Clopidogrel BMS

RSS

clopidogrel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Clopidogrel BMS has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 26/01/2010

Authorisation details

Product details
Name
Clopidogrel BMS
Agency product number
EMEA/H/C/000974
Active substance
clopidogrel (as hydrogen sulfate)
International non-proprietary name (INN) or common name
clopidogrel
Therapeutic area (MeSH)
  • Stroke
  • Peripheral Vascular Diseases
  • Myocardial Infarction
  • Acute Coronary Syndrome
Anatomical therapeutic chemical (ATC) code
B01AC04
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
16/07/2008
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

26/10/2009 Clopidogrel BMS - EMEA/H/C/000974 - N/0012

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:

  • 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.

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.

- 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.

Assessment history

Related content

How useful was this page?

Add your rating
Average
2 ratings
2 ratings