Clopidogrel Teva Pharma B.V.

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 21 October 2014 the European Commission withdrew the marketing authorisation for Clopidogrel Teva Pharma B.V. (clopidogrel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva Pharma B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Clopidogrel Teva Pharma B.V. was granted marketing authorisation in the EU on 16 June 2011 for the prevention of atherothrombotic events (problems caused by blood clots and hardening of the arteries). The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU. 

Clopidogrel Teva Pharma B.V. is a generic medicine of Plavix. There are other generic medicinal products of Plavix authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma B.V. is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Clopidogrel Teva Pharma B.V. : EPAR - Summary for the public

Product information

Clopidogrel Teva Pharma B.V. : EPAR - Product Information

Clopidogrel Teva Pharma B.V. : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel Teva Pharma B.V.
• Active substance:
  clopidogrel (as hydrobromide)
• 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

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;
• adult 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.

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation

In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Authorisation details

• EMA product number:
  EMEA/H/C/001226
• 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:
  Teva Pharma B.V.

  Teva Pharma B.V.; Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Marketing authorisation issued:
  16/06/2011
• Withdrawal of marketing authorisation:
  21/10/2014
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Clopidogrel Teva Pharma B.V. : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Clopidogrel Teva Pharma B.V. : EPAR - Public assessment report

Adopted Reference Number: WC500108104.pdf

CHMP positive summary of opinion for Clopidogrel Teva Pharma B.V.

Adopted Reference Number: EMA/CHMP/289096/2010