Arzerra

Withdrawn

This medicine's authorisation has been withdrawn

ofatumumab

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Assessment Report (EPAR) for Arzerra is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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

Product information

Arzerra : EPAR - Product Information

Arzerra : EPAR - All Authorised presentations

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

Changes since initial authorisation of medicine

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

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

Adopted Reference Number: EMA/CHMP/692752/2016

CHMP post-authorisation summary of positive opinion for Arzerra

Adopted Reference Number: EMA/CHMP/693024/2016

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

Adopted Reference Number: EMA/CHMP/77370/2016

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

Adopted Reference Number: EMA/433595/2016

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

Adopted Reference Number: EMA/475698/2014

CHMP post-authorisation summary of positive opinion for Arzerra

Adopted Reference Number: EMA/CHMP/312178/2014

Initial marketing authorisation documents

Arzerra : EPAR - Public assessment report

CHMP summary of positive opinion for Arzerra

Adopted Reference Number: EMA/CHMP/21426/2010