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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:
03/19/2007
Trade Name:
Keppra Tablets/ Keppra Oral Solution
Generic Name or Proper Name (*):
levetiracetam
Indications Studied:
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in children 6 years of age and older with idiopathic generalized epilepsy
Label Changes Summary:
Safety and effectiveness established in study that included patients down to 4 years of age Pediatric dosing information added Studies waived in children 1 month to 2 years of age and deferred in children 2-6 years of age New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
UCB
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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