Zevalin
ibritumomab tiuxetan
Table of contents
Overview
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.
Authorisation details
Product details | |
---|---|
Name |
Zevalin
|
Agency product number |
EMEA/H/C/000547
|
Active substance |
ibritumomab tiuxetan
|
International non-proprietary name (INN) or common name |
ibritumomab tiuxetan
|
Therapeutic area (MeSH) |
Lymphoma, Follicular
|
Anatomical therapeutic chemical (ATC) code |
V10XX02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Spectrum Pharmaceuticals B.V.
|
Revision |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
16/01/2004
|
Contact address |
Product information
08/12/2017 Zevalin - EMEA/H/C/000547 - PSUSA/00001704/201702
Contents
- 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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Pharmacotherapeutic group
Therapeutic indication
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
or
refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).