Ilaris: Withdrawal of the application to change the marketing authorisation
canakinumab
Table of contents
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.
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 |
|
Active substance |
|
Date of withdrawal |
26/10/2022 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Ilaris (PDF/1.92 MB)
Adopted
First published: 23/02/2023
EMA/881775/2022 -
List item
Withdrawal letter: Ilaris (PDF/9.34 KB)
First published: 11/11/2022 -
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 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 202211/11/2022
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16/12/2016
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24/06/2016
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26/07/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 201318/01/2013
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14/12/2012