The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Pylclari



Curium Pet FranceEU/1/23/1746/001

Main Information

Trade NamePylclari
Active Substances2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid
Dosage FormSolution for injection
Licence HolderCurium Pet France
Licence NumberEU/1/23/1746/001

Group Information

ATC CodeV09IX Other diagnostic radiopharmaceuticals for tumour detection
V09IX16 piflufolastat (18F)

Status

License statusAuthorised
Licence Issued24/07/2023
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back