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


Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU Effervescent Granules

35 mg + 1000 mg/800 international unit(s) Effervescent granules

PCO Manufacturing Ltd.PPA0465/305/001

Main Information

Trade NameActonel Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU Effervescent Granules
Active SubstancesColecalciferol
CALCIUM CARBONATE
Risedronate sodium
Strength35 mg + 1000 mg/800 international unit(s)
Dosage FormEffervescent granules
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/305/001

Group Information

ATC CodeM05BB Bisphosphonates, combinations
M05BB04 risedronic acid, calcium and colecalciferol, sequential

Status

Authorised/WithdrawnAuthorised
Licence Issued08/03/2013
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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