Abilify: Withdrawal of the application to change the marketing authorisation

aripiprazole

Overview

On 17 November 2009, Otsuka Pharmaceutical Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Abilify, in the treatment of resistant major depressive episodes.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Abilify (aripiprazole) (PDF/68.66 KB)


    First published: 05/01/2010
    Last updated: 05/01/2010
    EMA/809491/2009

  • Key facts

    Name
    Abilify
    Product number
    EMEA/H/C/000471
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    04/06/2004
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • aripiprazole
    Date of withdrawal
    17/11/2009
    Company making the application
    Otsuka Pharmaceutical Netherlands B.V.
    Withdrawal type
    Post-authorisation

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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