Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Shire Human Genetic Therapies AB, Vasagatan 7, 111 20, Stockholm, Sweden
Elaprase 2 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). A clear to slightly opalescent, colourless solution. |
Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase*.
Excipient with known effect: Each vial contains 0.482 mmol of sodium.
For the full list of excipients, see section 6.1.
* idursulfase is produced by recombinant DNA technology in a continuous human cell line.
| Active Ingredient | Description | |
|---|---|---|
| Idursulfase |
Idursulfase (idursulfase) is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme. Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). |
| List of Excipients |
|---|
|
Polysorbate 20 |
5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.
Pack sizes of 1, 4 and 10 vials. Not all pack sizes may be marketed.
Shire Human Genetic Therapies AB, Vasagatan 7, 111 20, Stockholm, Sweden
EU/1/06/365/001-003
Date of first authorisation: 08 January 2007
Date of latest renewal: 09 September 2016
| Drug | Countries | |
|---|---|---|
| ELAPRASE | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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