Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 13 July 2018

Indication(s)

- STELARA 130 mg concentrate for solution for infusion:

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.



- STELARA 45 mg solution for injection
- STELARA 90 mg solution for injection
- STELARA 45 mg solution for injection in pre-filled syringe
- STELARA 90 mg solution for injection in pre-filled syringe:

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 (MTX) or PUVA (psoralen and 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 (PsA)
STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

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.

Full Prescribing information

Learning Zones

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More information

Category Value
Agency product number EMEA/H/C/000958
Orphan designation No
Date First Approved 16-01-2009
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Janssen-Cilag International NV