Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - estradiol valerate, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; povidone; purified talc; maize starch - oral contraception. treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception.

Malta - English - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - dienogest, estradiol valerate - film-coated tablet - estradiol valerate dienogest - sex hormones and modulators of the genital system

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - estradiol valerate; dienogest - oral tablet - 2mg ; 2mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - dienogest; estradiol valerate - oral tablet - 3mg ; 2mg

United States - English - NLM (National Library of Medicine)

sandoz inc - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - 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/m2 has not been evaluated. 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)]. do not prescribe estradiol valerate and estradiol valerate/dienogest to women who are known to have the following: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce w

Malta - English - Medicines Authority

bayer plc - dienogest; estradiol valerate - film-coated tablet - dienogest 4.41 mg; estradiol valerate - sex hormones and modulators of the genital system

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - estradiol valerate; estradiol valerate; dienogest; dienogest; estradiol valerate - film-coated tablet - 0 milligram(s) - progestogens and estrogens, fixed combinations; dienogest and ethinylestradiol

Israel - English - Ministry of Health

bayer israel ltd - dienogest; dienogest; estradiol valerate; estradiol valerate; estradiol valerate - film coated tablets - estradiol valerate 1 mg; estradiol valerate 3 mg; dienogest 2 mg; dienogest 3 mg; estradiol valerate 2 mg - estradiol - estradiol - oral contraception.treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - estradiol valerate; dienogest -

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - estradiol valerate 3mg; dienogest 2mg; estradiol valerate 2mg; dienogest 3mg; estradiol valerate 2mg; estradiol valerate 1mg - film coated tablet - active: estradiol valerate 3mg excipient: hypromellose iron oxide yellow lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone pregelatinised maize starch purified talc titanium dioxide active: dienogest 2mg estradiol valerate 2mg excipient: hypromellose iron oxide red lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone pregelatinised maize starch purified talc titanium dioxide active: dienogest 3mg estradiol valerate 2mg excipient: hypromellose iron oxide yellow lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone pregelatinised maize starch purified talc titanium dioxide active: estradiol valerate 1mg excipient: hypromellose iron oxide red lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone pregelatinised maize starch purified talc titanium dioxide hypromellose lactose monohydrate magnesium stearate maize starch povidone pregelatinised maize starch purified talc titanium dioxide - oral contraception.