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

lupin australia pty limited - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; magnesium stearate; maize starch; titanium dioxide; hypromellose; macrogol 400 - ethinylestradiol/ drospirenone tablet is indicated for use as:,?an oral contraceptive.,?treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of ethinylestradiol/ drospirenone tablet for pmdd was not assessed beyond 3 cycles. ethinylestradiol/ drospirenone tablet has not been evaluated for treatment of pms (premenstrual syndrome).

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

teva pharmaceuticals usa, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - vestura®  (drospirenone and ethinyl estradiol) tablets are indicated for use by females of reproductive potential to prevent pregnancy. vestura is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. the effectiveness of vestura for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal ph

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - drospirenone 3mg (micro 15); ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) - tablet - 3mg/0.02mg - active: drospirenone 3mg (micro 15) ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) excipient: lactose monohydrate magnesium stearate maize starch opadry pink 02a34744 hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose purified talc titanium dioxide hypromellose lactose monohydrate magnesium stearate maize starch povidone purified talc titanium dioxide - yaz is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception. - treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms (premenstrual syndrome).

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - drospirenone 3mg (micronised); ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg); levomefolate calcium 0.451mg (micronised); levomefolate calcium 0.451mg (micronised) - film coated tablet - 3mg/0.02mg/0.451mg - active: drospirenone 3mg (micronised) ethinylestradiol betadex clathrate 0.02mg (ethinylestradiol betadex clathrade amount equivalent ethinylestradiol 0.02mg) levomefolate calcium 0.451mg (micronised) excipient: croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink active: levomefolate calcium 0.451mg (micronised) excipient: croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 02f32737 - an oral contraceptive · oral contraception in women seeking to improve folate levels whilst taking oral contraception

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - ethinylestradiol; levonorgestrel - tablet - 100/20 microgram(s) - progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

gedeon richter plc - ethinyloestradiol; levonorgestrel; levonorgestrel; ethinylestradiol; levonorgestrel; ethinylestradiol - coated tablet - . milligram(s) - progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

theramex ireland limited - ethinylestradiol; drospirenone - film-coated tablet - 0.02 mg / 3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and estrogen

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

eurodrug laboratories (m) sdn. bhd. - drospirenone; ethinylestradiol -

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo pharma b.v. - drospirenone 3 mg (pink tablet); ethinylestradiol 0,02 mg (pink tablet); placebo (white tablet) - film-coated tablet - 0,02 mg - 3 mg - drospirenone 3 mg; ethinylestradiol 0.02 mg; placebo - drospirenone and ethinylestradiol

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

effik benelux sa-nv - drospirenone 3 mg (pink tablet); ethinylestradiol 0,02 mg (pink tablet); placebo (white tablet) - film-coated tablet - 0,02 mg - 3 mg - drospirenone 3 mg; ethinylestradiol 0.02 mg; placebo - drospirenone and ethinylestradiol