Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Roche
 
Pediatric Exclusivity Granted Date:  09/18/1998
 
NNPS:  FALSE'
 
Therapeutic Category:  Hypnotic
 
-
-