Arzerra

RSS
Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.

Arzerra : EPAR - Summary for the public

English (EN) (529.97 KB - PDF)

First published: Last updated:
View

български (BG) (639.47 KB - PDF)

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

español (ES) (529.69 KB - PDF)

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

čeština (CS) (605.37 KB - PDF)

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

dansk (DA) (526.59 KB - PDF)

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

Deutsch (DE) (530.74 KB - PDF)

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

eesti keel (ET) (525.22 KB - PDF)

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

ελληνικά (EL) (645 KB - PDF)

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

français (FR) (530.34 KB - PDF)

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

hrvatski (HR) (550.17 KB - PDF)

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

italiano (IT) (525.56 KB - PDF)

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

latviešu valoda (LV) (601.3 KB - PDF)

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

lietuvių kalba (LT) (562.92 KB - PDF)

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

magyar (HU) (606.24 KB - PDF)

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

Malti (MT) (601.91 KB - PDF)

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

Nederlands (NL) (528.75 KB - PDF)

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

polski (PL) (614.43 KB - PDF)

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

português (PT) (529.49 KB - PDF)

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

română (RO) (559.74 KB - PDF)

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

slovenčina (SK) (600.96 KB - PDF)

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

slovenščina (SL) (592.67 KB - PDF)

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

Suomi (FI) (525.59 KB - PDF)

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

svenska (SV) (527.01 KB - PDF)

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

Product information

Arzerra : EPAR - Product Information

English (EN) (1.03 MB - PDF)

First published: Last updated:
View

български (BG) (2.51 MB - PDF)

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

español (ES) (1.46 MB - PDF)

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

čeština (CS) (2.04 MB - PDF)

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

dansk (DA) (1.48 MB - PDF)

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

Deutsch (DE) (1.47 MB - PDF)

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

eesti keel (ET) (1.38 MB - PDF)

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

ελληνικά (EL) (2.58 MB - PDF)

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

français (FR) (1.45 MB - PDF)

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

hrvatski (HR) (1.5 MB - PDF)

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

íslenska (IS) (1.4 MB - PDF)

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

italiano (IT) (1.11 MB - PDF)

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

latviešu valoda (LV) (2.08 MB - PDF)

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

lietuvių kalba (LT) (1.15 MB - PDF)

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

magyar (HU) (2.14 MB - PDF)

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

Malti (MT) (2.22 MB - PDF)

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

Nederlands (NL) (1.55 MB - PDF)

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

norsk (NO) (1.33 MB - PDF)

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

polski (PL) (2.04 MB - PDF)

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

português (PT) (1.37 MB - PDF)

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

română (RO) (1.57 MB - PDF)

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

slovenčina (SK) (2.07 MB - PDF)

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

slovenščina (SL) (1.95 MB - PDF)

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

Suomi (FI) (1.33 MB - PDF)

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

svenska (SV) (1.52 MB - PDF)

First published: 14/06/2010Last updated: 22/08/2017
View
Latest procedure affecting product information: II/0051
02/10/2017
icon globe

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:
View

български (BG) (499.43 KB - PDF)

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

español (ES) (463.19 KB - PDF)

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

čeština (CS) (481.28 KB - PDF)

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

dansk (DA) (456.65 KB - PDF)

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

Deutsch (DE) (451.69 KB - PDF)

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

eesti keel (ET) (455.91 KB - PDF)

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

ελληνικά (EL) (538.02 KB - PDF)

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

français (FR) (456.78 KB - PDF)

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

hrvatski (HR) (516.79 KB - PDF)

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

íslenska (IS) (454.34 KB - PDF)

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

italiano (IT) (455.89 KB - PDF)

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

latviešu valoda (LV) (487.34 KB - PDF)

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

lietuvių kalba (LT) (566.09 KB - PDF)

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

magyar (HU) (474.45 KB - PDF)

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

Malti (MT) (470.85 KB - PDF)

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

Nederlands (NL) (453.25 KB - PDF)

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

norsk (NO) (454.78 KB - PDF)

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

polski (PL) (529.8 KB - PDF)

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

português (PT) (483.59 KB - PDF)

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

română (RO) (495.54 KB - PDF)

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

slovenčina (SK) (519.11 KB - PDF)

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

slovenščina (SL) (503.38 KB - PDF)

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

Suomi (FI) (458.87 KB - PDF)

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

svenska (SV) (477.82 KB - PDF)

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

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)

First published: Last updated:
View

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

AdoptedReference Number: EMA/CHMP/692752/2016

English (EN) (5.64 MB - PDF)

First published: Last updated:
View

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:
View

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

AdoptedReference Number: EMA/CHMP/77370/2016

English (EN) (3.7 MB - PDF)

First published: Last updated:
View

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)

First published: Last updated:
View

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

AdoptedReference Number: EMA/475698/2014

English (EN) (2.37 MB - PDF)

First published: Last updated:
View

CHMP post-authorisation summary of positive opinion for Arzerra

AdoptedReference Number: EMA/CHMP/312178/2014

English (EN) (506.82 KB - PDF)

First published: Last updated:
View

Arzerra : EPAR - Public assessment report

English (EN) (1.58 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Arzerra

AdoptedReference Number: EMA/CHMP/21426/2010

English (EN) (511.39 KB - PDF)

First published: Last updated:
View

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

AdoptedReference Number: EMA/149805/2019

English (EN) (59.23 KB - PDF)

First published:
View

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.

This page was last updated on

Share this page

Back to top