| NDC Code | 49591-350-51 |
|---|
| Package Description | 1 VIAL, GLASS in 1 CARTON (49591-350-51) / 2.2 mL in 1 VIAL, GLASS (49591-350-02) |
|---|
| Product NDC | 49591-350 |
|---|
| Product Type Name | PLASMA DERIVATIVE |
|---|
| Proprietary Name | Winrho Sdf |
|---|
| Non-Proprietary Name | Human Rho(d) Immune Globulin |
|---|
| Dosage Form | INJECTION, SOLUTION |
|---|
| Usage | INTRAMUSCULAR; INTRAVENOUS |
|---|
| Start Marketing Date | 20230801 |
|---|
| End Marketing Date | 20260531 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA103649 |
|---|
| Manufacturer | Kamada Ltd. |
|---|
| Substance Name | HUMAN RHO(D) IMMUNE GLOBULIN |
|---|
| Strength | 2500 |
|---|
| Strength Unit | [iU]/2.2mL |
|---|
| Pharmacy Classes | Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE] |
|---|