KOVALTRY
STN: BL 125574
Proper Name: Antihemophilic Factor (Recombinant), Full Length
Tradename: KOVALTRY
Manufacturer: Bayer HealthCare, LLC
Indication:
- For use in adults and children with hemophilia A for:
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes
Product Information
Supporting Documents
- October 27, 2021 Approval Letter - KOVALTRY
- January 8, 2021 Approval Letter - KOVALTRY
- Clinical Review, March 10, 2016 - KOVALTRY
- Statistical Review - KOVALTRY
- Supporting Documents older than three years - KOVALTRY
- Approval History, Letters, Reviews, and Related Documents - KOVALTRY