COAGADEX

STN: 125506
Proper Name: Coagulation Factor X (Human)
Tradename: COAGADEX
Manufacturer: Bio Products Laboratory Limited
Indication:

• Indicated in adults and children with hereditary Factor X deficiency for:
  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding in patients with mild, moderate and severe hereditary Factor X deficiency

Product Information

• Package Insert - COAGADEX

Supporting Documents

• April 14, 2023 Approval Letter - COAGADEX
• September 21, 2018 Approval Letter - COAGADEX
• September 21, 2018 Summary Basis for Regulatory Action - COAGADEX
• Clinical Review - COAGADEX
• Addendum to Clinical Review - COAGADEX
• Approval History, Letters, Reviews, and Related Documents - COAGADEX
• Supporting Documents older than three years – COAGADEX