Stelara

RSS

ustekinumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name
Stelara
Agency product number
EMEA/H/C/000958
Active substance
Ustekinumab
International non-proprietary name (INN) or common name
ustekinumab
Therapeutic area (MeSH)
  • Psoriasis
  • Arthritis, Psoriatic
  • Crohn Disease
Anatomical therapeutic chemical (ATC) code
L04AC05
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
15/01/2009
Contact address
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

17/09/2018 Stelara - EMEA/H/C/000958 - PSUSA/00003085/201712

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

Crohn’s Disease

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.

Plaque psoriasis

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 adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Psoriatic arthritis

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.

Assessment history

Changes since initial authorisation of medicine

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