Arzerra

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ofatumumab

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Arzerra has been withdrawn at the request of the marketing authorisation holder.

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

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Changes since initial authorisation of medicine

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