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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/20/2000
 
Trade Name:  CellCept
 
Generic Name or Proper Name (*):  mycophenylate
 
Indications Studied:  Prophylaxis of organ rejection in renal transplant patients
 
Label Changes Summary:  * Approved for use down to 3 months of age as a combination regimen with cyclosporine and corticosteroids
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE
 
Therapeutic Category:  Immunosuppressant
 
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