An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Approved Blood Products

Kogenate FS

STN: BL 103332
Proper Name: Antihemophilic Factor (Recombinant)
Tradename: Kogenate FS
Manufacturer: Bayer Corp, License #0008
Indications:

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.

Product Information

Supporting Documents

Supporting Documents older than three years - Kogenate FS

Top