European Union - English - EMA (European Medicines Agency)

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastic agents - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

European Union - English - EMA (European Medicines Agency)

stemline therapeutics b.v. - selinexor - multiple myeloma - antineoplastic agents - nexpovio is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

European Union - English - EMA (European Medicines Agency)

stemline therapeutics b.v. - elacestrant - breast neoplasms - endocrine therapy - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.

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

stemline therapeutics, inc. - tagraxofusp (unii: 8zhs5657eh) (tagraxofusp - unii:8zhs5657eh) - elzonris is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (bpdcn) in adults and in pediatric patients 2 years and older. none. risk summary based on its mechanism of action, elzonris has the potential for adverse effects on embryo-fetal development [see clinical pharmacology (12.1)] . there are no available data on elzonris use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. animal reproduction or developmental toxicity studies have not been conducted with tagraxofusp-erzs. advise pregnant women of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. risk summary no data are available regarding the pre

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

stemline therapeutics, inc. - elacestrant (unii: fm6a2627a8) (elacestrant - unii:fm6a2627a8) - orserdu is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (er)-positive, human epidermal growth factor receptor 2 (her2)‑negative, esr1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. none. risk summary based on findings in animals and its mechanism of action, orserdu can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data on orserdu use in pregnant women to inform the drug-associated risk. in an animal reproduction study, oral administration of elacestrant to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at maternal exposures below the recommended dose based on auc (see data) . advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u

Israel - English - Ministry of Health

stemline israel ltd. - tagraxofusp - concentrate for solution for infusion - tagraxofusp 1 mg / 1 ml - tagraxofusp - elzonris is a cd123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (bpdcn) in adults.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company united states of america - 1 glass vial - injection or infusion - 1000 mcg/ml - n/a

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company united states of america - 30's hdpe bottle - tablet - 345mg/tablet - n/a

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company united states of america - 30's hdpe bottle - tablet - 86mg/tablet - n/a

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

modern pharmaceutical company netherlands - 20’s [5’s blister x4] - tablet - 20mg /tablet - malignant disease,immunosuppresion-cytotoxics