🇪🇺 [¹⁴C]Etelcalcetide in European Union

EMA authorised [¹⁴C]Etelcalcetide on 11 November 2016

Marketing authorisation

EMA — authorised 11 November 2016

  • Application: EMEA/H/C/003995
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Parsabiv
  • Indication: Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
  • Status: approved

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[¹⁴C]Etelcalcetide 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 [¹⁴C]Etelcalcetide approved in European Union?

Yes. EMA authorised it on 11 November 2016.

Who is the marketing authorisation holder for [¹⁴C]Etelcalcetide in European Union?

Amgen Europe B.V. holds the EU marketing authorisation.