Ireland - English - HPRA (Health Products Regulatory Authority)

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

Canada - English - Health Canada

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

Canada - English - Health Canada

mylan pharmaceuticals ulc - drospirenone; ethinyl estradiol - tablet - 3mg; 0.03mg - drospirenone 3mg; ethinyl estradiol 0.03mg - progestogens and estrogens, fixed combinations

Canada - English - Health Canada

mylan pharmaceuticals ulc - drospirenone; ethinyl estradiol - tablet - 3mg; 0.03mg - drospirenone 3mg; ethinyl estradiol 0.03mg - contraceptives

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)

lupin australia pty limited - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 30 microgram - tablet - excipient ingredients: lactose monohydrate; maize starch; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - for use as an oral contraceptive

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

lupin australia pty limited - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 30 microgram - tablet - excipient ingredients: lactose monohydrate; maize starch; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - for use as an oral contraceptive

Canada - English - Health Canada

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

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

camber pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone and ethinyl estradiol tablets are use by females of reproductive potential to prevent pregnancy.  drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions:  • renal impairment • adrenal insufficiency • a high risk of arterial or venous thrombotic diseases. examples include women who are known to:      o smoke, if over age 35 [see boxed warning and warnings and precautions ( 5.1 )]     o have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions ( 5.1 )]        o have cerebrovascular disease [see warnings and precautions ( 5.1 )]       o have coronary artery disease [see warnings and precautions ( 5.1 )]       o have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease,        or atrial fibrillation) [see warnings and precaut

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

glenmark pharmaceuticals inc., usa - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are 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 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 di