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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:  12/13/2001
 
Trade Name:  Elidel
 
Generic Name or Proper Name (*):  pimecrolimus
 
Indications Studied:  Treatment of mild/moderate atopic dermatitis
 
Label Changes Summary:  * Indicated for short-term and intermittent long-term therapy for mild to moderate atopic dermatitis in non-immunocompromised patients 2 years and older * Not recommended for use in pediatric patients less than 2 years of age. Infants on Elidel Cream had an increased incidence of some adverse events compared to vehicle which included pyrexia, URI, nasopharyngitis, gastroenteritis, otitis media, and diarrhea.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  09/24/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Immunomodulator
 
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