Asimtufii: Withdrawal of the marketing authorisation application
aripiprazole
Table of contents
Overview
Otsuka Pharmaceutical Netherlands B.V. withdrew its application for a marketing authorisation of Asimtufii for the maintenance treatment of schizophrenia.
The company withdrew the application on 2 May 2023.
Key facts
Name |
Asimtufii |
Product number |
EMEA/H/C/005929 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
02/05/2023 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Asimtufii (PDF/3.99 MB)
Adopted
First published: 07/07/2023
EMA/CHMP/231170/2023 -
List item
Withdrawal letter: Asimtufii (PDF/841.88 KB)
First published: 26/05/2023 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Asimtufii (aripiprazole) (PDF/135.05 KB)
First published: 26/05/2023
Last updated: 07/07/2023
EMA/225109/2023 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').