Glivec: Withdrawal of the application to change the marketing authorisation
On 18 October 2006, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Glivec, in the treatment of systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal letter : Glivec (PDF/165.02 KB)
First published: 18/10/2006
Last updated: 18/10/2006
Novartis withdraws its application to extend the marketing authorisation for Glivec (PDF/37.38 KB)
First published: 06/10/2006
Last updated: 06/10/2006
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Glivec (PDF/39 KB)
First published: 16/11/2006
Last updated: 16/11/2006
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').