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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:  08/13/2010
 
Trade Name:  ella
 
Generic Name or Proper Name (*):  ulipristal acetate
 
Indications Studied:  Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
 
Label Changes Summary:  * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for post pubertal adolescents <18 years and for users 18 years and older. * Use of ella before menarche is not indicated * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Laboratoire HRA Pharma
 
NNPS:  TRUE
 
Therapeutic Category:  Contraceptive
 
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