Abilify MyCite: Withdrawal of the marketing authorisation application

aripiprazole

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.

  • 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

  • Key facts

    Name
    Abilify MyCite
    Product number
    EMEA/H/C/005062
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • aripiprazole
    Date of withdrawal
    17/07/2020
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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