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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:
06/29/2018
Trade Name:
Yondelis injection
Generic Name or Proper Name (*):
trabectedin
Indications Studied:
Pediatric histotypes of sarcoma
Label Changes Summary:
*Safety and effectiveness in pediatric patients have not been established. *Safety (n=61) and efficacy (n=58) were assessed across five open-label studies in pediatric patients (aged 2 to less than 17 years) with pediatric histotypes of sarcoma. *No new safety signals were observed in pediatric patients across these studies. *Pharmacokinetic parameters in 17 pediatric patients (aged 3 to 17 years) were within the range of values previously observed in adults given the same dose per body surface area.
BPCA(B):
B
Sponsor:
Janssen
NNPS:
FALSE
Therapeutic Category:
Antineoplastic
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