Arzerra

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Withdrawn

This medicine's authorisation has been withdrawn

ofatumumab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 28 February 2019, the European Commission withdrew the marketing authorisation for Arzerra (ofatumumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Arzerra was granted marketing authorisation in the EU on 19 April 2010 for the treatment of chronic lymphocytic leukaemia (CLL). The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2015. 

The European Public Assessment Report (EPAR) for Arzerra is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Arzerra : EPAR - Summary for the public

English (EN) (529.97 KB - PDF)

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български (BG) (639.47 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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español (ES) (529.69 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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čeština (CS) (605.37 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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dansk (DA) (526.59 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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Deutsch (DE) (530.74 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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eesti keel (ET) (525.22 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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ελληνικά (EL) (645 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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français (FR) (530.34 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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hrvatski (HR) (550.17 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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italiano (IT) (525.56 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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latviešu valoda (LV) (601.3 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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lietuvių kalba (LT) (562.92 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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magyar (HU) (606.24 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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Malti (MT) (601.91 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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Nederlands (NL) (528.75 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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polski (PL) (614.43 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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português (PT) (529.49 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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română (RO) (559.74 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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slovenčina (SK) (600.96 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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slovenščina (SL) (592.67 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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Suomi (FI) (525.59 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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svenska (SV) (527.01 KB - PDF)

First published: 14/06/2010Last updated: 02/10/2017
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Product information

Arzerra : EPAR - Product Information

English (EN) (1.03 MB - PDF)

First published: Last updated:
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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)

First published: 14/06/2010Last updated: 22/08/2017
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dansk (DA) (1.48 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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Deutsch (DE) (1.47 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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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)

First published: 14/06/2010Last updated: 22/08/2017
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hrvatski (HR) (1.5 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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íslenska (IS) (1.4 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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italiano (IT) (1.11 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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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)

First published: 14/06/2010Last updated: 22/08/2017
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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)

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

First published: 14/06/2010Last updated: 22/08/2017
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português (PT) (1.37 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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română (RO) (1.57 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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slovenčina (SK) (2.07 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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slovenščina (SL) (1.95 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
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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)

First published: 14/06/2010Last updated: 22/08/2017
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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)

First published: Last updated:
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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
Withdrawal of marketing authorisation
28/02/2019
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)

First published: Last updated:
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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)

First published: Last updated:
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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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