Illuccix® (configuration a)

DESCRIPTION

Kit for the radiopharmaceutical preparation of Ga-68 gozetotide (25 µg) solution for injection, intended for use with a GalliaPharm generator from Eckert & Ziegler.

INDICATION

This medicinal product is for diagnostic use only.

Illuccix, after radiolabelling with gallium-68, is indicated for detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:

  • Primary staging of patients with high-risk PCa prior to primary curative therapy

  • Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy

  • Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated

Summary of Product Characteristics (SmPC)

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