YIMMUGO
STN: 125810
Proper Name: immune globulin intravenous, human-dira
Tradename: YIMMUGO
Manufacturer: Biotest AG
Indication:
- For the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older.
Product Information
- Package Insert - YIMMUGO
- Demographic Subgroup Information - YIMMUGO
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
- June 13, 2024 Approval Letter - YIMMUGO
- June 13, 2024 Summary Basis for Regulatory Action - YIMMUGO
- Approval History, Letters, Reviews, and Related Documents - YIMMUGO