🇪🇺 Scenesse in European Union

EMA authorised Scenesse on 12 December 2014

Marketing authorisations

EMA — authorised 12 December 2014

  • Marketing authorisation holder: Clinuvel UK Limited
  • Status: approved

EMA — authorised 22 December 2014

  • Application: EMEA/H/C/002548
  • Marketing authorisation holder: Clinuvel Europe Limited
  • Local brand name: Scenesse
  • Indication: Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
  • Pathway: exceptional circumstances
  • Status: approved

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Scenesse 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 Scenesse approved in European Union?

Yes. EMA authorised it on 12 December 2014; EMA authorised it on 22 December 2014.

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

Clinuvel UK Limited holds the EU marketing authorisation.