Epostim: Withdrawal of the marketing authorisation application

epoetin alfa


On 15 March 2011, Reliance GeneMedix Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epostim to be used to treat anaemia and stimulate red blood cell production.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Epostim (epoetin alfa) (PDF/133.21 KB)

    First published: 19/04/2011
    Last updated: 19/04/2011

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • epoetin alfa
    Active substance
    • epoetin alfa
    Date of withdrawal
    Company making the application
    Reliance GeneMedix Plc
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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
    1 rating