🇪🇺 Carvykti in European Union

EMA authorised Carvykti on 25 May 2022

Marketing authorisation

EMA — authorised 25 May 2022

  • Application: EMEA/H/C/005095
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Carvykti
  • Indication: Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
  • Pathway: orphan, ATMP, PRIME
  • Status: approved

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Carvykti 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 Carvykti approved in European Union?

Yes. EMA authorised it on 25 May 2022.

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

Janssen-Cilag International NV holds the EU marketing authorisation.