MabCampath

alemtuzumab

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The marketing authorisation for MabCampath has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
MabCampath : EPAR - Summary for the public BG = bălgarski 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public ES = español 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public CS = čeština 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public DA = dansk 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public DE = Deutsch 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public ET = eesti keel 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public EL = elliniká 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public EN = English 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public FR = français 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public IT = italiano 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public LV = latviešu valoda 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public LT = lietuvių kalba 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public HU = magyar 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public MT = Malti 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public NL = Nederlands 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public PL = polski 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public PT = português 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public RO = română 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public SK = slovenčina 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public SL = slovenščina 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public FI = suomi 05/08/2008 15/08/2012
MabCampath : EPAR - Summary for the public SV = svenska 05/08/2008 15/08/2012

This EPAR was last updated on 15/08/2012 .

Authorisation details

Product details

Product details for MabCampath
NameMabCampath
Agency product numberEMEA/H/C/000353
Active substance

alemtuzumab

International non-proprietary name (INN) or common name

alemtuzumab

Therapeutic area Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XC04

Publication details

Publication details for MabCampath
Marketing-authorisation holder

Genzyme Europe B.V.

Revision14
Date of issue of marketing authorisation valid throughout the European Union06/07/2001

Contact address:

Genzyme Europe B.V.
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

Product information

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

Name Language First published Last updated
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012
MabCampath : EPAR - Product Information SV = svenska 03/08/2009 15/08/2012

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.


Name Language First published Last updated
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - All Authorised presentations SV = svenska 21/10/2005 15/08/2012

Name Language First published Last updated
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012
MabCampath : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 06/02/2008 15/08/2012

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
MabCampath : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005 15/08/2012
MabCampath : EPAR - Scientific Discussion SV = svenska 21/10/2005 15/08/2012

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on MabCampath