🇪🇺 trientine dihydrochloride in European Union

EMA authorised trientine dihydrochloride on 25 July 2019

Marketing authorisation

EMA — authorised 25 July 2019

  • Application: EMEA/H/C/004111
  • Marketing authorisation holder: Univar Solutions BV
  • Local brand name: Cufence
  • Indication: Cufence is indicated for the treatment of Wilson’s disease in patients intolerant to D-Penicillamine therapy, in adults and children aged 5 years or older.
  • Status: approved

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trientine dihydrochloride in other countries

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

Other Metabolic/Genetic Disorders approved in European Union

Frequently asked questions

Is trientine dihydrochloride approved in European Union?

Yes. EMA authorised it on 25 July 2019.

Who is the marketing authorisation holder for trientine dihydrochloride in European Union?

Univar Solutions BV holds the EU marketing authorisation.