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.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').