Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Wilate
Proper Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Tradename: Wilate
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H., License #1646
STN: 125251/0
Approval Date: December 4, 2009
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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.
Clinical Pharmacology Review - Wilate, June 4, 2009 (PDF - 710KB)Final Review of CMC Information - Wilate, December 1, 2009 (PDF - 236KB)Statistical Review and Evaluation - Wilate (PDF - 264KB)Lot Release / Conformance Testing Review Memo - Wilate (PDF - 71KB)Review Memo - Wilate, (PDF - 227KB)Final review of Adventitious Agent Safety Evaluation - Wilate, November 27, 2009 Categorical Exclusion Memo - Wilate, November 19, 2009 Meeting Summary - Willate, November 18, 2009 Proprietary Name Review Letter - Wilate, November 9, 2009 Re-evaluation of Proposed Proprietary Name - Wilate, November 9, 2009 Pediatric Page Memo - Wilate, November 6,2009 (PDF - 161KB)Meeting Summary Status - Wilate, November 3, 2009 Mid-Cycle Review Memorandum - Wilate, August 31, 2009 (PDF - 51KB)Mid Cycle Meeting Summary - Wilate, August 31, 2009 Recommendation to Waive Pre-Approval Inspection - Wilate, August 7, 2009 Response to CR letter - Wilate, August 6, 2009 Resubmission Letter - Wilate, June 24, 2009 Clinical Review Memorandum - Wilate, January 8, 2008 (PDF - 285KB)Statistical Review and Evaluation - Wilate, December 20, 2007 (PDF - 208KB)Bioresearch Monitoring BLA Summary Report - Wilate, December 13, 2007 Final Review of CMC Information - Wilate, December 11, 2007 (PDF - 215KB)Residual Moisture Test - Wilate, December 10, 2007 Recommendation to Waive Pre-Approval Inspection - Wilate, November 28, 2007 Wilate Analytical Method Memo - Wilate, October 29, 2007 Pharmacology / Toxicology Review Memorandum - Wilate, September 11, 2007 Review of Stability Information - Wilate, August 30, 2007 (PDF - 133KB)Submission dated 7/23/07 - Wilate, July 30, 2007 Mid-Cycle Review Memo - Wilate, May 11, 2007 (PDF - 191KB)Mid-cycle review of Adventitious Agent Safety Evaluation-Wilate, May 10, 2007 Filing Memo - Wilate, January 22, 2007 (PDF - 33KB)Mid-Cycle Statistical Review and Evaluation - Wilate (PDF - 202KB)Clinical Pharmacology Review - Wilate (PDF - 711KB)Memo: Review of Proprietary Name: Wilate, July 10, 2007 (PDF - 109KB)Memorandum - Wilate, January 31, 2007 (PDF - 49KB)Memorandum on Clinical Section - Wilate, January 25, 2007 (PDF - 312KB)Mid-Cycle Review Clinical Memorandum - Wilate (PDF - 126KB)Memorandum - Wilate (PDF - 58KB)Final Review Memorandum OBE/DE Review for Pharmacovigilance Planning - (PDF - 343KB)Initial Review Memorandum - Wilate, February 7, 2007 (PDF - 81KB)Review of Original BLA Submission - Wilate, December 6, 2007 (PDF - 5.8MB)Laboratory Quality Product Testing Policy (TP) - Wilate (PDF - 159KB)
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Administrative Documents
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
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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.
Record of Telephone Conversation - Wilate, December 3, 2009 Compliance Check Email - Wilate, November 20, 2009 (PDF - 24KB)Compliance Check Email - Wilate, November 17, 2009 Telephone Call from CBER RE Wilate, November 5, 2009 Record of Telephone Conversation - Wilate, November 3, 2009 Record of Telephone Conversation - Wilate, August 11, 2009 CRMTS 6909 Cover Letter - Wilate, December 23, 2008 Major Amendment - Wilate, August 2, 2007 Proprietary Name Accepted - Wilate, July 24, 2007
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