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

amgen australia pty ltd - talimogene laherparepvec -

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

amgen australia pty ltd - denosumab, quantity: 60 mg/ml - injection, solution - excipient ingredients: acetate; water for injections; polysorbate 20; sodium hydroxide; sorbitol - the treatment of osteoporosis in postmenopausal women. prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.,treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer (see clinical trials).,treatment to increase bone mass in men with osteoporosis at increased risk of fracture.,treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.

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

amgen australia pty ltd - filgrastim, quantity: 960 microgram/ml - injection, solution - excipient ingredients: sodium; sorbitol; polysorbate 80; acetate; water for injections - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing 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 of myelosuppressive therapy in patients with non-myeloid 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, for reducing 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 - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: water for injections; sodium; acetate; sorbitol; polysorbate 80 - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing 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 of myelosuppressive therapy in patients with non-myeloid 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, for reducing 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 - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 300 microgram/ml - injection, solution - excipient ingredients: polysorbate 80; water for injections; sorbitol; acetate; sodium - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing 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 of myelosuppressive therapy in patients with non-myeloid 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, for reducing 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 - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - filgrastim, quantity: 300 microgram/ml - injection, solution - excipient ingredients: acetate; sorbitol; water for injections; polysorbate 80; sodium - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation. for reducing 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 of myelosuppressive therapy in patients with non-myeloid 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, for reducing 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

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - darbepoetin alfa 100 µg/ml;   - solution for injection - 100 mcg/ml - active: darbepoetin alfa 100 µg/ml   excipient: dibasic sodium phosphate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - darbepoetin alfa 15 µg/ml;   - solution for injection - 15 mcg/ml - active: darbepoetin alfa 15 µg/ml   excipient: dibasic sodium phosphate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - darbepoetin alfa 200 µg/ml;   - solution for injection - 200 mcg/ml - active: darbepoetin alfa 200 µg/ml   excipient: dibasic sodium phosphate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - darbepoetin alfa 25 µg/ml;   - solution for injection - 25 mcg/ml - active: darbepoetin alfa 25 µg/ml   excipient: dibasic sodium phosphate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection