Deferasirox Accord

deferasirox

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Deferasirox Accord 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 [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 Accord contains the active substance deferasirox and is a ‘generic medicine’. This means that Deferasirox Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Exjade.

: The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.
Deferasirox Accord is available as film-coated tablets (90 mg, 180 mg and 360 mg), to be taken once a day at around the same time.
The starting dose of Deferasirox Accord depends on the patient’s body weight, what the medicine is used for, and the level of iron overload. The dose is then adjusted as needed, every 3 to 6 months, according to the iron levels in the blood.
For more information about using Deferasirox Accord, see the package leaflet or contact your doctor or pharmacist.

: When the body cannot remove iron effectively, the excess iron can cause damage. The active substance in Deferasirox Accord, deferasirox, is an ‘iron chelator’. It attaches to excess iron in the body to form a compound called a ‘chelate’ that can be removed by the body, mainly in the stool. This helps to correct the iron overload and prevents damage to organs such as the heart or liver from excess iron.

: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Exjade, and do not need to be repeated for Deferasirox Accord.
As for every medicine, the company provided studies on the quality of Deferasirox Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

: Because Deferasirox Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The European Medicines Agency concluded that, in accordance with EU requirements, Deferasirox Accord has been shown to have comparable quality and to be bioequivalent to Exjade. Therefore, the Agency’s view was that, as for Exjade, the benefits of Deferasirox Accord outweigh the identified risks and it can be authorised for use in the EU.

: The company that markets Deferasirox Accord must issue an education pack to healthcare professionals. This pack aims to inform them about the treatment recommendations with Deferasirox Accord, including choosing the right dose and the need to monitor the patient’s health, especially kidney function. The company will also prepare a similar pack for patients.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferasirox Accord have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Deferasirox Accord are continuously monitored. Side effects reported with Deferasirox Accord are carefully evaluated and any necessary action taken to protect patients.

: Deferasirox Accord received a marketing authorisation valid throughout the EU on 09 January 2020.

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Deferasirox Accord : EPAR - Medicine overview (PDF/170.24 KB)

First published: 04/03/2020
EMA/626874/2019
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Deferasirox Accord : EPAR - Risk-management-plan summary (PDF/172.88 KB)

First published: 04/03/2020
Last updated: 08/05/2023

This EPAR was last updated on 14/09/2023

Authorisation details

Product details
Name	Deferasirox Accord
Agency product number	EMEA/H/C/005156
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
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	Accord Healthcare S.L.U.
Revision	5
Date of issue of marketing authorisation valid throughout the European Union	09/01/2020
Contact address	Accord Healthcare S.L.U. Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona SPAIN

Product information

13/09/2023 Deferasirox Accord - EMEA/H/C/005156 - IB/0009/G

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Deferasirox Accord : EPAR - Product information (PDF/381.73 KB) (updated)

First published: 04/03/2020
Last updated: 14/09/2023
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Other EU languages available icon 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.

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Deferasirox Accord : EPAR - All authorised presentations (PDF/20.95 KB)

First published: 04/03/2020
Last updated: 07/01/2022
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Pharmacotherapeutic group

All other therapeutic products
Iron chelating agents

Therapeutic indication

Deferasirox Accord 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.

Deferasirox Accord is also indicated for 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.

Deferasirox Accord is also indicated for 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

Changes since initial authorisation of medicine

List item

Deferasirox Accord : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/111.86 KB) (updated)

First published: 08/07/2021
Last updated: 14/09/2023

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)

15/11/2019

Deferasirox Accord

Table of contents

Overview