Rinvoq - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
upadacitinib
Post-authorisationHuman
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Rinvoq. The marketing authorisation holder for this medicinal product is Abbvie Deutschland GmbH & Co. KG.
The CHMP adopted a new indication as follows:
Polyarticular juvenile idiopathic arthritis
Rinvoq is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate.
For information, the full indications for Rinvoq will be as follows:
Rheumatoid arthritis
Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate.
Polyarticular juvenile idiopathic arthritis
Rinvoq is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Giant cell arteritis
Rinvoq is indicated for the treatment of giant cell arteritis in adult patients.
Atopic dermatitis
Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn’s disease
Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold.
CHMP post-authorisation summary of positive opinion for Rinvoq (X-0000304823)
Adopted
Reference Number: EMADOC-1700519818-3330037
English (EN) (139.43 KB - PDF)
First published: