Zevalin

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ibritumomab tiuxetan

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 12/12/2017

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
Prins Bernhardplein 200
1097 JB Amsterdam
The Netherlands

Product information

08/12/2017 Zevalin - EMEA/H/C/000547 - PSUSA/00001704/201702

Contents

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Pharmacotherapeutic group

THERAPEUTIC RADIOPHARMACEUTICALS

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).

Assessment history

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