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Community register of medicinal products for human use


Product information

Invented name: Ilaris   
Auth. number : EU/1/09/564
Active substance : Canakinumab
Orphan market exclusivity for "Treatment of cryopirin-associated periodic syndromes (Familial Cold Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID), also known as Chronic Infantile Neurological Cutaneous" (based on designation EU/3/07/439) started on 27/10/2009
   10 years of market exclusivity
   This orphan market exclusivity has ended on 02/12/2010
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC08 - canakinumab
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/10/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1109 (2009)8376 of 23/10/2009
27/10/2009 Centralised - Authorisation EMEA/H/C/1109 (2009)8375 of 23/10/2009
30/03/2010 Centralised - Variation EMEA/H/C/1109/II/1 (2010)2161 of 26/03/2010
25/05/2010 Centralised - Variation EMEA/H/C/1109/IB/3
Updated with Decision(2010)8968 of 06/12/2010
25/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1109/IB/2
16/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1109/IB/5
16/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1109/IB/4
05/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1109/IB/8
02/12/2010 Centralised - (orphan status)
08/12/2010 Centralised - Variation (2010)8968 of 06/12/2010
13/01/2011 Centralised - Variation EMEA/H/C/1109/IG/32/G
Updated with Decision(2011)2418 of 31/03/2011
04/03/2011 Centralised - Annual reassessment EMEA/H/C/1109/S/7 (2011)1492 of 28/02/2011
09/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1109/II/6
04/04/2011 Centralised - Variation (2011)2418 of 31/03/2011
06/04/2011 Centralised - Variation EMEA/H/C/1109/IB/11
Updated with Decision(2011)6603 of 16/09/2011
20/09/2011 Centralised - Variation EMEA/H/C/1109/X/9 (2011)6603 of 16/09/2011
18/01/2012 Centralised - Annual reassessment EMEA/H/C/1109/S/12 (2012)193 of 13/01/2012
16/01/2013 Centralised - Annual reassessment EMEA/H/C/1109/S/24 (2013)136 of 14/01/2013
29/01/2013 Centralised - 2-Monthly update EMEA/H/C/1109/II/21 (2013)493 of 24/01/2013
20/02/2013 Centralised - Variation EMEA/H/C/1109/II/10 (2013)1018 of 18/02/2013
28/08/2013 Centralised - 2-Monthly update EMEA/H/C/1109/II/26 (2013)5600 of 26/08/2013
03/01/2014 Centralised - Annual reassessment EMEA/H/C/1109/S/29
23/06/2014 Centralised - Renewal EMEA/H/C/1109/R/31 (2014)4277 of 19/06/2014
22/09/2014 PSUSA - Modification EMEA/H/C/1109/PSUV/32 (2014)6788 of 18/09/2014
10/10/2014 Centralised - Variation EMEA/H/C/1109/IAIN/36
Updated with Decision(2015)6682 of 23/09/2015
18/12/2014 Centralised - Annual reassessment EMEA/H/C/1109/S/35
28/10/2015 Centralised - Yearly update (2015)6682 of 23/09/2015
12/11/2015 Centralised - Variation EMEA/H/C/1109/II/40/G
Updated with Decision(2016) 5128 of 01/08/2016
17/12/2015 Centralised - Annual reassessment EMEA/H/C/1109/S/42
03/08/2016 Centralised - 2-Monthly update EMEA/H/C/1109/II/43 (2016) 5128 of 01/08/2016
27/02/2017 Centralised - Variation EMEA/H/C/1109/X/45/G (2017) 1412 of 23/02/2017
22/03/2017 Corrigendum (2017) 2058 of 22/03/2017
24/03/2017 Centralised - Variation EMEA/H/C/1109/S/47 (2017) 2058 of 22/03/2017
16/04/2018 Centralised - Variation EMEA/H/C/1109/IB/57