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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  10/18/2016
 
Trade Name:  Zemplar
 
Generic Name or Proper Name (*):  paricalcitol
 
Indications Studied:  Secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3, 4 and 5 in pediatric patients 10 to 16 years
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 10 to 16 years of age. *Use in this age group is supported by evidence from adequate and well controlled studies in adults with CKD, a 12-week double-blind placebo-controlled randomized multicenter study in 36 pediatric patients 10 to 16 years of age with CKD Stages 3 and 4, and safety data from a 12-week open-label single-arm multicenter study in 13 pediatric patients 10 to 16 years of age with CKD Stage 5 receiving peritoneal dialysis or hemodialysis. *Safety and effectiveness in pediatric patients under the age of 10 years have not been established. *Adverse reactions were similar to those reported in adults. *Information on dosing, pharmacokinetic parameters, and clinical trial. *Postmarketing study
 
PREA(P):  P
 
Sponsor:  AbbVie Inc.
 
NNPS:  FALSE
 
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