🇪🇺 KRN23 in European Union

EMA authorised KRN23 on 19 February 2018

Marketing authorisation

EMA — authorised 19 February 2018

  • Application: EMEA/H/C/004275
  • Marketing authorisation holder: Kyowa Kirin Holdings B.V.
  • Local brand name: Crysvita
  • Indication: Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.
  • Pathway: orphan
  • Status: approved

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KRN23 in other countries

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

Frequently asked questions

Is KRN23 approved in European Union?

Yes. EMA authorised it on 19 February 2018.

Who is the marketing authorisation holder for KRN23 in European Union?

Kyowa Kirin Holdings B.V. holds the EU marketing authorisation.