Last update 26 May 2025

Human prothrombin complex (Octapharma)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
4 Factor Prothrombin Concentrate Complex - Octapharma, 4-FACTOR PCC, 4F PCC
+ [6]
Action
modulators
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (21 Jul 2023),
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
Acquired coagulation factor deficiency
United States
21 Jul 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhagePhase 3
United States
08 Jun 2017
HemorrhagePhase 3
Belarus
08 Jun 2017
HemorrhagePhase 3
Bulgaria
08 Jun 2017
HemorrhagePhase 3
Georgia
08 Jun 2017
HemorrhagePhase 3
Germany
08 Jun 2017
HemorrhagePhase 3
Poland
08 Jun 2017
HemorrhagePhase 3
Romania
08 Jun 2017
HemorrhagePhase 3
Russia
08 Jun 2017
HemorrhagePhase 3
Spain
08 Jun 2017
HemorrhagePhase 3
Ukraine
08 Jun 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
FDA
ManualManual
Not Applicable
208
mceisygkhl(wtcrvmmmig) = pxtumzhnhu sodhczkuur (udvzlhihsw )
Positive
21 Jul 2023
mceisygkhl(wtcrvmmmig) = uwruaovhgv sodhczkuur (udvzlhihsw )
Phase 3
208
(Octaplex)
vbrvmmckyg = ojwqxvcwzd apepdateiw (qdnzmxkdrq, qpmkopvpwi - kaegjvfxwd)
-
08 Mar 2023
Beriplex P/N (Kcentra)
(Beriplex P/N (Kcentra))
vbrvmmckyg = wffpkvqzjw apepdateiw (qdnzmxkdrq, wwthamfhdu - bpnvakwoav)
Phase 3
-
200
(Octaplex (Human Prothrombin Complex Concentrate))
xlursqfodq = cdfiuftrxu wgzcljfzbb (zjkiphtjii, dpjweqxefq - xbztwxacgm)
-
31 Jan 2023
Fresh frozen plasma
(Fresh Frozen Plasma)
xlursqfodq = ttklnbwrng wgzcljfzbb (zjkiphtjii, ngjqtkkdio - kztbjaqkmj)
Not Applicable
-
-
urpehrwdbk(mtxuivfcds) = gbcxbxfmph svcqfygnqs (mqysocgtxu )
-
09 Jul 2022
urpehrwdbk(mtxuivfcds) = gsehzxrpnl svcqfygnqs (mqysocgtxu )
Not Applicable
-
Fixed-dose 1500-unit 4F-PCC
daylyuvveo(itvbzdukwc) = wipbsfzdee vpltiktwep (eddrmogssp )
-
17 Jul 2021
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Clinical Trial

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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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