🇪🇺 SPARSENTAN in European Union

EMA authorised SPARSENTAN on 19 April 2024

Marketing authorisation

EMA — authorised 19 April 2024

  • Application: EMEA/H/C/005783
  • Marketing authorisation holder: Vifor France
  • Local brand name: Filspari
  • Indication: Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion > 1.0 g/day (or urine protein-to-creatinine ratio > 0.75 g/g, see section 5.1).
  • Pathway: orphan
  • Status: approved

The European Medicines Agency (EMA) granted marketing authorisation for Filspari (SPARSENTAN) on 19 April 2024. Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of more than 1.0 g/day or a urine protein-to-creatinine ratio of more than 0.75 g/g. This approval was granted under the orphan designation, which is reserved for medicines treating rare diseases.

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SPARSENTAN 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 SPARSENTAN approved in European Union?

Yes. EMA authorised it on 19 April 2024.

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

Vifor France holds the EU marketing authorisation.