Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - TachoSil
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Memorandum/Reviews
Filing of Final Pre-Clinical Review of STN 125351/0 – Nycomeed’s Original BLA for Fibrin Sealant Patch [TachoSil] - TachoSil (PDF - 109KB)Final CMC Review of Nycomed’s BLA 125351/0 for Fibrin Sealant Patch (TachoSil) - TachoSil (PDF - 211KB)Mid-Cycle Statistical Review and Evaluation - BLA - TachoSil (PDF - 461KB)TachoSil Pharmacovigilance Final Review Memo - TachoSil (PDF - 160KB)Filing Memo for STN 125351/0 for Fibrin Sealant TachoSil, Nycomed Danmark ApS, dated 22 May 2009 - TachoSil, May 22, 2009 (PDF - 40KB)Bioresearch Monitoring Filing Memo- TachoSil, July 6, 2009 Preliminary review of Nycomed’s BLA for Fibrin Sealant Patch (TachoSil) - TachoSil, July 29, 2009 Mid-Cycle Meeting Summary for BLA 125351/0; DATS466198 - TachoSil, November 20, 2009 Fax is Regarding STN 125351\0 - TachoSil, November 25, 2009 (PDF - 39KB)Statistical Review and Evaluation for Sponsor’s Response- BLA - TachoSil, December 15, 2009 Re-evaluation of Proposed Proprietary Name TachoSil - TachoSil, February 19, 2010 STN 125351.00 TachoSil Hemostatic Pad Final Clinical Review Memo - TachoSil - March 3, 2010 (PDF - 1.7MB)Bioresearch Monitoring Inspection Results Memorandum - TachoSil, March 17, 2010 Labeling Review: TachoSil Full Prescribing Information BLA STN: 125351/0/008 - TachoSil, March 25, 2010 DMPQ Review of Manufacturing and Facility Data in BLA - TachoSil, April 5, 2010 (PDF - 123KB)
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Administrative
Intercenter Request for Consultative or Collaborative Review Form - TachoSil (PDF - 41KB)Response to Information Request - Tachosil (PDF - 88KB)Record of Telephone Conversation - TachoSil, September 2, 2009 Record of Telephone Conversation - TachoSil, February 23, 2010 Record of Telephone Conversation - TachoSil, March 11, 2010 BLA Questions on Equipment - TachoSil, March 12, 2010 Record of Telephone Conversation - TachoSil, January 22, 2010
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Correspondence
Letter Regarding Biologics License Application (BLA) for Fibrin Sealant Patch - TachoSil, June 3, 2009 Proprietary Name Acceptance Letter - TachoSil, June 26, 2009 Fax Regarding STN 125351\0 - TachoSil, October 22, 2009 (PDF - 36KB)Fax Regarding STN 125351\0 - TachoSil - February 25, 2010 (PDF - 42KB)Fax Regarding STN 125351/0 - TachoSil, March 4, 2010 (PDF - 41KB)
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