Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiulcerative
 
-
-