STN: BL 125251
Proper Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H., License #1646
- Indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes and perioperative management of bleeding.
August 21, 2015 Approval Letter with errata - Wilate
This letter supersedes the August 5, 2015 letter to include the Pediatric requirements language.
Statistical Review - Wilate(PDF - 1.5MB) Clinical Review - Wilate(PDF - 889KB) July 7, 2015 Summary Basis of Regulatory Action - Wilate(PDF - 88KB) December 4, 2009 Approval Letter - Wilate Summary Basis for Regulatory Action - Wilate(PDF - 232KB) Approval History, Letters, Reviews, and Related Documents - Wilate[ARCHIVED]
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