🇪🇺 Tavneos in European Union

EMA authorised Tavneos on 11 January 2022

Marketing authorisations

EMA — authorised 11 January 2022

  • Marketing authorisation holder: Vifor Fresenius Medical Care Renal Pharma France
  • Local brand name: Tavneos
  • Status: approved

EMA — authorised 11 January 2022

  • Application: EMEA/H/C/005523
  • Marketing authorisation holder: Vifor Fresenius Medical Care Renal Pharma France
  • Local brand name: Tavneos
  • Indication: Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
  • Pathway: orphan, PRIME
  • Status: approved

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EMA

  • Application: EMEA/H/C/004487
  • Marketing authorisation holder: ChemoCentryx Ltd
  • Local brand name: Vynpenta (previously AvacopanChemoCentryx)
  • Indication: Induction of response in adult patients with granulomatosis with polyangiitis (Wegener’s) (GPA) or microscopic polyangiitis (MPA)
  • Pathway: orphan
  • Status: withdrawn

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Tavneos in other countries

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

Other Rare Disease approved in European Union

Frequently asked questions

Is Tavneos approved in European Union?

Yes. EMA authorised it on 11 January 2022; EMA authorised it on 11 January 2022; EMA has authorised it.

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

Vifor Fresenius Medical Care Renal Pharma France holds the EU marketing authorisation.