Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Hizentra
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Memorandum/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Statistical Review and Evaluation - Hizentra, October 5, 2011 (PDF - 161KB)Clinical Review - Hizentra, September 26, 2011 (PDF - 124KB)Clinical Review - Hizentra, January 20, 2011 (PDF - 228KB)BLA review memo for IgPro20, CSL Bern, Switzerland - Hizentra, February 28th, 2010 (PDF - 206KB)Reconciliation of Data on Infusions with Temporally Associated Adverse Events - Hizentra, February 26, 2010 Final CMC Review: Viral Validation - Hizentra, February 24, 2010 (PDF - 163KB)Re-evaluation of proposed proprietary name Hizentra BLA STN: 125350 - Hizentra, February 22, 2010 Review Memorandum - Hizentra, January 15, 2010 (PDF - 77KB)Midcycle Review - Hizentra, October 19, 2009 (PDF - 92KB)Mid-cycle Review (Viral Validation) - Hizentra, October 16, 2009 (PDF - 58KB)Mid-Cycle Meeting Minutes Memorandum - Hizentra, September 30, 2009 Midcycle review: Status of Bioresearch Monitoring Inspections - Hizentra, September 28, 2009 Memorandum of Concurrence on Proprietary Name BLA STN125350/0, CSL-Behring’s HizentraTM (Immune Globulin Subcutaneous (Human)) - Hizentra, June 15, 2009 First Committee Meeting Minutes - Hizentra, May 18, 2009 Review of proposed proprietary name Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid BLA 125350 - Hizentra, June 9. 2009 (PDF - 153KB)Review of proposed proprietary name Hizentra - Hizentra, June 9, 2009 (PDF - 158KB)Filing of Original BLA: IgPro20, IGSC 20% Solution (CSL-Behring) - Hizentra, June 10, 2009 (PDF - 39KB)Clinical Pharmacology Review - Hizentra, April 30, 2009 (PDF - 286KB)A Phase III, Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects with Primary Immunodeficiency (PID) - Hizentra, April 30, 2009 (PDF - 307KB)Final Review - Hizentra (PDF - 87KB)Final Review - Hizentra (PDF - 110KB)Final Review of STN 125350/0, Original BLA for Immune Globulin Subcutaneous (Human) - Hizentra (PDF - 104KB)Final Memo, Nonclinical Pharmacology/Toxicology - Hizentra (PDF - 182KB)Final Memo, Nonclinical Pharmacology/Toxicology - Hizentra (PDF - 167KB)Midcycle CMC Review: Original BLA - Hizentra (PDF - 172KB)Midcycle Review of STN 125350/0, Original BLA for Immune Globulin Subcutaneous (Human), 20% Liquid (IgPro20): Raw materials and stability - Hizentra (PDF - 90KB)Memo, Nonclinical Pharmacology/Toxicology (PDF - 122KB)Final CMC Review: Original BLA (PDF - 338KB)DMPQ Filing Memo - Hizentra
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Administrative
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Record of Telephone Conversation - Hizentra, February 16, 2010 (PDF - 42KB)Record of Telephone Conversation - Hizentra, January 20, 2010 Record of Telephone Conversation - Hizentra, January 20, 2010 (PDF - 50KB)Memorandum of Teleconference, August 20, 2009 - Hizentra Record of Telephone Conversation - Hizentra, June 30, 2009
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Correspondence
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
CSL Behring AG Letter - Hizentra, February 3, 2010 (PDF - 18KB)CSL Behring AG Letter - Hizentra, January 19, 2010 CSL Behring AG - Hizentra, December 23, 2009 (PDF - 28KB)Letter to CSL Behring AG - Hizentra, December 17, 2009 CSL Behring AG Letter - Hizentra, November 5, 2009 (PDF - 35KB)Information Request - Hizentra, November 3, 2009 STN 125350/0 Information Request - Hizentra, October 23, 2009 STN 125350/0 Information Request - Hizentra, August 19, 2009 STN 125350/0 Information Request - Hizentra, August 14, 2009 (PDF - 86KB)RE: STN 125350/0 Information Request Letter - Hizentra, August 14, 2009 STN 125350/0 Information Request - Hizentra, August 12, 2009 Filing Notification Letter - Hizentra, June 30, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 11, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra , June 11, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009 CSL Behring AG Letter - Hizentra, May 21, 2009 CSL Behring AG Letter - Hizentra, January 15, 2009
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