🇪🇺 Exondys 51 in European Union

Exondys 51 (ETEPLIRSEN) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/004355
  • Local brand name: Exondys
  • Status: refused

Exondys 51 in other countries

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

Other Rare Disease approved in European Union

Frequently asked questions

Is Exondys 51 approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Exondys 51 in European Union?

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