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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:  10/01/2009
 
Trade Name:  Mirena
 
Generic Name or Proper Name (*):  levonorgestrel-releasing intrauterine system
 
Indications Studied:  Treatment of heavy menstrual bleeding for women using intrauterine contraception
 
Label Changes Summary:  * New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception * Use before menarche is not indicated
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Berlex
 
NNPS:  TRUE
 
Therapeutic Category:  Contaceptive
 
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