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NDA022252 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage • Estradiol Valerate And Estradiol Valerate/dienogest Is An Estrogen/progestin Coc Indicated For Use By Women To Prevent Pregnancy. ( 1 ) • Treatment Of Heavy Menstrual Bleeding In Women Without Organic Pathology Who Choose To Use An Oral Contraceptive As Their Method Of Contraception. ( 1.2 ) • The Efficacy Of Estradiol Valerate And Estradiol Valerate/dienogest In Women With A Body Mass Index (Bmi) Of >30 Kg/m 2 Has Not Been Evaluated. ( 1 , 8.8 ) 1.1 Oral Contraception Estradiol Valerate And Estradiol Valerate/dienogest Is Indicated For Use By Women To Prevent Pregnancy. The Efficacy Of Estradiol Valerate And Estradiol Valerate/dienogest In Women With A Body Mass Index (Bmi) Of > 30 Kg/m 2 Has Not Been Evaluated. 1.2 Heavy Menstrual Bleeding Estradiol Valerate And Estradiol Valerate/dienogest Is Also Indicated For The Treatment Of Heavy Menstrual Bleeding In Women Without Organic Pathology Who Choose To Use An Oral Contraceptive As Their Method Of Contraception [See Clinical Studies ( 14.2 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Estradiol Valerate And Estradiol Valerate/dienogest

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