🇪🇺 Carbaglu in European Union

EMA authorised Carbaglu on 23 June 2017

Marketing authorisations

EMA — authorised 23 June 2017

  • Application: EMEA/H/C/004019
  • Marketing authorisation holder: Eurocept International BV
  • Local brand name: Ucedane
  • Indication: Ucedane is indicated in treatment of: hyperammonaemia due to N-acetylglutamate synthase primary deficiency; Hyperammonaemia due to isovaleric acidaemia; Hyperammonaemia due to methymalonic acidaemia; Hyperammonaemia due to propionic acidaemia.
  • Status: approved

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EMA

  • Application: EMEA/H/C/000461
  • Local brand name: Carbaglu
  • Status: approved

Carbaglu in other countries

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

Other Gastroenterology approved in European Union

Frequently asked questions

Is Carbaglu approved in European Union?

Yes. EMA authorised it on 23 June 2017; EMA has authorised it.

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

Eurocept International BV holds the EU marketing authorisation.