🇪🇺 Versed in European Union

Versed (midazolam) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/005657
  • Local brand name: Omforro
  • Status: application withdrawn

Versed in other countries

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

Other Neuroscience approved in European Union

Frequently asked questions

Is Versed approved in European Union?

Yes. EMA has authorised it.

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

Generic (originally Roche) is the originator. The local marketing authorisation holder may differ — check the official source linked above.