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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:
12/28/2001
Trade Name:
Rebetron; Rebetrol
Generic Name or Proper Name (*):
ribavirin/intron a; ribavirin
Indications Studied:
Chronic hepatitis C
Label Changes Summary:
Labeling for 3 years to 16 years There are no safety and efficacy data on treatment for longer than 48 weeks in pediatric patients Pharmacokinetic information on patients 5 to 16 years with chronic hepatitis C virus infection Increased incidence of suicidal ideation or attempts (2.4% versus 1%) among pediatric patients compared to adult patients Decrease in rate of linear growth (mean percentile assignment decrease of 9%) and in rate of weight gain (mean percentile assignment decrease of 13%) during 48 weeks of treatment; a general reversal was noted during the 24 week post treatment period Patients with viral genotype 1, had a lower response rate to combination therapy compared to patients with genotype non-1, 36% versus 81% In general, the adverse event profile in the pediatric population was similar to that observed in adults New oral suspension developed
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Schering
Pediatric Exclusivity Granted Date:
05/09/2001
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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