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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  UCB
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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