Clopidogrel Teva Pharma B.V.

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

The marketing authorisation for Clopidogrel Teva Pharma B.V. has been withdrawn at the request of the marketing authorisation holder.

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
• 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

AdoptedReference Number: WC500108104.pdf

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

AdoptedReference Number: EMA/CHMP/289096/2010