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Human medicines European public assessment report (EPAR): Zevalin, ibritumomab tiuxetan, Date of authorisation: 16/01/2004, Revision: 23, Status: Lapsed

Overview

The marketing authorisation for Zevalin has lapsed because it has not been marketed in the European Union for more than 3 consecutive years.

English (EN) (101.11 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

български (BG) (235.65 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

español (ES) (167.8 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

čeština (CS) (158.35 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

dansk (DA) (167.38 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

Deutsch (DE) (170.86 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

eesti keel (ET) (165.08 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

ελληνικά (EL) (316.18 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

français (FR) (124.1 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

italiano (IT) (171.86 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

latviešu valoda (LV) (235.47 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

lietuvių kalba (LT) (207.27 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

magyar (HU) (131.89 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

Malti (MT) (152.17 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

Nederlands (NL) (104.93 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

polski (PL) (217.85 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

português (PT) (103.05 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

română (RO) (149.34 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

slovenčina (SK) (202.36 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

slovenščina (SL) (197.3 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

Suomi (FI) (170.1 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

svenska (SV) (102.28 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011

English (EN) (223.87 KB - PDF)

First published: 29/06/2021

Product information

English (EN) (993.89 KB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

български (BG) (1.16 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

español (ES) (1.22 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

čeština (CS) (1.08 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

dansk (DA) (1.05 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

Deutsch (DE) (1.04 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

eesti keel (ET) (1.07 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

ελληνικά (EL) (1.35 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

français (FR) (1.19 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

hrvatski (HR) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

íslenska (IS) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

italiano (IT) (1.14 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

latviešu valoda (LV) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

lietuvių kalba (LT) (1.09 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

magyar (HU) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

Malti (MT) (1.3 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

Nederlands (NL) (1 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

norsk (NO) (1.01 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

polski (PL) (1.16 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

português (PT) (1006 KB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

română (RO) (1.28 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

slovenčina (SK) (1.08 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

slovenščina (SL) (1.1 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

Suomi (FI) (1.03 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

svenska (SV) (980.3 KB - PDF)

First published: 03/11/2009Last updated: 09/03/2020

Latest procedure affecting product information: II/0053

10/06/2021

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).

English (EN) (89.7 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

български (BG) (113.57 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

español (ES) (88.92 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

čeština (CS) (113.13 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

dansk (DA) (89.63 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

Deutsch (DE) (95.28 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

eesti keel (ET) (86.95 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

ελληνικά (EL) (115.31 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

français (FR) (88.95 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

italiano (IT) (86.79 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

latviešu valoda (LV) (111.44 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

lietuvių kalba (LT) (108.71 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

magyar (HU) (100.3 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

Malti (MT) (109.14 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

Nederlands (NL) (87.37 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

polski (PL) (115.49 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

português (PT) (90.8 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

română (RO) (104.73 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

slovenčina (SK) (112.29 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

slovenščina (SL) (97.31 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

Suomi (FI) (85.11 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

svenska (SV) (88.69 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006

Product details

Name of medicine: Zevalin
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

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).

More information on Zevalin

English (EN) (118.27 KB - PDF)

First published: 10/07/2024

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