Kanada - Englisch - Health Canada

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

Irland - Englisch - HPRA (Health Products Regulatory Authority)

generics (uk) limited - cyproterone acetate ethinylestradiol - tablets - 2mg/35ug %v/v

Kanada - Englisch - Health Canada

mylan pharmaceuticals ulc - cyproterone acetate; ethinyl estradiol - tablet - 2mg; 0.035mg - cyproterone acetate 2mg; ethinyl estradiol 0.035mg - other miscellaneous therapeutic agents

Malaysia - Englisch - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

vitamode sdn.bhd - ethinylestradiol; cyproterone acetate -

Israel - Englisch - Ministry of Health

bayer israel ltd - cyproterone acetate; ethinylestradiol - tablets - ethinylestradiol 35 mcg; cyproterone acetate 2 mg - cyproterone and estrogen - cyproterone and estrogen - treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. for the treatment of acne, diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed.

Israel - Englisch - Ministry of Health

bayer israel ltd - cyproterone acetate; ethinylestradiol - tablets - ethinylestradiol 35 mcg; cyproterone acetate 2 mg - cyproterone and estrogen - cyproterone and estrogen - treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. for the treatment of acne, diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed.

Irland - Englisch - HPRA (Health Products Regulatory Authority)

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

Neuseeland - Englisch - Medsafe (Medicines Safety Authority)

viatris limited - cyproterone acetate 2mg; ethinylestradiol 0.035mg - film coated tablet - active: cyproterone acetate 2mg ethinylestradiol 0.035mg excipient: lactose monohydrate magnesium stearate maize starch opadry pink 03f540049 povidone purified talc lactose monohydrate magnesium stearate maize starch povidone purified talc - 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 ed will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives. if the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis.

Irland - Englisch - HPRA (Health Products Regulatory Authority)

bayer limited - cyproterone acetate; ethinylestradiol ph.eur. - coated tablet - 2/35 milligram(s) - antiandrogens and estrogens; cyproterone and estrogen

Irland - Englisch - HPRA (Health Products Regulatory Authority)

imbat limited - cyproterone acetate; ethinylestradiol - film-coated tablet - 2/35 milligram(s) - antiandrogens and estrogens; cyproterone and estrogen