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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
Therapeutic Category:  Immunosuppressant