EMA — authorised 27 November 2023
- Application: EMEA/H/C/005520
- Marketing authorisation holder: Curium Pet France
- Local brand name: Pylclari
- Indication: This medicinal product is for diagnostic use only. Pylclari is indicated for the 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 initial curative therapy, To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent. Pylclari is indicated for use with positron emission tomography (PET)
- Status: approved