Clopidogrel Krka

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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. 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.

This EPAR was last updated on 10/06/2022

Authorisation details

Product details
Name
Clopidogrel Krka
Agency product number
EMEA/H/C/001056
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
B01AC04
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
Marketing-authorisation holder
Krka, d.d., Novo mesto
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
23/09/2009
Contact address

KRKA d.d., Novo mesto
Šmarješka cesta 6
SI-8501 Novo mesto
Slovenia

Product information

09/06/2022 Clopidogrel Krka - EMEA/H/C/001056 - IB/0039

Other EU languages available icon 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:

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.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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.

Assessment history

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