CUVITRU
STN: BL 125596
Proper Name: Immune Globulin Subcutaneous (Human), 20% Solution
Tradename: CUVITRU
Manufacturer: Baxalta US, Inc.
Indication:
- Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
Product Information
Supporting Documents
- September 23, 2021 Approval Letter - CUVITRU
- Clinical Review - CUVITRU
- Statistical Review - CUVITRU
- Supporting Documents older than three years - CUVITRU
- Approval History, Letters, Reviews, and Related Documents - CUVITRU