Deferasirox Mylan
deferasirox
Table of contents
Overview
Deferasirox Mylan is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
- patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin - the protein that carries oxygen around the body - in the blood) and who receive frequent blood transfusions;
- children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;
- patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;
- patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;
- patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate. Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions. In these patients iron overload is caused by excess absorption of iron from the gut.
Deferasirox Mylan contains the active substance deferasirox and is a ‘generic medicine’. This means that Deferasirox Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Exjade.
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Deferasirox Mylan : EPAR - Medicine overview (PDF/145.07 KB)
First published: 10/10/2019
EMA/515414/2019 -
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Deferasirox Mylan : EPAR - Risk-management-plan summary (PDF/429.49 KB)
First published: 10/10/2019
Last updated: 17/05/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Deferasirox Mylan
|
| Agency product number |
EMEA/H/C/005014
|
| Active substance |
deferasirox
|
| International non-proprietary name (INN) or common name |
deferasirox
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
V03AC03
|
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 | |
|---|---|
| Marketing-authorisation holder |
Mylan Pharmaceuticals Limited
|
| Revision |
8
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/09/2019
|
| Contact address |
Mylan Pharmaceuticals Limited |
Product information
04/01/2023 Deferasirox Mylan - EMEA/H/C/005014 - IB/0010
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
Deferasirox Mylan is indicated for
- the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older
- the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:
- in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,
- in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older,
- in adult and paediatric patients with other anaemias aged 2 years and older.
- the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older.