Arzerra

ofatumumab

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.

List item

Arzerra : EPAR - Summary for the public (PDF/529.97 KB)

First published: 14/06/2010
Last updated: 02/10/2017
- Bulgarian
  (PDF/639.47 KB)
- Croatian
  (PDF/550.17 KB)
- Czech
  (PDF/605.37 KB)
- Danish
  (PDF/526.59 KB)
- Dutch
  (PDF/528.75 KB)
- Estonian
  (PDF/525.22 KB)
- Finnish
  (PDF/525.59 KB)
- French
  (PDF/530.34 KB)
- German
  (PDF/530.74 KB)
- Greek
  (PDF/645 KB)
- Hungarian
  (PDF/606.24 KB)
- Italian
  (PDF/525.56 KB)
- Latvian
  (PDF/601.3 KB)
- Lithuanian
  (PDF/562.92 KB)
- Maltese
  (PDF/601.91 KB)
- Polish
  (PDF/614.43 KB)
- Portuguese
  (PDF/529.49 KB)
- Romanian
  (PDF/559.74 KB)
- Slovak
  (PDF/600.96 KB)
- Slovenian
  (PDF/592.67 KB)
- Spanish
  (PDF/529.69 KB)
- Swedish
  (PDF/527.01 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 10/05/2019

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	Frimley Business Park Camberley GU16 7SR United Kingdom

Product information

02/10/2017 Arzerra - EMEA/H/C/001131 - II/0051

List item

Arzerra : EPAR - Product Information (PDF/1.03 MB)

First published: 14/06/2010
Last updated: 22/08/2017
- Bulgarian
  (PDF/2.51 MB)
- Croatian
  (PDF/1.5 MB)
- Czech
  (PDF/2.04 MB)
- Danish
  (PDF/1.48 MB)
- Dutch
  (PDF/1.55 MB)
- Estonian
  (PDF/1.38 MB)
- Finnish
  (PDF/1.33 MB)
- French
  (PDF/1.45 MB)
- German
  (PDF/1.47 MB)
- Greek
  (PDF/2.58 MB)
- Hungarian
  (PDF/2.14 MB)
- Icelandic
  (PDF/1.4 MB)
- Italian
  (PDF/1.11 MB)
- Latvian
  (PDF/2.08 MB)
- Lithuanian
  (PDF/1.15 MB)
- Maltese
  (PDF/2.22 MB)
- Norwegian
  (PDF/1.33 MB)
- Polish
  (PDF/2.04 MB)
- Portuguese
  (PDF/1.37 MB)
- Romanian
  (PDF/1.57 MB)
- Slovak
  (PDF/2.07 MB)
- Slovenian
  (PDF/1.95 MB)
- Spanish
  (PDF/1.46 MB)
- Swedish
  (PDF/1.52 MB)

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.

List item

Arzerra : EPAR - All Authorised presentations (PDF/461.05 KB)

First published: 14/06/2010
Last updated: 05/08/2014
- Bulgarian
  (PDF/499.43 KB)
- Croatian
  (PDF/516.79 KB)
- Czech
  (PDF/481.28 KB)
- Danish
  (PDF/456.65 KB)
- Dutch
  (PDF/453.25 KB)
- Estonian
  (PDF/455.91 KB)
- Finnish
  (PDF/458.87 KB)
- French
  (PDF/456.78 KB)
- German
  (PDF/451.69 KB)
- Greek
  (PDF/538.02 KB)
- Hungarian
  (PDF/474.45 KB)
- Icelandic
  (PDF/454.34 KB)
- Italian
  (PDF/455.89 KB)
- Latvian
  (PDF/487.34 KB)
- Lithuanian
  (PDF/566.09 KB)
- Maltese
  (PDF/470.85 KB)
- Norwegian
  (PDF/454.78 KB)
- Polish
  (PDF/529.8 KB)
- Portuguese
  (PDF/483.59 KB)
- Romanian
  (PDF/495.54 KB)
- Slovak
  (PDF/519.11 KB)
- Slovenian
  (PDF/503.38 KB)
- Spanish
  (PDF/463.19 KB)
- Swedish
  (PDF/477.82 KB)

Pharmacotherapeutic group

Monoclonal antibodies

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.

Arzerra

Table of contents

Overview

Arzerra : EPAR - Summary for the public (PDF/529.97 KB)

Authorisation details

Product information

Arzerra : EPAR - Product Information (PDF/1.03 MB)

Contents

Arzerra : EPAR - All Authorised presentations (PDF/461.05 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Arzerra : EPAR - Procedural steps taken and scientific information after authorisation (PDF/637.29 KB)

Arzerra-H-C-1131-II-0045 : EPAR - Assessment Report - Variation (PDF/5.64 MB)

CHMP post-authorisation summary of positive opinion for Arzerra (PDF/505.24 KB)

Arzerra-H-C-1131-II-41 : EPAR - Assessment Report - Variation (PDF/3.7 MB)

Questions and answers on refusal of a change to the marketing authorisation for Arzerra (ofatumumab) (PDF/512.37 KB)

Arzerra-H-C-1131-II-0023 : EPAR - Assessment Report - Variation (PDF/2.37 MB)

CHMP post-authorisation summary of positive opinion for Arzerra (PDF/506.82 KB)

Initial marketing-authorisation documents

Arzerra : EPAR - Public assessment report (PDF/1.58 MB)

CHMP summary of positive opinion for Arzerra (PDF/511.39 KB)

News

Public statement on Arzerra: Withdrawal of the marketing authorisation in the European Union (PDF/59.23 KB)

More information on Arzerra

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