🇪🇺 Talvey in European Union

EMA authorised Talvey on 21 August 2023

Marketing authorisation

EMA — authorised 21 August 2023

  • Application: EMEA/H/C/005864
  • Marketing authorisation holder: Janssen-Cilag International N.V.
  • Local brand name: Talvey
  • Indication: Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 antibody and have demonstrated disease progression on the last therapy.
  • Pathway: conditional, orphan, PRIME
  • Status: approved

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Talvey 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 Talvey approved in European Union?

Yes. EMA authorised it on 21 August 2023.

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

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