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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:  08/11/2005
 
Trade Name:  Mobic
 
Generic Name or Proper Name (*):  meloxicam
 
Indications Studied:  Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis
 
Label Changes Summary:  Safety and efficacy established in patients 2 years of age and older Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk Information on dose, PK parameters, AE profile and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Boehringer Ingelheim
 
Pediatric Exclusivity Granted Date:  04/15/2005
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory
 
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