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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:
02/28/2018
Trade Name:
Cimduo
Generic Name or Proper Name (*):
lamivudine and tenofovir disoproxil fumarate
Indications Studied:
Treatment of HIV-1 infection in adult and pediatric patients weighing at least 35 kg
Label Changes Summary:
*Safety and effectiveness as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue CIMDUO as clinically appropriate. *New drug.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Mylan
NNPS:
FALSE
Therapeutic Category:
Antiviral
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