Overview
Factor IX (or Christmas factor) is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes hemophilia B.
Indication
Factor IX is used to treat Christmas disease. Factor IX deficiency is treated by injection factor IX produced from human plasma. Tranexamic acid may be of value in patients undergoing surgery who have inherited factor IX deficiency in order to reduce the perioperative risk of bleeding.
Associated Conditions
- Acquired Coagulation Factor Deficiency
- Bleeding caused by Hemophilia B
- Major Bleeding
- Vitamin K antagonist induced major bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/03/16 | Early Phase 1 | Completed | |||
2005/08/31 | Phase 4 | Completed | Prothya Biosolutions | ||
1999/10/28 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REPLENINE-VF 500 FOR INJECTION | SIN08984P | INJECTION, POWDER, FOR SOLUTION | min 500 iu/vial | 10/30/1996 | |
| PROFILNINE FOR INJECTION 500 iu/5 ml | SIN09068P | INJECTION | 500 iu per 5 ml vial | 12/9/1996 | |
| ALPHANINE SD FOR INJECTION 500 iu/vial | SIN08961P | INJECTION, POWDER, FOR SOLUTION | 500 iu per 10ml vial | 10/7/1996 | |
| PROFILNINE FOR INJECTION 1000 iu/10 ml | SIN09048P | INJECTION | 1000 iu per 10 ml vial | 11/28/1996 | |
| ALPHANINE SD FOR INJECTION 1500 iu/vial | SIN08962P | INJECTION, POWDER, FOR SOLUTION | 1500 iu per 10ml vial | 10/7/1996 | |
| ALPHANINE SD FOR INJECTION 1000 iu/vial | SIN08963P | INJECTION, POWDER, FOR SOLUTION | 1000 iu per 10ml vial | 10/7/1996 | |
| PROFILNINE FOR INJECTION 1500 iu/10 ml | SIN09049P | INJECTION | 1500 iu per 10 ml vial | 11/28/1996 | |
| OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU | SIN14933P | INJECTION, POWDER, FOR SOLUTION | 500 IU/vial | 1/28/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Help Us Improve
Your feedback helps us provide better drug information and insights.