Is Lumasiran 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 Lumasiran, including Oxlumo (94.5/0.5 mg/ml, Solution for injection, SAR 264372.20).

Is Lumasiran approved by the US FDA?

Drugs@FDA lists 1 application product line for Lumasiran, including OXLUMO (Prescription).

Is Lumasiran authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lumasiran: Oxlumo.

Are there safety signals or safety updates for Lumasiran?

US FDA: 1 entry (latest 2025-04-04).

Active substance

Lumasiran

SFDA 1
US FDA 1
EMA 1
Health Canada 1
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
Oxlumo	94.5/0.5 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 264372.20	NCE · Prescription	Alnylam Netherlands B.V	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	solution · subcutaneous	ALNYLAM PHARMS INC	Prescription	23 Nov 2020

EMA European Union — centrally authorised medicines

Oxlumo Alnylam Netherlands B.V. · Authorised · authorised 19 Nov 2020 · ATC A16AX18

Therapeutic indication (EMA)

Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OXLUMO	02525755	94.5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ALNYLAM NETHERLANDS B.V.

Safety signals and safety-related labeling changes

US FDA 4 Apr 2025 OXLUMO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for lumasiran →

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.