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U.S. Department of Health and Human Services

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 patients* Effectiveness has not been established in patients less than 1 month of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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