| EMA number | EMEA/H/C/001131 |
| ATC code | L01XC10 |
| Authorisation | 19 April 2010 |
| Withdrawn | 28 February 2019 |
| Revision | 16 |
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.
KESIMPTA β NOVARTIS, approved 2026-04-01 (BLA125326).
36,800 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System β they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.