This is a summary of the European public assessment report (EPAR) for Zevalin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zevalin.
Zevalin : EPAR - Summary for the public (PDF/62.65 KB)
First published: 02/03/2009
Last updated: 27/09/2011
Zevalin : EPAR - Risk-management-plan summary (PDF/103.13 KB)
First published: 29/06/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Ceft Biopharma s.r.o.
|Date of issue of marketing authorisation valid throughout the European Union||
10/06/2021 Zevalin - EMEA/H/C/000547 - II/0053
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Zevalin is indicated in adults.
[90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
[90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed
refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).