Pylclari (piflufolastat (18F))
- Region
- 🇪🇺 EU
- Active substance
- piflufolastat (18F)
- Company
- Curium Pet France
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 25 May 2023
- EU approval
- Mon 27 Nov 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005520
- ATC
- V09
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.