Coagulation factor VII human

Overview

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 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
OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU	Octapharma Pharmazeutika Produktionsges m.b.H.(Powder), Octapharma S.A.S. (Powder), Solupharm Pharmazeutische Erzeugnisse GmbH (Solvent)	SIN14933P	INJECTION, POWDER, FOR SOLUTION	180 - 480 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

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BERIPLEX AU human prothrombin complex 250 IU powder for injection vial	328514	CSL Behring (Australia) Pty Ltd	Medicine	A	7/7/2020
BERIPLEX P/N human prothrombin complex 250 IU powder for injection vial	156330	CSL Behring (Australia) Pty Ltd	Medicine	A	2/5/2010
BERIPLEX AU human prothrombin complex 1000 IU powder for injection vial	328516	CSL Behring (Australia) Pty Ltd	Medicine	A	7/7/2020
BERIPLEX AU human prothrombin complex 500 IU powder for injection vial	328515	CSL Behring (Australia) Pty Ltd	Medicine	A	7/7/2020
BERIPLEX P/N human prothrombin complex 500 IU powder for injection vial	156459	CSL Behring (Australia) Pty Ltd	Medicine	A	2/5/2010
PRONATIV human prothrombin complex powder for injection vial and solution for injection vial	129151	Octapharma Australia Pty Ltd	Medicine	A	10/12/2007
BERIPLEX P/N human prothrombin complex 1000 IU powder for injection vial	228338	CSL Behring (Australia) Pty Ltd	Medicine	A	8/5/2015

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	480 UNIT / VIAL	7/8/2008
BERIPLEX P/N 1000	csl behring canada inc	02410826	Powder For Solution - Intravenous	1000 UNIT	11/21/2013
FEIBA VH IMMUNO ANTI INHIBITOR	osterreichisches institut fur haemoderivate ges m.b.h.	00609137	Powder For Solution - Intravenous	null NIL / ML	12/31/1986
BERIPLEX P/N 500	csl behring canada inc	02359251	Powder For Solution - Intravenous	500 UNIT	7/28/2011
OCTAPLEX	octapharma pharmazeutika produktionsges m b h	02434970	Powder For Solution , Kit - Intravenous	960 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	Baxalta Innovations Gmbh	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
BERIPLEX 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Csl Behring Gmbh	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	Prothya Biosolutions Netherlands B.V.	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
BERIPLEX 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Csl Behring Gmbh	69890	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
OCTAPLEX, 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE.	Octapharma S.A.	66447	POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PROTHROMPLEX TOTAL 500 UI POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Baxalta Innovations Gmbh	88851	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
COFACT 500 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Prothya Biosolutions Netherlands B.V.	86490	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not 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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