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Human prothrombin complex - CSL Behring

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Drug Profile

Human prothrombin complex - CSL Behring

Alternative Names: 4-factor PCC; 4-factor prothrombin complex concentrate; BE 1116; Beriplex; Beriplex P/N; Confidex; Kcentra

Latest Information Update: 13 Apr 2023

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At a glance

  • Originator CSL Behring
  • Class Blood coagulation factors
  • Mechanism of Action Blood coagulation factor replacements; Factor IX stimulants; Factor VII stimulants; Factor X stimulants; Protein C inhibitors; Prothrombin stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haemorrhage
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemorrhage

Most Recent Events

  • 28 Mar 2023 Phase-III clinical trials in Haemorrhage (In adolescents, In adults, In the elderly) in USA (IV) (NCT05568888)
  • 18 Oct 2021 CSL plans to initiate a phase III trial in Haemorrhage
  • 30 Sep 2017 Launched for Haemorrhage in Japan (IV)

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