Is Galsulfase approved by the US FDA?

Drugs@FDA lists 1 application product line for Galsulfase, including NAGLAZYME (Prescription).

Is Galsulfase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Galsulfase: Naglazyme.

Are there safety signals or safety updates for Galsulfase?

US FDA: 1 entry (latest 2024-09-12).

Active substance

Galsulfase

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
NAGLAZYME	5MG/5ML	injectable · injection	BIOMARIN	Prescription	31 May 2005

EMA European Union — centrally authorised medicines

Naglazyme BioMarin International Limited · Authorised · authorised 23 Jan 2006 · ATC A16AB

Therapeutic indication (EMA)

Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. A key issue is to treat young patients aged <5 years suffering from a severe form of the disease, even though patients <5 years were not included in the pivotal phase-3 study.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NAGLAZYME	02412683	1 MG / ML	SOLUTION · INTRAVENOUS	BIOMARIN PHARMACEUTICAL INC.

Safety signals and safety-related labeling changes

US FDA 12 Sep 2024 NAGLAZYME — 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 galsulfase →

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.