Aripiprazole Mylan: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 7 May 2015, Generics (UK) Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder.
Key facts
Name |
Aripiprazole Mylan |
Product number |
EMEA/H/C/003926 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
07/05/2015 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Aripiprazole Mylan (PDF/3.39 MB)
Adopted
First published: 20/07/2015
Last updated: 20/07/2015
EMA/CHMP/705827/2014 -
List item
Withdrawal letter: Aripiprazole Mylan (PDF/33.22 KB)
First published: 22/05/2015
Last updated: 22/05/2015 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Aripiprazole Mylan (aripiprazole) (PDF/81.01 KB)
First published: 22/05/2015
Last updated: 22/05/2015
EMA/324241/2015 -
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').