Clopidogrel Teva Generics B.V.

Lapsed

This medicine's authorisation has lapsed

clopidogrel

Overview

On 28 October 2010 the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Clopidogrel Teva Generics B.V. (clopidogrel hydrochloride), indicated for the prevention of atherothrombotic events in patients with myocardial infarction and acute coronary syndrome. 

It was also authorised for the prevention of atherothrombotic and thromboembolic events in atrial fibrillation. Clopidogrel Teva Generics B.V. has not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause')1 , the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation. Because of this, the marketing authorisation for Clopidogrel Teva Generics B.V. is no longer valid. 

Clopidogrel Teva Generics 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for Clopidogrel Teva Generics B.V. is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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

Product information

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

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

Product details

• Name of medicine:
  Clopidogrel Teva Generics B.V.
• Active substance:
  clopidogrel (as hydrochloride)
• 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/002254
• 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.

  Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Marketing authorisation issued:
  28/10/2010
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

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

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

AdoptedReference Number: EMA/CHMP/455692/2010