JANSSEN ABIRATERONE abiraterone acetate 500 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

abiraterone acetate, Quantity: 500 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

Abiraterone acetate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

60 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: Purple oval shaped film-coated tablet debossed with AA on one side and 500 on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2017-02-17