Agency product number
EMEA/H/C/001137
Active substance
clopidogrel hydrochloride
International non-proprietary name (INN) or common name
clopidogrel
Anatomical therapeutic chemical (ATC) code
B01AC03
GenericGeneric

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.

Publication details
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
20/09/2009

Product information

25/09/2019 Clopidogrel Krka d.d. (previously Zopya) - EMEA/H/C/001137 - IB/0028

Contents

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Pharmacotherapeutic group

Not yet assigned

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.

Assessment history

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