Danica 35 ED

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cyproterone acetate 2mg; Ethinylestradiol 0.035mg

Available from:

Viatris Limited

Pharmaceutical form:

Film coated tablet

Composition:

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

Prescription type:

Prescription

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al (21 x active tablets, 7 x inactive tablets) - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2019-04-24