Uniunea Europeană - engleză - 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.

Israel - engleză - 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.

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

international consolidated business group pty ltd - 34020 - glove, patient examination, latex - to prevent contamination between carer and patient during patient examination, first aid or attending to minor injuries.

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

adirel consolidated pty ltd t/a surgiplas medical -

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

adirel consolidated pty ltd t/a surgiplas medical -

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

flourish consolidated pty ltd -

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

teva pharma australia pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: glacial acetic acid; polysorbate 80; sodium hydroxide; sorbitol; water for injections - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs in doses not usually requiring bone marrow transplantation. to reduce the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with nonmyeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, to reduce the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

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

teva pharma australia pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: glacial acetic acid; polysorbate 80; sodium hydroxide; sorbitol; water for injections - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs in doses not usually requiring bone marrow transplantation. to reduce the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with nonmyeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, to reduce the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. in patients with hiv infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

Israel - engleză - Ministry of Health

mbi pharma ltd., israel - cytarabine - concentrate for solution for infusion - cytarabine 5 g / 50 ml - cytarabine - ara-cell® 100 mg/ml is used in combination with other cytostatic agents in high-dose therapy for:• refractory non-hodgkin’s lymphoma• refractory acute non-lymphocytic leukaemia• refractory acute lymphoblastic leukaemia• recurrent cases of acute leukaemia• types of leukaemia with special risk: – secondary leukaemia following previous chemotherapy and/or radiation treatment – manifest leukaemia following transformation of pre-leukaemia• consolidation of the remission of acute non-lymphocytic leukaemia in patients under 60 years of age.

Israel - engleză - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.