Tibsovo: Withdrawal of the marketing authorisation application

ivosidenib

Overview

Agios Netherlands B.V. withdrew its application for a marketing authorisation of Tibsovo for the treatment of acute myeloid leukaemia (AML), a cancer of white blood cells.

The company withdrew the application on 13 October 2020.

Key facts

Name
Tibsovo
Product number
EMEA/H/C/005056
International non-proprietary name (INN) or common name
  • ivosidenib
Active substance
  • Ivosidenib
Date of withdrawal
13/10/2020
Company making the application
Agios Netherlands B.V.
Withdrawal type
Initial authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

How useful was this page?

Add your rating