The marketing authorisation for Raptiva has been withdrawn at the request of the marketing authorisation holder.
Raptiva : EPAR - Summary for the public (PDF/476.19 KB)
First published: 04/08/2009
Last updated: 04/08/2009
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Serono Europe Limited
|Date of issue of marketing authorisation valid throughout the European Union||
25/11/2008 Raptiva - EMEA/H/C/000542 - II/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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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).