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

Fentanyl 50 micrograms/ml solution for injection

AS KalceksPA2165/011/001

Main Information

Trade NameFentanyl 50 micrograms/ml solution for injection
Active SubstancesFentanyl
Dosage FormSolution for injection
Licence HolderAS Kalceks
Licence NumberPA2165/011/001

Group Information

ATC CodeN01AH01 fentanyl


License statusAuthorised
Licence Issued28/08/2020
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017.
Marketing StatusMarketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back