Is Laronidase 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 Laronidase, including ALDURAZYME 100 U/ML VIAL (100 U, Concentrate for solution for infusion, SAR 2972.65).

Is Laronidase approved by the US FDA?

Drugs@FDA lists 1 application product line for Laronidase, including ALDURAZYME (Prescription).

Is Laronidase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Laronidase: Aldurazyme.

Are there safety signals or safety updates for Laronidase?

US FDA: 1 entry (latest 2023-12-14).

Active substance

Laronidase

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
ALDURAZYME 100 U/ML VIAL	100 U	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2972.65	Biological · Prescription	Sanofi B.V	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ALDURAZYME	2.9MG/ML	vial	BIOMARIN	Prescription	30 Apr 2003

EMA European Union — centrally authorised medicines

Aldurazyme Sanofi B.V. · Authorised · authorised 9 Jun 2003 · ATC A16AB05

Therapeutic indication (EMA)

Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALDURAZYME	02254506	0.58 MG / ML	SOLUTION · INTRAVENOUS	SANOFI-AVENTIS CANADA INC

Safety signals and safety-related labeling changes

US FDA 14 Dec 2023 ALDURAZYME — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for laronidase →

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.