Canada - English - Health Canada

teva canada limited - cyproterone acetate; ethinyl estradiol - tablet - 2mg; 0.035mg - cyproterone acetate 2mg; ethinyl estradiol 0.035mg - other miscellaneous therapeutic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

lexon (uk) ltd - cyproterone acetate; ethinylestradiol - coated tablet - 2 mg/35 microgram(s) - cyproterone and estrogen

Ireland - English - HPRA (Health Products Regulatory Authority)

lexon pharmaceuticals (ireland) limited - cyproterone acetate; ethinylestradiol - coated tablet - 2 mg/35 microgram(s) - cyproterone and estrogen

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - cyproterone acetate 2mg;  ; ethinylestradiol 0.035mg;   - film coated tablet - active: cyproterone acetate 2mg   ethinylestradiol 0.035mg   excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry buff oy-3690 opadry white y-1r-7000b opaglos white 6000 povidone purified water quinoline yellow sucrose lactose monohydrate magnesium stearate microcrystalline cellulose - estelle-35 and estelle-35 ed are indicated for the treatment of androgen dependent diseases in women, such as acne (where oral antibiotics or local treatment alone has not been successful), especially pronounced forms and those which are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenic alopecia, mild forms of hirsutism. estelle-35 and estelle-35 ed are also indicated for oral contraception in women requiring treatment for these androgen-dependent diseases; it is not recommended in women solely for contraception. estelle-35 and estelle-35 ed are also indicated for treating the symptoms of polycystic ovary syndrome.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - cyproterone acetate 2mg; ethinylestradiol 0.035mg - film coated tablet - active: cyproterone acetate 2mg ethinylestradiol 0.035mg excipient: calcium carbonate glycerol glycol montanate iron oxide yellow lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone   purified talc   sucrose titanium dioxide calcium carbonate glycol montanate lactose monohydrate macrogol 6000 magnesium stearate maize starch povidone   purified talc   sucrose - · the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bayer sa-nv - ethinylestradiol 0,035 mg; cyproterone acetate 2 mg - coated tablet - 2 mg - 0,035 mg - ethinylestradiol 35 µg; cyproterone acetate 2 mg - cyproterone and estrogen

Israel - English - Ministry of Health

bayer israel ltd - cyproterone acetate - tablets - cyproterone acetate 10 mg - cyproterone - cyproterone - treatment of pronounced signs of virilisation in women, which make hormone therapy necessary:• severe forms of acne, when it is accompanied by inflammation and the formation of nodes (acne papulopustulosa, acne nodulocystica) or if there is a risk of scarring,• moderate to severe forms of hirsutism,• moderate to severe forms of androgenic alopecia.cyproterone acetate 10 mg is indicated for pronounced signes of virilisation in women, which make hormone therapy necessary if satisfactory results could not be obtained with medicinal products containing low-dose cyproterone or with other treatment options. when treating acne, hormone treatment should be weighed against systemic antibiotic treatment

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

medis pharma pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone-ga inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone-ga is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. cyproterone-ga reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone-ga should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

medis pharma pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone-ga inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone-ga is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. cyproterone-ga reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone-ga should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - cyproterone acetate - oral tablet - 50mg