• 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:  12/19/2012
 
Trade Name:  Advair HFA
 
Generic Name or Proper Name (*):  fluticasone/ salmeterol
 
Indications Studied:  Treatment of asthma
 
Label Changes Summary:  Safety and effectiveness in children < 12 years have not been established.Information on clinical trials, adverse reactions, and pharmacokinetics/ pharmacodynamics, Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
-
-