Zevalin

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Lapsed

This medicine's authorisation has lapsed

ibritumomab tiuxetan
MedicineHumanLapsed
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

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

Zevalin : EPAR - Summary for the public

English (EN) (101.11 KB - PDF)

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български (BG) (235.65 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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español (ES) (167.8 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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čeština (CS) (158.35 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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dansk (DA) (167.38 KB - PDF)

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Deutsch (DE) (170.86 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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eesti keel (ET) (165.08 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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ελληνικά (EL) (316.18 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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français (FR) (124.1 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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italiano (IT) (171.86 KB - PDF)

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latviešu valoda (LV) (235.47 KB - PDF)

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lietuvių kalba (LT) (207.27 KB - PDF)

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magyar (HU) (131.89 KB - PDF)

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Malti (MT) (152.17 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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Nederlands (NL) (104.93 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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polski (PL) (217.85 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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português (PT) (103.05 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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română (RO) (149.34 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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slovenčina (SK) (202.36 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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slovenščina (SL) (197.3 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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Suomi (FI) (170.1 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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svenska (SV) (102.28 KB - PDF)

First published: 02/03/2009Last updated: 27/09/2011
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Zevalin : EPAR - Risk-management-plan summary

English (EN) (223.87 KB - PDF)

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Product information

Zevalin : EPAR - Product Information

English (EN) (993.89 KB - PDF)

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български (BG) (1.16 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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español (ES) (1.22 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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čeština (CS) (1.08 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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dansk (DA) (1.05 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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Deutsch (DE) (1.04 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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eesti keel (ET) (1.07 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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ελληνικά (EL) (1.35 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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français (FR) (1.19 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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hrvatski (HR) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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íslenska (IS) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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italiano (IT) (1.14 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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latviešu valoda (LV) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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lietuvių kalba (LT) (1.09 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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magyar (HU) (1.15 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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Malti (MT) (1.3 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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Nederlands (NL) (1 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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norsk (NO) (1.01 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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polski (PL) (1.16 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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português (PT) (1006 KB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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română (RO) (1.28 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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slovenčina (SK) (1.08 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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slovenščina (SL) (1.1 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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Suomi (FI) (1.03 MB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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svenska (SV) (980.3 KB - PDF)

First published: 03/11/2009Last updated: 09/03/2020
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Latest procedure affecting product information: II/0053
10/06/2021
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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).

Zevalin : EPAR - All Authorised presentations

English (EN) (89.7 KB - PDF)

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български (BG) (113.57 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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español (ES) (88.92 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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čeština (CS) (113.13 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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dansk (DA) (89.63 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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Deutsch (DE) (95.28 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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eesti keel (ET) (86.95 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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ελληνικά (EL) (115.31 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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français (FR) (88.95 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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italiano (IT) (86.79 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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latviešu valoda (LV) (111.44 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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lietuvių kalba (LT) (108.71 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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magyar (HU) (100.3 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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Malti (MT) (109.14 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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Nederlands (NL) (87.37 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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polski (PL) (115.49 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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português (PT) (90.8 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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română (RO) (104.73 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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slovenčina (SK) (112.29 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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slovenščina (SL) (97.31 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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Suomi (FI) (85.11 KB - PDF)

First published: 13/11/2006Last updated: 13/11/2006
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svenska (SV) (88.69 KB - PDF)

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

Authorisation details

EMA product number
EMEA/H/C/000547
Marketing authorisation holder
Ceft Biopharma s.r.o.

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

Marketing authorisation issued
16/01/2004
Lapse of marketing authorisation
04/01/2024
Revision
23

Assessment history

Zevalin : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (462.2 KB - PDF)

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Zevalin-H-C-PSUSA-1704-201704 - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/821222/2017

English (EN) (118.12 KB - PDF)

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Zevalin-H-C-547-II-18 : EPAR - Assessment Report - Variation

English (EN) (429.06 KB - PDF)

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CHMP post authorisation summary of positive opinion for Zevalin on 19 March 2008

AdoptedReference Number: EMEA/CHMP/144112/2008

English (EN) (57.79 KB - PDF)

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Zevalin : EPAR - Scientific Discussion

English (EN) (1.16 MB - PDF)

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Zevalin : EPAR - Procedural steps taken before authorisation

English (EN) (122.53 KB - PDF)

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More information on Zevalin

Public statement on Zevalin: Cessation of validity of the marketing authorisation in the European Union

Reference Number: EMA/226889/2024

English (EN) (118.27 KB - PDF)

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