Zevalin
Lapsed
This medicine's authorisation has lapsed
ibritumomab tiuxetan
MedicineHumanLapsed
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 4 January 2024 the marketing authorisation of Zevalin (Ibritumomab tiuxetan) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Ceft Biopharma s.r.o., discontinued marketing of Zevalin in the European Union (EU) in May 2020. In accordance with provisions of the sunset clause, the marketing authorisation of a medicinal product lapses if the product had not been marketed in any EU Member States for three consecutive years. The European Commission rejected a request for an exemption from the ‘sunset clause’ for Zevalin. Ceft Biopharma s.r.o. confirmed that it discontinued the marketing of the product due to manufacturing reasons.
Zevalin was granted marketing authorisation in the EU on 16 January 2004 for the treatment of nonHodgkin's lymphoma (NHL) and follicular lymphoma. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2009.
The European Public Assessment Report (EPAR) for Zevalin is updated to indicate that the marketing authorisation is no longer valid.
Product information
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).
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).
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