Simponi

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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 from 2 years of age who have not responded adequately to treatment with methotrexate.

Simponi contains the active substance golimumab. 

This EPAR was last updated on 17/10/2019

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
37
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

11/10/2019 Simponi - EMEA/H/C/000992 - IAIN/0091

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis (RA)

Simponi, in combination with methotrexate (MTX), is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.

Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function.

For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.

Psoriatic arthritis (PsA)

Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Non radiographic axial spondyloarthritis (nr Axial SpA)

Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ulcerative colitis (UC)

Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis (pJIA)

Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.

Rheumatoid arthritis (RA)

Simponi, in combination with methotrexate (MTX), is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.

Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis (pJIA)

Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.

Psoriatic arthritis (PsA)

Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Non radiographic axial spondyloarthritis (nr Axial SpA)

Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ulcerative colitis (UC)

Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Assessment history

Changes since initial authorisation of medicine

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