Arsenic trioxide medac (arsenic trioxide)
- Region
- 🇪🇺 EU
- Active substance
- arsenic trioxide
- Company
- medac Gesellschaft für klinische Spezialpräparate mbH
- Status
- Authorised
- Therapeutic area
- Leukemia, Promyelocytic, Acute
- CHMP opinion
- Thu 23 Jul 2020
- EU approval
- Thu 17 Sep 2020
- Designations
- Generic
- Application
- EMEA/H/C/005218
- ATC
- L01XX27
- Official record
- www.ema.europa.eu
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 arsenic trioxide has not been examined.
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- 🇪🇺 Arsenic trioxide Mylan Withdrawn · Mylan Ireland Limited
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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.