Overview

The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.

Arzerra : EPAR - Summary for the public

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eesti keel (ET) (525.22 KB - PDF)

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ελληνικά (EL) (645 KB - PDF)

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français (FR) (530.34 KB - PDF)

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hrvatski (HR) (550.17 KB - PDF)

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italiano (IT) (525.56 KB - PDF)

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latviešu valoda (LV) (601.3 KB - PDF)

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lietuvių kalba (LT) (562.92 KB - PDF)

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magyar (HU) (606.24 KB - PDF)

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Malti (MT) (601.91 KB - PDF)

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Nederlands (NL) (528.75 KB - PDF)

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polski (PL) (614.43 KB - PDF)

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português (PT) (529.49 KB - PDF)

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română (RO) (559.74 KB - PDF)

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slovenčina (SK) (600.96 KB - PDF)

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slovenščina (SL) (592.67 KB - PDF)

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Suomi (FI) (525.59 KB - PDF)

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svenska (SV) (527.01 KB - PDF)

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Product information

Arzerra : EPAR - Product Information

English (EN) (1.03 MB - PDF)

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български (BG) (2.51 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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español (ES) (1.46 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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čeština (CS) (2.04 MB - PDF)

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dansk (DA) (1.48 MB - PDF)

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Deutsch (DE) (1.47 MB - PDF)

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eesti keel (ET) (1.38 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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ελληνικά (EL) (2.58 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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français (FR) (1.45 MB - PDF)

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hrvatski (HR) (1.5 MB - PDF)

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íslenska (IS) (1.4 MB - PDF)

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italiano (IT) (1.11 MB - PDF)

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latviešu valoda (LV) (2.08 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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lietuvių kalba (LT) (1.15 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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magyar (HU) (2.14 MB - PDF)

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Malti (MT) (2.22 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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Nederlands (NL) (1.55 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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norsk (NO) (1.33 MB - PDF)

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polski (PL) (2.04 MB - PDF)

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português (PT) (1.37 MB - PDF)

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română (RO) (1.57 MB - PDF)

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slovenčina (SK) (2.07 MB - PDF)

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slovenščina (SL) (1.95 MB - PDF)

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Suomi (FI) (1.33 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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svenska (SV) (1.52 MB - PDF)

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Latest procedure affecting product information: II/0051

02/10/2017

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Arzerra : EPAR - All Authorised presentations

English (EN) (461.05 KB - PDF)

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български (BG) (499.43 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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español (ES) (463.19 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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čeština (CS) (481.28 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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dansk (DA) (456.65 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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Deutsch (DE) (451.69 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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eesti keel (ET) (455.91 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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ελληνικά (EL) (538.02 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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français (FR) (456.78 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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hrvatski (HR) (516.79 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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íslenska (IS) (454.34 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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italiano (IT) (455.89 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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latviešu valoda (LV) (487.34 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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lietuvių kalba (LT) (566.09 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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magyar (HU) (474.45 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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Malti (MT) (470.85 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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Nederlands (NL) (453.25 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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norsk (NO) (454.78 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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polski (PL) (529.8 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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português (PT) (483.59 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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română (RO) (495.54 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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slovenčina (SK) (519.11 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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slovenščina (SL) (503.38 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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Suomi (FI) (458.87 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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svenska (SV) (477.82 KB - PDF)

First published: 14/06/2010Last updated: 05/08/2014
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Product details

Name of medicine
Arzerra
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

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.

Authorisation details

EMA product number
EMEA/H/C/001131
Marketing authorisation holder
Novartis Europharm Ltd

Frimley Business Park
Camberley GU16 7SR
United Kingdom

Marketing authorisation issued
19/04/2010
Revision
16

Assessment history

Arzerra : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (637.29 KB - PDF)

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Arzerra-H-C-1131-II-0045 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/692752/2016

English (EN) (5.64 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Arzerra

AdoptedReference Number: EMA/CHMP/693024/2016

English (EN) (505.24 KB - PDF)

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Arzerra-H-C-1131-II-41 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/77370/2016

English (EN) (3.7 MB - PDF)

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

AdoptedReference Number: EMA/433595/2016

English (EN) (512.37 KB - PDF)

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Arzerra-H-C-1131-II-0023 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/475698/2014

English (EN) (2.37 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Arzerra

AdoptedReference Number: EMA/CHMP/312178/2014

English (EN) (506.82 KB - PDF)

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Arzerra : EPAR - Public assessment report

English (EN) (1.58 MB - PDF)

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CHMP summary of positive opinion for Arzerra

AdoptedReference Number: EMA/CHMP/21426/2010

English (EN) (511.39 KB - PDF)

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Public statement on Arzerra: Withdrawal of the marketing authorisation in the European Union

AdoptedReference Number: EMA/149805/2019

English (EN) (59.23 KB - PDF)

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More information on Arzerra

This product was originally designated an orphan medicine on 7 November 2008. Arzerra was withdrawn from the Community register of orphan medicinal products in December 2018 upon request of the marketing authorisation holder.

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