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Deferasirox Mylan: A new generic drug for the treatment of iron overload in β-thalassaemia major obtained approval by the EMA

 

The European Medicines Agency’s (EMA) has recently granted marketing authorisation for the medicinal product ”Deferasirox Mylan”, intended for the treatment of chronic iron overload due to blood transfusions in patients with β-thalassaemia major, non-transfusion-dependent thalassaemia syndromes and other anaemias. The manufacturer of this medicinal product is Mylan S.A.S.

”Deferasirox Mylan” will be available as 90 mg, 180 mg and 360 mg film-coated tablets. The active substance of ”Deferasirox Mylan” is deferasirox, an iron binding agent that is highly selective for iron (III) and promotes excretion of iron primarily in the faeces.

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

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Generic drugs:

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. Cost is the main difference between generic and brand name prescription drugs. Generic medicines are subject to stringent international, regional and national regulations governing their approval, quality, manufacturing (GMP) and post-marketing surveillance (pharmacovigilance) to ensure the highest levels of safety, quality and efficacy.

To learn more information about generic medicines, you can read the following Questions & Answers document issued by the EMA:

Q&A document on generic medicines