The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.
Arzerra : EPAR - Summary for the public (PDF/529.97 KB)
First published: 14/06/2010
Last updated: 02/10/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Lymphocytic, Chronic, B-Cell
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
02/10/2017 Arzerra - EMEA/H/C/001131 - II/0051
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.