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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:
05/27/2016
Trade Name:
Ativan Injection
Generic Name or Proper Name (*):
lorazepam
Indications Studied:
Status epilepticus
Label Changes Summary:
*Safety and effectiveness for status epilepticus have not been established in pediatric patients. *A randomized, double-blind, superiority-design clinical trial of Ativan versus intravenous diazepam in 273 pediatric patients ages 3 months to 17 years failed to establish efficacy for the treatment of status epilepticus. *Information on adverse reactions, and clinical trial. *Off-patent Written Request.
BPCA(B):
B
Sponsor:
Eurohealth International SARL
NNPS:
FALSE
Therapeutic Category:
Anticonvulsant
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