Zevalin (ibritumomab tiuxetan)
- Region
- 🇪🇺 EU
- Active substance
- ibritumomab tiuxetan
- Company
- Ceft Biopharma s.r.o.
- Status
- Lapsed
- Therapeutic area
- Lymphoma, Follicular
- CHMP opinion
- Thu 25 Sep 2003
- EU approval
- Fri 16 Jan 2004
- Application
- EMEA/H/C/000547
- ATC
- V10XX02
- Official record
- www.ema.europa.eu
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 relapsedorrefractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.