Clopidogrel Sandoz

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 21 September 2009 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Clopidogrel Sandoz (clopidogrel). Clopidogrel Sandoz 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 Sandoz was Acino Pharma GmbH. 

The European Commission was notified by letter dated 9 March 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Clopidogrel Sandoz for commercial reasons. On 31 March 2011 the European Commission issued a decision to withdraw the marketing authorisation for Clopidogrel Sandoz. 

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Public Assessment Report for Clopidogrel Sandoz is updated to reflect the fact that the marketing authorisation is no longer valid.

Clopidogrel Sandoz : EPAR - Summary for the public

Product information

Clopidogrel Sandoz : EPAR - Product Information

Clopidogrel Sandoz : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel Sandoz
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
• 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.

For further information please refer to section 5.1.

Authorisation details

• EMA product number:
  EMEA/H/C/001174
• 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:
  21/09/2009
• Withdrawal of marketing authorisation:
  31/03/2011
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Clopidogrel Sandoz-H-001174-A-20-0007 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/12005/2011

Initial marketing authorisation documents

Clopidogrel Sandoz : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Clopidogrel Sandoz

Reference Number: EMEA/CHMP/376597/2009