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, to control blood glucose (sugar) levels 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 satisfactorily controlled with metformin alone;
  • in combination with other diabetes medicines, including insulin, when these medicines together with metformin are not providing adequate control of the diabetes. Xigduo can also be used to replace dapagliflozin and metformin taken as separate tablets.
This EPAR was last updated on 06/06/2019

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
13
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address
SE-151-85 Sodertalje
Sweden

Product information

01/03/2019 Xigduo - EMEA/H/C/002672 - IG/1064

Contents

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Pharmacotherapeutic group

Film coated tablet

Therapeutic indication

Xigduo is indicated 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
  • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.

Assessment history

Changes since initial authorisation of medicine

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