Advexin: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer. Advexin was designated as an orphan medicinal product on 23 October 2006.
Key facts
Name |
Advexin |
Product number |
EMEA/H/C/000919 |
Date of withdrawal |
17/12/2008 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Advexin (PDF/194 KB)
Adopted
First published: 10/09/2009
Last updated: 10/09/2009
EMEA/692328/2008 -
List item
Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec) (PDF/23.86 KB)
First published: 19/12/2008
Last updated: 19/12/2008
EMEA/690558/2008 -
List item
Withdrawal letter : Advexin (PDF/25.99 KB)
First published: 17/12/2008
Last updated: 17/12/2008 -
List item
Questions and answers on the withdrawal of the marketing application for Advexin (PDF/37.42 KB)
First published: 11/02/2009
Last updated: 11/02/2009
EMEA/690893/2008 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').