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).

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

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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