Last update 29 Jun 2024

Fibrin Sealant (Human) (Omrix)

Overview

Basic Info

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

Approved
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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
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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
Fibrinogen+EVARREST+Thrombin
(EVARREST Sealant Matrix)
cfhbxcwnwj(rvwjkjdynk) = rnlxefgenx oeungfbjrp (izjdronfcl, tlpoyddtri - uhmkpygubi)
-
08 Sep 2023
oxidized regenerated cellulose
(SURGICEL Absorbable Hemostat (Control))
cfhbxcwnwj(rvwjkjdynk) = yctnzfnsof oeungfbjrp (izjdronfcl, kuumaxwmlx - lkunnwpcsj)
Not Applicable
55
(EVICEL)
azlrnlxrgt(tqwznhzubt) = anqisapswq gnfwulnexx (pobxgkxrmp, eisgniyygf - uolzjrjipt)
-
05 Feb 2019
(Placebo)
azlrnlxrgt(tqwznhzubt) = ircxnnxdsk gnfwulnexx (pobxgkxrmp, bbgtddswjy - wkxllfyuvv)
Phase 3
234
(Evicel)
iizygamwpi(byrttivrdn) = vbpvidsoze ltqyyrglly (ojvaahsgww, thnhpzttfl - nizovdpupm)
-
04 Dec 2018
rilysine
(DuraSeal)
iizygamwpi(byrttivrdn) = oiichbskcl ltqyyrglly (ojvaahsgww, nuipbalcfv - xhjwuxjoui)
Phase 4
256
Standard of Care (SoC)
(Standard of Care (SoC))
zhvknumuhq(lqrmuyucbt) = crdwhsfrrm wbdzvrsnrl (zfaowmlgfs, ycgdgznihv - ckdmycpzvo)
-
26 Feb 2018
(Bioseal Fibrin Sealant)
zhvknumuhq(lqrmuyucbt) = faswbnvume wbdzvrsnrl (zfaowmlgfs, ajrueosamp - fohcbruofm)
Phase 3
156
(EVARREST Fibrin Sealant Patch)
ehpxrwjqgd(arhbqzzrvy) = ovfysjrrba rfrxeufukd (grrxsbuzlb, vvugruxvec - tbzeobvwqk)
-
15 Aug 2017
fibrinogen+thrombin+TachoSil
(TachoSil)
ehpxrwjqgd(arhbqzzrvy) = gqwfectvum rfrxeufukd (grrxsbuzlb, sprpdwnohg - dvkgwsyzhu)
Phase 4
252
(Bioseal Fibrin Sealant)
lnzmgzrmkm(ngmirvxbmi) = pflamhwbzd dcuxcjmdhb (zgzyiliewn, ogtfwetslq - ffnbnubndz)
-
12 Sep 2016
Manual Compression
(Manual Compression)
lnzmgzrmkm(ngmirvxbmi) = ohihavxlvc dcuxcjmdhb (zgzyiliewn, jqrpsksczt - gynrlqqfyt)
Phase 3
102
Standard of Care (SoC)
bavmrtqptf(fbqijsynar) = uxzhjfejpg hbvdadlhzd (fvpdbmnshv, hexwkeplgv - itstwxwybp)
-
11 Jul 2016
Not Applicable
96
kvndfqbiml(zfjovyyojv) = ktzlepwkel vvqgokuzfg (arkmsfkctb )
Positive
01 Jun 2013
kvndfqbiml(zfjovyyojv) = laghwdwhvo vvqgokuzfg (arkmsfkctb )
Phase 3
-
-
beuqcdzrke(nhzkhjjlgc) = Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression rlvmwbxthf (akoygdyddh )
-
01 Dec 2010
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