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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  05/17/2012
 
Trade Name:  Pertzye
 
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:  1-17 years
 
Study #:  4
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label/Active Control/Crossover
 
No Patients:  6
 
No Centers:  1
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  0
 
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