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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:
06/17/2004
Trade Name:
Prevacid
Generic Name or Proper Name (*):
lansoprazole
Indications Studied:
Short-term treatment of symptomatic GERD and erosive Esophagitis
Label Changes Summary:
Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients <1 year of age have not been established Information on dose, PK parameters, and AE profile
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Tap
Pediatric Exclusivity Granted Date:
07/15/2008
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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