MabCampath

RSS

alemtuzumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for MabCampath has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 15/08/2012

Authorisation details

Product details
Name
MabCampath
Agency product number
EMEA/H/C/000353
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
Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
06/07/2001
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

06/07/2001 MabCampath - EMEA/H/C/000353 - N/0055

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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