Tekinex: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 11 January 2011, ChemGenex Europe SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tekinex intended to be used to treat patients with Philadelphia chromosome-positive chronic myeloid leukaemia who have the 'Bcr-Abl T315I kinase domain' mutation and whose previous treatment with imatinib had failed.
Key facts
Name |
Tekinex |
Product number |
EMEA/H/C/001244 |
Active substance |
|
Date of withdrawal |
11/01/2011 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Tekinex (PDF/558.5 KB)
Adopted
First published: 17/03/2011
Last updated: 17/03/2011 -
List item
Tekinex: Withdrawal letter (PDF/439.23 KB)
First published: 31/01/2011
Last updated: 31/01/2011 -
List item
ChemGenex Europe SAS withdraws its marketing authorisation application for Tekinex (omacetaxine mepesuccinate) (PDF/111.01 KB)
First published: 12/01/2011
Last updated: 12/01/2011
EMA/9192/2011 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Tekinex (PDF/56.35 KB)
First published: 31/01/2011
Last updated: 31/01/2011
EMA/13310/2011 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').