European Union - English - EMA (European Medicines Agency)

eckert ziegler radiopharma gmbh - yttrium (90y) chloride - radionuclide imaging - diagnostic radiopharmaceuticals - to be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.radiopharmaceutical precursor - not intended for direct use in patients.

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

eckert & ziegler radiopharma gmbh - gallium 68 ga chloride - solution - 1.85gbq - gallium 68 ga chloride 1.85gbq - radioactive agents

Canada - English - Health Canada

eckert & ziegler radiopharma gmbh - yttrium-90 chloride - solution - 300gbq - yttrium-90 chloride 300gbq - radioactive agents

Singapore - English - HSA (Health Sciences Authority)

transmedic pte ltd - radiology / imaging - coms eye applicators are designed for eye tumour brachytherapy. they are used together with i-125 sources, known as isoseeds i25.s16. the typical application time of coms eye applicators is 2-7 days. the maximum duration of 14 days should not be exceeded.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eckert & ziegler radiopharma gmbh - 68 ge - 68 ga - radionuclide generator - 0,74-1,85 gbq - germanium (ge-68) chloride; gallium (ga-68) chloride - various diagnostic radiopharmaceuticals

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

clc medical pty ltd - 13730 - sterilization container - the safety and sterilization container is an accessory for ru-106 brachytherapy eye applicators. the product is manufactured by eckert & ziegler bebig gmbh who also manufacture the ru-106 eye applicators. the safety and sterilization container is used for storage, transport at the clinical site, and sterilization of ru-106 eye applicators. the device is designed to provide optimum radiation protection as well as optimum performance of the steam sterilization technique used. the sterilization procedure verified by the manufacturer is according to iso 17 665 steam sterilization.

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

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

clc medical pty ltd - 38434 - brachytherapy applicator, manual, eye - brachytherapy for occular tumors

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

gamma gurus pty ltd - 38300 - radionuclide system, therapeutic, brachytherapy, remote afterloading - system used to deliver a source of radiation in a high or low dose rate remote afterloading brachytherapy system designed to deliver curative or palliative radiotherapy treatments.