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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:  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:  urlLabeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  False
 
Therapeutic Category:  Antiasthmatic
 
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