This is a summary of the European public assessment report (EPAR) for Stelara. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Stelara.
For practical information about using Stelara, patients should read the package leaflet or contact their doctor or pharmacist.
Stelara : EPAR - Summary for the public (PDF/89.59 KB)
First published: 09/02/2009
Last updated: 25/11/2016
Stelara : EPAR - Risk-management-plan summary (PDF/227.76 KB) (updated)
First published: 12/09/2019
Last updated: 22/01/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International NV
|Date of issue of marketing authorisation valid throughout the European Union||
20/01/2020 Stelara - EMEA/H/C/000958 - II/0073
- 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.
Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen ultraviolet A.
Paediatric plaque psoriasis
Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Stelara, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 201913/12/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)21/09/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014