Raptiva

RSS

efalizumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Raptiva has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 04/08/2009

Authorisation details

Product details
Name
Raptiva
Agency product number
EMEA/H/C/000542
Active substance
efalizumab
International non-proprietary name (INN) or common name
efalizumab
Therapeutic area (MeSH)
Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AA21
Publication details
Marketing-authorisation holder
Serono Europe Limited
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
20/09/2004
Contact address
Serono Europe Ltd.
56 Marsh Wall
London E14 9TP
United Kingdom

Product information

25/11/2008 Raptiva - EMEA/H/C/000542 - II/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

Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 - Clinical Efficacy).

Assessment history

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