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Ursofalk 500 mg film-coated tablets



PCO Manufacturing Ltd.PPA0465/183/002

Main Information

Trade NameUrsofalk 500 mg film-coated tablets
Active SubstancesUrsodeoxycholic acid
Dosage FormFilm-coated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/183/002

Group Information

ATC CodeA05AA Bile acid preparations
A05AA02 ursodeoxycholic acid

Status

License statusAuthorised
Licence Issued26/03/2021
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
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