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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
06/30/2008
Trade Name:
Aciphex
Generic Name or Proper Name (*):
rabeprazole
Indications Studied:
Gastroesophageal reflux in adolescent patients 12 years of age and above
Label Changes Summary:
Use in adolescent patients 12 years of age and older is supported by extrapolation of results from studies in adults and safety and PK studies performed in adolescent patients Safety and effectiveness for GERD have not been established for pediatric patients <12 years of age Safety and effectiveness for other uses have not been established in pediatric patients Adverse events (Aes) similar to those seen in adults Information on dose, Aes, clinical studies
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Eisai Medical Research
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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