Draft reflection paper on the wording of the indication for medicinal products for the treatment of type-2 diabetes

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Download document Draft reflection paper on the wording of the indication for medicinal products for the treatment of type-2 diabetes
Reference number EMA/CHMP/50673/2014
Status draft: consultation open
First published 03/03/2014
Last updated 03/03/2014
Consultation start date 03/03/2014
Consultation end date 03/06/2014
Email address for submissions cvswpsecretariat@ema.europa.eu

Summary

Currently, the wording of the indication in section 4.1 of the summary of product characteristics for recently approved centrally authorised medicinal products intended for the treatment of patients with type-2 diabetes contains two sections addressing mono- and combination therapy. One of the reasons to specifically describe monotherapy in the indication wording is to reflect the widely accepted recommendation to use metformin as first-line treatment. The adequacy of reflecting treatment algorithms within the wording of the indication may be questioned. Based on these considerations, a more general, simplified wording for these products could be considered as a more relevant way of reflecting the intended use.