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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:
04/28/2006
Trade Name:
Nexium
Generic Name or Proper Name (*):
esomeprazole
Indications Studied:
Short-term treatment of GERD
Label Changes Summary:
Use in adolescent patients 12 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in adolescent patients Safety and effectiveness in patients < 12 years has not been established Safety and effectiveness for other pediatric uses have not been established Information on dose, treatment related AEs, clinical study
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
05/01/2009
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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