🇪🇺 Sephience in European Union

Sephience (SEPIAPTERIN) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/006331
  • Local brand name: Sephience
  • Status: approved

Sephience in other countries

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

Other Metabolic approved in European Union

Frequently asked questions

Is Sephience approved in European Union?

Yes. EMA has authorised it.

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

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