Vaccines, Blood & Biologics
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STN: BL 125350
Proper Name: Immune Globulin Subcutaneous (Human), 20% Liquid
Manufacturer: CSL Behring AG, License #1766
- Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
September 12, 2013 Summary Basis for Regulatory Action - Hizentra(PDF - 372KB) Clinical Review - Hizentra(PDF - 429KB) Clinical Pharmacology Review - Hizentra(PDF - 1.7MB) September 25, 2013 Approval Letter - Hizentra September 23, 2013 Approval Letter - Hizentra
Approval Letter for Safety Labeling Changes
October 3, 2011 Approval Letter - Hizentra
To include efficacy and safety data from European Study ZLB06_001CR into the package insert.
February 17, 2011 Approval Letter - Hizentra
To include revised labeling to fulfill the required pediatric assessments.
Summary Basis for Regulatory Action - Hizentra , September 26, 2011(PDF - 55KB) March 4, 2010 Approval Letter - Hizentra Summary Basis for Regulatory Action - Hizentra, March 1, 2010(PDF - 250KB) Approval History, Letters, Reviews, and Related Documents - Hizentra