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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:
04/07/2017
Trade Name:
Sovaldi
Generic Name or Proper Name (*):
sofosbuvir
Indications Studied:
In combination with ribavirin for the treatment of chronic hepatitis C virus genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 to 17 years of age or weighing at least 35 kg
Label Changes Summary:
*Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Sovaldi was evaluated in an open-label clinical trial which included 50 patients 12 years of age and older. *Safety and efficacy have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg with HCV genotype 2 or 3. Safety and efficacy have not been established in pediatric patients with HCV genotype 1 or 4. *Adverse reactions were similar to those observed in adults. *Information on dosing,clinical trial, and PK.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Gilead Sciences
NNPS:
FALSE
Therapeutic Category:
Antiviral
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