JANSSEN APALUTAMIDE apalutamide 60 mg film-coated tablet bottle

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

apalutamide, Quantity: 60 mg

MAH:

Janssen-Cilag Pty Ltd

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; hypromellose acetate succinate; croscarmellose sodium; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black

administration_route:

Oral

units_in_package:

120 tablets

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

JANSSEN APALUTAMIDE (apalutamide) is indicated for the treatment of patients with: ? metastatic castration-sensitive prostate cancer (mCSPC) or ? non-metastatic, castration-resistant prostate cancer (nmCRPC).

leaflet_short:

Visual Identification: Slightly yellowish green to greyish green, oblong-shaped, film-coated tablets, debossed with AR 60 on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

authorization_status:

Registered

authorization_date:

2018-07-05