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

sandoz pty ltd - eribulin mesilate, quantity: 1 mg - injection, solution - excipient ingredients: ethanol absolute; sodium hydroxide; hydrochloric acid; water for injections - eribulin sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless these are contraindicated.,eribulin sandoz is indicated for the treatment of patients with unresectable liposarcoma who have received prior chemotherapy for advanced or metastatic disease.

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

eisai australia pty ltd - eribulin mesilate, quantity: 1 mg - injection, solution - excipient ingredients: water for injections; ethanol absolute; hydrochloric acid; sodium hydroxide - halaven is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless these are contraindicated.,halaven is indicated for the treatment of patients with unresectable liposarcoma who have received prior chemotherapy for advanced or metastatic disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

advanz pharma limited - eribulin mesylate - solution for injection - eribulin

Canada - English - Health Canada

natco pharma (canada) inc - eribulin mesylate - solution - 0.5mg - eribulin mesylate 0.5mg

Israel - English - Ministry of Health

eisai israel ltd., israel - eribulin as mesilate - solution for injection - eribulin as mesilate 0.44 mg/ml - eribulin - eribulin - halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Israel - English - Ministry of Health

eisai israel ltd., israel - eribulin as mesilate - solution for injection - eribulin as mesilate 0.44 mg/ml - eribulin - eribulin - halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

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

eisai inc. - eribulin mesylate (unii: av9u0660cw) (eribulin - unii:lr24g6354g) - eribulin mesylate 0.5 mg in 1 ml - halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.  prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting [see clinical studies (14.1) ] . halaven is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [see clinical studies (14.2) ] . none. risk summary based on findings from an animal reproduction study and its mechanism of action, halaven can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . there are no available data on the use of halaven during pregnancy. in an animal reproduction study, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended human dose [see data] .  advise pregnant women of the pote

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

eisai (malaysia) sdn bhd (18039-d) - eribulin mesilate -

European Union - English - EMA (European Medicines Agency)

eisai gmbh - eribulin - breast neoplasms; liposarcoma - antineoplastic agents - halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).

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

eisai australia pty ltd - eribulin mesilate -