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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:
02/07/2007
Trade Name:
Actiq
Generic Name or Proper Name (*):
fentanyl
Indications Studied:
Treatment of breakthrough pain in opioid tolerant children
Label Changes Summary:
Safety and efficacy in patients below the age of 16 years was not established in a clinical trial of 15 patients 5 to 15 years Information on PK parameters and clinical studies
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Cephalon
NNPS:
FALSE'
Therapeutic Category:
Anesthetic agent
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