Cerepro:

Withdrawal of the marketing authorisation application

sitimagene ceradenovec

Overview

On 8 March 2010, 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, which was intended to be used with ganciclovir sodium to treat operable high grade glioma.

  • List item

    Questions and answers on withdrawal of marketing authorisation application for Cerepro (PDF/59.67 KB)


    First published: 23/03/2010
    Last updated: 23/03/2010
    EMA/152214/2010

  • Key facts

    Name
    Cerepro
    Product number
    EMEA/H/C/001103
    International non-proprietary name (INN) or common name
    • sitimagene ceradenovec
    Active substance
    • sitimagene ceradenovec
    Date of withdrawal
    08/03/2010
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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