Arsenic trioxide medac
arsenic trioxide
Table of contents
Overview
Arsenic trioxide medac is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL).
APL is a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation’ (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Arsenic trioxide medac is used in:
- patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA);
- patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Arsenic trioxide medac is a ‘generic medicine’. This means that Arsenic trioxide medac contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Trisenox.
Arsenic trioxide medac contains the active substance arsenic trioxide.
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Arsenic trioxide medac : EPAR - Medicine overview (PDF/174.82 KB)
First published: 01/10/2020
EMA/407447/2020 -
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Arsenic trioxide medac : EPAR - Risk-management-plan summary (PDF/151.78 KB)
First published: 01/10/2020
Authorisation details
Product details | |
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Name |
Arsenic trioxide medac
|
Agency product number |
EMEA/H/C/005218
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Active substance |
Arsenic trioxide
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International non-proprietary name (INN) or common name |
arsenic trioxide
|
Therapeutic area (MeSH) |
Leukemia, Promyelocytic, Acute
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Anatomical therapeutic chemical (ATC) code |
L01XX27
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Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
medac Gesellschaft für klinische Spezialpräparate mbH
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Date of issue of marketing authorisation valid throughout the European Union |
17/09/2020
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Contact address |
Product information
17/09/2020 Arsenic trioxide medac - EMEA/H/C/005218 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic 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/μl) 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/RARα) gene.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.