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


Apixaban Mylan 5 mg film-coated tablets



McDermott Laboratories Ltd., T/A Gerard LaboratoriesPA0577/233/002

Main Information

Trade NameApixaban Mylan 5 mg film-coated tablets
Active SubstancesApixaban
Dosage FormFilm-coated tablet
Licence HolderMcDermott Laboratories Ltd., T/A Gerard Laboratories
Licence NumberPA0577/233/002

Group Information

ATC CodeB01AF02 apixaban

Status

License statusAuthorised
Licence Issued09/07/2021
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 StatusNot marketed

Documents

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

Generics Information

Interchangeable List CodeIC0124-001-003
Interchangeable List DocumentPDF of Interchangeable List
« Back