🇪🇺 Copiktra in European Union

EMA authorised Copiktra on 19 May 2021

Marketing authorisations

EMA — authorised 19 May 2021

  • Marketing authorisation holder: Verastem Europe GmbH
  • Status: approved

EMA — authorised 19 May 2021

  • Application: EMEA/H/C/005381
  • Marketing authorisation holder: Secura Bio Limited
  • Local brand name: Copiktra
  • Indication: Copiktra monotherapy is indicated for the treatment of adult patients with:  Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.  Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.
  • Status: withdrawn

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Copiktra 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 Copiktra approved in European Union?

Yes. EMA authorised it on 19 May 2021; EMA authorised it on 19 May 2021.

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

Verastem Europe GmbH holds the EU marketing authorisation.