Invega: Withdrawal of the application to change the marketing authorisation
On 15 December 2008, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Invega, to add the treatment of acute manic episodes associated with bipolar I disorder.
|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|
Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone) (PDF/24.94 KB)
First published: 17/12/2008
Last updated: 17/12/2008
17 December 2008
Withdrawal letter : Invega (PDF/26.24 KB)
First published: 15/12/2008
Last updated: 15/12/2008
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Invega (PDF/39.82 KB)
First published: 22/01/2009
Last updated: 22/01/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone)17/12/2008