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

Actonel Once a week 35mg Film-coated tablets

35 milligram(s) Film-coated tablet

PCO Manufacturing Ltd.PPA0465/165/001

Main Information

Trade NameActonel Once a week 35mg Film-coated tablets
Active SubstancesRisedronate sodium
Strength35 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/165/001

Group Information

ATC CodeM05BA Bisphosphonates
M05BA07 risedronic acid


Licence Issued04/11/2005
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis authorisation permits the holder to parallel-distribute product marketed in Ireland under the product authorisation number PA1390/193/003
Marketing StatusUnknown


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

Generics Information

Interchangeable List CodeIC0068-124-003
Interchangeable List DocumentPDF of Interchangeable List
« Back