The marketing authorisation for Zenapax has been withdrawn at the request of the marketing authorisation holder.
Zenapax : EPAR - Summary for the public (PDF/256.5 KB)
First published: 08/04/2008
Last updated: 08/04/2008
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
23/01/2007 Zenapax - EMEA/H/C/000198 - IA/0026
- 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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Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.