QIVIGY

STN:125822
Proper Name: Immune Globulin Intravenous, Human -kthm, 10% Solution
Trade Name: QIVIGY
Manufacturer: Kedrion S.p.A.

Indication

• Treatment of adults with Primary Humoral Immunodeficiency (PI)

Product Information

• Package Insert - QIVIGY
• Demographic Subgroup Information – Immune Globulin Intravenous Human -kthm 10% Solution [QIVIGY]
  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

• September 26, 2025 Approval Letter - QIVIGY
• September 26, 2025 Summary Basis for Regulatory Action - QIVIGY
• Letters, Reviews, Related Documents - QIVIGY