Naglazyme

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galsulfase

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Naglazyme. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Naglazyme.

This EPAR was last updated on 11/07/2022

Authorisation details

Product details
Name
Naglazyme
Agency product number
EMEA/H/C/000640
Active substance
galsulfase
International non-proprietary name (INN) or common name
galsulfase
Therapeutic area (MeSH)
Mucopolysaccharidosis VI
Anatomical therapeutic chemical (ATC) code
A16AB
Publication details
Marketing-authorisation holder
BioMarin International Limited
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
23/01/2006
Contact address

Shanbally
Ringaskiddy
County Cork
P43 R298
Ireland

Product information

01/04/2022 Naglazyme - EMEA/H/C/000640 - II/0086

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

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.

Assessment history

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