Proper Name: Coagulation Factor IX (Recombinant), GlycoPEGylated
Manufacturer: Novo Nordisk Inc.
- Is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management of bleeding.
- Package Insert - REBINYN
- Demographic Subgroup Information - REBINYN, Coagulation Factor IX (Recombinant), glycoPEGylated
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- May 31, 2017 Approval Letter - REBINYN
- May 31, 2017 Summary Basis for Regulatory Action - REBINYN
- Statistical Review - REBINYN
- Approval History, Letters, Reviews, and Related Documents - REBINYN