Abilify MyCite: Withdrawal of the marketing authorisation application



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.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Abilify MyCite (aripiprazole) (PDF/142.79 KB)


    First published: 24/07/2020

  • Key facts

    Abilify MyCite
    Product number
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • aripiprazole
    Date of withdrawal
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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
    1 rating
    2 ratings