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

bayer australia ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: maize starch; lactose monohydrate; magnesium stearate; povidone - inoperable prostatic carcinoma. because of its anti-androgenic effect androcur is indicated for the treatment of inoperable prostatic carcinoma in patients who have failed primary hormonal manipulation or who are at risk from cardiovascular disease and/or who are intolerant of oestrogen therapy. indications as at 1 june 1995: inoperable prostatic carcinoma to suppress 'flare' with initial 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)

cipla australia pty ltd - cyproterone acetate -

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

cipla australia pty ltd - cyproterone acetate -

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 opaglos 6000 white lactose monohydrate magnesium stearate microcrystalline cellulose opadry buff oy-3690 opadry white y-1r-7000b povidone purified water quinoline yellow sucrose - 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)

rex medical ltd - cyproterone acetate 2mg;  ;  ; ethinylestradiol 0.035mg;   - film coated tablet - active: cyproterone acetate 2mg     ethinylestradiol 0.035mg   excipient: hypromellose lactose monohydrate magnesium stearate povidone propylene glycol purified talc   quinoline yellow starch titanium dioxide - androgen-dependent diseases in women are an indication for treatment with ginet-63. these diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with ginet-63. however ginet-63 is not recommended in women solely for contraception.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - cyproterone acetate 2mg; ethinylestradiol 0.035mg (micronised) - film coated tablet - 2mg/0.035mg - active: cyproterone acetate 2mg ethinylestradiol 0.035mg (micronised) excipient: ethanol lactose monohydrate magnesium stearate maize starch opadry pink 03f540049 povidone purified talc purified water   - danica 35 is indicated for 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. danica 35 will also provide effective contraception in this patient group. danica 35 is also indicated for the relief of symptoms of polycystic ovary syndrome.

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - cyproterone acetate; ethinylestradiol - coated tablet - 2 mg/35 microgram(s) - antiandrogens and estrogens; cyproterone and estrogen

Canada - English - Health Canada

paladin labs inc. - cyproterone acetate; ethinyl estradiol - tablet - 2mg; 0.035mg - cyproterone acetate 2mg; ethinyl estradiol 0.035mg - other miscellaneous therapeutic agents

Canada - English - Health Canada

altius healthcare inc - cyproterone acetate; ethinyl estradiol - tablet - 2mg; 0.035mg - cyproterone acetate 2mg; ethinyl estradiol 0.035mg - other miscellaneous therapeutic agents

Canada - English - Health Canada

bayer inc - cyproterone acetate; ethinyl estradiol - tablet - 2mg; 35mcg - cyproterone acetate 2mg; ethinyl estradiol 35mcg - other miscellaneous therapeutic agents