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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:
01/11/2016
Trade Name:
E-Z-HD
Generic Name or Proper Name (*):
barium sulfate
Indications Studied:
For use in double contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal tract in patients 12 years and older
Label Changes Summary:
*Approved for use in adults and pediatric patients 12 years and older *Safety and efficacy have not been approved in pediatric patients less than 12 years of age * Information on dosing, adverse reactions *New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Bracco Diagnostics
NNPS:
FALSE
Therapeutic Category:
Medical imaging
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