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The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.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
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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
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16/12/2016
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 201611/11/2016
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24/06/2016
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23/05/2014