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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:  12/21/2011
 
Trade Name:  Isentress
 
Generic Name or Proper Name (*):  raltegravir
 
Indications Studied:  In combination with other antiretroviral agents for the treatment of HIV-1 infection
 
Label Changes Summary:  *Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg *Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years *Safety and effectiveness in patients <2 years have not been established*Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet *Safety profile similar to that observed in adults *Information on dosing, adverse reactions, clinical trial and PK parameters *New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Merck
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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