NAGLAZYME Concentrate for solution for infusion Ref.[9218] Active ingredients: Galsulfase

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Sodium phosphate monobasic, monohydrate
Sodium phosphate dibasic, heptahydrate
Polysorbate 80
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

Marketing authorization dates and numbers

EU/1/05/324/001

EU/1/05/324/002

Date of first authorisation: 24 January 2006

Date of latest renewal: 26 January 2011

Drugs

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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