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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:
08/30/2002
Trade Name:
Nolvadex
Generic Name or Proper Name (*):
tamoxifen
Indications Studied:
McCune-Albright Syndrome
Label Changes Summary:
A study in 28 female patients aged 2-10 years with McCune-Albright Syndrome and precocious puberty did not demonstrate safety and effectiveness. Long term effects have not been established Mean uterine volume increased after 6 months of therapy and doubled at end of 1-year study
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
05/16/2002
NNPS:
FALSE'
Therapeutic Category:
Hormone
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