Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
Naglazyme 1 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. A clear to slightly opalescent, and colourless to pale yellow solution. |
Each ml of solution contains 1 mg galsulfase. One vial of 5 ml contains 5 mg galsulfase.
Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Excipients: Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Galsulfase |
Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase 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). |
| List of Excipients |
|---|
|
Sodium chloride |
Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
Pack sizes: 1 and 6 vials.
Not all package sizes may be marketed.
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
EU/1/05/324/001
EU/1/05/324/002
Date of first authorisation: 24 January 2006
Date of latest renewal: 26 January 2011
| Drug | Countries | |
|---|---|---|
| NAGLAZYME | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, United Kingdom, United States |
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