🇪🇺 Tofacitinib tablet in European Union

EMA authorised Tofacitinib tablet on 22 March 2017

Marketing authorisations

EMA — authorised 22 March 2017

  • Application: EMEA/H/C/004214
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Xeljanz
  • Indication: Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who
  • Status: approved

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EMA — authorised 23 July 2018

  • Application: EMEA/H/C/002542
  • Marketing authorisation holder: Pfizer Limited
  • Local brand name: Xeljanz
  • Indication: Treatment of rheumatoid arthritis.
  • Status: rejected

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Tofacitinib tablet in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is Tofacitinib tablet approved in European Union?

Yes. EMA authorised it on 22 March 2017; EMA authorised it on 23 July 2018.

Who is the marketing authorisation holder for Tofacitinib tablet in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.