STN:  BL 125350
Proper Name: Immune Globulin Subcutaneous (Human), 20% Liquid
Tradename: Hizentra
Manufacturer: CSL Behring AG, License #1766
Indication:

• Indicated for (1) Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older; (2)  Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

Product Information

• Package Insert - Hizentra

Supporting Documents

• April 23, 2021 Approval Letter - Hizentra
• March 15, 2018 Approval Letter - Hizentra
• March 14, 2018 Summary Basis for Regulatory Action - Hizentra
• Approval History, Letters, Reviews, and Related Documents - Hizentra
• Supporting Documents older than three years - Hizentra