Glivec: Withdrawal of the application to change the marketing authorisation

imatinib

Overview

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.

Key facts

Name
Glivec
Product number
EMEA/H/C/000406
Date of issue of market authorisation valid throughout the European Union (if applicable)
07/11/2001
International non-proprietary name (INN) or common name
  • imatinib
Active substance
  • imatinib
Date of withdrawal
18/10/2006
Company making the application
Novartis Europharm Limited
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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