IXinity:

Withdrawal of the marketing authorisation application

trenonacog alfa / trenonacog alfa

Overview

On 13 June 2013, Cangene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prevention of bleeding in patients with haemophilia B.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for IXinity (PDF/73.5 KB)

    Adopted

    First published: 28/06/2013
    Last updated: 28/06/2013
    EMA/379048/2013

  • Key facts

    Name
    IXinity
    Product number
    EMEA/H/C/002349
    International non-proprietary name (INN) or common name
    • trenonacog alfa / trenonacog alfa
    Active substance
    • Trenonacog alfa
    • Trenonacog alfa
    Date of withdrawal
    13/06/2013
    Company making the application
    Cangene Europe Limited
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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