Proper Name: Coagulation Factor IX (Recombinant), Fc Fusion Protein
Manufacturer: Bioverativ Therapeutics, Inc.
- Perioperative management of surgical prophylaxis; Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; Control and prevention of bleeding episodes.
- October 29, 2020 Approval Letter - ALPROLIX
- July 12, 2019 Approval Letter - ALPROLIX
- October 19, 2017 Summary Basis for Regulatory Action - ALPROLIX
- November 3, 2017 Approval Letter - ALPROLIX
- Approval History, Letters, Reviews, and Related Documents - ALPROLIX
- Supporting Documents older than three years - ALPROLIX