Deferasirox Mylan

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deferasirox

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 10/10/2019

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)
  • Iron Overload
  • beta-Thalassemia
Anatomical therapeutic chemical (ATC) code
V03AC03
GenericGeneric

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 S.A.S
Date of issue of marketing authorisation valid throughout the European Union
26/09/2019
Contact address

117 Allee des Parcs
69800 Saint-Priest
France

Product information

26/09/2019 Deferasirox Mylan - EMEA/H/C/005014 -

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Pharmacotherapeutic group

Iron chelating agents

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

Assessment history

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