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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:  05/10/2018
 
Trade Name:  Briviact
 
Generic Name or Proper Name (*):  brivaracetam
 
Indications Studied:  Treatment of partial onset seizures (POS) to include patients 4 years to less than 16 years of age
 
Label Changes Summary:  *Safety and effectiveness of Briviact tablets and oral solution have been established in pediatric patients 4 years to less than 16 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Briviact in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 149 pediatric patients 4 years to less than 16 years. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Briviact injection in pediatric patients has not been established. *Adverse reactions, including psychiatric adverse reactions, were observed in open-label pediatric trials and were generally similar to those observed in adults. *Information on dosing, dosing in pediatric patients with hepatic impairment, PK parameters, adverse reactions, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  UCB, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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