|Download document||Draft reflection paper on the wording of the indication for medicinal products for the treatment of type-2 diabetes|
|Status||draft: consultation open|
|Consultation start date||03/03/2014|
|Consultation end date||03/06/2014|
|Email address for firstname.lastname@example.org|
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.