WILATE
STN: BL 125251
Proper Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Tradename: WILATE
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
WILATE is indicated in adult and pediatric patients with von Willebrand disease for:
- On-demand treatment and control of bleeding episodes.
- Perioperative management of bleeding.
- Routine prophylaxis to reduce the frequency of bleeding episodes
WILATE is indicated in adult and pediatric patients 12 years of age and older with hemophilia A for:
- On-demand treatment and control of bleeding episodes
- Routine prophylaxis to reduce the frequency of bleeding episodes
- Statistical Review STN 125251/454 - WILATE
- Clinical Review STN 125251/454 - WILATE
- July 2, 2026 Approval Letter - WILATE
- November 8, 2024 Approval Letter - WILATE
- March 22, 2024 Approval Letter - WILATE
- March 22, 2024 Clinical Memo - WILATE
- January 23, 2024 Clinical Review Memo - Wilate
- 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