Kanada - İngilizce - Health Canada

glenmark pharmaceuticals canada inc. - drospirenone; ethinyl estradiol - tablet - 3mg; 0.02mg - drospirenone 3mg; ethinyl estradiol 0.02mg - contraceptives

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.02 mg/ 3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

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

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

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

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose; povidone; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - this medicine 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 drospirenone 3 mg /ethinylestradiol 20 ?g for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of pms (premenstrual syndrome), see section 5.1 pharmacodynamic properties - clinical trials.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: povidone; lactose; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - indicated for use as an oral contraceptive

ABD - İngilizce - NLM (National Library of Medicine)

watson pharma, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - drospirenone 3 mg

ABD - İngilizce - NLM (National Library of Medicine)

actavis pharma, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - drospirenone 3 mg

ABD - İngilizce - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - safyral is indicated for use by females of reproductive potential to prevent pregnancy. safyral is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. safyral is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, safyral should be discontinued during 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 chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, r

ABD - İngilizce - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - beyaz® is indicated for use by females of reproductive potential to prevent pregnancy. beyaz 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 beyaz 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 phase and remit within a few days following onset of m