🇪🇺 Oleogel-S10 in European Union

EMA authorised Oleogel-S10 on 14 January 2016

Marketing authorisations

EMA — authorised 14 January 2016

  • Application: EMEA/H/C/003938
  • Marketing authorisation holder: Amryt AG
  • Local brand name: Episalvan
  • Indication: Treatment of partial thickness wounds in adults. See sections 4.4 and 5.1 in Product Information with respect to type of wounds studied.
  • Status: withdrawn

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EMA — authorised 21 June 2022

  • Application: EMEA/H/C/005035
  • Marketing authorisation holder: Chiesi Farmaceutici S.p.A
  • Local brand name: Filsuvez
  • Indication: Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
  • Pathway: orphan
  • Status: approved

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Frequently asked questions

Is Oleogel-S10 approved in European Union?

Yes. EMA authorised it on 14 January 2016; EMA authorised it on 21 June 2022.

Who is the marketing authorisation holder for Oleogel-S10 in European Union?

Amryt AG holds the EU marketing authorisation.