🇪🇺 Epkinly in European Union

EMA authorised Epkinly on 22 September 2023

Marketing authorisation

EMA — authorised 22 September 2023

  • Application: EMEA/H/C/005985
  • Marketing authorisation holder: AbbVie Deutschland GmbH & Co. KG
  • Local brand name: Tepkinly
  • Indication: Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult
  • Pathway: conditional
  • Status: approved

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Epkinly 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 Epkinly approved in European Union?

Yes. EMA authorised it on 22 September 2023.

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

AbbVie Deutschland GmbH & Co. KG holds the EU marketing authorisation.