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
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Spectrum Pharmaceuticals B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
08/12/2017 Zevalin - EMEA/H/C/000547 - PSUSA/00001704/201702
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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).