European Union - English - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - chlormethine - mycosis fungoides - antineoplastic agents - ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous t-cell lymphoma (mf-type ctcl) in adult patients.

European Union - English - EMA (European Medicines Agency)

les laboratoires servier - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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

stark medical - 44776 - electrosurgical system, general-purpose - high frequency surgical equipment used to cut and coagulate soft tissue

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

juniper biologics pty ltd - chlormethine hydrochloride, quantity: 0.2 mg/g (equivalent: chlormethine, qty 0.16 mg/g) - gel - excipient ingredients: butylated hydroxytoluene; disodium edetate; diethylene glycol monoethyl ether; isopropyl alcohol; hyprolose; lactic acid; propylene glycol; glycerol; menthol; sodium chloride - ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous t-cell lymphoma (mf-type ctcl) in adult patients.

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

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

Israel - English - Ministry of Health

rafa laboratories ltd - chlormethine as hydrochloride - gel - chlormethine as hydrochloride 160 mcg/g - chlormethine - topical treatment of stage ia and ib mycosis fungoides-type cutaneous t-cell lymphoma in patients who have received prior skin-directed therapy

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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.,