Arsenic trioxide Mylan (arsenic trioxide)
- Region
- 🇪🇺 EU
- Active substance
- arsenic trioxide
- Company
- Mylan Ireland Limited
- Status
- Withdrawn
- Therapeutic area
- Leukemia, Promyelocytic, Acute
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Wed 01 Apr 2020
- Designations
- Generic
- Application
- EMEA/H/C/005235
- ATC
- L01XX27
- Official record
- www.ema.europa.eu
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 myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Trisenox Authorised · Teva B.V.
- 🇪🇺 Arsenic trioxide Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Arsenic trioxide medac Authorised · medac Gesellschaft für klinische Spezialpräparate mbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.