DANICA-35 ED cyproterone acetate 2 mg, ethinylestradiol 35 microgram tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 2 mg; ethinylestradiol, Quantity: 35 microgram

Available from:

Strides Pharma Science Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate

Administration route:

Oral

Units in package:

28 tablets (1 Blister pack contains 1x 21 yellow active tablets and 1x7 white placebo tablets), 28 tablets x 3 (3x 21 yellow active tablets and 3x7 white placebo tablets)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nordularity 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-35ED will also provide effective oral contraception in this patient group. 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:

Visual Identification: White, round, biconvex tablet, plain on both surfaces.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-09-03