IXINITY
STN: 125426
Proper Name: Coagulation Factor IX (Recombinant)
Tradename: IXINITY
Manufacturer: Medexus Pharma, Inc.
Indication
- For routine prophylaxis to reduce the frequency of bleeding episodes in adults and children >/= 12 years of age with Hemophilia B
- Control and prevention of bleeding episodes and peri-operative management in patients with hemophilia B
Product Information
Supporting Documents
- November 17, 2022 Approval Letter - IXINITY
- March 3, 2021 Approval Letter - IXINITY
- February 17, 2021 Partial Rescission of Approval - IXINITY
- September 25, 2020 Approval Letter - IXINITY
- Clinical Review (STN: 125426/177) - IXINITY
- Statistical Review (STN: 125426/177) - IXINITY
- Approval History, Letters, Reviews, and Related Documents - IXINITY
- Supporting Documents older than three years - IXINITY