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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:  03/14/2012
 
Trade Name:  Natazia
 
Generic Name or Proper Name (*):  estradiol valerate and estradiol valerate/dienogest
 
Indications Studied:  Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception
 
Label Changes Summary:  "Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older "Use of this product before menarche is not indicated "New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
Therapeutic Category:  Contraceptive
 
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