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U.S. Department of Health and Human Services

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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