Febseltiq: Withdrawal of the marketing authorisation application

infigratinib

Overview

Helsinn Birex Pharmaceuticals Ltd withdrew its application for a marketing authorisation of Febseltiq for the treatment of cholangiocarcinoma (cancer of the bile ducts).

The company withdrew the application on 11 October 2022.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Febseltiq (infigratinib) (PDF/89.7 KB)


    First published: 11/11/2022
    Last updated: 30/01/2023
    EMA/870501/2022

  • Key facts

    Name
    Febseltiq
    Product number
    EMEA/H/C/005361
    International non-proprietary name (INN) or common name
    • infigratinib
    Active substance
    • Infigratinib monophosphate
    Date of withdrawal
    11/10/2022
    Company making the application
    Helsinn Birex Pharmaceuticals 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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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