Abilify: Withdrawal of the application to change the marketing authorisation
aripiprazole
Table of contents
Overview
On 17 November 2009, Otsuka Pharmaceutical Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Abilify, in the treatment of resistant major depressive episodes.
Key facts
Name |
Abilify |
Product number |
EMEA/H/C/000471 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
04/06/2004 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
17/11/2009 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Abilify (PDF/321.64 KB)
Adopted
First published: 24/02/2010
Last updated: 24/02/2010
EMA/CHMP/820673/2009 -
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Withdrawal letter : Abilify (PDF/51.34 KB)
First published: 05/01/2010
Last updated: 05/01/2010 -
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Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole) (PDF/25 KB)
First published: 19/11/2009
Last updated: 19/11/2009
EMEA/749487/2009 -
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Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Abilify (aripiprazole) (PDF/68.66 KB)
First published: 05/01/2010
Last updated: 05/01/2010
EMA/809491/2009 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').