🇪🇺 TYENNE in European Union

EMA authorised TYENNE on 15 September 2023

Marketing authorisation

EMA — authorised 15 September 2023

  • Application: EMEA/H/C/005781
  • Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
  • Local brand name: Tyenne
  • Indication: Tyenne, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tocilizumab has
  • Pathway: biosimilar
  • Status: approved

Read official source →

TYENNE 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 TYENNE approved in European Union?

Yes. EMA authorised it on 15 September 2023.

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

Fresenius Kabi Deutschland GmbH holds the EU marketing authorisation.