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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  04/29/2011
 
Trade Name:  Nexium IV
 
Generic or Proper Name (*):  esomeprazole
 
Indications Studied:  Treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis
 
Therapeutic Category:  Antiulcerative
 
Study #:  1
 
Study Type:  Pharmacokinetic
 
Study Design:  Open Label/Traditional PK
 
No Patients:  59
 
No Centers:  10
 
No Countries:  4
 
BPCA(B), PREA(P):  P
 
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