Simponi is an anti-inflammatory medicine. It is used to treat the following diseases:
- active rheumatoid arthritis (a disease causing inflammation of the joints). Simponi is used in combination with methotrexate (a medicine that acts on the immune system). It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive;
- active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). Simponi is used in adults who have not responded adequately to other treatments. It can be used alone or in combination with methotrexate;
- axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including:
- adults with severe active ankylosing spondylitis who have not responded adequately to other treatments;
- adults with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);
- moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut). Simponi is used in adults who have not responded adequately to, or cannot use, conventional treatment;
- polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints). Simponi is used in combination with methotrexate. It is used in children with a body weight of at least 40 kg who have not responded adequately to treatment with methotrexate.
Simponi contains the active substance golimumab.
Simponi : EPAR - Summary for the public (PDF/137.97 KB)
First published: 20/10/2009
Last updated: 20/12/2018
Simponi : EPAR - Risk-management-plan summary (PDF/179.86 KB)
First published: 23/10/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen Biologics B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
06/09/2018 Simponi - EMEA/H/C/000992 - II/0084
- 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
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- Arthritis, rheumatoid
- Axial spondyloarthritis:
- Spondylitis, ankylosing
- Non‑radiographic axial spondyloarthritis (nr‑Axial SpA)
- Arthritis, psoriatic
- Colitis, ulcerative
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 201814/12/2018