Formulary Decisions

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Dapagliflozin + Metformin
Xigduo
Not routinely available
SMC (983/14)
29/03/2023

Indication

In adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of metformin alone;in combination with other glucose-lowering medicinal products, including insulin, ...

In adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of metformin alone;in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products; n patients already being treated with the combination of dapagliflozin and metformin as separate tablets. SMC restriction: to use in patients for whom a combination of dapagliflozin and metformin is an appropriate choice of therapy, i.e. - when metformin alone does not provide adequate glycaemic control and a sulphonylurea is inappropriate; - in combination with insulin, when insulin and metformin does not provide adequate control; - in combination with a sulphonylurea, when a sulphonylurea and metformin does not provide adequate control.

Therapeutic Area

Endocrine system

Status Description

Not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines

Formulation

5mg/850mg and 5mg/1000mg film-coated tablets

Comments

-

Link to Advice

983/14

Advice Published

11/08/2014

SMC Submission Type

Abbreviated

SMC Status

Restricted