Wilate
STN: BL 125251
Proper Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Tradename: Wilate
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Indication:
- In adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes.
- For the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
- For routine prophylaxis to reduce the frequency of bleeding episodes in patients with von Willebrand Disease.
Product Information
Supporting Documents
- December 11, 2023 Approval Letter - Wilate
- December 1, 2023 Approval Letter - Wilate
- Clinical Pharmacology Review - Wilate
- Statistical Review - Wilate
- Clinical Pharmacology Supplement Review STN 125251/244- Wilate
- Statistical Review Memo STN 125251/244 - Wilate
- Clinical Review STN 125251/244 - Wilate
- September 25, 2019 Approval Letter - Wilate
- Statistical Review - Wilate
- Clinical Review - Wilate
- Approval History, Letters, Reviews, and Related Documents - Wilate
- Supporting Documents older than three years - Wilate