This is a summary of the European Public Assessment Report (EPAR) for Arzerra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use of Arzerra.
For practical information about using Arzerra, patients should read the package leaflet or contact their doctor or pharmacist.
Arzerra : EPAR - Summary for the public (PDF/92.9 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||
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.