Evoltra: Withdrawal of the application to change the marketing authorisation

clofarabine

Overview

On 18 March 2008, Bioenvision Ltd, a wholly owned subsidiary of Genzyme Corporation, officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Evoltra. The change concerned an extension of indication to add the treatment of acute myeloid leukaemia in elderly patients. Evoltra was designated as an orphan medicine for this condition on 8 May 2003.

  • List item

    Questions and answers on the withdrawal of a change to the marketing authorisation for Evoltra (PDF/36.91 KB)


    First published: 24/04/2008
    Last updated: 24/04/2008
    EMEA/138069/2008

  • Key facts

    Name
    Evoltra
    Product number
    EMEA/H/C/000613
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    29/05/2006
    International non-proprietary name (INN) or common name
    • clofarabine
    Active substance
    • clofarabine
    Date of withdrawal
    18/03/2008
    Company making the application
    Genzyme Europe B.V.
    Withdrawal type
    Post-authorisation

    All documents

    Related content

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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