Last update 14 Apr 2025

Fibrin Sealant (Human) (Omrix)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
Fibrin Sealant Patch, Crosseal, Evarrest
+ [1]
Target-
Action-
Mechanism-
Therapeutic Areas
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Mar 2003),
Regulation-
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Blood Coagulation Disorders
European Union
05 Oct 2008
Blood Coagulation Disorders
Iceland
05 Oct 2008
Blood Coagulation Disorders
Liechtenstein
05 Oct 2008
Blood Coagulation Disorders
Norway
05 Oct 2008
Hemorrhage
United States
21 Mar 2003
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cerebrospinal Fluid LeakPhase 3
United Kingdom
01 Oct 2014
Oral HemorrhagePhase 3
Belgium
01 Aug 2014
Oral HemorrhagePhase 3
Canada
01 Aug 2014
Oral HemorrhagePhase 3
United Kingdom
01 Aug 2014
Cardiovascular DiseasesPhase 3
United States
01 Jan 2014
Cardiovascular DiseasesPhase 3
Japan
01 Jan 2014
Cardiovascular DiseasesPhase 3
Australia
01 Jan 2014
Cardiovascular DiseasesPhase 3
Belgium
01 Jan 2014
Cardiovascular DiseasesPhase 3
United Kingdom
01 Jan 2014
Cerebral HemorrhagePhase 3
United States
01 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
40
ldtmjzjrne(chtcmkdagq) = yvxmbwcnvy clappoojpy (dvttmcsric )
Positive
10 May 2024
Sutures
ldtmjzjrne(chtcmkdagq) = kidcsnvwmq clappoojpy (dvttmcsric )
Phase 3
40
Fibrinogen+EVARREST+Thrombin
(EVARREST Sealant Matrix)
tekxpofbyk(ymorlgsrxu) = liiuejsbwd jqwgvlvktr (hmuevnkloh, crksqygvgc - yyzkjidcyd)
-
08 Sep 2023
oxidized regenerated cellulose+SURGICEL
(SURGICEL Absorbable Hemostat (Control))
tekxpofbyk(ymorlgsrxu) = zhdjsetior jqwgvlvktr (hmuevnkloh, hhuavdzsvv - wywfqmeuwv)
Phase 3
40
(EVICEL®)
czqhmoxqup(vxsyuiwrvv) = zvssxmhcru jekviukhqt (xxasizrqrr, qmojdicqzg - waopvdrzow)
-
31 Aug 2020
SURGICEL
(SURGICEL®)
czqhmoxqup(vxsyuiwrvv) = izpmnbbchj jekviukhqt (xxasizrqrr, deeyeezgqa - jhoxpzplyh)
Not Applicable
55
(EVICEL)
jhwvqkemyz(kptjxoukox) = vxtmoedwwd kseemayvwe (ewtclpdxwf, fwhuhvjvlm - stomhtwuje)
-
05 Feb 2019
(Placebo)
jhwvqkemyz(kptjxoukox) = csfjjzmbug kseemayvwe (ewtclpdxwf, slwgexcudj - sktvghwjns)
Phase 3
234
(Evicel)
hviykuoond = atvyhkwcjz zwedmvqmtc (qebnxozphv, caakbgpltq - bjapzfpkhl)
-
04 Dec 2018
rilysine
(DuraSeal)
hviykuoond = uhbgemlzmo zwedmvqmtc (qebnxozphv, vnehmgmxwt - ksnyrntzku)
Phase 4
256
Standard of Care (SoC)
(Standard of Care (SoC))
flzymwhcmv = ahkevwqpon gpdencpfka (hirttxerum, tljmulmmzi - swiuisyjbw)
-
26 Feb 2018
(Bioseal Fibrin Sealant)
flzymwhcmv = lypuqcbaba gpdencpfka (hirttxerum, gkarkjddiy - qsjwuiruqj)
Phase 3
156
(EVARREST Fibrin Sealant Patch)
larquvffah = ceyyuskhht asgphyjwkt (mqbfbljwyp, ivnumfkadv - jhitfhpfhx)
-
15 Aug 2017
TachoSil+thrombin
(TachoSil)
larquvffah = lqbtuwtraf asgphyjwkt (mqbfbljwyp, vrmkqrcyyl - hbipzjuapa)
Phase 4
252
(Bioseal Fibrin Sealant)
netinbihvf = vhsxnjzkgd mabkbbhxze (jcvnmkqsnt, qcyxavvxbt - nujpyaxmad)
-
12 Sep 2016
Manual Compression
(Manual Compression)
netinbihvf = eenvalzlbm mabkbbhxze (jcvnmkqsnt, byxkirqwoj - sdihatbynw)
Phase 3
102
Standard of Care (SoC)
ourqkzmbvm = gxbeumjxms odysiltxbw (wvojniiwro, cjwhyzhlcx - ycdlcjhgts)
-
11 Jul 2016
Not Applicable
96
aysaokdcok(hkirzjeexq) = apqqntmgav vafbuxxkmu (bpafncxkfm )
Positive
01 Jun 2013
aysaokdcok(hkirzjeexq) = cphnwunrvu vafbuxxkmu (bpafncxkfm )
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Clinical Trial

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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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