🇪🇺 Aptiom in European Union

Aptiom (ESLICARBAZEPINE ACETATE) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/000988
  • Local brand name: Zebinix
  • Status: approved

Aptiom 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 Aptiom approved in European Union?

Yes. EMA has authorised it.

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

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