Withdrawal of the marketing authorisation application

adenovirus-mediated Herpes simplex virus-thymidine kinase gene


On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma. Cerepro was designated an orphan medicinal product on 6 February 2002.

  • List item

    Questions and answers on the withdrawal of the marketing application for Cerepro (PDF/51.03 KB)

    First published: 19/07/2007
    Last updated: 19/07/2007

  • Key facts

    Product number
    International non-proprietary name (INN) or common name
    • adenovirus-mediated Herpes simplex virus-thymidine kinase gene
    Active substance
    • adenovirus-mediated Herpes simplex virus-thymidine kinase gene
    Date of withdrawal
    Company making the application
    Ark Therapeutics
    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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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