ALPROLIX

STN: 125444
Proper Name: Coagulation Factor IX (Recombinant), Fc Fusion Protein
Tradename: ALPROLIX
Manufacturer: Bioverativ Therapeutics, Inc.
Indication:

• Perioperative management of surgical prophylaxis; Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; Control and prevention of bleeding episodes.

Product Information

• Package Insert - ALPROLIX

Supporting Documents

• 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