Anpheros Search · Treatment

Piflufolastat (18F)

Also known as: Pylclari

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In short

Piflufolastat (18F) is a diagnostic medicinal product indicated in the European Union for use with positron emission tomography to detect prostate-specific membrane antigen positive lesions in adults with prostate cancer. It is used for the primary staging of patients with high-risk prostate cancer prior to initial curative therapy, and to localize recurrence in patients with suspected recurrence based on increasing serum prostate-specific antigen levels after primary curative treatment. The substance has an approved indication for malignant neoplasm of the prostate.

Source: European Medicines Agency (EMA), Pylclari — EPAR, 09/10/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

EMA
EMEA/H/C/005520

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Pylclari

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).

Source: European Medicines Agency (EMA), Pylclari — EPAR, 09/10/2026. © European Medicines Agency.

Document date: 09/10/2026 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Piflufolastat (18F) approved for in the European Union?

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). (Source: European Medicines Agency (EMA), Pylclari — EPAR, 09/10/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Pylclari — EPAR, 09/10/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →