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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:
04/29/2011
Trade Name:
Nexium IV
Generic Name or Proper Name (*):
esomeprazole
Indications Studied:
Treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis
Label Changes Summary:
Extended indication from adults to pediatric patients 1 month to 17 years Use in pediatric patients 1 month to 17 years is supported by studies in adults, and PK and PD studies performed in pediatric patientsEffectiveness has not been established in patients less than 1 month of ageInformation on dosing, adverse reactions, pharmacokinetics and clinical trialPostmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
AstraZeneca
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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