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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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