Clopidogrel Teva Pharma: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.
Key facts
Name |
Clopidogrel Teva Pharma |
Product number |
EMEA/H/C/001052 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/04/2009 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Clopidogrel Teva Pharma (PDF/85.34 KB)
Adopted
First published: 24/06/2009
Last updated: 24/06/2009
EMEA/CHMP/363700/2009 -
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Teva Pharma B.V. withdraws its marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel hydrobromide) (PDF/23.51 KB)
First published: 23/04/2009
Last updated: 23/04/2009
EMEA/251627/2009 -
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Withdrawal letter : Clopidogrel Teva Pharma (PDF/30.48 KB)
First published: 22/04/2009
Last updated: 22/04/2009 -
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Questions and answers on the withdrawal of the marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel) (PDF/41.24 KB)
First published: 24/06/2009
Last updated: 24/06/2009
EMEA/254399/2009 -
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').