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.

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

aspen pharma pty ltd - cyproterone acetate,ethinylestradiol -

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

aspen pharma pty ltd - cyproterone acetate,ethinylestradiol -

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة مستودع الأدوية الأردني - the jordan drugstore co - cyproterone acetate 2 mg, ethinylestradiol 0.035 mg - 2 mg, 0.035 mg

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

alphapharm pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; povidone; colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch - women -moderately severe to severe signs of androgenization -moderately severe/severe forms of hirsutism -moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe androgenetic alopecia) -moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenization,cyproterone acetate inhibits the influence of male sex hormones, which are also produced by the female. it is thus possible to treat diseases in women caused either by 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 cyprone 50 is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyl oestradiol taken as well to ensure contraception. this also promotes regular menstruation.,men - reduction of drive in sexual deviations,cyprone 50 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.,cyprone 50 therapy should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social re-orientation. - 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

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

ceres pharma sa-nv - cyproterone acetate 2 mg (yellow tablet); ethinylestradiol 35 µg (yellow tablet); placebo (white tablet) - tablet - 2 mg - 0,035 mg - cyproterone acetate 2 mg; ethinylestradiol 35 µg; placebo - cyproterone and estrogen

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

eurodrug laboratories (m) sdn. bhd. - cyproterone acetate; ethinylestradiol -

Ireland - English - HPRA (Health Products Regulatory Authority)

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

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - cyproterone acetate 2mg; ethinylestradiol 0.035mg - film coated tablet - active: cyproterone acetate 2mg ethinylestradiol 0.035mg excipient: calcium carbonate carnauba wax gelatin glucose liquid lactose monohydrate macrogol 35000 magnesium stearate povidone purified talc starch sucrose titanium dioxide

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