Cerepro:

Withdrawal of the marketing authorisation application

adenovirus-mediated Herpes simplex virus-thymidine kinase gene

Overview

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
    EMEA/318692/2007

  • Key facts

    Name
    Cerepro
    Product number
    EMEA/H/C/000694
    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
    13/07/2007
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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