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

• Package Insert - XEMBIFY

Supporting Documents

• 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