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

Cholurso 500 mg film-coated tablets

Laboratoires Mayoly SpindlerPA1913/002/002

Main Information

Trade NameCholurso 500 mg film-coated tablets
Active SubstancesUrsodeoxycholic acid
Dosage FormFilm-coated tablet
Licence HolderLaboratoires Mayoly Spindler
Licence NumberPA1913/002/002

Group Information

ATC CodeA05AA Bile acid preparations
A05AA02 ursodeoxycholic acid


License statusAuthorised
Licence Issued13/10/2017
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 StatusNot marketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportPDF Version
« Back