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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:
02/27/2004
Trade Name:
Myfortic Delayed-Release Tablets
Generic Name or Proper Name (*):
mycophenolic acid
Indications Studied:
Prevention of organ rejection in patients receiving allogeneic renal transplants in children 5-16 years of age with stable renal transplants
Label Changes Summary:
Approval based on extrapolation of safety and effectiveness in adult patients One PK study with information down to 5 years of age Waived studies in birth to 10 years because there are too few children to study. New active ingredient
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Novartis
NNPS:
FALSE'
Therapeutic Category:
Immunosuppressant
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