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

• Package Insert - KOVALTRY (Vial Adapter)
• Package Insert - KOVALTRY (BIO-SET)

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