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


Capecitabine medac

300 milligram(s) Film-coated tablet

Medac Gesellschaft fur Klinische Spezialpraparate mbH EU/1/12/802/015-028

Main Information

Trade NameCapecitabine medac
Active SubstancesCapecitabine
Strength300 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderMedac Gesellschaft fur Klinische Spezialpraparate mbH
Licence NumberEU/1/12/802/015-028

Group Information

ATC CodeL01BC Pyrimidine analogues
L01BC06 capecitabine

Status

Authorised/WithdrawnAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing Status

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Generics Information

Interchangeable List CodeIC0079-029-003
Interchangeable List DocumentPDF of Interchangeable List
« Back