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

elanco animal health - pegbovigrastim (unii: 87m3b1263r) (pegbovigrastim - unii:87m3b1263r) - for the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers.

European Union - English - EMA (European Medicines Agency)

elanco gmbh - pegbovigrastim - colony stimulating factors, immunostimulants, antineoplastic agents - cattle (cows and heifers); cattle - as an aid in a herd management programme, to reduce the risk of clinical mastitis in periparturient dairy cows and heifers during the 30 days following calving.

New Zealand - English - Ministry for Primary Industries

elanco australasia pty ltd - pegbovigrastim - pegbovigrastim 5.5 g/litre - immune stimulant

Canada - English - Health Canada

elanco canada limited - pegbovigrastim - solution - 15mg - pegbovigrastim 15mg - cattle; cattle

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

elanco animal health (pty) ltd - injection - see ingredients - each 2, ml solution contains pegbovigrastim 15,0 mgpegbovigrastim 15,0 mg - c 21. immune modulating agents c 21. immune modulating agents

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

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

European Union - English - EMA (European Medicines Agency)

mundipharma corporation (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).

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

amgen australia pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections - for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.