Canada - English - Health Canada

glenmark pharmaceuticals canada inc. - drospirenone; ethinyl estradiol - tablet - 3mg; 0.03mg - drospirenone 3mg; ethinyl estradiol 0.03mg - contraceptives

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

lupin australia pty limited - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - indicated for use:,? as an oral contraceptive.,? for the treatment of moderate acne vulgaris in women who seek oral contraception.,? for the 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 20 microgram/3 mg tablets for pmdd was not assessed beyond 3 cycles. ethinylestradiol/drospirenone 20 microgram/3 mg tablets have not been evaluated for treatment of pms (premenstrual syndrome) (see section 5.1 pharmacodynamic properties ? clinical trials).

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

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone and ethinyl estradiol tablets 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

Malta - English - Medicines Authority

bayer plc - drospirenone; ethinylestradiol - film-coated tablet - drospirenone 3 mg; ethinylestradiol 0.03 mg - sex hormones and modulators of the genital system

Malta - English - Medicines Authority

mithra pharmaceuticals s.a rue saint-georges 5, 4000, liege, belgium - ethinylestradiol, drospirenone - film-coated tablet - ethinylestradiol 0.02 mg drospirenone 3 mg - sex hormones and modulators of the genital system

Israel - English - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol - film coated tablets - drospirenone 3 mg; ethinylestradiol 0.02 mg - drospirenone and estrogen - - oral contraception. - 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 ).

Israel - English - Ministry of Health

easy care ltd, israel - drospirenone; ethinylestradiol - film coated tablets - ethinylestradiol 0.02 mg; drospirenone 3 mg - drospirenone and estrogen - - oral contraception.- 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 ethinylestradiol and drospirenone combination for pmdd was not assessed beyond 3 cycles. ethinylestradiol and drospirenone combination has not been evaluated for treatment of pms ( premenstrual syndrome ).

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - drospirenone; ethinylestradiol - film-coated tablet - 0.03 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - ethinylestradiol; drospirenone - film-coated tablet - 0.02 mg/ 3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - drospirenone; ethinylestradiol - film-coated tablet - 0.03 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol