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

Actiq 400 micrograms compressed lozenge with integral oromucosal applicator

PCO Manufacturing Ltd.PPA0465/407/002

Main Information

Trade NameActiq 400 micrograms compressed lozenge with integral oromucosal applicator
Active SubstancesFentanyl
Dosage FormCompressed lozenge
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/407/002

Group Information

ATC CodeN02AB03 fentanyl


License statusAuthorised
Licence Issued15/05/2015
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 StatusUnknown


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