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.

  • List item

    Questions and answers on the withdrawal for the marketing authorisation of Tibsovo (ivosidenib) (PDF/133.05 KB) (updated)


    First published: 13/11/2020
    Last updated: 16/04/2021
    EMA/577847/2020

  • 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

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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