STN #: BLA 125668
Proper Name: Immune Globulin Subcutaneous (Human) -hipp, 16.5%
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
- Treatment of primary humoral immunodeficiency (PI) in adults
- Package Insert and Patient Information - CUTAQUIG
- Demographic Subgroup Information – Immune Globulin Subcutaneous (Human)
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- May 14, 2020 Approval Letter - CUTAQUIG
- December 12, 2018 Approval Letter - CUTAQUIG
- December 12, 2018 Summary Basis for Regulatory Action - CUTAQUIG
- Approval History, Letters, Reviews, and Related Documents - CUTAQUIG