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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:  10/06/2005
 
Trade Name:  Norvir
 
Generic Name or Proper Name (*):  ritonavir
 
Indications Studied:  Treatment of HIV-infection in combination with other antiretroviral agents
 
Label Changes Summary:  * Extended age range from 2 years down to 1 month * AE profile in the pediatric population was similar to that for adults * Information on dose and PK parameters
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Abbott
 
Pediatric Exclusivity Granted Date:  06/14/2005
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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