Overview
Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication
For treatment of hemophilia (Christmas disease).
Associated Conditions
- Bleeding
- Hemophilia B
- Perioperative bleeding caused by Hemophilia B
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/03/27 | Phase 2 | Completed | |||
2015/01/12 | Phase 4 | Completed | |||
2014/08/11 | Phase 1 | Completed | |||
2009/12/07 | Phase 3 | Completed | |||
2008/07/14 | N/A | Completed | |||
2007/06/08 | N/A | Completed | |||
2004/10/07 | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2004/10/07 | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2002/05/20 | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer |
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 |
---|---|---|---|
Authorised | 12/19/2014 | ||
Authorised | 8/27/1997 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
BeneFIX Powder and Solvent for Solution for Injection 500iu/vial | SIN13804P | INJECTION, POWDER, FOR SOLUTION | 500IU/vial(138IU/mL) | 5/20/2010 | |
BeneFIX Powder and Solvent for Solution for Injection 2000iu/vial | SIN13806P | INJECTION, POWDER, FOR SOLUTION | 2000IU/vial(550IU/mL) | 5/20/2010 | |
BeneFIX Powder and Solvent for Solution for Injection 1000iu/vial | SIN13805P | INJECTION, POWDER, FOR SOLUTION | 1000IU/vial(275IU/mL) | 5/20/2010 | |
BeneFIX Powder and Solvent for Solution for Injection 250iu/vial | SIN13803P | INJECTION, POWDER, FOR SOLUTION | 250IU/vial (69IU/mL) | 5/20/2010 |
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 |
---|---|---|---|---|---|
RIXUBIS | takeda canada inc | 02431963 | Kit
,
Powder For Solution - Intravenous | 3000 UNIT / VIAL | 9/25/2018 |
BENEFIX | 02392984 | Powder For Solution - Intravenous | 3000 UNIT / VIAL | 2/12/2013 | |
RIXUBIS | takeda canada inc | 02431947 | Kit
,
Powder For Solution - Intravenous | 1000 UNIT / VIAL | 4/18/2017 |
BENEFIX - (250IU) | wyeth canada | 02231018 | Kit
,
Powder For Solution
,
Liquid - Intravenous | 250 UNIT / VIAL | 8/12/1998 |
RIXUBIS | takeda canada inc | 02431955 | Kit
,
Powder For Solution - Intravenous | 2000 UNIT / VIAL | 4/18/2017 |
BENEFIX | 02293803 | Powder For Solution - Intravenous | 2000 UNIT / VIAL | 7/12/2008 | |
BENEFIX | 02466619 | Powder For Solution - Intravenous | 1500 UNIT / VIAL | N/A | |
BENEFIX - (500IU) | wyeth canada | 02231019 | Kit
,
Powder For Solution
,
Liquid - Intravenous | 500 UNIT / VIAL | 8/12/1998 |
BENEFIX | 02293781 | Powder For Solution - Intravenous | 1000 UNIT / VIAL | 4/14/2007 | |
BENEFIX -(1000IU) | wyeth canada | 02231020 | Powder For Solution
,
Liquid
,
Kit - Intravenous | 1000 UNIT / VIAL | 8/12/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
BENEFIX 3000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 197047008 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
Rixubis 250UI/vial polvo y disolvente para solucion inyectable | 114970001 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
Rixubis 2000UI/vial polvo y disolvente para solucion inyectable | 114970004 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
BENEFIX 500 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 97047005 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
BENEFIX 2000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 97047007 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
BENEFIX 250 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 97047004 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
Rixubis 500UI/vial polvo y disolvente para solucion inyectable | 114970002 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
Rixubis 1000UI/vial polvo y disolvente para solucion inyectable | 114970003 | POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
BENEFIX 1000 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 97047006 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
Rixubis 3000UI/vial polvo y disolvente para solucion inyectable | 114970005 | POLVO Y DISOLVENTE PARA SUSPENSIÓN 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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