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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:  11/09/2007
 
Trade Name:  Kaletra Oral Solution, 80 mg/20 mg & Kaletra (1opinavir/ritonavir) Tablets, 200 mg/50 mg
 
Generic Name or Proper Name (*):  lopinavir/ ritonavir
 
Indications Studied:  HIV -1 protease inibitor indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection.
 
Label Changes Summary:  Dosing and administration information provided for children Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg New dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Abbott Laboratories
 
NNPS:  TRUE'
 
Therapeutic Category:  Antiviral
 
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