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Therapeutic Galsulfase enzyme from the original Naglazyme® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
Dermatan sulfate , Perilipin-3 |
Enzyme |
Naglazyme® |
1,0 mg/mL |
– |
0,2 mg |
-80°C |
2023.07 |
565,00 € |
| Drug name | Naglazyme® | |||
| INN | Galsulfase | |||
| API type | 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 | |||
| Pharmacotherapeutic group | Other alimentary tract and metabolism products, enzymes | |||
| ATC code | A16AB08 | |||
| Target of antibody | ||||
| General function | 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) | |||
| Short description | ||||
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Galsulfase is an enzyme replacement therapy. Enzyme replacement therapy provides patients with the enzyme they are lacking. The active substance in Naglazyme, galsulfase, is a copy of the human enzyme N-acetylgalactosamine 4-sulfatase. Naglazyme helps to break down the GAGs and stop them building up in the cells. This can improve the symptoms of MPS VI, including the ability of patients to move about. | |||
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain. Patients can also have reactions to the infusion (such as fever, chills, rash and hives). Naglazyme should not be used in people who may be hypersensitive (allergic) to galsulfase or any of the other ingredients. | |||
| Original license holder | ||||
| Marketing authorisation numbers | EU/1/05/324/001 | |||
| Marketing authorisation holder | BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298 Ireland | |||
| Name of the manufacturer of the biological active substance | BioMarin Pharmaceutical Inc. 46 Galli Drive, Novato, CA 94949 United States of America | |||
| Name and address of the manufacturer(s) responsible for batch release | BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Ireland | |||
| Max shelf life | 3 years | |||
| Storage conditions | 2°C - 8°C | |||
| List of excipients | Sodium chloride - Sodium phosphate monobasic, monohydrate - Sodium phosphate dibasic, heptahydrate - Polysorbate 80 - Water for injections |
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