🇪🇺 Ruxolitinib 1.5% Cream in European Union

EMA authorised Ruxolitinib 1.5% Cream on 19 April 2023

Marketing authorisation

EMA — authorised 19 April 2023

  • Application: EMEA/H/C/005843
  • Marketing authorisation holder: Incyte Biosciences Distribution B.V.
  • Local brand name: Opzelura
  • Indication: Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
  • Status: approved

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Ruxolitinib 1.5% Cream 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 Ruxolitinib 1.5% Cream approved in European Union?

Yes. EMA authorised it on 19 April 2023.

Who is the marketing authorisation holder for Ruxolitinib 1.5% Cream in European Union?

Incyte Biosciences Distribution B.V. holds the EU marketing authorisation.