Aripiprazole Mylan: Withdrawal of the marketing authorisation application



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

  • Key facts

    Aripiprazole Mylan
    Product number
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • aripiprazole
    Date of withdrawal
    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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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