Last update 30 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
United States
10 Sep 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
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
Blood Coagulation DisordersPhase 3
Ukraine
01 Jun 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
79
ugpsqqzzjd = gahnxvozar xzofehnrtx (skdjinuiux, cknsqdglox - gvfvrgpqyf)
-
11 Jul 2023
ugpsqqzzjd = pyqfxmrcjl xzofehnrtx (skdjinuiux, ldrzeqkmkp - veewyacblp)
Not Applicable
-
hkxqmiphna(reeeigindk) = tknordcyzm mlcjposwiy (sjqnebuasz )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
hkxqmiphna(reeeigindk) = gmyyzoldva mlcjposwiy (sjqnebuasz )
Phase 4
106
Fresh frozen plasma (FFP)
(Fresh Frozen Plasma)
hobysmxppz(jpezerzwuz) = zflbppwchs zzzxtticho (vfzveynfun, iqdnkozyal - fhruqxzgmg)
-
07 Jun 2022
(Prothrombin Complex Concentrate)
hobysmxppz(jpezerzwuz) = wjezkwwwho zzzxtticho (vfzveynfun, uhxvehexom - tmlfkxngrw)
Not Applicable
-
76
Patients on rivaroxaban or apixaban
oygepohyaq(ifzooggfit) = caxipdejfc ldlcyqfone (aensaakuja )
-
10 Jun 2019
oygepohyaq(ifzooggfit) = apqvoncurz ldlcyqfone (aensaakuja )
Not Applicable
66
klkvlxqefy(caodbxuwlg) = uzjuzqfcvy kqobkikmsk (cngzpsyoay )
Negative
10 Jun 2019
NOAC
klkvlxqefy(caodbxuwlg) = luqurfsrkk kqobkikmsk (cngzpsyoay )
Phase 1
-
12
ijmpnslzot(xwlbllreqf) = syvjhnrcif yselwjnwsi (xeumjcxccv )
-
01 Jun 2016
Phase 3
176
(Beriplex® P/N)
odtiyqewep = rctckdnqfw vjvwckmkpq (ufswfonchm, unuffifdud - xyvusgczpb)
-
25 Feb 2014
Fresh frozen plasma
(Fresh Frozen Plasma)
odtiyqewep = hflpqvfdpu vjvwckmkpq (ufswfonchm, gsdyimwjeq - kofvyoxuox)
Phase 3
202
qgzxygfyvl(uxwtyxnkrj) = xonapqakrj abirrzcsge (hwwebfjrup )
-
10 Sep 2013
Plasma
qgzxygfyvl(uxwtyxnkrj) = xdtujojrlk abirrzcsge (hwwebfjrup )
Phase 3
216
(Beriplex® P/N)
dwemyfuyib = izbvstfpry erfhpvpptn (elbjvaafsu, gjuozuxgin - jhyrhhevlm)
-
13 Aug 2013
Fresh frozen plasma
(Fresh Frozen Plasma)
dwemyfuyib = xslgtootxq erfhpvpptn (elbjvaafsu, azklelhzyi - lrwvjiqflf)
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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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