European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide 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 promyelocytic 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)

mylan ireland limited - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide mylan 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 promyelocytic leukaemia/retinoic acid receptor alpha (pml/rar alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide medac 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 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/rarα) 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

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

Canada - English - Health Canada

auro pharma inc - arsenic trioxide - solution - 2mg - arsenic trioxide 2mg

Canada - English - Health Canada

sandoz canada incorporated - arsenic trioxide - solution - 10mg - arsenic trioxide 10mg - antineoplastic agents

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - arsenic trioxide - concentrate for solution for infusion - arsenic trioxide 1 mg / 1 ml - arsenic trioxide - arsenic trioxide s.k. 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, ≤ 10x1000µl incombination 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

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.