🇪🇺 Benepali in European Union

EMA authorised Benepali on 13 January 2016

Marketing authorisation

EMA — authorised 13 January 2016

  • Application: EMEA/H/C/004007
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Benepali
  • Indication: Rheumatoid arthritis Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Benepali, alone or in com
  • Pathway: biosimilar
  • Status: approved

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Benepali in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Benepali approved in European Union?

Yes. EMA authorised it on 13 January 2016.

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

Samsung Bioepis NL B.V. holds the EU marketing authorisation.