Theraloc: Withdrawal of the marketing authorisation application

nimotuzumab

Overview

On 1 December 2008, Oncoscience AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Theraloc, for the treatment of children and adolescents with resistant or recurrent high-grade glioma. Theraloc was designated as an orphan medicinal product on 2 September 2004.

  • List item

    Questions and answers on the withdrawal of the marketing application for Theraloc (PDF/43.31 KB)


    First published: 23/01/2009
    Last updated: 23/01/2009
    EMEA/651597/2008

  • Key facts

    Name
    Theraloc
    Product number
    EMEA/H/C/000931
    International non-proprietary name (INN) or common name
    • nimotuzumab
    Active substance
    • nimotuzumab
    Date of withdrawal
    01/12/2008
    Company making the application
    Oncoscience AG
    Withdrawal type
    Initial authorisation

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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