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


Galtasa 1000 mg gastro-resistant tablets



Faes Farma S.A.PA0864/001/003

Main Information

Trade NameGaltasa 1000 mg gastro-resistant tablets
Active SubstancesMesalazine
Dosage FormGastro-resistant tablet
Licence HolderFaes Farma S.A.
Licence NumberPA0864/001/003

Group Information

ATC CodeA07EC02 mesalazine

Status

License statusAuthorised
Licence Issued12/08/2022
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

Documents

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