Zactima: Withdrawal of the marketing authorisation application
On 27 October 2009, AstraZeneca officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zactima, for use in combination with chemotherapy, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received anticancer treatment.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
AstraZeneca withdraws its marketing authorisation application for Zactima (vandetanib) (PDF/24.52 KB)
First published: 30/10/2009
Last updated: 30/10/2009
Withdrawal letter : Zactima (PDF/55.53 KB)
First published: 27/10/2009
Last updated: 27/10/2009
Questions and answers on the withdrawal of the marketing authorisation application for Zactima (vandetanib) (PDF/31.02 KB)
First published: 19/11/2009
Last updated: 19/11/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').