Qinprezo: Withdrawal of the marketing authorisation application

vosaroxin

Overview

On 10 May 2017, Sunesis 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 the cancer medicine Qinprezo, intended to be used in combination with cytarabine for the treatment of acute myeloid leukaemia (AML).

  • List item

    Questions and answers on the withdrawal of the application for the marketing authorisation for Qinprezo (vosaroxin) (PDF/74.41 KB)


    First published: 19/05/2017
    Last updated: 19/05/2017
    EMA/249992/2017

  • Key facts

    Name
    Qinprezo
    Product number
    EMEA/H/C/004118
    International non-proprietary name (INN) or common name
    • vosaroxin
    Active substance
    • vosaroxin
    Date of withdrawal
    10/05/2017
    Company making the application
    Sunesis Europe Ltd
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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