🇪🇺 Wayrilz in European Union

EMA authorised Wayrilz on 22 December 2025

Marketing authorisation

EMA — authorised 22 December 2025

  • Application: EMEA/H/C/006425
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Wayrilz
  • Indication: Wayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)
  • Pathway: orphan
  • Status: approved

The EMA granted marketing authorisation for Wayrilz, an orphan medicinal product, on 22 December 2025. Wayrilz is indicated for the treatment of adult patients with immune thrombocytopenia (ITP) who are refractory to other treatments. This approval was granted under the orphan designation, which is reserved for medicines that treat rare diseases.

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Wayrilz 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 Wayrilz approved in European Union?

Yes. EMA authorised it on 22 December 2025.

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

Sanofi B.V. holds the EU marketing authorisation.