New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - abiraterone acetate 250mg - film coated tablet - 250 mg - active: abiraterone acetate 250mg excipient: colloidal silicon dioxide croscarmellose sodium lactose monohydrate macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol povidone purified talc sodium laurilsulfate titanium dioxide - abiraterone sandoz is indicated in combination with prednisone or prednisolone and androgen depreviation therapy (adt) for the treatment of high-risk metastatic hormone naive prostate cancer (mhnpc) or newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) abiraterone sandoz is also indicated with prednisone or prednisolone for: . the treatment of patients with metastatic castration resistant prostate cancer (mcprc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) in whom chemotherapy is not yet clinically indicated . the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcprc) who have received prior chemotherapy containing a taxane.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - abiraterone acetate 500mg - film coated tablet - 500 mg - active: abiraterone acetate 500mg excipient: colloidal silicon dioxide croscarmellose sodium iron oxide black iron oxide red lactose monohydrate macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol povidone purified talc sodium laurilsulfate titanium dioxide - abiraterone sandoz is indicated in combination with prednisone or prednisolone and androgen depreviation therapy (adt) for the treatment of high-risk metastatic hormone naive prostate cancer (mhnpc) or newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) abiraterone sandoz is also indicated with prednisone or prednisolone for: . the treatment of patients with metastatic castration resistant prostate cancer (mcprc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) in whom chemotherapy is not yet clinically indicated . the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcprc) who have received prior chemotherapy containing a taxane.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; microcrystalline cellulose; povidone; magnesium stearate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - abiraterone-teva is indicated in combination with 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

Canada - English - Health Canada

pharmaris canada inc - abiraterone acetate - tablet - 500mg - abiraterone acetate 500mg

Israel - English - Ministry of Health

j-c health care ltd - abiraterone acetate - tablets - abiraterone acetate 250 mg - abiraterone - abiraterone - zytiga is a cyp17 inhibitor indicated:- in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.- for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt).

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - 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 - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 250 mg - tablet - excipient ingredients: colloidal anhydrous silica; povidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium - 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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dr. reddy`s laboratories malaysia sdn. bhd. - abiraterone acetate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cipla malaysia sdn bhd - abiraterone acetate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

duopharma hapi sdn. bhd. - abiraterone acetate -