- Patients or legally authorized representatives of pediatric patients agree to provide
written informed consent form (data privacy statement).
- Pediatric and adult patients who have been treated with original or reformulated
BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from
first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for
example, patients switching from pdFIX to BeneFIX).
- Patients with a known history of hypersensitivity to original or reformulated BeneFIX
or any component of the product.
- Patients with a known history of hypersensitivity to hamster protein.
- Patients participating in an interventional trial of any investigational drug or
device.