Tasigna: Withdrawal of the application to change the marketing authorisation

nilotinib

Overview

On 21 May 2014, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tasigna to treat patients with Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) in whom treatment with another cancer medicine, imatinib, has not led to a 'complete molecular response'.

Key facts

Name
Tasigna
Product number
EMEA/H/C/000798
Date of issue of market authorisation valid throughout the European Union (if applicable)
19/11/2007
International non-proprietary name (INN) or common name
  • nilotinib
Active substance
  • nilotinib
Date of withdrawal
21/05/2014
Company making the application
Novartis Europharm Ltd
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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