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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:
04/29/2016
Trade Name:
Fycompa
Generic Name or Proper Name (*):
perampanel
Indications Studied:
Adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older
Label Changes Summary:
* New Fycompa oral suspension has comparable bioavailability to Fycompa tablets under steady state. Both formulations may be used interchangeably. *Measure oral suspension using provided adaptor and dosing syringe. * Information on administration of oral suspension. *New formulation.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Eisai Inc.
NNPS:
FALSE
Therapeutic Category:
Anticonvulsant
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