🇪🇺 Saphris in European Union

Saphris (ASENAPINE) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/001177
  • Local brand name: Sycrest
  • Status: approved

Saphris 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 Saphris approved in European Union?

Yes. EMA has authorised it.

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

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