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

Fesoterodine Accord 8 mg prolonged-release tablets

Accord Healthcare Ireland Ltd.PA2315/243/001

Main Information

Trade NameFesoterodine Accord 8 mg prolonged-release tablets
Active SubstancesFesoterodine fumarate
Dosage FormProlonged-release tablet
Licence HolderAccord Healthcare Ireland Ltd.
Licence NumberPA2315/243/001

Group Information

ATC CodeG04BD11 fesoterodine


License statusAuthorised
Licence Issued10/12/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed


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

Generics Information

Interchangeable List CodeIC0139-009-024
Interchangeable List DocumentPDF of Interchangeable List
« Back