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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:
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 ageInformation on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years Postmarketing study
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Pfizer
NNPS:
FALSE'
Therapeutic Category:
Smoking cessation
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