The marketing authorisation for MabCampath has been withdrawn at the request of the marketing-authorisation holder.
MabCampath : EPAR - Summary for the public (PDF/295.96 KB)
First published: 05/08/2008
Last updated: 15/08/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Lymphocytic, Chronic, B-Cell
|Anatomical therapeutic chemical (ATC) code||
Genzyme Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
06/07/2001 MabCampath - EMEA/H/C/000353 - N/0055
- 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
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MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.