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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B) and PREA(P):
B,P
Sponsor:
Boehringer Ingelheim
NNPS:
FALSE
Therapeutic Category:
Antiasthmatic
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