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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:
05/06/2010
Trade Name:
Natazia
Generic Name or Proper Name (*):
estradiol valerate and estradiol valerate/dienogest
Indications Studied:
Prevention of pregnancy
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 drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Bayer
NNPS:
TRUE'
Therapeutic Category:
Contaceptive
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