🇪🇺 Myrbetriq in European Union

Myrbetriq (MIRABEGRON) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/002388
  • Local brand name: Betmiga
  • Status: approved

Myrbetriq in other countries

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

Other Urology approved in European Union

Frequently asked questions

Is Myrbetriq approved in European Union?

Yes. EMA has authorised it.

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

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