Arzerra
ofatumumab
Table of contents
Overview
The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
Product details | |
---|---|
Name |
Arzerra
|
Agency product number |
EMEA/H/C/001131
|
Active substance |
ofatumumab
|
International non-proprietary name (INN) or common name |
ofatumumab
|
Therapeutic area (MeSH) |
Leukemia, Lymphocytic, Chronic, B-Cell
|
Anatomical therapeutic chemical (ATC) code |
L01XC10
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Ltd
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
19/04/2010
|
Contact address |
Product information
02/10/2017 Arzerra - EMEA/H/C/001131 - II/0051
Contents
- 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.
Pharmacotherapeutic group
Therapeutic 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.
Assessment history
News
-
16/12/2016
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 201611/11/2016
-
24/06/2016
-
23/05/2014