European Union - English - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - pegfilgrastim - neutropenia - immunostimulants, , colony stimulating factors - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

European Union - English - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

juta pharma gmbh - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - pegfilgrastim 10 mg/ml;   - solution for injection - 6 mg/0.6ml - active: pegfilgrastim 10 mg/ml   excipient: acetic acid polysorbate 20 sodium hydroxide sorbitol water for injection - reduction in the duration of neutropenia, the incidence of febrile neutropenia and the incidence of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenia - immunostimulants, - accofil 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 accofil are similar in adults and children receiving cytotoxic chemotherapy.accofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).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 accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.accofil 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.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenia - immunostimulants, - grastofil 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 grastofil are similar in adults and children receiving cytotoxic chemotherapy.grastofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).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 grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.grastofil 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - filgrastim 200 µg/ml - solution for injection - 100 mcg/0.5ml - active: filgrastim 200 µg/ml excipient: polysorbate 80 sodium acetate trihydrate sorbitol water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - filgrastim 600 µg/ml;   - solution for injection - 300 mcg/0.5ml - active: filgrastim 600 µg/ml   excipient: glacial acetic acid polysorbate 80 sodium hydroxide sorbitol water for injection - neupogen is indicated for 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 and its clinical sequelae 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 neupogen are similar in adults and children receiving cytotoxic chemotherapy. neupogen is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 10^9/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections, when other options to manage neutropenia are inappropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - filgrastim 300 µg/ml;   - solution for injection - 300 mcg/ml - active: filgrastim 300 µg/ml   excipient: glacial acetic acid polysorbate 80 sodium hydroxide sorbitol water for injection - neupogen is indicated for 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 and its clinical sequelae 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 neupogen are similar in adults and children receiving cytotoxic chemotherapy. neupogen is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 10^9/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections, when other options to manage neutropenia are inappropriate.