🇪🇺 ATO in European Union

EMA authorised ATO on 14 November 2019

Marketing authorisations

Application: EMEA/H/C/005175
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Arsenic trioxide Accord
Indication: Arsenic trioxide 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/?l) 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 promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous
Status: approved

Application: EMEA/H/C/005235
Marketing authorisation holder: Mylan Ireland Limited
Local brand name: Arsenic trioxide Mylan
Indication: Arsenic trioxide Mylan 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/?l) 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 promyelocytic leukaemia/retinoic acid receptor alpha (PML/RAR alpha) gene. The response rate of other acute myel
Status: withdrawn

Application: EMEA/H/C/005218
Marketing authorisation holder: medac Gesellschaft für klinische Spezialpräparate mbH
Local brand name: Arsenic trioxide medac
Indication: Arsenic trioxide medac 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/?l) in combination with all-trans-retinoic acid (ATRA) Relapsed/refractory 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?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsen
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is ATO approved in European Union?

Yes. EMA authorised it on 14 November 2019; EMA authorised it on 1 April 2020; EMA authorised it on 17 September 2020.

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

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