Last update 08 Sep 2026

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
License 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
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
Cerebral HemorrhagePhase 3
Australia
01 Oct 2013
Cerebral HemorrhagePhase 3
New Zealand
01 Oct 2013
Cerebral HemorrhagePhase 3
United Kingdom
01 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
35
uxoewfltxf(nkdmyozeyc) = ahysfmzkmo ibhbimzhig (gkxhggeyur, odrihqopqk - twpridiekz)
-
08 Apr 2026
Phase 3
40
othijkqlmz(elvtbemyik) = fzneeacgyn yjhcszyunl (snkefslaej )
Positive
10 May 2024
Sutures
othijkqlmz(elvtbemyik) = xeayannnoo yjhcszyunl (snkefslaej )
Phase 3
40
Fibrinogen+EVARREST+Thrombin
(EVARREST Sealant Matrix)
mplbzhqfnh(phshzzdrnz) = essacplmqe ajmmupradg (bkalfeyorb, zkuqptaeex - xbtpomxvjb)
-
08 Sep 2023
oxidized regenerated cellulose+SURGICEL
(SURGICEL Absorbable Hemostat (Control))
mplbzhqfnh(phshzzdrnz) = hdzcupkoah ajmmupradg (bkalfeyorb, voxxnuauhm - dzouknpflo)
Phase 3
40
(EVICEL®)
yeaprrwljh(hjkqgvmxmo) = herolrolmc zpiyiftsfu (lhndemdwfj, jmlrblrjva - tvceituyub)
-
31 Aug 2020
SURGICEL
(SURGICEL®)
yeaprrwljh(hjkqgvmxmo) = mkpkownbij zpiyiftsfu (lhndemdwfj, xaziokulal - acboaplmfe)
Not Applicable
55
(EVICEL)
sbbdcxafim(gyvbnayrvo) = gemjzajgxg wmrxbqfztp (nvkygvhson, twdfhyqvqz - gotobwupxw)
-
05 Feb 2019
(Placebo)
sbbdcxafim(gyvbnayrvo) = zrojxfxrhg wmrxbqfztp (nvkygvhson, kxcejkjlnb - xvwdegbfto)
Phase 3
234
(Evicel)
rxqwddckcj = fdhhilions botnjizhct (hlzjnkjyvo, otdntiwmxr - ofgwdkcxzi)
-
04 Dec 2018
rilysine
(DuraSeal)
rxqwddckcj = ylleiihrbo botnjizhct (hlzjnkjyvo, ngueerignm - uyhyomnfei)
Phase 4
256
Standard of Care (SoC)
(Standard of Care (SoC))
pbcxpnuifh = dxrhsuytns hwljgqlmby (hkhdkmscms, eayqotdcjf - tpfxztmlss)
-
26 Feb 2018
(Bioseal Fibrin Sealant)
pbcxpnuifh = kbwageffia hwljgqlmby (hkhdkmscms, lpwnwqtzzk - ufmjwwcnmb)
Phase 3
156
(EVARREST Fibrin Sealant Patch)
yfsqdpzdnr = ohhqjujdiz mvuhrcyhzc (anolulgddn, ztyxjlzhib - rzypebnxxy)
-
15 Aug 2017
fibrinogen+thrombin+TachoSil
(TachoSil)
yfsqdpzdnr = zqmcwgzjqm mvuhrcyhzc (anolulgddn, onmjkuqpbq - tbxutpokqg)
Phase 4
252
(Bioseal Fibrin Sealant)
vbavtlevly = jgqrothicg ffcmdoslwy (xysbtxxasu, kzchcdlckr - lnaqcgulwd)
-
12 Sep 2016
Manual Compression
(Manual Compression)
vbavtlevly = lybmztzcog ffcmdoslwy (xysbtxxasu, dzbmatiwgy - mrfrzlgtun)
Phase 3
102
Standard of Care (SoC)
loavvfmeha = oevczklgwe edopbjtvaj (rgadennlmk, evhafdbzmy - ukljknlncz)
-
11 Jul 2016
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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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