🇪🇺 Drug: Carfilzomib + Lenalidomide + Dexamethasone in European Union

EMA authorised Drug: Carfilzomib + Lenalidomide + Dexamethasone on 19 November 2015

Marketing authorisation

EMA — authorised 19 November 2015

  • Application: EMEA/H/C/003790
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Kyprolis
  • Indication: Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  • Pathway: accelerated assessment
  • Status: approved

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Drug: Carfilzomib + Lenalidomide + Dexamethasone in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is Drug: Carfilzomib + Lenalidomide + Dexamethasone approved in European Union?

Yes. EMA authorised it on 19 November 2015.

Who is the marketing authorisation holder for Drug: Carfilzomib + Lenalidomide + Dexamethasone in European Union?

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