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Therapeutic Velaglucerase alfa enzyme from the original Vpriv® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
Glucosylceramidase |
Enzyme |
Vpriv® |
100 IU/mL |
– |
10 IU |
-80°C |
03/2023 |
433,80 € |
| Drug name | Vpriv® | |||
| INN | Velaglucerase alfa | |||
| API type | Velaglucerase alfa is produced in an HT-1080 human fibroblast cell line by recombinant DNA technology. | |||
| Pharmacotherapeutic group | Other alimentary tract and metabolism products, enzymes | |||
| ATC code | A16AB10 | |||
| Target of antibody | ||||
| General function | Velaglucerase alfa is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. | |||
| Short description | ||||
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyses the hydrolysis of glucocerebroside to glucose and ceramide in the lysosome, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease. Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease. | |||
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells". In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs. The accumulation of glucocerebroside in the liver and spleen leads to organomegaly. Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises. Deposits in the bone marrow and splenic sequestration lead to clinically significant anaemia and thrombocytopenia. | |||
| Original license holder | ||||
| Marketing authorisation numbers | EU/1/10/646/002 | |||
| Marketing authorisation holder | Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | |||
| Name of the manufacturer of the biological active substance | Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 USA; Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 USA | |||
| Name and address of the manufacturer(s) responsible for batch release | Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 Ireland | |||
| Max shelf life | 3 years | |||
| Storage conditions | 2°C-8°C | |||
| List of excipients | Sucrose - Sodium citrate dihydrate (E331) - Citric acid monohydrate (E330) - Polysorbate 20 |
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