Zenapax

RSS

daclizumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zenapax has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 13/02/2009

Authorisation details

Product details
Name
Zenapax
Agency product number
EMEA/H/C/000198
Active substance
daclizumab
International non-proprietary name (INN) or common name
daclizumab
Therapeutic area (MeSH)
  • Graft Rejection
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AA08
Publication details
Marketing-authorisation holder
Roche Registration Ltd.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
26/02/1999
Contact address
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

23/01/2007 Zenapax - EMEA/H/C/000198 - IA/0026

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

Immunosuppressants

Therapeutic indication

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.

Assessment history

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