Arzerra (ofatumumab)
- Region
- 🇪🇺 EU
- Active substance
- ofatumumab
- Company
- Novartis Europharm Ltd
- Status
- Withdrawn
- Therapeutic area
- Leukemia, Lymphocytic, Chronic, B-Cell
- EU approval
- Mon 19 Apr 2010
- Application
- EMEA/H/C/001131
- ATC
- L01XC10
- Official record
- www.ema.europa.eu
Indication
Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Relapsed CLL: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL. Refractory CLL: Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Kesimpta Authorised · Novartis Europharm Limited
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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.