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


Ezetimibe Rowa 10 mg tablets



Rowa Pharmaceuticals LimitedPA0074/074/001

Main Information

Trade NameEzetimibe Rowa 10 mg tablets
Active SubstancesEzetimibe
Dosage FormTablet
Licence HolderRowa Pharmaceuticals Limited
Licence NumberPA0074/074/001

Group Information

ATC CodeC10AX Other lipid modifying agents
C10AX09 ezetimibe

Status

License statusAuthorised
Licence Issued28/07/2017
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 StatusMarketed

Documents

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

Generics Information

Interchangeable ListEzetimibe 10mg Tablets
Interchangeable List CodeIC0104-002-002
Interchangeable List DocumentPDF of Interchangeable List
« Back