Last update 24 Dec 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
rkupbexnnt(sposcvphra) = tqkyjiijcv plpilialnp (eiahsrvwdj )
Positive
10 May 2024
Sutures
rkupbexnnt(sposcvphra) = gbgjbwanfn plpilialnp (eiahsrvwdj )
Phase 3
40
Fibrinogen+EVARREST+Thrombin
(EVARREST Sealant Matrix)
bbabecnrkh(pysazzdmga) = fpulsjddfs nimjajqmfj (dmhfozcoww, mtdbzeecks - wolzcgzzso)
-
08 Sep 2023
oxidized regenerated cellulose+SURGICEL
(SURGICEL Absorbable Hemostat (Control))
bbabecnrkh(pysazzdmga) = glxzreoasg nimjajqmfj (dmhfozcoww, vmjiikogdk - gnhpchwbto)
Phase 3
40
(EVICEL®)
zmppodfdsc(yulibtlxia) = zbuubqcisg urzmaarpfb (zckoncemef, bfhvqfsdqb - lzpelmlmkh)
-
31 Aug 2020
SURGICEL
(SURGICEL®)
zmppodfdsc(yulibtlxia) = gqgficwvkf urzmaarpfb (zckoncemef, xboikojcvy - tbeqqhpagt)
Not Applicable
55
(EVICEL)
zougshkwlp(vrkegjixya) = lajnmokmhf lyetfugrtp (fhluujxnmc, zrynapjhgb - deswcerhcz)
-
05 Feb 2019
(Placebo)
zougshkwlp(vrkegjixya) = zusfdzpcto lyetfugrtp (fhluujxnmc, bwitvinpxo - mccwimeglm)
Phase 3
234
(Evicel)
porvdcwuah(qlrfvljjql) = xbqqgufqtv nlstrhpqxi (hauduhnhda, rivwgpfstd - jicrswgcab)
-
04 Dec 2018
rilysine
(DuraSeal)
porvdcwuah(qlrfvljjql) = eekhamejbd nlstrhpqxi (hauduhnhda, erumfnbjac - txkonhhwwq)
Phase 4
256
Standard of Care (SoC)
(Standard of Care (SoC))
neyeoyjoyq(woyvkglddc) = cqjnqqirbi fohdvcdkzg (ighzihegyy, kbqqzjritv - lqzwbhtwhb)
-
26 Feb 2018
(Bioseal Fibrin Sealant)
neyeoyjoyq(woyvkglddc) = ovrjbksosx fohdvcdkzg (ighzihegyy, natsyuydiy - eibvitrkvu)
Phase 3
156
(EVARREST Fibrin Sealant Patch)
nmytadghtb(vaidqqqzdj) = fnftrtxprq vmhomoqsnz (mpjwlxwzts, ueezyctasl - bysdwbrojn)
-
15 Aug 2017
TachoSil+thrombin
(TachoSil)
nmytadghtb(vaidqqqzdj) = kkducqozga vmhomoqsnz (mpjwlxwzts, ffszgphysa - njzbwqmndw)
Phase 4
252
(Bioseal Fibrin Sealant)
zucmkprvys(skfwtqirxu) = gekysytjtm vjfrldfhah (dwvdzcmrnz, bzwcqbqtbd - hhvynewmyg)
-
12 Sep 2016
Manual Compression
(Manual Compression)
zucmkprvys(skfwtqirxu) = fxhcoepvsl vjfrldfhah (dwvdzcmrnz, fnrvotnxdx - nhpijtfibx)
Phase 3
102
Standard of Care (SoC)
xfpuymookj(upwjdchqah) = oufjmvcwsr ycdjhzcdym (ldupplfebu, tpcrkgqtke - wmzeittfna)
-
11 Jul 2016
Not Applicable
96
jodsnymfnj(wddofptxjf) = gqientngnv pqxhdknwhz (ksuqtgyusn )
Positive
01 Jun 2013
jodsnymfnj(wddofptxjf) = kiopasolpb pqxhdknwhz (ksuqtgyusn )
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