Israel - English - Ministry of Health

teva israel ltd - filgrastim - solution for injection / infusion - filgrastim 0.6 mg/ml - filgrastim - filgrastim - tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes ) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of tevagrastim are similar in adults and children receiving cytotoxic chemotherapy. tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). in patients children or adults with severe congenital neutropenia cyclic or idiopathic neutropenia with an absolute nuetrophil count (anc) less than or equal to 0.5 x 1000000000 /l and a history of severe or recurrent infections long term administration of tevagrastim is indicated to increase neutophil count and to reduce the incidence and duration of infection-related events. tevagrastim in indicated for the treatment of persistent neutopenia (anc less than or equal to 1.0 x 1000000000/l ) in patients with advanced hiv infection in order to reduce the risk of bacterial infections when other options to manage neutopenia are inappropriate.

Israel - English - Ministry of Health

teva israel ltd - caffeine; chlorpheniramine maleate; paracetamol; phenylephrine hydrochloride - caplets - paracetamol 300 mg; chlorpheniramine maleate 2 mg; phenylephrine hydrochloride 10 mg; caffeine 30 mg - phenylephrine, combinations - phenylephrine, combinations - symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain.

Israel - English - Ministry of Health

teva israel ltd - caffeine anhydrous; chlorpheniramine maleate; paracetamol; phenylephrine hydrochloride - tablets - paracetamol 300 mg; chlorpheniramine maleate 2.0 mg; phenylephrine hydrochloride 10 mg; caffeine anhydrous 30 mg - phenylephrine, combinations - symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain.

European Union - English - EMA (European Medicines Agency)

teva gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.tevagrastim is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

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

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 18.15 mg - capsule - excipient ingredients: microcrystalline cellulose; indigo blue; titanium dioxide; croscarmellose sodium; gelatin; purified talc; colloidal anhydrous silica; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

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

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 12.1 mg - capsule - excipient ingredients: colloidal anhydrous silica; gelatin; croscarmellose sodium; iron oxide yellow; purified talc; microcrystalline cellulose; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

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

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 6.05 mg - capsule - excipient ingredients: colloidal anhydrous silica; gelatin; purified talc; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

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

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 30.25 mg - capsule - excipient ingredients: gelatin; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; croscarmellose sodium; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Australia - English - 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 - English - 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.