coagulation factor IX recombinant, GlycoPEGylated
coagulation factor IX recombinant, GlycoPEGylated is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including REBINYN. Available dosage form: kit.
Drug Details
- Generic Name
- coagulation factor IX recombinant, GlycoPEGylated
- Brand Names
- REBINYN
- Application Number
- BLA125611
- Sponsor
- Novo Nordisk
- NDC Codes
- 4
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes Limitations of Use : REBINYN is not indicated for immune tolerance induction in patients with hemophilia B. REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes Limitations of Use : REBINYN is not indicated for immune tolerance induction in patients with hemophilia B ( 1 ).