Zavesca: Withdrawal of the application to change the marketing authorisation
On 19 February 2008, Actelion Registration Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zavesca, in the treatment of neurological manifestations in patients with Niemann Pick type C disease.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Zavesca (PDF/269.83 KB)Adopted
First published: 24/04/2008
Last updated: 24/04/2008
Actelion withdraws its application for an extension of indication for Zavesca (PDF/19.16 KB)
First published: 25/02/2008
Last updated: 25/02/2008
Withdrawal letter : Zavesca (PDF/23.28 KB)
First published: 19/02/2008
Last updated: 19/02/2008
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zavesca (PDF/42.09 KB)
First published: 19/03/2008
Last updated: 19/03/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').