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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:
08/22/2007
Trade Name:
Risperdal
Generic Name or Proper Name (*):
risperidone
Indications Studied:
Schizophrenia; short-term treatment of acute manic or mixed Episodes associated with Bipolar I Disorder
Label Changes Summary:
Extended schizophrenia indication from adults to adolescents 1317 years; extended bipolar mania indication from adults to children and adolescents 10-17 years Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established No additional benefit was seen above 3 mg/day in schizophrenia studies and 2.5 mg/day in the Bipolar mania study; higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied. Information on dose, clinical studies, AE profile
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Johnson & Johnson
Pediatric Exclusivity Granted Date:
02/28/2007
NNPS:
FALSE'
Therapeutic Category:
Antipsychotic
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