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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:  09/19/2008
 
Trade Name:  Retrovir syrup, capsules and tablets
 
Generic Name or Proper Name (*):  zidovudine
 
Indications Studied:  Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection
 
Label Changes Summary:  * Dosing and administration information provided to children 6 weeks to less than 18 years of age * Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies * New dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  TRUE
 
Therapeutic Category:  Antiviral
 
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