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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCTAPLEX | octapharma pharmazeutika produktionsges m b h | 02294664 | Kit
,
Powder For Solution - Intravenous | 500 UNIT / VIAL | 7/8/2008 |
| BERIPLEX P/N 1000 | csl behring canada inc | 02410826 | Powder For Solution - Intravenous | 1240 UNIT | 11/21/2013 |
| BERIPLEX P/N 500 | csl behring canada inc | 02359251 | Powder For Solution - Intravenous | 620 UNIT | 7/28/2011 |
| IMMUNINE VH | takeda canada inc | 02206021 | Powder For Solution - Intravenous | 720 UNIT / 5 ML | 10/18/1996 |
| OCTAPLEX | octapharma pharmazeutika produktionsges m b h | 02434970 | Powder For Solution
,
Kit - Intravenous | 1000 UNIT / VIAL | 8/11/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PROTHROMPLEX TOTAL 600 UI / 20 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 78913 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| COMPLEJO PROTROMBINICO OCTAPHARMA 1000 UI POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Octapharma S.A. | 85721 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| BERININ P 1200 UI | 65405 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| BERIPLEX 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 76961 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| OCTAPLEX 1000 UI POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Octapharma S.A. | 80417 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| COFACT 250 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 86489 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| COMPLEJO PROTROMBINICO OCTAPHARMA 500 UI POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Octapharma S.A. | 85722 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| IMMUNINE 1200 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PARA PERFUSION | 69603 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| NOVIX 50 UI/ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 65917 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| OCTANINE 100 UI/ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | Octapharma S.A. | 72466 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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