PANZYGA

STN: 125587
Proper Name: Immune Globulin Intravenous, human-ifas
Tradename: PANZYGA
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H.
Indication:

• Indicated for 1.) Primary humoral immunodeficiency (PI) in patients 2 years of age and older  2.) Chronic immune thrombocytopenic purpura (ITP) in adults.

Product Information

• Package Insert - PANZYGA

Supporting Documents

• August 2, 2018 Approval Letter - PANZYGA
• August 1, 2018 Summary Basis for Regulatory Action - PANZYGA
• Clinical Review - PANZYGA
• Statistical Review - PANZYGA
• Approval History, Letters, Reviews, and Related Documents - PANZYGA