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: 03 Oct 2021
Price :
$35
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At a glance
- Drugs Pancrelipase (Primary)
- Indications Pancreatic disorders
- Focus Registrational; Therapeutic Use
- Sponsors Aptalis
- 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