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

Canada - English - Health Canada

telix pharmaceuticals (us), inc. - gallium (68ga) gozetotide - powder for solution - 25mcg - gallium (68ga) gozetotide 25mcg

Canada - English - Health Canada

novartis pharmaceuticals canada inc - gallium (68ga) gozetotide - kit - 25mcg - gallium (68ga) gozetotide 25mcg

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

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: sodium acetate; hydrochloric acid; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

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

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: hydrochloric acid; sodium acetate; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

Singapore - English - HSA (Health Sciences Authority)

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

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

Singapore - English - HSA (Health Sciences Authority)

labgistics asia pte ltd - germanium (68ge) chloride; gallium (68ga) chloride - injection, solution (radiopharmaceutical) - germanium (68ge) chloride 0.74 – 1.85 gbq; gallium (68ga) chloride > 60 % of the loaded activity

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.

Canada - English - Health Canada

ire elit s.a. - gallium 68 ga chloride - solution - 1.85gbq - gallium 68 ga chloride 1.85gbq - roentgenography