Human prothrombin complex - CSL Behring

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: 15 Apr 2016

Price : $50

At a glance

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

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

    Yes - Haemorrhage
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemorrhage

Most Recent Events

  • 01 Mar 2016 CSL Behring completes a phase IIIb trial for Haemorrhage in Japan (NCT02281201)
  • 08 Sep 2015 CSL Behring receives extension of new technology add-on payment from the U.S. Centres for Medicare and Medicaid Services for human prothrombin complex for development in Haemorrhage
  • 17 Mar 2015 Efficacy data from a phase IIIb trial in Haemorrhage (Prevention) released by CSL Behring
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