Asimtufii: Withdrawal of the marketing authorisation application



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

Product number
International non-proprietary name (INN) or common name
  • aripiprazole
Active substance
  • Aripiprazole monohydrate
Date of withdrawal
Company making the application
Otsuka Pharmaceutical Netherlands B.V.
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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