NDC Code | 25682-007-01 |
Package Description | 1 VIAL, GLASS in 1 CARTON (25682-007-01) / 10 mL in 1 VIAL, GLASS |
Product NDC | 25682-007 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Kanuma |
Non-Proprietary Name | Sebelipase Alfa |
Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
Usage | INTRAVENOUS |
Start Marketing Date | 20151208 |
Marketing Category Name | BLA |
Application Number | BLA125561 |
Manufacturer | Alexion Pharmaceuticals, Inc. |
Substance Name | SEBELIPASE ALFA |
Strength | 2 |
Strength Unit | mg/mL |
Pharmacy Classes | Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS] |