🇪🇺 EVKEEZA in European Union

EMA authorised EVKEEZA on 17 June 2021

Marketing authorisation

EMA — authorised 17 June 2021

  • Application: EMEA/H/C/005449
  • Marketing authorisation holder: Ultragenyx Germany GmbH
  • Local brand name: Evkeeza
  • Indication: Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).
  • Pathway: exceptional circumstances
  • Status: approved

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EVKEEZA 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 EVKEEZA approved in European Union?

Yes. EMA authorised it on 17 June 2021.

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

Ultragenyx Germany GmbH holds the EU marketing authorisation.