This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Clopidogrel Krka.
For practical information about using Clopidogrel Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Clopidogrel Krka : EPAR - Summary for the public (PDF/93.95 KB)
First published: 14/10/2009
Last updated: 13/09/2017
|Agency product number||
clopidogrel (as hydrochloride)
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
Krka, d.d., Novo mesto
|Date of issue of marketing authorisation valid throughout the European Union||
KRKA d.d., Novo mesto
09/06/2022 Clopidogrel Krka - EMEA/H/C/001056 - IB/0039
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
- 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.