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

astellas pharma us, inc. - gilteritinib fumarate (unii: 5rzz0z1gjt) (gilteritinib - unii:66d92mgc8m) - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a fms-like tyrosine kinase 3 (flt3) mutation as detected by an fda-approved test. xospata is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. anaphylactic reactions have been observed in clinical trials [see adverse reactions (6) and description (11)] . risk summary based on findings from animal studies (see data) and its mechanism of action, xospata can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on xospata use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures (auc24 ) approximately 0.4 times the auc

Israel - English - Ministry of Health

astellas pharma international b.v., israel - gilteritinib as fumarate - film coated tablets - gilteritinib as fumarate 40 mg - gilteritinib - xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a flt3 mutation

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

astellas pharma australia pty ltd - gilteritinib fumarate, quantity: 44.2 mg - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; mannitol; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukemia, myeloid, acute - antineoplastic agents - xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.,

Canada - English - Health Canada

astellas pharma canada inc - gilteritinib (gilteritinib fumarate) - tablet - 40mg - gilteritinib (gilteritinib fumarate) 40mg - antineoplastic agents

Singapore - English - HSA (Health Sciences Authority)

astellas pharma singapore pte. ltd. - gilteritinib fumarate eqv gilteritinib - tablet, film coated - gilteritinib fumarate eqv gilteritinib 40mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astellas pharma europe b.v., netherlands - gilteritinib - film-coated tablet - 40 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

everest pharmaceuticals ltd. - gilteritinib - tablet - 40 mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

astellas pharama inc. - gilteritinib fumarate - pale yellow tablet, diameter: approx. 7.1 mm, thickness: approx. 3.5 mm