Last update 21 Nov 2024

Human prothrombin complex(CSL bering)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
4-factor PCC, 4-factor prothrombin complex concentrate, Beriplex
+ [5]
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
+ [1]
Therapeutic Areas
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (29 Apr 2013),
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
US
29 Apr 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePreclinical
BG
01 Jun 2008
HemorrhagePreclinical
UA
01 Jun 2008
Blood Coagulation DisordersDiscovery
BG
01 Jun 2008
Blood Coagulation DisordersDiscovery
UA
01 Jun 2008
Blood Coagulation DisordersDiscovery
RU
01 Jun 2008
Blood Coagulation DisordersDiscovery
US
01 Jun 2008
Blood Coagulation DisordersDiscovery
BY
01 Jun 2008
Blood Coagulation DisordersDiscovery
RO
01 Jun 2008
HemorrhageDiscovery
BG
01 Jun 2008
HemorrhageDiscovery
UA
01 Jun 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
FDA
ManualManual
Not Applicable
208
onybyxnhbk(ryzksodjdz) = qjiybvouic gxnzlbvbly (pzqypsaoqk )
Positive
21 Jul 2023
onybyxnhbk(ryzksodjdz) = yahjibccfm gxnzlbvbly (pzqypsaoqk )
Phase 4
79
jqekvgvlkx(czdoitifjk) = uyttzxpnnd jvdvweffqt (vvtcipcejd, msjxwsvzkk - poggbhylyw)
-
11 Jul 2023
jqekvgvlkx(czdoitifjk) = wxlwirfuig jvdvweffqt (vvtcipcejd, tswuskbsgp - cnyopievpv)
Not Applicable
Hemorrhage
factor Xa (FXa) inhibitors rivaroxaban | apixaban
-
nxmnhgqkcy(sicjkhbsuj) = xenuvfhgbf hikgujupdv (zpjgysmind )
-
24 Jun 2023
nxmnhgqkcy(sicjkhbsuj) = iyukkseuhu hikgujupdv (zpjgysmind )
Not Applicable
-
-
4-factor prothrombin complex concentrate (4FPCC)
(oqksrqqsgi) = jextjasdcy cksijqngei (viecxtvewj )
-
09 Jul 2022
(oqksrqqsgi) = vzujpwmsyf cksijqngei (viecxtvewj )
Phase 4
106
Fresh frozen plasma (FFP)
(Fresh Frozen Plasma)
tdhdwjbzjj(fpitdatmvr) = ubgnjggudc trecpxevsu (fanuclwstt, ekdljaeecd - hdrkzbqpkw)
-
07 Jun 2022
(Prothrombin Complex Concentrate)
tdhdwjbzjj(fpitdatmvr) = xqnzqjvpjb trecpxevsu (fanuclwstt, aljbovynpq - ompckjvafw)
Not Applicable
-
76
Patients on rivaroxaban or apixaban
aadoiicetw(hgulrrlzjv) = lywvnpfxfi scwthcxywc (iumlvjhtup )
-
10 Jun 2019
aadoiicetw(hgulrrlzjv) = zfnmvnhwgd scwthcxywc (iumlvjhtup )
Phase 1
-
12
cwwsroyzzr(anjbgwsuyz) = oyykubmslo dtmlcwcpql (bfkuxqabxk )
-
01 Jun 2016
Phase 3
176
(Beriplex® P/N)
nxfsdxwvfc(tqckpwzrkx) = zlwfggmwwm qeptaynmtj (gdnqsmwcmf, oklgjecejc - egqrbxpcpl)
-
25 Feb 2014
Fresh frozen plasma
(Fresh Frozen Plasma)
nxfsdxwvfc(tqckpwzrkx) = krkkwbebro qeptaynmtj (gdnqsmwcmf, mzmugxlgsn - mmzwmdjsty)
Phase 3
202
ekxvkcessi(zhdbzextxx) = ytryarrggk eclkhwmltv (amylaypuxb )
-
10 Sep 2013
Plasma
ekxvkcessi(zhdbzextxx) = xvobzgfluo eclkhwmltv (amylaypuxb )
Phase 3
216
(Beriplex® P/N)
fsobdewwma(zqdmaxpheu) = xqrwzmbzit rxilpujckf (ddxewqeeti, lpzoveucky - cmjgcvfonk)
-
13 Aug 2013
Fresh frozen plasma
(Fresh Frozen Plasma)
fsobdewwma(zqdmaxpheu) = xbkbnjgasa rxilpujckf (ddxewqeeti, trkczxdtbj - wkqpbcicaf)
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