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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:  02/15/2017
 
Trade Name:  Spiriva Respimat Inhalation Spray
 
Generic Name or Proper Name (*):  tiotropium bromide
 
Indications Studied:  Long-term, once-daily, maintenance treatment of asthma in patients 6 through 11 years of age
 
Label Changes Summary:  *Expanded indication down to 6 years and older based on three clinical trials in patients 6 to 11 years; previously approved in 12 years and older. *The safety and efficacy have not been established in pediatric patients less than 6 years of age. *The safety of Spiriva Respimat delivered with a valved holding chamber with facemask once daily has been studied in pediatric patients with asthma aged 1 to 5 years who were on background treatment of at least Inhaled Corticosteroid in one placebo-controlled clinical trial of 12 weeks duration. *The adverse reaction profile was similar to that observed in adults and older pediatric patients. *Information on dosing, adverse reactions and clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Boehringer Ingelheim
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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