🇪🇺 Arcalyst in European Union

Arcalyst (RILONACEPT) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/006537
  • Local brand name: Rilonacept FGK Representative Service GmbH
  • Status: application withdrawn

Arcalyst 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 Arcalyst approved in European Union?

Yes. EMA has authorised it.

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

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