• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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
Therapeutic Category:  Anti-inflammatory