Ilaris

RSS

canakinumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Ilaris
Agency product number
EMEA/H/C/001109
Active substance
Canakinumab
International non-proprietary name (INN) or common name
canakinumab
Therapeutic area (MeSH)
  • Cryopyrin-Associated Periodic Syndromes
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Gouty
Anatomical therapeutic chemical (ATC) code
L04AC08
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
22/10/2009
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

30/07/2018 Ilaris - EMEA/H/C/001109 - T/0058

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 (see section 5.1).

Assessment history

Changes since initial authorisation of medicine

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