Xigduo

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dapagliflozin / metformin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/11/2019

Authorisation details

Product details
Name
Xigduo
Agency product number
EMEA/H/C/002672
Active substance
  • metformin hydrochloride
  • dapagliflozin propanediol monohydrate
International non-proprietary name (INN) or common name
dapagliflozin / metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD15
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address
SE-151-85 Sodertalje
Sweden

Product information

26/11/2019 Xigduo - EMEA/H/C/002672 - WS/1637

Contents

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Pharmacotherapeutic group

Film coated tablet

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.

Assessment history

Changes since initial authorisation of medicine

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