🇪🇺 ELFABRIO in European Union

EMA authorised ELFABRIO on 4 May 2023

Marketing authorisation

EMA — authorised 4 May 2023

  • Application: EMEA/H/C/005618
  • Marketing authorisation holder: Chiesi Farmaceutici S.p.A
  • Local brand name: Elfabrio
  • Indication: Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
  • Status: approved

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ELFABRIO 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 ELFABRIO approved in European Union?

Yes. EMA authorised it on 4 May 2023.

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

Chiesi Farmaceutici S.p.A holds the EU marketing authorisation.