Is Canakinumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Canakinumab, including ILARIS (150 mg/ml, Solution for injection, SAR 43890.42).

Is Canakinumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Canakinumab, including ILARIS (Prescription).

Is Canakinumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Canakinumab: Ilaris.

Are there safety signals or safety updates for Canakinumab?

EMA PRAC: 6 entries; US FDA: 1 entry (latest 2024-11-01).

Active substance

Canakinumab

SFDA 1
US FDA 1
EMA 2
Health Canada 1
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ILARIS	150 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 43890.42	Biological · Prescription	Novartis Europharm Limited	Valid

Indications — CHI Daman Drug Formulary

GOUT; SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ILARIS	180MG	injectable · subcutaneous	NOVARTIS PHARMS	Prescription	17 Jun 2009

EMA European Union — centrally authorised medicines

Ilaris Novartis Europharm Limited · Authorised · authorised 23 Oct 2009 · ATC L04AC08

Therapeutic indication (EMA)

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.

Canakinumab Novartis Novartis Europharm Limited · Application withdrawn · ATC L04AC08

Therapeutic indication (EMA)

Prevention of major cardiovascular events

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ILARIS	02460351	150 MG / ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 1 Nov 2024 ILARIS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 2 Dec 2021 PRAC signal: Interstitial lung disease (ILD) and alveolar proteinosis
Action for MAH: update of the product information: No
EMA PRAC 11 Mar 2021 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes
EMA PRAC 29 Oct 2020 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 9 Jul 2020 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2016 PRAC signal: Weight increased
Action for MAH: update of the product information: No
EMA PRAC 13 May 2016 PRAC signal: Weight increased
Action for MAH: update of the product information: No

All safety entries for canakinumab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.