🇪🇺 Daybue in European Union

Daybue (TROFINETIDE) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/006482
  • Local brand name: Daybu
  • Status: opinion under re-examination

Daybue in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Daybue approved in European Union?

Yes. EMA has authorised it.

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

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