🇪🇺 VADADUSTAT in European Union

EMA authorised VADADUSTAT on 24 April 2023

Marketing authorisation

EMA — authorised 24 April 2023

  • Application: EMEA/H/C/005131
  • Marketing authorisation holder: Medice Arzneimittel Pütter GmbH & Co. KG
  • Local brand name: Vafseo
  • Indication: Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
  • Status: approved

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VADADUSTAT 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 VADADUSTAT approved in European Union?

Yes. EMA authorised it on 24 April 2023.

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

Medice Arzneimittel Pütter GmbH & Co. KG holds the EU marketing authorisation.