Clopidogrel Hexal

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 28 July 2009 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Clopidogrel Hexal (clopidogrel). Clopidogrel Hexal was approved for the prevention of atherothrombotic events in patients with peripherial vascular diseases or who have had a stroke or myocardial infarction. The marketing authorisation holder (MAH) responsible for Clopidogrel Hexal was Acino Pharma GmbH. 

The European Commission was notified by letter dated 11 January 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Clopidogrel Hexal for commercial reasons. 

On 9 February 2012 the European Commission issued a decision to withdraw the marketing authorisation for Clopidogrel Hexal. 

Pursuant to this decision the European Public Assessment Report for Clopidogrel Hexal is updated to reflect the fact that the marketing authorisation is no longer valid.

Clopidogrel Hexal : EPAR - Summary for the public

Product information

Clopidogrel Hexal : EPAR - Product Information

Clopidogrel Hexal : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel Hexal
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Stroke
• Anatomical therapeutic chemical (ATC) code:
  B01AC04

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.

For further information please refer to section 5.1.

Authorisation details

• EMA product number:
  EMEA/H/C/001139
• Generic:

  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.

• Marketing authorisation holder:
  Acino Pharma GmbH

  Am Windfeld 35; 83714 Miesbach; Germany

• Marketing authorisation issued:
  28/07/2009
• Withdrawal of marketing authorisation:
  09/02/2012
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Clopidogrel Hexal : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel Hexal-H-C-1139-A20-06 : EPAR - Assessment Report - Variation

Adopted

Initial marketing authorisation documents

Clopidogrel Hexal : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Clopidogrel Hexal

Reference Number: EMEA/CHMP/227915/2009