Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 09 August 2018

Indication(s)

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).

A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study. Limited data are available in patients < 1 year of age.

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More information

Category Value
Agency product number EMEA/H/C/000640
Orphan designation No
Date First Approved 24-01-2006
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder BioMarin International Limited
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions