STN:  BLS 125350
Proper Name: Immune Globulin Subcutaneous (Human), 20% Liquid
Tradename: HIZENTRA
Manufacturer: CSL Behring AG
Indication:

Indicated for the treatment of:

• Primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
• Maintenance therapy in adults with indicated for the treatment of: chronic inflammatory demyelinating polyneuropathy (CIDP).

Product Information

• Package Insert - HIZENTRA

Supporting Documents

• April 21, 2022 Approval Letter - HIZENTRA
• 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