🇪🇺 Ravicti in European Union

EMA authorised Ravicti on 26 November 2015

Marketing authorisation

EMA — authorised 26 November 2015

  • Application: EMEA/H/C/003822
  • Marketing authorisation holder: Immedica Pharma AB
  • Local brand name: Ravicti
  • Indication: Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplemen
  • Pathway: orphan
  • Status: approved

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Ravicti in other countries

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

Other Metabolic approved in European Union

Frequently asked questions

Is Ravicti approved in European Union?

Yes. EMA authorised it on 26 November 2015.

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

Immedica Pharma AB holds the EU marketing authorisation.