САЩ - английски - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets 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 (5.5)] have d

САЩ - английски - NLM (National Library of Medicine)

pharmaceutics international, inc. (pii) - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets, usp 3 mg/0.02 mg are indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablets, usp 3 mg/0.02 mg are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. drospirenone and ethinyl estradiol tablets, usp 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. do not prescribe drospirenone and ethinyl estradiol tablets, usp 3 mg/0.02 mg 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 warnin

САЩ - английски - NLM (National Library of Medicine)

apotex corp. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. do not prescribe drospirenone and ethinyl estradiol tablets 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 (5.5)]

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - drospirenone; estradiol hemihydrate - oral tablet - 2mg ; 1mg

Австралия - английски - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Белгия - английски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pi pharma - estradiol hemihydrate; drospirenone - film-coated tablet - 1 mg - 2 mg - estradiol hemihydrate; drospirenone 2 mg - dienogest and estrogen

Австралия - английски - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; povidone; 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Австралия - английски - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 30 microgram - tablet, uncoated - excipient ingredients: lactose monohydrate; dl-alpha-tocopherol; maize starch; pregelatinised maize starch; brilliant blue fcf; magnesium stearate - indicated for use as an oral contraceptive

Австралия - английски - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 30 microgram - tablet, uncoated - excipient ingredients: pregelatinised maize starch; maize starch; brilliant blue fcf; dl-alpha-tocopherol; lactose monohydrate; magnesium stearate - indicated for use as an oral contraceptive