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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:  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  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Eisai Medical Research
Therapeutic Category:  Antiulcerative