Aripiprazole Mylan: Withdrawal of the marketing authorisation application

aripiprazole

Overview

On 7 May 2015, Generics (UK) Limited 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/81.01 KB)


    First published: 22/05/2015
    Last updated: 22/05/2015
    EMA/324241/2015

  • Key facts

    Name
    Aripiprazole Mylan
    Product number
    EMEA/H/C/003926
    International non-proprietary name (INN) or common name
    • aripiprazole
    Active substance
    • aripiprazole
    Date of withdrawal
    07/05/2015
    Company making the application
    Generics (UK) Limited
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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