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

teva pharma australia pty ltd - lipegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections - lonquex? is indicated for 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)

Israel - English - Ministry of Health

abic marketing ltd, israel - lipegfilgrastim - solution for injection - lipegfilgrastim 6 mg / 0.6 ml - lipegfilgrastim - 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).

Singapore - English - HSA (Health Sciences Authority)

teva pharmaceutical investments singapore pte. ltd. - lipegfilgrastim - injection, solution - lipegfilgrastim 6.00 mg/0.6ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - lipegfilgrastim - solution for injection - 10mg/1ml

European Union - English - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - neutropenia - immunostimulants, , colony stimulating factors - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - lipegfilgrastim 10 mg/ml;  ;   - solution for injection - 6 mg/0.6ml - active: lipegfilgrastim 10 mg/ml     excipient: acetic acid polysorbate 20 sodium hydroxide sorbitol water for injection - 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).

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

teva pharmaceuticals (pty) ltd - injection - see ingredients - each pre-filled syringe contains : lipegfilgrastim 6,0 mg

Israel - English - Ministry of Health

kamada ltd, israel - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

United States - English - NLM (National Library of Medicine)

amgen inc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - pegfilgrastim 6 mg in 0.6 ml - neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . limitations of use neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see dosage and administration (2.2) and clinical studies (14.2)] . neulasta is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. reactions have included anaphylaxis [see warnings and precautions (5.3)] . risk summary although available data with neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outc