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


Roteas



Berlin-Chemie AGEU/1/16/1152/003-015

Main Information

Trade NameRoteas
Active SubstancesEdoxaban tosilate
Dosage FormFilm-coated tablet
Licence HolderBerlin-Chemie AG
Licence NumberEU/1/16/1152/003-015

Group Information

ATC CodeB01AF Direct factor Xa inhibitors
B01AF03 edoxaban

Status

License statusAuthorised
Licence Issued20/04/2017
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 StatusUnknown

Documents

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