🇪🇺 Daridorexant 50 mg in European Union

EMA authorised Daridorexant 50 mg on 29 April 2022

Marketing authorisation

EMA — authorised 29 April 2022

  • Application: EMEA/H/C/005634
  • Marketing authorisation holder: Idorsia Pharmaceuticals Deutschland GmbH
  • Local brand name: Quviviq
  • Indication: Quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
  • Status: approved

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Daridorexant 50 mg in other countries

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

Frequently asked questions

Is Daridorexant 50 mg approved in European Union?

Yes. EMA authorised it on 29 April 2022.

Who is the marketing authorisation holder for Daridorexant 50 mg in European Union?

Idorsia Pharmaceuticals Deutschland GmbH holds the EU marketing authorisation.