European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.4).

Ireland - English - HPRA (Health Products Regulatory Authority)

eckert & ziegler radiopharma gmbh - germanium (68ge) chloride; gallium (68ga) chloride - radionuclide generator - 0.74-1.85 gigabecquerel(s) - other diagnostic radiopharmaceuticals

European Union - English - EMA (European Medicines Agency)

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.after radiolabelling with gallium (68ga) chloride solution, the solution of gallium (68ga) edotreotide obtained is indicated for positron emission tomography (pet) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (gep-net) for localizing primary tumours and their metastases.

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - gozetotide - injection, powder, lyophilized, for solution - gozetotide 25μg/vial

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

budget distributors pty ltd - 64142 - capillary patient thermometer, gallium-alloy - the thermometers are intended to measure the human body temperature orally, under the armpit or groin. the devices are reusable for clinical or home use on people of all ages, including infants and children with adult supervision.

Canada - English - Health Canada

kroeger herb products - gallic acid - liquid - 6x - gallic acid 6x - homeopathic products

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

novartis pharmaceuticals australia pty ltd - desferrioxamine mesylate -

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - deferoxamine mesilate 500mg - powder for injection - 500 mg - active: deferoxamine mesilate 500mg - monotherapy iron chelation treatment for chronic iron overload, e.g. · transfusional haemosiderosis, as seen in thalassaemia major, sideroblastic anaemia, autoimmune haemolytic anaemia, and other chronic anaemias. · idiopathic (primary) haemochromatosis in patients in whom concomitant disorders (e.g. severe anaemia, cardiac disease, hypoproteinaemia) preclude phlebotomy. · iron overload associated with porphyria cutanea tarda in patients unable to tolerate phlebotomy.

Israel - English - Ministry of Health

novartis israel ltd - deferoxamine mesylate - powder for solution for inj/inf - deferoxamine mesylate 0.5 g/vial - deferoxamine - deferoxamine - treatment of chronic iron overload e.g.: transfusional haemosiderosis especially in thalassaemia major sideroblastic anaemia autoimmune haemolytic anaemia and other chronic anaemias idiopathic (primary) haemochromatosis in patients in whom concomitant disorders ( e.g. severe anaemia cardiac disease hypoproteinaemia) preclude phlebotomy iron overload associated with porphyria cutanea tarda. treatment of acute iron poisoning. treatment of chronic aluminium overload in patients with terminal renal failure (under maintenance dialysis) with: aluminium-related bone disease and/or dialysis encephalopathy and/or aluminium-related anaemia. diagnosis of iron overload.

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

advanced accelerator applications usa, inc - dotatate (unii: mrl3739g66) (dotatate gallium ga-68 - unii:9l17y0h71p) - dotatate 40 ug - netspot, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (pet) for localization of somatostatin receptor positive neuroendocrine tumors (nets) in adult and pediatric patients. none. risk summary there are no studies with gallium ga 68 dotatate in pregnant women to inform any drug-associated risks; however, radioactive emissions, including those from gallium ga 68 dotatate, can cause fetal harm. animal reproduction studies have not been conducted with gallium ga 68 dotatate. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. risk summary there is no information on the presence of gallium ga 68 dotatate in human milk, the effect on the breastfed child, or the effect on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gallium ga 68 dotatate injection and a