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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:
06/18/2009
Trade Name:
Nexium
Generic Name or Proper Name (*):
esomeprazole
Indications Studied:
Short-term treatment of GERD
Label Changes Summary:
Effectiveness was not demonstrated in a randomized, placebo-controlled study in neonates to < 1 year Information on clinical study, PK/PD parameters
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
05/01/2009
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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