🇪🇺 Orudis in European Union

Orudis (KETOPROFEN) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/000865
  • Local brand name: Diractin
  • Status: application withdrawn

Orudis in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is Orudis approved in European Union?

Yes. EMA has authorised it.

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

Marketing authorisation holder not available in our data.