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


Ceft Biopharma s.r.oEU/1/03/264/001

Main Information

Trade NameZevalin
Active SubstancesIbritumomabum tiuxetan
Dosage FormKit for radiopharmaceutical preparation
Licence HolderCeft Biopharma s.r.o
Licence NumberEU/1/03/264/001

Group Information

ATC CodeV10XX Various therapeutic radiopharmaceuticals
V10XX02 ibritumomab tiuxetan [90Y]


License statusAuthorised
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 StatusUnknown


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