🇪🇺 Tasigna in European Union

EMA authorised Tasigna on 22 August 2024

Marketing authorisation

EMA — authorised 22 August 2024

  • Application: EMEA/H/C/006315
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Nilotinib Accord
  • Indication: Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
  • Status: approved

The European Medicines Agency (EMA) approved Nilotinib Accord (Tasigna) for the treatment of adult and paediatric patients with Philadelphia chromosome positive chronic myelogenous leukaemia (CML). This includes newly diagnosed patients in the chronic phase, and adult patients with chronic or accelerated phase CML who have developed resistance or intolerance to imatinib. The approval also covers paediatric patients with chronic phase CML who have resistance or intolerance to imatinib.

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Tasigna 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 Tasigna approved in European Union?

Yes. EMA authorised it on 22 August 2024.

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

Accord Healthcare S.L.U. holds the EU marketing authorisation.