Coagulation factor VII human
- Generic Name
- Coagulation factor VII human
- Brand Names
- Balfaxar, Beriplex, Kcentra, Octaplex
- Drug Type
- Biotech
- Unique Ingredient Identifier
- 4156XVB4QD
Overview
Coagulation factor VII is human serine protease type enzyme that is involved in the extrinsic coagulation cascade which results in blood clotting.
Background
Coagulation factor VII is human serine protease type enzyme that is involved in the extrinsic coagulation cascade which results in blood clotting.
Indication
May be administered in cases of uncontrolled bleeding. Factor VII alone can be used in the treatment of congenital hemophilia A or B, acquired hemophilia, congenital factor VII deficiency, and Glanzmann's thrombasthenia. Off label use in the treatment of refractory bleeding after cardiac surgery and warfarin related intracerebral hemorrhage. Brands for human factor VII are currently only in combination with other vitamin K coagulation factors and can be used to reverse vitamin K antagonist activity in patients with acute major bleeds or for urgent surgery/invasive procedures.
Associated Conditions
- Vitamin K antagonist induced major bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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No FDA products found
No FDA products found for this drug
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
|---|---|---|---|---|---|
INJECTION, POWDER, FOR SOLUTION | 180 - 480 IU/vial | 2016/01/28 | SIN14933P |
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
|---|---|---|---|---|---|
328514 | Active | 2020/07/07 | Factor VII | ||
156330 | Active | 2010/02/05 | Factor VII | ||
328516 | Active | 2020/07/07 | Factor VII | ||
328515 | Active | 2020/07/07 | Factor VII | ||
156459 | Active | 2010/02/05 | Factor VII | ||
129151 | Octapharma Australia Pty Ltd | Active | 2007/10/12 | Factor VII | |
228338 | Active | 2015/08/05 | Factor VII |