XEMBIFY
BL: 125683
Proper Name: XEMBIFY
Tradename: Immune Globulin Subcutaneous, Human - klhw, 20%
Manufacturer: Grifols Therapeutics LLC
Indication:
- For subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older.
Product Information
Supporting Documents
- July 18, 2024 Clinical and Clinical Pharmacology Review - XEMBIFY
- PHARMACOVIGILANCE SUPPLEMENTAL MEMO - XEMBIFY
- Statistical Review - XEMBIFY
- July 18, 2024 Approval Letter - XEMBIFY
- July 3, 2019 Approval Letter - XEMBIFY
- July 3, 2019 Summary Basis for Regulatory Action - XEMBIFY
- Clinical Review - XEMBIFY
- Statistical Review - XEMBIFY
- Approval History, Letters, Reviews, and Related Documents - XEMBIFY