Asimtufii: Withdrawal of the marketing authorisation application

aripiprazole

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.

  • 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

  • Key facts

    Name
    Asimtufii
    Product number
    EMEA/H/C/005929
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • Aripiprazole monohydrate
    Date of withdrawal
    02/05/2023
    Company making the application
    Otsuka Pharmaceutical Netherlands B.V.
    Withdrawal type
    Initial authorisation

    All documents

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating