🇪🇺 Anti-TNFα continued perioperatively in European Union

EMA authorised Anti-TNFα continued perioperatively on 13 February 2017

Marketing authorisations

EMA — authorised 13 February 2017

  • Application: EMEA/H/C/004167
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Lifmior
  • Indication: Rheumatoid arthritis; Juvenile idiopathic arthritis Psoriatic arthritis; Axial spondyloarthritis; Plaque psoriasis; Paediatric plaque psoriasis.
  • Status: withdrawn

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EMA — authorised 22 March 2017

  • Application: EMEA/H/C/004373
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Solymbic
  • Indication: Please refer to section 4.1 of the Summary of product characteristics in the product information document.
  • Pathway: biosimilar
  • Status: withdrawn

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EMA — authorised 24 August 2017

  • Application: EMEA/H/C/004279
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Imraldi
  • Indication: Rheumatoid arthritis Imraldi in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint d
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 26 July 2018

  • Application: EMEA/H/C/004865
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Hefiya
  • Indication: Rheumatoid arthritis Hefiya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint dam
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 26 July 2018

  • Application: EMEA/H/C/004866
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Halimatoz
  • Indication: Rheumatoid arthritis Halimatoz in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Halimatoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joi
  • Pathway: biosimilar
  • Status: withdrawn

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EMA — authorised 2 April 2019

  • Application: EMEA/H/C/005158
  • Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
  • Local brand name: Kromeya
  • Indication: Rheumatoid arthritis Kromeya in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint d
  • Pathway: biosimilar
  • Status: withdrawn

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EMA — authorised 13 February 2020

  • Application: EMEA/H/C/004879
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Amsparity
  • Indication: Rheumatoid arthritis Amsparity in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joi
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 20 May 2020

  • Application: EMEA/H/C/004711
  • Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
  • Local brand name: Nepexto
  • Indication: Rheumatoid arthritis Nepexto 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. Nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.  Nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Nepexto, alone or in c
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 12 November 2021

  • Application: EMEA/H/C/005947
  • Marketing authorisation holder: Stada Arzneimittel AG
  • Local brand name: Libmyris
  • Indication: Rheumatoid arthritis Libmyris in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 15 November 2021

  • Application: EMEA/H/C/005548
  • Marketing authorisation holder: Stada Arzneimittel AG
  • Local brand name: Hukyndra
  • Indication: Rheumatoid arthritis Hukyndra in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of
  • Pathway: biosimilar
  • Status: approved

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EMA

  • Application: EMEA/H/C/005253
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Fyzoclad
  • Indication: Treatment of juvenile idiopathic arthritis, paediatric plaque psoriasis, paediatric uveitis
  • Status: withdrawn

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EMA

  • Application: EMEA/H/C/006738
  • Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
  • Local brand name: Fubelv
  • Indication: Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, paediatric plaque psoriasis 
  • Pathway: biosimilar
  • Status: approved

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Anti-TNFα continued perioperatively in other countries

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

Frequently asked questions

Is Anti-TNFα continued perioperatively approved in European Union?

Yes. EMA authorised it on 13 February 2017; EMA authorised it on 22 March 2017; EMA authorised it on 24 August 2017.

Who is the marketing authorisation holder for Anti-TNFα continued perioperatively in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.