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.
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Product information
English (EN) (993.89 KB - PDF)
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български (BG) (1.16 MB - PDF)
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español (ES) (1.22 MB - PDF)
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čeština (CS) (1.08 MB - PDF)
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dansk (DA) (1.05 MB - PDF)
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eesti keel (ET) (1.07 MB - PDF)
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hrvatski (HR) (1.15 MB - PDF)
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português (PT) (1006 KB - PDF)
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română (RO) (1.28 MB - PDF)
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Suomi (FI) (1.03 MB - PDF)
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svenska (SV) (980.3 KB - PDF)
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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).
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български (BG) (113.57 KB - PDF)
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español (ES) (88.92 KB - PDF)
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čeština (CS) (113.13 KB - PDF)
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dansk (DA) (89.63 KB - PDF)
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Deutsch (DE) (95.28 KB - PDF)
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eesti keel (ET) (86.95 KB - PDF)
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ελληνικά (EL) (115.31 KB - PDF)
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français (FR) (88.95 KB - PDF)
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italiano (IT) (86.79 KB - PDF)
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latviešu valoda (LV) (111.44 KB - PDF)
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lietuvių kalba (LT) (108.71 KB - PDF)
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português (PT) (90.8 KB - PDF)
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română (RO) (104.73 KB - PDF)
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slovenčina (SK) (112.29 KB - PDF)
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slovenščina (SL) (97.31 KB - PDF)
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Suomi (FI) (85.11 KB - PDF)
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svenska (SV) (88.69 KB - PDF)
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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 radiopharmaceuticalsTherapeutic 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
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