dapagliflozin / metformin
Xigduo is a diabetes medicine used, together with diet and exercise in adults with type 2 diabetes. It contains the active substances dapagliflozin and metformin.
Xigduo is used:
- on its own in patients whose disease is not controlled well enough with metformin alone;
- in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Xigduo can also be used to replace dapagliflozin and metformin taken as separate tablets.
Xigduo : EPAR - Medicine overview (PDF/132.54 KB)
First published: 10/02/2014
Last updated: 29/08/2019
Xigduo : EPAR - Risk Management Plan (PDF/6.02 MB)
First published: 26/05/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
151 85 Sodertalje
30/05/2023 Xigduo - EMEA/H/C/002672 - IG1616
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Drugs used in diabetes
Combinations of oral blood glucose lowering drugs
Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:
• in patients insufficiently controlled on their maximally tolerated dose of metformin alone
• in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products
• in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013