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