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Efficacy and Safety of Ultrase MT20 in Improving the Coefficient of Fat Absorption (CFA%) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)

Trial Profile

Efficacy and Safety of Ultrase MT20 in Improving the Coefficient of Fat Absorption (CFA%) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2017

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At a glance

  • Drugs Pancrelipase (Primary)
  • Indications Pancreatic disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Aptalis
  • Most Recent Events

    • 29 Apr 2016 According to an Allergan media release, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted a positive opinion for the marketing authorization of pacnrelipase (ENZEPI) for patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
    • 23 Apr 2014 New trial record
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