🇪🇺 OPC-34712 in European Union

EMA authorised OPC-34712 on 26 July 2018

Marketing authorisation

EMA — authorised 26 July 2018

  • Application: EMEA/H/C/003841
  • Marketing authorisation holder: Otsuka Pharmaceutical Netherlands B.V.
  • Local brand name: Rxulti
  • Indication: Rxulti is indicated for the treatment of schizophrenia in adult and adolescents aged 13 years and older.
  • Status: approved

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OPC-34712 in other countries

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

Other Psychiatry/Neurology approved in European Union

Frequently asked questions

Is OPC-34712 approved in European Union?

Yes. EMA authorised it on 26 July 2018.

Who is the marketing authorisation holder for OPC-34712 in European Union?

Otsuka Pharmaceutical Netherlands B.V. holds the EU marketing authorisation.