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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:
10/15/1998
Trade Name:
Versed
Generic Name or Proper Name (*):
midazolam
Indications Studied:
Sedation/anxiolysis/ amnesia
Label Changes Summary:
Specified the effective dose, effective dose range, and time of onset Defined volume of distribution and similarity to adult protein binding and elimination Additional information on AE's and warnings about concomitant medications Identified a subpopulation (children with congenital heart disease and pulmonary hypertension) at higher risk for AE's and the need to start therapy at the lower end of the dosing range
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Roche
Pediatric Exclusivity Granted Date:
09/18/1998
NNPS:
FALSE'
Therapeutic Category:
Hypnotic
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