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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:
10/06/2006
Trade Name:
Risperdal Tablets Risperdal Oral Solution Risperdal M-Tabs
Generic Name or Proper Name (*):
risperidone
Indications Studied:
Treatment of irritability associated with autistic disorder in children 5 years of age and older
Label Changes Summary:
Effectiveness and safety established based on two 8 week studies in patients 5-16 years of age and one long-term study of 4-6 months Studies waived in children under 2 years of age due to difficulty to diagnose and treat this population New indicatiContraindicated in infants, small children, or any child who may be unable to swallow a capsule. Dosing information provided Information to monitor disease provided No clinical studies submitted New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Janssen
NNPS:
FALSE'
Therapeutic Category:
Antipsychotic
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