🇪🇺 Naglazyme® in European Union

EMA authorised Naglazyme® on 23 January 2006

Marketing authorisation

EMA — authorised 23 January 2006

  • Application: EMEA/H/C/000640
  • Marketing authorisation holder: BioMarin International Limited
  • Local brand name: Naglazyme
  • 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 i
  • Status: approved

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Naglazyme® in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Rare genetic disease / Lysosomal storage disorder approved in European Union

Frequently asked questions

Is Naglazyme® approved in European Union?

Yes. EMA authorised it on 23 January 2006.

Who is the marketing authorisation holder for Naglazyme® in European Union?

BioMarin International Limited holds the EU marketing authorisation.