🇪🇺 Trisenox in European Union

EMA authorised Trisenox on 5 March 2002

Marketing authorisation

EMA — authorised 5 March 2002

  • Application: EMEA/H/C/000388
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Trisenox
  • Indication: Trisenox is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ? 10 x 103/µl) in combination with all?trans?retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leuk
  • Status: approved

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Trisenox 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 Trisenox approved in European Union?

Yes. EMA authorised it on 5 March 2002.

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

Teva B.V. holds the EU marketing authorisation.