ALDURAZYME Concentrate for solution for infusion Ref.[9232] Active ingredients: Laronidase

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Product name and form

Aldurazyme 100 U/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

1 ml contains 100 U (approximately 0.58 mg) of laronidase.

Each vial of 5 ml contains 500 U of laronidase.

The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute.

Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.

Excipient(s) with known effect: Each vial of 5 ml contains 1.29 mmol sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Laronidase

Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology. Laronidase is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the non-neurological manifestations of the disease.

List of Excipients

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

Pack sizes and marketing

5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).

Pack sizes: 1, 10 and 25 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/03/253/001-003

Date of first authorisation: 10 June 2003

Date of latest renewal: 10 June 2008

Drugs

Drug Countries
ALDURAZYME Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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