Stelara

RSS

ustekinumab

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

Overview

Stelara is a medicine used to treat:

  • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light;
  • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Stelara may be used alone or combined with methotrexate (a DMARD);
  • moderately to severely active Crohn’s disease (a disease-causing inflammation of the gut) in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments;
  • moderately to severely active ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.

Stelara contains the active substance ustekinumab.

This EPAR was last updated on 06/04/2020

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
32
Date of issue of marketing authorisation valid throughout the European Union
15/01/2009
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

16/01/2020 Stelara - EMEA/H/C/000958 - II/0075

Contents

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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.

Ulcerative colitis
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.

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 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.

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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