Canada - English - Health Canada

novartis pharmaceuticals canada inc - lutetium (177lu) oxodotreotide - solution - 370mbq - lutetium (177lu) oxodotreotide 370mbq - antineoplastic agents

Israel - English - Ministry of Health

s.r.y. (medical services ) ltd, israel - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 600 mbq/ml - lutetium (177lu) oxodotreotide - for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep-nets) in adults.

Israel - English - Ministry of Health

novartis israel ltd - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 370 mbq/ml - lutetium (177lu) oxodotreotide - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep nets) in adults.

Israel - English - Ministry of Health

marshall isotope ltd, israel - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 370 mbq/ml - lutetium (177lu) oxodotreotide - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep nets) in adults.

Israel - English - Ministry of Health

marshall isotope ltd, israel - lutetium (177lu) oxodotreotide - solution for infusion - lutetium (177lu) oxodotreotide 370 mbq/ml - lutetium (177lu) oxodotreotide - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep nets) in adults.

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - lutetium (177lu) oxodotreotide - injection, solution (radiopharmaceutical) - lutetium (177lu) oxodotreotide 370 mbq/ml

European Union - English - EMA (European Medicines Agency)

advanced accelerator applications - lutetium (177lu) oxodotreotide - neuroendocrine tumors - other therapeutic radiopharmaceuticals - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep‑nets) in adults.

European Union - English - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuclide imaging - therapeutic radiopharmaceuticals - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

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

australian nuclear science and technology organisation t/a ansto - lutetium (177lu) chloride, quantity: 10 gbq/ml - solution - excipient ingredients: dilute hydrochloric acid; purified water - lutetium (177lu) chloride is a radiopharmaceutical precursor, and it is not intended for direct use in patients. for the treatment of non resectable or metastatic neuroendocrine tumours (nets) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.

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

advanced accelerator applications usa, inc - lutetium oxodotreotide lu-177 (unii: ae221im3bb) (lutetium oxodotreotide lu-177 - unii:ae221im3bb) - lutetium oxodotreotide lu-177 10 mci in 1 ml - lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors in adults. none. risk summary based on its mechanism of action, lutathera can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on lutathera use in pregnant women. no animal studies using lutetium lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from lutathera, can cause fetal harm. advise pregnant women of the potential risk to a fetus. in the u.s. 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 there are no data on the presence of lutetium lu 177 dotatate in human milk, or its effects on the breastfed child or