Is Sarilumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Sarilumab, including KEVZARA 150MG SOL. FOR INJ. IN PRE - FILLED PEN (150 mg, Solution for injection, SAR 3183.55); KEVZARA 150MG SOL. FOR INJ. IN PRE-FILLED SYRINGE (150 mg, Solution for injection, SAR 3183.55); KEVZARA 200MG SOL. FOR INJ. IN PRE - FILLED PEN (200 mg, Solution for injection, SAR 3577.75); KEVZARA 200MG SOL. FOR INJ. IN PRE-FILLED SYRINGE (200 mg, Solution for injection, SAR 3577.75).

Is Sarilumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Sarilumab, including KEVZARA (Prescription).

Is Sarilumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sarilumab: Kevzara.

Are there safety signals or safety updates for Sarilumab?

US FDA: 1 entry (latest 2024-06-10).

Active substance

Sarilumab

SFDA 4
US FDA 1
EMA 1
Health Canada 3
US price lines 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
KEVZARA 150MG SOL. FOR INJ. IN PRE - FILLED PEN	150 mg	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 3183.55	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid
KEVZARA 150MG SOL. FOR INJ. IN PRE-FILLED SYRINGE	150 mg	Solution for injection · Subcutaneous use	2 Pre-filled syringe	SAR 3183.55	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid
KEVZARA 200MG SOL. FOR INJ. IN PRE - FILLED PEN	200 mg	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 3577.75	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid
KEVZARA 200MG SOL. FOR INJ. IN PRE-FILLED SYRINGE	200 mg	Solution for injection · Subcutaneous use	2 Pre-filled syringe	SAR 3577.75	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid

Indications — CHI Daman Drug Formulary

RHEUMATOID ARITHRITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
KEVZARA	150MG/1.14ML; 200MG/1.14ML	injectable · injection	SANOFI SYNTHELABO	Prescription	22 May 2017

EMA European Union — centrally authorised medicines

Kevzara Sanofi Winthrop Industrie · Authorised · authorised 23 Jun 2017 · ATC L04AC14

Therapeutic indication (EMA)

Rheumatoid arthritisKevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Polymyalgia rheumaticaKevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. Polyarticular juvenile idiopathic arthritis Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KEVZARA	02460548	200 MG / 1.14 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
KEVZARA	02472961	150 MG / 1.14 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
KEVZARA	02472988	200 MG / 1.14 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KEVZARA 200 MG/1.14 ML PEN INJ	$2075.29678	per ML	23 Sep 2026
US NADAC	KEVZARA 200 MG/1.14 ML SYRINGE	$2068.06403	per ML	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 10 Jun 2024 KEVZARA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sarilumab →

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.