Proper Name: Immune Globulin Intravenous (Human)-ifas
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.HIndication
- for the treatment of adults 18 years of age and older with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.
- Primary humoral immunodeficiency (PI) in patients 2 years of age and older.
- Chronic immune thrombocytopenia (ITP) in adults.
- Statistical Review (125587/70) - PANZYGA
- Pharm/Tox Review - PANZYGA
- Clinical Review (125587/70) - PANZYGA
- February 11, 2021 Approval Letter - PANZYGA
- 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