IXINITY

STN: 125426
Proper Name: Coagulation Factor IX (Recombinant)
Tradename: IXINITY
Manufacturer: Cangene Corporation
Indication:

• Indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.

Product Information

• Package Insert - IXINITY

Supporting Documents

• May 14, 2015 Approval Letter - IXINITY
  The original posted document has been replaced with a revised approval letter correcting where labeling and packaging will be done.
• Approval History, Letters, Reviews, and Related Documents - IXINITY
• Supporting Documents older than three years - IXINITY