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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:
12/16/2011
Trade Name:
Keppra
Generic Name or Proper Name (*):
levetiracetam
Indications Studied:
Adjunctive therapy in the treatment of partial onset seizures
Label Changes Summary:
Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and olderIn pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patientsInformation on dosing, clinical trial, adverse reactions
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
UCB
Pediatric Exclusivity Granted Date:
06/03/2008
NNPS:
TRUE'
Therapeutic Category:
Anticonvulsant
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