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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:  08/28/2009
 
Trade Name:  Valcyte
 
Generic Name or Proper Name (*):  valganciclovir
 
Indications Studied:  Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age
 
Label Changes Summary:  * Use in pediatric patients e 4 months is based on efficacy data from a study in adults and PK, safety, and efficacy data from an open-label trial in pediatric solid organ transplant recipients at risk for developing CMV disease * The efficacy and safety have not been established in children for: 1. Prevention of CMV disease in liver transplant patients 2. Prevention of CMV disease in solid organ transplants other than those indicated 3. Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age 4. Treatment of congenital CMV disease * Adverse events (AEs) similar to adult patients, however, certain Aes including upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, and neutropenia were reported more frequently in pediatric patients * Information on dosing, PK, and clinical study * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Roche
 
Pediatric Exclusivity Granted Date:  07/24/2008
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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