Ilaris
canakinumab
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Ilaris. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ilaris.
For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Ilaris : EPAR - Summary for the public (PDF/85.94 KB)
First published: 12/11/2009
Last updated: 17/05/2017 -
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List item
Ilaris : EPAR - Risk-management-plan summary (PDF/1.18 MB)
First published: 20/06/2019
Last updated: 14/09/2022
Authorisation details
Product details | |
---|---|
Name |
Ilaris
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Agency product number |
EMEA/H/C/001109
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Active substance |
Canakinumab
|
International non-proprietary name (INN) or common name |
canakinumab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AC08
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
30
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Date of issue of marketing authorisation valid throughout the European Union |
23/10/2009
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Contact address |
Vista Building |
Product information
25/08/2023 Ilaris - EMEA/H/C/001109 - IAIN/0083/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Interleukin inhibitors
Therapeutic indication
Periodic fever syndromes
Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Cryopyrin-associated periodic syndromes
Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:
- Muckle-Wells syndrome (MWS),
- Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA),
- Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.
Tumour necrosis factor receptor associated periodic syndrome (TRAPS)
Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).
Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD)
Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
Familial Mediterranean fever (FMF)
Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate.
Ilaris is also indicated for the treatment of:
Still’s disease
Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.
Gouty arthritis
Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Assessment history
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