Tysabri: Withdrawal of the application to change the marketing authorisation

natalizumab

Overview

On 14 May 2013, Elan Pharma International Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw an application to extend the use (indication) of Tysabri in treating multiple sclerosis. The application was for the treatment of relapsing-remitting multiple sclerosis that is not highly active in patients who do not have antibodies against the JC virus.The withdrawn application was part of a grouped application which included another extension of indication (to include patients with high disease activity after glatiramer acetate has failed). This other extension applied for is not affected by the withdrawal.

Key facts

Name
Tysabri
Product number
EMEA/H/C/000603
Date of issue of market authorisation valid throughout the European Union (if applicable)
26/06/2006
International non-proprietary name (INN) or common name
  • natalizumab
Active substance
  • natalizumab
Date of withdrawal
14/05/2013
Company making the application
Biogen Netherlands B.V.
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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