The Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency‘ (EMA) committee responsible for human medicines, has recently adopted a positive opinion recommending the granting of a marketing authorisation for the medicinal product Deferasirox Accord, by Accord Healthcare S.L.U.
Deferasirox Accord is a generic of Exjade, which has been authorised in the EU since 2006 for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemias. The drug 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.
The full summary of the EMA’s positive opinion for Deferasirox Accord can be accessed here.
In addition, a question and answer document on generic medicines by the EMA can be found here.