Abilify MyCite: Withdrawal of the marketing authorisation application
aripiprazole
Table of contents
Overview
Otsuka Pharmaceutical Netherlands B.V. withdrew its application for a marketing authorisation of Abilify MyCite for the treatment of schizophrenia and bipolar I disorder.
The company withdrew the application on 17 July 2020.
Key facts
Name |
Abilify MyCite |
Product number |
EMEA/H/C/005062 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
17/07/2020 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Abilify MyCite (PDF/1.44 MB)
Adopted
First published: 22/10/2020
EMA/CHMP/431264/2020 -
List item
Withdrawal letter: Abilify Mycite (PDF/178.38 KB)
First published: 24/07/2020 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Abilify MyCite (aripiprazole) (PDF/142.79 KB)
Adopted
First published: 24/07/2020
EMA/390789/2020 -
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.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').