#Netspot dotatate generator#

Tel.: +49 (0) 30 / 94 10 84-252,, www.ezag. This pharmaceutical goes by several names: Gallium-68, Gallium Dotatate, and NETSpot.

#Netspot dotatate generator#

These are essential factors for the patient safety and enable the usage of the GalliaPharm® generator for kit labeling for its appropriate medicinal use for PET.Įckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700), with approximately 700 employees, is one of the world’s largest providers of isotope technology for radiation therapy and nuclear medicine.

GalliaPharm® meets all the strict requirements of the relevant EU pharmacopoeia monograph including sterility over the entire one-year shelf-life and the Ge-68 breakthrough limit (< 0.001%). For the USA a Type II Drug Master File (DMF No. GalliaPharm® is the only Ge-68/Ga-68 generator registered as a medicinal product in several countries of the European Union. This successful kit approval links the Eckert & Ziegler GalliaPharm® Ge-68/Ga-68 generator as the source of the Ga-68 in the kit’s package insert (PI). NETSPOT™ is the first kit approved by the FDA that will utilize the improved imaging enabled by the PET emitting Ga-68, which is conveniently obtained from Eckert & Ziegler Radiopharma’s GalliaPharm® Ge-68/Ga-68 generator. The kit will be used for the labeling of 68Ga-68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (PET). GaTate, a somatostatin analog, has recently been accorded orphan drug status by the U.S. J– Advanced Accelerator Applications (AAA - The radiopharmaceutical company headquartered in SAINT-GENIS-POUILLY, France) have obtained approval from the US FDA for their diagnostic imaging NETSPOT™ Gallium Ga 68 dotatate kit. Gallium 68 (68Ga) 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)octreotate (DOTATATE, GaTate) positron emission tomography (PET)/computed tomography (CT) is an imaging technique for detecting and characterizing neuroendocrine tumors (NETs).