🇪🇺 Filsuvez in European Union

Filsuvez (garadacimab) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/006116
  • Local brand name: Andembry
  • Status: approved

Filsuvez in other countries

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

Other Hematology approved in European Union

Frequently asked questions

Is Filsuvez approved in European Union?

Yes. EMA has authorised it.

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

CSL Behring is the originator. The local marketing authorisation holder may differ — check the official source linked above.