Theralugand®

About:

Sterile [177Lu]Lutetium Chloride solution for radiolabeling.

Marketing Authorization:

Lutetium-177 Chloride Solution is regarded as a drug product in Europe and requires full registration to receive marketing authorization. Theralugand® has been registered in all countries of the European Economic Area (EEA).

Specifications:

  • [177Lu]Lutetium Chloride solution (clear and colorless)

  • [177Lu]Lutetium Chloride, 40 GBq/mL

  • Hydrochloric Acid (0.04 mol/L)

  • [177Lu]LuCl3 in 0.04 mol/L hydrochloric acid solution

  • As requested: 4 – 200 GBq per vial (activity tolerance ± 10%)

  • 10 days after production

  • [ 177Lu]Lutetium can be produced to meet specific customer requirements for calibration date

  • 10 days after production

  • > 99.0 % [177Lu]Lutetium as Lu3+

  • ≥ 99,9%

    [175Yb]Ytterbium ≤ 0.1%

    [177mLu]Lutetium ≤ 0.07%

    All other radionuclide impurities ≤ 0.01%

  • Max. 3 mL in a (3 mL) V-glass vial

    Max. 5 mL in a 10R-glass flat bottom vial

    Closure with crimp cap and pharma-grade stopper

  • 1 - 2

  • < 20 EU/mL

  • Sterile

  • Within 4 business days worldwide

Summary of Product Characteristics (SmPC) for: EU