Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1208203
Name of medicinal product: ZEVALIN
Active substances:
Ibritumomab tiuxetan
Estonian, English, Latin
ATC code: V10XX02
Dosage form: kit for radiopharmaceutical preparation
Route of administration: intravenous use
Strengh: 1,6mg 1ml
Amount in package: 2ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: May 30, 2011
Marketing authorization holder: Ceft Biopharma s.r.o. 
Marketing authorization number: EU/1/03/264 
Marketing authorization issued on: January 16, 2004 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: February 18, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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