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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
05/26/2017
Trade Name:
Isentress HD
Generic Name or Proper Name (*):
raltegravir
Indications Studied:
In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and in pediatric patients weighing at least 40 kg
Label Changes Summary:
*New 600 mg film coated tablet approved for once daily use. *Isentress HD once daily has not been studied in pediatric patients. However population PK modeling and simulation support the use of 1200 mg (2 x 600 mg) once daily in pediatric patients weighing at least 40 kg. *New dosage form.
PREA(P):
P
Sponsor:
Merck Sharp & Dohme Corp.
NNPS:
FALSE
Therapeutic Category:
Antiviral
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