Simponi

RSS

golimumab

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

Overview

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. 

This EPAR was last updated on 20/12/2018

Authorisation details

Product details
Name
Simponi
Agency product number
EMEA/H/C/000992
Active substance
Golimumab
International non-proprietary name (INN) or common name
golimumab
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Colitis, Ulcerative
  • Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AB06
Publication details
Marketing-authorisation holder
Janssen Biologics B.V.
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
01/10/2009
Contact address
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands

Product information

06/09/2018 Simponi - EMEA/H/C/000992 - II/0084

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

  • Arthritis, rheumatoid
  • Axial spondyloarthritis:

- Spondylitis, ankylosing

- Non‑radiographic axial spondyloarthritis (nr‑Axial SpA)

  • Arthritis, psoriatic
  • Colitis, ulcerative

Assessment history

Changes since initial authorisation of medicine

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