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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:
12/15/2011
Trade Name:
Nexium
Generic Name or Proper Name (*):
esomeprazole
Indications Studied:
Erosive esophagitis due to acid-mediated gastroesophageal reflux disease
Label Changes Summary:
Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients Safety and effectiveness have not been established in neonatesInformation on weight-based dosing, adverse reactions, clinical study
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
AstraZeneca
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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