Israel - English - Ministry of Health

medison pharma ltd - arsenic trioxide - solution for injection - arsenic trioxide 1 mg/ml - arsenic trioxide - arsenic trioxide - trisenox is indicated for induction of remission, and consolidation in adult patients with:• newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 1000/μl) in combination with all-trans-retinoic acid (atra)• relapsed/refractory acute promyelocytic leukaemia (apl)(previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rar-alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - arsenic trioxide - concentrate for solution for injection - arsenic trioxide 2 mg / 1 ml - arsenic trioxide - trisenox is indicated for induction of remission, and consolidation in adult patients with:• newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/µl) in combination with all trans retinoic acid (atra)• relapsed/refractory acute promyelocytic leukaemia (apl)(previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rar-alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

European Union - English - EMA (European Medicines Agency)

teva b.v. - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - trisenox is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/µl) in combination with all‑trans‑retinoic acid (atra)relapsed/refractory acute promyelocytic leukaemia (apl) (previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rar-alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Canada - English - Health Canada

teva canada limited - arsenic trioxide - solution - 10mg - arsenic trioxide 10mg - antineoplastic agents

Canada - English - Health Canada

teva canada limited - arsenic trioxide - solution - 12mg - arsenic trioxide 12mg - antineoplastic agents

Canada - English - Health Canada

teva canada limited - arsenic trioxide - solution - 10mg - arsenic trioxide 10mg - antineoplastic agents

Canada - English - Health Canada

teva canada limited - arsenic trioxide - solution - 12mg - arsenic trioxide 12mg - antineoplastic agents

Canada - English - Health Canada

phebra pty ltd - arsenic trioxide - solution - 10mg - arsenic trioxide 10mg - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

flexipharm austrading ltd - arsenic trioxide - solution for infusion - 1mg/1ml

Canada - English - Health Canada

sterimax inc - arsenic trioxide - solution - 1mg - arsenic trioxide 1mg - antineoplastic agents