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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:  08/02/2012
 
Trade Name:  Risperdal
 
Generic Name or Proper Name (*):  risperidone
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  Information on postmarketing clinical study of a lower than recommended dose for irritability associated with autistic patients in patients 5 to 17 years Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
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