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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Medicines360
 
NNPS:  TRUE
 
Therapeutic Category:  Contraceptive
 
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