JIVI
STN: BL 125661
Proper Name: Antihemophilic Factor (Recombinant), PEGylated-aucl
Tradename: JIVI
Manufacturer: Bayer Healthcare, Inc
Indication:
- Indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
(1) On-demand treatment and control of bleeding episodes ; (2) Perioperative management of bleeding; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.
Product Information
Supporting Documents
- August 29, 2018 Approval Letter - JIVI
- August 29, 2018 Summary Basis for Regulatory Action - JIVI
- August 23, 2018 Clinical Review - JIVI
- Statistical Review - JIVI
- Approval History, Letters, Reviews, and Related Documents - JIVI