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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
03/01/2012
Trade Name:
Ultresa
Generic or Proper Name (*):
pancrelipase
Indications Studied:
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
Therapeutic Category:
Pancreatic enzyme
Ages Studied:
1 - < 4 years (weighing 14 kg or more) and patients 4 - 17 years (weighing 28 kg or more)
Study #:
1
Study Type:
Efficacy/Safety
Study Design:
Blind/Placebo
No Patients:
15
No Centers:
8
No Countries:
1
BPCA(B), PREA(P):
P
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