Antihemophilic factor, human recombinant

Overview

Human recombinant antihemophilic factor (AHF) or Factor VIII, 2332 residues, glycosylated, produced by CHO cells

Indication

The human recombinant antihemophilic factor is indicated for use in adults and children with hemophilia A for the control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Associated Conditions

Bleeding
Joint Damage
Perioperative Blood Loss

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A	2021/09/13	NCT05042440	Phase 1	Completed	Sanofi
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®	2016/12/30	NCT03006965	N/A	Completed	Spanish Society of Thrombosis and Haemostasis
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)	2016/10/13	NCT02932618	Phase 3	Recruiting	Baxalta now part of Shire
Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients	2015/06/23	NCT02479087	Phase 4	UNKNOWN	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease	2015/06/16	NCT02472665	Phase 4	Recruiting	Grifols Therapeutics LLC
International PMS Study - KOGENATE Bayer	2009/03/18	NCT00864552	N/A	Completed	Bayer
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A	2008/07/17	NCT00717626	Phase 2	Completed	The Hospital for Sick Children
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A	2008/02/22	NCT00621673	Phase 4	Terminated	Bayer
BAY14-2222 Continuous Infusion in Surgeries	2008/02/01	NCT00606060	Phase 3	Completed	Bayer
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)	2008/01/04	NCT00586521	Phase 4	Completed	Bayer

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
Advate	Takeda Manufacturing Austria AG,Industriestrasse 67,1221 Vienna,Austria	Authorised	3/2/2004
Kovaltry	Bayer AG,Kaiser-Wilhelm-Allee 1,51373 Leverkusen,Germany	Authorised	2/18/2016

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
ADVATE octocog alfa (rch) 500 IU powder for injection vial with diluent vial	100385	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	4/4/2005
KOVALTRY octocog alfa (bhk) 3000IU powder for injection vial	246796	Bayer Australia Ltd	Medicine	A	4/1/2016
ADVATE octocog alfa (rch) 3000 IU powder for injection vial with diluent vial	150366	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	11/13/2008
KOVALTRY octocog alfa (bhk) 1000IU powder for injection vial	246794	Bayer Australia Ltd	Medicine	A	4/1/2016
ADVATE octocog alfa (rch) 1500 IU powder for injection vial with diluent vial	100387	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	4/4/2005
KOVALTRY octocog alfa (bhk) 250IU powder for injection vial	236280	Bayer Australia Ltd	Medicine	A	4/1/2016
ADVATE octocog alfa rch 2000 IU intravenous injection vial	136204	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	1/23/2008
ADVATE octocog alfa (rch) 1000 IU powder for injection vial with diluent vial	100386	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	4/4/2005
KOVALTRY octocog alfa (bhk) 2000IU powder for injection vial	246795	Bayer Australia Ltd	Medicine	A	4/1/2016
ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial	214709	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	7/16/2014

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ADVATE	takeda canada inc	02446413	Powder For Solution - Intravenous	500 UNIT / VIAL	N/A
HELIXATE FS	BAYER HEALTHCARE LLC	02243186	Powder For Solution - Intravenous	250 UNIT / VIAL	4/24/2008
KOVALTRY	Bayer Inc	02451638	Powder For Solution , Kit - Intravenous	1000 UNIT / VIAL	N/A
KOGENATE FS	Bayer Inc	02242490	Powder For Solution - Intravenous	500 UNIT / VIAL	9/29/2000
ADVATE	takeda canada inc	02446480	Powder For Solution - Intravenous	3000 UNIT / VIAL	N/A
ADVATE	takeda canada inc	02313111	Powder For Solution - Intravenous	2000 UNIT / VIAL	9/4/2008
ADVATE	takeda canada inc	02365987	Powder For Solution - Intravenous	1500 UNIT / VIAL	N/A
RECOMBINATE PWS INJ 250I.U./VIAL	BAXTER HEALTHCARE CORPORATION	02015129	Powder For Solution - Intravenous	250 UNIT / VIAL	12/31/1992
KOVALTRY	Bayer Inc	02451476	Kit , Powder For Solution - Intravenous	1000 UNIT / VIAL	7/6/2016
KOGENATE - PWS IV 1000I.U./VIAL	Bayer Corporation	02178834	Powder For Solution - Intravenous	1000 UNIT / VIAL	7/9/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ADVATE 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Takeda Manufacturing Austria Ag	103271019	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
KOGENATE BAYER 250 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Bayer Ag	00143004	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
KOGENATE BAYER 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Bayer Ag	00143005	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
ADVATE 3000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Takeda Manufacturing Austria Ag	103271016	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
KOVALTRY 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Bayer Ag	1151076004	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
KOGENATE BAYER 3000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Bayer Ag	00143012	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
KOVALTRY 2000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Bayer Ag	1151076008	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
ADVATE 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Takeda Manufacturing Austria Ag	03271002	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
ADVATE 250 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Takeda Manufacturing Austria Ag	03271001	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
KOGENATE BAYER 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Bayer Schering Gmbh	00143002	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.

AI-Powered Research

Premium Access