• 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:  11/09/2011
 
Trade Name:  Chantix
 
Generic Name or Proper Name (*):  varenicline
 
Indications Studied:  Smoking cessation
 
Label Changes Summary:  * Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of age* Information on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years * Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Pfizer
 
NNPS:  FALSE
 
Therapeutic Category:  Smoking cessation
 
-
-