NDC Code | 49591-051-51 |
Package Description | 1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05) |
Product NDC | 49591-051 |
Product Type Name | PLASMA DERIVATIVE |
Proprietary Name | Hepagam B |
Non-Proprietary Name | Human Hepatitis B Virus Immune Globulin |
Dosage Form | INJECTION, SOLUTION |
Usage | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20231201 |
Marketing Category Name | BLA |
Application Number | BLA125035 |
Manufacturer | Kamada Ltd. |
Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
Strength | 312 |
Strength Unit | [iU]/mL |
Pharmacy Classes | Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT] |