Deferasirox Accord

deferasirox

Opinion

On 14 November 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Deferasirox Accord, intended for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemias. The applicant for this medicinal product is Accord Healthcare S.L.U.

Deferasirox Accord will be available as film-coated tablets (90, 180 and 360 mg). The active substance of Deferasirox Accord is deferasirox, a selective iron (III) binding agent (ATC code: V03AC03) that promotes excretion of iron in the faeces.

Deferasirox Accord is a generic of Exjade, which has been authorised in the EU since 28 August 2006. Studies have demonstrated the satisfactory quality of Deferasirox Accord, and its bioequivalence to the reference product Exjade.

The full indication is:

“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.”

It is proposed that Deferasirox Accord be prescribed by physicians experienced in the treatment of chronic iron overload.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Deferasirox Accord
Agency product number
EMEA/H/C/005156
International non-proprietary name (INN) or common name
  • deferasirox
Active substance
  • deferasirox
Therapeutic area
Iron Overload
beta-Thalassemia
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.

Date opinion adopted
14/11/2019
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

More information on Deferasirox Accord

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