Megestrol Alkermes: Withdrawal of the marketing authorisation application

Overview

On 6 March 2012, Alkermes Pharma Ireland Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Megestrol Alkermes, intended to treat weight loss and loss of appetite in patients with cancer or AIDS.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Megestrol Alkermes (megestrol) (PDF/97.78 KB)


    First published: 20/03/2012
    Last updated: 20/03/2012
    EMA/190839/2012

  • Key facts

    Name
    Megestrol Alkermes
    Product number
    EMEA/H/C/002177
    Date of withdrawal
    06/03/2012
    Company making the application
    Alkermes Pharma Ireland Ltd.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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