🇪🇺 Darzalex in European Union

EMA authorised Darzalex on 20 May 2016

Marketing authorisation

EMA — authorised 20 May 2016

  • Application: EMEA/H/C/004077
  • Marketing authorisation holder: Janssen-Cilag International N.V.
  • Local brand name: Darzalex
  • Indication: Multiple Myeloma  Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of&n
  • Pathway: accelerated assessment, orphan
  • Status: approved

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Darzalex 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 Darzalex approved in European Union?

Yes. EMA authorised it on 20 May 2016.

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

Janssen-Cilag International N.V. holds the EU marketing authorisation.