JANSSEN ABIRATERONE abiraterone acetate 250 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

abiraterone acetate, Quantity: 250 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

Abiraterone acetate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: colloidal anhydrous silica; povidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium

Administration route:

Oral

Units in package:

120 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

JANSSEN ABIRATERONE is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or ? patients with mCRPC who have received prior chemotherapy containing a taxane.

Product summary:

Visual Identification: White to off-white, oval shaped tablets with "AA250" on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2012-03-01