Stelara 路 EMEA/H/C/000958 路 Authorised, authorised Jan 16, 2009 (Commission decision C(2009) 236) 路 EPAR
Adult Crohn鈥檚 Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn鈥檚 disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF伪 antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn鈥檚 disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult 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. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. 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) (see section 5.1). 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 (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 (see section 5.1).
EMA's summary; the full indication is in the product information on the EPAR page.
