Last update 24 Mar 2025

Human Fibrinogen / Human Thrombin(Takeda Pharmaceuticals International Gmbh)

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Fibrin sealant patch (Takeda), Fibrin Sealant Patch, Absorbable(Takeda Pharma), human fibrinogen / human thrombin(Takeda Pharmaceuticals International GmbH)
+ [5]
Action
modulators
Mechanism
Fibrinogen modulators, prothrombin modulators(Prothrombin modulators)
Drug Highest PhaseApproved
First Approval Date
Austria (31 Dec 1992),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Tissue Adhesions
Japan
26 Sep 2011
Hemorrhage
United States
05 Apr 2010
Hemorrhage
United States
05 Apr 2010
Blood Coagulation Disorders
European Union
08 Jun 2004
Blood Coagulation Disorders
Iceland
08 Jun 2004
Blood Coagulation Disorders
Liechtenstein
08 Jun 2004
Blood Coagulation Disorders
Norway
08 Jun 2004
Cerebrospinal Fluid Leak
European Union
08 Jun 2004
Cerebrospinal Fluid Leak
Iceland
08 Jun 2004
Cerebrospinal Fluid Leak
Liechtenstein
08 Jun 2004
Cerebrospinal Fluid Leak
Norway
08 Jun 2004
Wounds and Injuries
Austria
31 Dec 1992
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Intraoperative ComplicationsPhase 3
Denmark
01 Feb 2006
Lung DiseasesPhase 3
Denmark
01 Feb 2006
Liver DiseasesPhase 3
Denmark
01 Oct 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
23
(MTI+Tachosil)
yryoamgdzu(ukybmdumlu) = no significant changes in PDUSS scores post-operatively oiwyncazjf (uiqizfftxz )
-
01 Sep 2021
Phase 3
142
(No TachoSil® patches)
wtapujaelu(rhaeitbkib) = xqatxijqtj udkiiosbmh (lpmyhmqonv )
Negative
01 Sep 2018
Phase 3
150
(TachoSil®)
ygykepfhpg = pujtpnqvbu spdlztxlsp (doqcfvfywx, ostrvvstjc - uvgvdzxcwi)
-
08 Feb 2017
Surgicel® Original
(Surgicel® Original)
ygykepfhpg = ndmhejnijk spdlztxlsp (doqcfvfywx, wheetukfiv - caycgrekoq)
Phase 3
253
(TachoSil® (Adult Participants))
xheirvgjux = mxsfllckhz ybprzmirui (hbacshqqjy, howdccyzfi - ifnwdjqrpv)
-
25 Nov 2015
Surgicel
(Surgicel® Original (Adult Participants))
xheirvgjux = kzdqzggsqn ybprzmirui (hbacshqqjy, vlxrqlukli - vcemhqoeog)
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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