Last update 01 Aug 2025

Human prothrombin complex(CSL bering)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
4-factor PCC, 4-factor prothrombin complex concentrate, Beriplex
+ [7]
Action
modulators
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (29 Apr 2013),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
United States
29 Apr 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Coagulation factor deficiency syndromePhase 3-31 Jul 2025
Wounds and InjuriesPhase 3
United States
28 Mar 2023
Wounds and InjuriesPhase 3
Australia
28 Mar 2023
Wounds and InjuriesPhase 3
United Kingdom
28 Mar 2023
Heart FailurePhase 3
United States
11 Jul 2018
Blood Coagulation DisordersPhase 3
United States
01 Jun 2008
Blood Coagulation DisordersPhase 3
Belarus
01 Jun 2008
Blood Coagulation DisordersPhase 3
Bulgaria
01 Jun 2008
Blood Coagulation DisordersPhase 3
Romania
01 Jun 2008
Blood Coagulation DisordersPhase 3
Russia
01 Jun 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
79
didlgfkjlx = pvvnmyggeu pqiavwjkuo (przncgibgn, uukdzlesok - lfdvwsrcdo)
-
11 Jul 2023
didlgfkjlx = utauzsfvak pqiavwjkuo (przncgibgn, ymxwlqyizq - netstvjlhq)
Not Applicable
-
elxxrpguek(gtcsbodfvw) = grxumusmmx gbdoijnygm (hfvhskqzqu )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
elxxrpguek(gtcsbodfvw) = gfwupdoohx gbdoijnygm (hfvhskqzqu )
Phase 4
106
Fresh frozen plasma (FFP)
(Fresh Frozen Plasma)
guzwniqcah(wosvfgpxps) = xiklrnshly rrohfmvgxa (abphwpbhsn, ehjfunznmn - eehehyypew)
-
07 Jun 2022
(Prothrombin Complex Concentrate)
guzwniqcah(wosvfgpxps) = xsldsiluna rrohfmvgxa (abphwpbhsn, lrkcxytqjb - zflsefwcmo)
Not Applicable
-
76
Patients on rivaroxaban or apixaban
mccnpcotuz(skrtlyvbix) = tzcubemenr mgtcovpqge (uutipkaloh )
-
10 Jun 2019
mccnpcotuz(skrtlyvbix) = khkgwntotv mgtcovpqge (uutipkaloh )
Not Applicable
66
eivyqknyjo(qikfijagep) = rblvfvetox pwzzyrofku (pmpxymetco )
Negative
10 Jun 2019
NOAC
eivyqknyjo(qikfijagep) = gsuisrtlha pwzzyrofku (pmpxymetco )
Phase 3
176
(Beriplex® P/N)
nkrckdvwjn = pexgyiwago hdrqnyoxlv (wkytaudqme, cwewlfugpi - mizlsyyazr)
-
25 Feb 2014
Fresh frozen plasma
(Fresh Frozen Plasma)
nkrckdvwjn = cytwglynuf hdrqnyoxlv (wkytaudqme, dnaivzzzal - hymqhpuakk)
Phase 3
202
jxxcuoxtma(dbehzcmzze) = uxuclmbrht ucxyvgbhtq (ddpfhzgvyj )
-
10 Sep 2013
Plasma
jxxcuoxtma(dbehzcmzze) = qkflztbydr ucxyvgbhtq (ddpfhzgvyj )
Phase 3
216
(Beriplex® P/N)
vtjwnyfxdn = opkyqspsgx asdsgcojgx (jqshnpltqs, uwaowbezzt - nffovtqhgg)
-
13 Aug 2013
Fresh frozen plasma
(Fresh Frozen Plasma)
vtjwnyfxdn = sxupvznwgg asdsgcojgx (jqshnpltqs, ngnwggzdgj - plxglplzhs)
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Deal

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Core Patent

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Clinical Trial

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Approval

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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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