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
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