Megestrol Alkermes: Withdrawal of the marketing authorisation application


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

  • Key facts

    Megestrol Alkermes
    Product number
    Date of withdrawal
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating