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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:
02/26/2015
Trade Name:
Liletta
Generic Name or Proper Name (*):
levonorgestrel-releasing intrauterine system
Indications Studied:
Prevention of pregnancy for up to 3 years
Label Changes Summary:
*Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under 16 years and for users 16 years and older *Use before menarche is not indicated *New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Medicines360
NNPS:
TRUE
Therapeutic Category:
Contraceptive
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