Withdrawal of the marketing authorisation application
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.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Advexin (PDF/194 KB)Adopted
First published: 10/09/2009
Last updated: 10/09/2009
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
Withdrawal letter : Advexin (PDF/25.99 KB)
First published: 17/12/2008
Last updated: 17/12/2008
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
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').