MabCampath

Withdrawn

This medicine's authorisation has been withdrawn

alemtuzumab

Overview

On 6 July 2001 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product MabCampath (alemtuzumab) for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate. 

The marketing authorisation holder (MAH) responsible for MabCampath was Genzyme Europe B.V. The European Commission was notified by letter of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for MabCampath for commercial reasons. 

On 8 August 2012 the European Commission issued a decision to withdraw the marketing authorisation for MabCampath. The MAH has committed to ensure that patients who need treatment with MabCampath for B-CLL and some other transplant/oncology indications will continue to receive it through patient access programmes. Details of these programmes are being discussed at national level and will be governed by national competent authorities. 

Pursuant to this decision the European Public Assessment Report for MabCampath is updated to reflect that the marketing authorisation is no longer valid.

MabCampath : EPAR - Summary for the public

Product information

MabCampath : EPAR - Product Information

MabCampath : EPAR - All Authorised presentations

MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

Product details

• Name of medicine:
  MabCampath
• Active substance:
  alemtuzumab
• International non-proprietary name (INN) or common name:
  alemtuzumab
• Therapeutic area (MeSH):
  Leukemia, Lymphocytic, Chronic, B-Cell
• Anatomical therapeutic chemical (ATC) code:
  L01XC04

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.

Authorisation details

• EMA product number:
  EMEA/H/C/000353
• Marketing authorisation holder:
  Genzyme Europe B.V.

  Paasheuvelweg 25; 1105 BP Amsterdam; The Netherlands

• Marketing authorisation issued:
  06/07/2001
• Withdrawal of marketing authorisation:
  08/08/2012
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

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

MabCampath-H-C-353-II-30 : EPAR - Scientific Discussion - Variation

Adopted

MabCampath : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

MabCampath : EPAR - Scientific Discussion

MabCampath : EPAR - Procedural steps taken before authorisation