Proper Name: Coagulation Factor IX (Recombinant)
Manufacturer: Cangene Corporation
- Indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.
- 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