Tekinex: Withdrawal of the marketing authorisation application

Overview

On 11 January 2011, ChemGenex Europe SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tekinex intended to be used to treat patients with Philadelphia chromosome-positive chronic myeloid leukaemia who have the 'Bcr-Abl T315I kinase domain' mutation and whose previous treatment with imatinib had failed.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Tekinex (PDF/56.35 KB)


    First published: 31/01/2011
    Last updated: 31/01/2011
    EMA/13310/2011

  • Key facts

    Name
    Tekinex
    Product number
    EMEA/H/C/001244
    Active substance
    • omacetaxine mepesuccinate
    Date of withdrawal
    11/01/2011
    Company making the application
    ChemGenex Europe SAS
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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