Zactima: Withdrawal of the marketing authorisation application

vandetanib

Overview

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.

Key facts

Name
Zactima
Product number
EMEA/H/C/001194
International non-proprietary name (INN) or common name
  • vandetanib
Active substance
  • Vandetanib
Date of withdrawal
27/10/2009
Company making the application
AstraZeneca
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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