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


Takeda Pharma A/SEU/1/14/923/005-007

Main Information

Trade NameEntyvio
Active SubstancesVedolizumab
Dosage FormSolution for injection in pre-filled pen
Licence HolderTakeda Pharma A/S
Licence NumberEU/1/14/923/005-007

Group Information

ATC CodeL04AA33 vedolizumab


License statusAuthorised
Licence Issued28/04/2020
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 StatusUnknown


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

Educational Materials - HCP

Educational Materials - Patient

« Back