Epostim: Withdrawal of the marketing authorisation application

epoetin alfa

Overview

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
    EMA/287731/2011

  • Key facts

    Name
    Epostim
    Product number
    EMEA/H/C/002265
    International non-proprietary name (INN) or common name
    • epoetin alfa
    Active substance
    • epoetin alfa
    Date of withdrawal
    15/03/2011
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating
    Average
    1 rating