Clopidogrel 1A Pharma

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On the 28 July 2009 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Clopidogrel 1A Pharma, a medicine that contains the active substance clopidogrel, which had been approved 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. 

The marketing authorisation holder (MAH) responsible for Clopidogrel 1A Pharma was Acino Pharma GmBH. The European Commission was notified by a letter dated 20 December 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Clopidogrel 1A Pharma for commercial reasons. Clopidogrel 1A Pharma was not marketed in any European country. On 1 February 2011 the European Commission issued a decision to withdraw the marketing authorisation for Clopidogrel 1A Pharma. 

Pursuant to this decision the European Public Assessment Report for Clopidogrel 1A Pharma is updated to reflect that the marketing authorisation is no longer valid.

Clopidogrel 1A Pharma : EPAR - Summary for the public

Product information

Clopidogrel 1A Pharma : EPAR - Product Information

Clopidogrel 1A Pharma : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel 1A Pharma
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  Peripheral Vascular Diseases
• 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/001054
• 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

  Acino Pharma GmbH; Am Windfeld 35; D-83714 Miesbach; Germany

• Marketing authorisation issued:
  28/07/2009
• Withdrawal of marketing authorisation:
  01/02/2011
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Clopidogrel 1A Pharma : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel 1A Pharma-H-1054-A-20-0004: EPAR - Assessment Report

AdoptedReference Number: EMA/11498/2011

Initial marketing authorisation documents

Clopidogrel 1A Pharma : EPAR - Public assessment report