MabCampath

Withdrawn

This medicine's authorisation has been withdrawn

alemtuzumab

Overview

The marketing authorisation for MabCampath has been withdrawn at the request of the marketing-authorisation holder.

MabCampath : EPAR - Summary for the public

Product information

MabCampath : EPAR - Product Information

Latest procedure affecting product information: N/0055

06/07/2001

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).

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
• 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