Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
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. |
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 |
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.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/03/253/001-003
Date of first authorisation: 10 June 2003
Date of latest renewal: 10 June 2008
| Drug | Countries | |
|---|---|---|
| ALDURAZYME | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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