🇪🇺 Rezolsta in European Union

EMA authorised Rezolsta on 19 November 2014

Marketing authorisation

EMA — authorised 19 November 2014

  • Application: EMEA/H/C/002819
  • Marketing authorisation holder: Janssen-Cilag International N.V.
  • Local brand name: Rezolsta
  • Indication: Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients (aged 6years and older, weighing at least 25 kg).Genotypic testing should guide the use of Rezolsta.
  • Status: approved

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Other Other approved in European Union

Frequently asked questions

Is Rezolsta approved in European Union?

Yes. EMA authorised it on 19 November 2014.

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

Janssen-Cilag International N.V. holds the EU marketing authorisation.