Clopidogrel BGR (previously Zylagren)

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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 BGR. 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 BGR.

This EPAR was last updated on 08/07/2019

Authorisation details

Product details
Name
Clopidogrel BGR (previously Zylagren)
Agency product number
EMEA/H/C/001138
Active substance
clopidogrel hydrogen sulphate
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
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
Marketing-authorisation holder
Biogaran
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
21/09/2009
Contact address
15, boulevard Charles de Gaulle
92707 Colombes Cedex
France

Product information

05/06/2019 Clopidogrel BGR (previously Zylagren) - EMEA/H/C/001138 - IB/0036

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Prevention of atherothrombotic events Clopidogrel is indicated in:

Adult 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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