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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:
09/15/2015
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 12
Label Changes Summary:
*Safety and efficacy Spiriva Respimat 2.5 mcg have been established in patients 12 to 17 years with asthma in 3 clinical trials up to 1 year in duration. *In 3 clinical trials, 327 patients aged 12 to 17 years with asthma were treated with Spiriva Respimat 2.5 mcg. *Safety and efficacy of Spiriva Respimat have not been established in pediatric patients less than 12 years of age. *Adverse reactions in adolescents were similar to those observed in adults. *Information on dosing, adverse reactions and clinical trials in adults and adolescents. *New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Boehringer Ingelheim
NNPS:
FALSE
Therapeutic Category:
Antiasthmatic
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