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
- Clinical Review - Wilate
- July 7, 2015 Summary Basis of Regulatory Action - Wilate
- Approval History, Letters, Reviews, and Related Documents - Wilate
- Supporting Documents older than three years - Wilate