BIVIGAM

STN: 125389
Proper Name: Immune Globulin Intravenous (Human) 10% Liquid
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).

Product Information

• Package Insert - BIVIGAM

Supporting Documents

• September 29, 2026 Approval Letter - BIVIGAM
• March 1, 2024 Approval Letter - BIVIGAM
• 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

Related Information

• Expiration Date Extension for 120 BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] Lots manufactured in 2020 - 2022