Ilaris: Withdrawal of the application to change the marketing authorisation

canakinumab

Overview

Novartis withdrew its application for the use of Ilaris in the treatment of Schnitzler syndrome.

The company withdrew the application on 26 October 2022.

  • List item

    Questions and answers on the withdrawal of application to change the marketing authorisation for Ilaris (canakinumab) (II-0075) (PDF/145.56 KB)


    First published: 11/11/2022
    Last updated: 23/02/2023
    EMEA/H/C/001109/II/75

  • Key facts

    Name
    Ilaris
    Product number
    EMEA/H/C/001109
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    23/10/2009
    International non-proprietary name (INN) or common name
    • canakinumab
    Active substance
    • Canakinumab
    Date of withdrawal
    26/10/2022
    Company making the application
    Novartis Europharm Limited
    Withdrawal type
    Post-authorisation

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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