BIVIGAM
STN: 125389
Proper Name: Immune Globulin Intravenous (Human), 10%
Tradename: BIVIGAM
Manufacturer: ADMA Biologics, Inc.
Indication:
- For the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Product Information
Supporting Documents
- December 8, 2023 Approval Letter - BIVIGAM
- Statistical Review - BIVIGAM
- Clinical Review Memo - BIVIGAM
- September 11, 2023 Approval Letter - BIVIGAM
- December 7, 2022 Approval Letter - BIVIGAM
- Approval History, Letters, Reviews, and Related Documents - Bivigam
- Supporting Documents older than three years - Bivigam