Zevalin

RSS

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 29/06/2021

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
Ceft Biopharma s.r.o.
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
16/01/2004
Contact address

Trtinova 260/1
Cakovice, 196 00 Praha 9
Czech Republic

Product information

10/06/2021 Zevalin - EMEA/H/C/000547 - II/0053

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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.

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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