European marketing authorization allows SHINE to distribute lutetium-177 for targeted radioligand therapies across the EU.
SHINE Technologies has received centralised marketing authorization from the European Union for Ilumira, its non-carrier-added lutetium-177 (Lu-177) radioisotope. The approval enables the company to sell Lu-177 across all EU member states, expanding access for targeted radioligand therapies in nuclear medicine.
The clearance follows SHINE’s acquisition of a U.S. isotope manufacturing and distribution operation in January, which included diagnostic products like Tc-99m generators and xenon-133. These isotopes are used in millions of medical procedures annually, positioning SHINE as a supplier for both diagnostic and therapeutic nuclear medicine needs.
SHINE SPECT CEO Michael Rossi stated the approval supports scaling radioligand therapies and broadens nuclear medicine’s reach to patients. The move aligns with the company’s strategy to consolidate its position in the global radioisotope market.