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

apotex pty ltd - drospirenone,ethinylestradiol -

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

apotex pty ltd - drospirenone,ethinylestradiol -

Canada - English - Health Canada

mylan pharmaceuticals ulc - drospirenone; ethinyl estradiol - tablet - 3mg; 0.02mg - drospirenone 3mg; ethinyl estradiol 0.02mg - contraceptives

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - drospirenone; ethinylestradiol - tablet - 0.02mg/3 milligram(s) - drospirenone and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - drospirenone; ethinylestradiol - tablet - 0.03mg/3 milligram(s) - drospirenone and ethinylestradiol

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - drospirenone ; ethinyl estradiol - film coated tablet - 0.02/3.0 milligram - drospirenone and ethinylestradiol

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

rpk pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zarah® (drospirenone/ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. do not prescribe zarah to women who are known to have the following: - renal impairment - adrenal insufficiency - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.6)] have diabetes mellitus

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

rpk pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - ocella® is indicated for use by females of reproductive potential to prevent pregnancy. ocella is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, ocella 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, respectively. a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth we

Malta - English - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - drospirenone, ethinylestradiol - film-coated tablet - drospirenone 3 mg ethinylestradiol 0.02 mg - sex hormones and modulators of the genital system

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

besins healthcare australia pty ltd - drospirenone, quantity: 4 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; triacetin; polysorbate 80; titanium dioxide; indigo carmine aluminium lake; iron oxide yellow - contraception