Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Boehringer Ingelheim
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
-
-