ALYGLO
STN: 125743
Proper Name: immune globulin intravenous human-stwk
Tradename: ALYGLO
Manufacturer: GC Biopharma Corp.
Indication:
- Indicated for the treatment of primary humoral immunodeficiency (PI) in adults.
Production Information
- Package Insert - ALYGLO
- Demographic Subgroup Information- immune globulin intravenous, human-stwk, ALYGLO
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- December 15, 2023 Approval Letter - ALYGLO
- December 15, 2023 Summary Basis for Regulatory Action - ALYGLO
- Approval History, Letters, Reviews, and Related Documents - ALYGLO