STN: BL 103332
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: Kogenate FS
Manufacturer: Bayer Corp, License #0008
- Control and prevention of bleeding episodes in adults and children with hemophilia A.
- Peri-operative management in adults and children with hemophilia A.
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
- Kogenate FS Package Insert - For Intravenous Use
- Package Insert - Kogenate FS, Antihemophilic Factor w Vial Adapter
- Package Insert - Kogenate FS w BIO-SET
- May 9, 2015 Approval Letter - Kogenate FS
To expand the indication of Kogenate FS to include adult prophylaxis.
- Supporting Documents older than three years - Kogenate FS