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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:  11/06/2009
 
Trade Name:  Retrovir
 
Generic Name or Proper Name (*):  zidovudine
 
Indications Studied:  Treatment of HIV-1 infection in combination with other antiretroviral agents
 
Label Changes Summary:  * Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  TRUE
 
Therapeutic Category:  Antiviral
 
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