Is Anakinra 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 Anakinra, including Kineret (150 mg/ml, Solution for injection, SAR 996.30).

Is Anakinra approved by the US FDA?

Drugs@FDA lists 1 application product line for Anakinra, including KINERET (Prescription).

Is Anakinra authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Anakinra: Kineret.

Are there safety signals or safety updates for Anakinra?

EMA PRAC: 9 entries; US FDA: 1 entry (latest 2026-09-03).

Active substance

Anakinra

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Kineret	150 mg/ml	Solution for injection · Subcutaneous use	7 Pre-filled syringe	SAR 996.30	Biological · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid

Indications — CHI Daman Drug Formulary

CASTLEMAN DISEASE; JUVENILE IDIOPATHIC ARTHRITIS (JIA)

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

Product	Strength	Form · route	Applicant	Status	First approved
KINERET	10MIU/VIAL; 18MIU/VIAL; 25MIU/VIAL	vial · subcutaneous	BIOVITRUM AB	Prescription	14 Nov 2001

EMA European Union — centrally authorised medicines

Kineret Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 8 Mar 2002 · ATC L04AC03

Therapeutic indication (EMA)

Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KINERET	02245913	150 MG / ML	SOLUTION · SUBCUTANEOUS	SWEDISH ORPHAN BIOVITRUM AB (PUBL)

Safety signals and safety-related labeling changes

EMA PRAC 3 Sep 2026 PRAC signal: Fulminant hepatitis
Action for MAH: update of the product information: No
US FDA 27 Oct 2025 KINERET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Apr 2024 PRAC signal: Amyloidosis
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
EMA PRAC 8 Oct 2015 PRAC signal: Thrombocytopenia
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jun 2015 PRAC signal: Thrombocytopenia
Action for MAH: update of the product information: No

All safety entries for anakinra →

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.