PYLCLARI Solution for injection Ref.[51072] Active ingredients: Piflufolastat ¹⁸F

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: CURIUM PET FRANCE, 3 rue Marie Curie, Biopole Clermont-Limagne, 63 360 Saint-Beauzire France

Product name and form

Pylclari 1 000 MBq/mL solution for injection.

Pylclari 1 500 MBq/mL solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution with a pH ranging from 4.5 to 7.5.

Qualitative and quantitative composition

Pylclari 1 000 MBq/mL solution for injection: Each mL of solution contains 1 000 MBq of piflufolastat (18F) at the date and time of calibration. The total activity per vial ranges from 500 MBq to 10 000 MBq at the date and time of calibration.

Pylclari 1 500 MBq/mL solution for injection: Each mL of solution contains 1 500 MBq of piflufolastat (18F) at the date and time of calibration. The total activity per vial ranges from 750 MBq to 15 000 MBq at the date and time of calibration.

Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV.

Excipients with known effect: Each mL of solution contains a maximum of 3.5 mg of sodium and 90 mg of ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Piflufolastat ¹⁸F

Piflufolastat (18F) is a selective secondgeneration fluorine-18-labeled small-molecule PSMA inhibitor. Based on the intensity of the signals, PET images obtained using piflufolastat (18F) indicate the presence of PSMA expressing tissues.
List of Excipients

Ethanol
Sodium chloride 9 mg/mL (0.9%) solution for injection
Sodium ascorbate

Pack sizes and marketing

15 mL colourless Type I glass vial, closed with a chlorobutyl stopper and an aluminium seal.

Pack size: one multidose vial contains 0.5 mL to 10 mL of solution, corresponding to:

  • 500 to 10 000 MBq at calibration time of Pylclari 1 000 MBq/mL
  • 750 to 15 000 MBq at calibration time of Pylclari 1 500 MBq/mL

Marketing authorization holder

CURIUM PET FRANCE, 3 rue Marie Curie, Biopole Clermont-Limagne, 63 360 Saint-Beauzire – France

Marketing authorization dates and numbers

EU/1/23/1746/001
EU/1/23/1746/002

Drugs

Drug Countries
PYLCLARI France, Croatia, Ireland, Italy, Lithuania
 
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