🇪🇺 Simponi in European Union

EMA authorised Simponi on 1 October 2009

Marketing authorisation

EMA — authorised 1 October 2009

  • Application: EMEA/H/C/000992
  • Marketing authorisation holder: Janssen Cilag International NV
  • Local brand name: Simponi
  • 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 i
  • Status: approved

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Simponi in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Simponi approved in European Union?

Yes. EMA authorised it on 1 October 2009.

Who is the marketing authorisation holder for Simponi in European Union?

Janssen Cilag International NV holds the EU marketing authorisation.