Xigduo
dapagliflozin / metformin
Table of contents
Overview
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.
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List item
Xigduo : EPAR - Medicine overview (PDF/132.54 KB)
First published: 10/02/2014
Last updated: 29/08/2019
EMA/476561/2019 -
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List item
Xigduo : EPAR - Risk Management Plan (PDF/6.02 MB)
First published: 26/05/2023
Authorisation details
Product details | |
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Name |
Xigduo
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Agency product number |
EMEA/H/C/002672
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BD15
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Publication details | |
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Marketing-authorisation holder |
AstraZeneca AB
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Revision |
21
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Date of issue of marketing authorisation valid throughout the European Union |
16/01/2014
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Contact address |
151 85 Sodertalje |
Product information
30/05/2023 Xigduo - EMEA/H/C/002672 - IG1616
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Drugs used in diabetes
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Combinations of oral blood glucose lowering drugs
Therapeutic indication
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.