Advexin: Withdrawal of the marketing authorisation application

contusugene ladenovec

Overview

On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer. Advexin was designated as an orphan medicinal product on 23 October 2006.

  • List item

    Questions and answers on the withdrawal of the marketing application for Advexin (PDF/37.42 KB)


    First published: 11/02/2009
    Last updated: 11/02/2009
    EMEA/690893/2008

  • Key facts

    Name
    Advexin
    Product number
    EMEA/H/C/000919
    International non-proprietary name (INN) or common name
    • contusugene ladenovec
    Active substance
    • contusugene ladenovec
    Date of withdrawal
    17/12/2008
    Company making the application
    Gendux Molecular Limited
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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