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Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

Trial Profile

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2019

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At a glance

  • Drugs Turoctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms PATHFINDER 3
  • Sponsors Novo Nordisk; Novo Nordisk Pharma
  • Most Recent Events

    • 20 Jun 2019 According to a Novo Nordisk media release, the European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents (=12 years of age) and adults with haemophilia A.
    • 26 Apr 2019 The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of Esperoct (turoctocog alfa pegol, N8-GP) recommending marketing authorisation for the treatment of adolescents and adults with haemophilia A, based on the results from this study.
    • 26 Feb 2019 This trial has been completed in Germany, according to European Clinical Trials Database.
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