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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1208203
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Name of medicinal product:
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ZEVALIN
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Active substances:
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ATC code:
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V10XX02
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Dosage form:
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kit for radiopharmaceutical preparation
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Route of administration:
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intravenous use
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Strengh:
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1,6mg 1ml
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Amount in package:
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2ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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May 30, 2011
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Marketing authorization holder:
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Ceft Biopharma s.r.o.
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Marketing authorization number:
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EU/1/03/264
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Marketing authorization issued on:
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January 16, 2004
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Description
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Additional condition
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Ei ole lubatud väljastada korduvretsepti
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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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