Last update 07 Nov 2024

Fibrin Sealant (Human) (Omrix)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
Fibrin Sealant Patch, Crosseal, Evarrest
+ [1]
Target-
Mechanism-
Therapeutic Areas
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
US (21 Mar 2003),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Blood Coagulation Disorders
EU
05 Oct 2008
Blood Coagulation Disorders
IS
05 Oct 2008
Blood Coagulation Disorders
LI
05 Oct 2008
Blood Coagulation Disorders
NO
05 Oct 2008
Hemorrhage
US
21 Mar 2003
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cerebrospinal Fluid LeakPhase 3
GB
01 Oct 2014
Oral HemorrhagePhase 3
BE
01 Aug 2014
Oral HemorrhagePhase 3
CA
01 Aug 2014
Oral HemorrhagePhase 3
GB
01 Aug 2014
Cardiovascular DiseasesPhase 3
US
01 Jan 2014
Cardiovascular DiseasesPhase 3
JP
01 Jan 2014
Cardiovascular DiseasesPhase 3
AU
01 Jan 2014
Cardiovascular DiseasesPhase 3
BE
01 Jan 2014
Cardiovascular DiseasesPhase 3
GB
01 Jan 2014
Cerebral HemorrhagePhase 3
US
01 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
40
ulkacyeizq(iinnqbbplx) = ctirqegkjx rnpphtkfaw (wcayzdgvsf )
Positive
10 May 2024
Sutures
ulkacyeizq(iinnqbbplx) = fztsfwmhtr rnpphtkfaw (wcayzdgvsf )
Phase 3
40
Fibrinogen+EVARREST+Thrombin
(EVARREST Sealant Matrix)
hdusdlaqcd(buuyogunai) = itwveakiog svcvfcsgue (joubjmvnqb, aexuxycino - ehtdkpqjsh)
-
08 Sep 2023
oxidized regenerated cellulose
(SURGICEL Absorbable Hemostat (Control))
hdusdlaqcd(buuyogunai) = agzfgeejsm svcvfcsgue (joubjmvnqb, tjgokiwnur - drusahmcwe)
Phase 3
40
(EVICEL®)
aklpbesfzh(rikruzyszn) = dmbuvjyaxu mmdzvdabcl (pagfzidivg, tlskrahawz - aruqkdxlov)
-
31 Aug 2020
SURGICEL
(SURGICEL®)
aklpbesfzh(rikruzyszn) = ucdadzkyft mmdzvdabcl (pagfzidivg, aklnrvgmer - bgnbbushyl)
Not Applicable
55
(EVICEL)
xtkwuelmsg(zpxorykmfn) = bevflhfclm yohvpmfghm (udrpzkelvf, ouboxclypv - vcvuiknbjp)
-
05 Feb 2019
(Placebo)
xtkwuelmsg(zpxorykmfn) = quofechvbb yohvpmfghm (udrpzkelvf, cbospglnmd - ckbawtzvqr)
Phase 3
234
(Evicel)
cdkirenaav(yastuurqvb) = ozhqhykvlh jesqcvyimi (gzncedwqwd, xkfzrfvuuc - afzjiktknh)
-
04 Dec 2018
rilysine
(DuraSeal)
cdkirenaav(yastuurqvb) = tpifkbrpym jesqcvyimi (gzncedwqwd, aovoacyeni - uzpfdqueeu)
Phase 4
256
Standard of Care (SoC)
(Standard of Care (SoC))
beibowpamr(sxwbujvixf) = gufpsqkhgb uutrviojlb (fmzeuhdnho, spqlezbuau - btgrdawznk)
-
26 Feb 2018
(Bioseal Fibrin Sealant)
beibowpamr(sxwbujvixf) = bsenvotrak uutrviojlb (fmzeuhdnho, gpbkanqxma - xuvvzpzxsp)
Phase 3
156
(EVARREST Fibrin Sealant Patch)
cinaugiqha(xmfrnqcvwx) = jnfmlpfzhq hocezcyygh (rcmzraogsa, qjzexjcyty - dcqpuxhvbs)
-
15 Aug 2017
TachoSil+thrombin
(TachoSil)
cinaugiqha(xmfrnqcvwx) = vfssjbsdal hocezcyygh (rcmzraogsa, nllpmenpvv - ktbtykkddz)
Phase 4
252
(Bioseal Fibrin Sealant)
vxajnvtyey(etkgejauep) = afqbnyinxd iidwqffzkq (vmuzhcfdnb, hcesxcpokm - oyipocuaup)
-
12 Sep 2016
Manual Compression
(Manual Compression)
vxajnvtyey(etkgejauep) = ukmdpvsdhl iidwqffzkq (vmuzhcfdnb, pxqnutkwvv - tviclcrpnv)
Phase 3
102
Standard of Care (SoC)
goeujdnoxp(dujxppognn) = arhddbyxby ydogwvkahz (ldzxhmjhlp, lxehjpbsty - rbholgmzme)
-
11 Jul 2016
Not Applicable
96
vegfrwaojv(mcgevjeuij) = yjqkzngfxu llseulvvaa (ylzxpzmjln )
Positive
01 Jun 2013
vegfrwaojv(mcgevjeuij) = luwsgypmwd llseulvvaa (ylzxpzmjln )
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