Aripiprazole Mylan: Withdrawal of the marketing authorisation application

aripiprazole

Overview

On 8 January 2016, Mylan S.A.S. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aripiprazole Mylan, for the treatment of schizophrenia and the treatment and prevention of manic episodes in patients with bipolar I disorder.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Aripiprazole Mylan (aripiprazole) (PDF/76.19 KB)


    First published: 29/01/2016
    Last updated: 29/01/2016
    EMA/55039/2016

  • Key facts

    Name
    Aripiprazole Mylan
    Product number
    EMEA/H/C/004236
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • aripiprazole
    Date of withdrawal
    08/01/2016
    Company making the application
    Mylan S.A.S.
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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