ILLUCCIX (Telix Pharmaceuticals (ANZ) Pty Ltd)
Product name
ILLUCCIX
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days)
Active ingredients
Glu-urea-Lys(ahx)-hbed-CC
Registration type
NCE/NBE
Indication
ILLUCCIX (powder and dilutent for injection), 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.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available