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

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

bayer australia ltd - drospirenone,ethinylestradiol -

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

alphapharm pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 0.03 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; polacrilin potassium - drospirenone/ethinyloestradiol-alphapharm 3/30 is indicated for use as an oral contraceptive.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.02 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram

Israel - English - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol - film coated tablets - drospirenone 3 mg; ethinylestradiol 0.03 mg - drospirenone and estrogen - drospirenone and estrogen - oral contraception.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.02 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - drospirenone ethinylestradiol - film coated tablet - 0.03 / 3 milligram