Xigduo

dapagliflozin / metformin

Opinion

On 27 June 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xigduo. The marketing authorisation holder for this medicinal product is Astra Zeneca AB.

The CHMP adopted a change to the existing indication in type 2 diabetes as follows:*

“Xigduo is indicated in adults aged 18 years and older with for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • in patients inadequately insufficiently controlled on their maximally tolerated dose of metformin alone
  • in combination with other glucose-lowering medicinal products, including insulin, for the treatment of diabetes in patients inadequately insufficiently controlled with metformin and these medicinal products (see sections 4, 4.5 and 5.1 for available data on different combinations)
  • in patients already being treated with the combination of dapagliflozin and metformin as separate

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


*New text shown in bold; removed text as strikethrough

Key facts

Name
Xigduo
Agency product number
EMEA/H/C/002672
International non-proprietary name (INN) or common name
  • dapagliflozin / metformin
Active substance
  • metformin hydrochloride
  • dapagliflozin propanediol monohydrate
Therapeutic area
Diabetes Mellitus, Type 2
Date opinion adopted
27/06/2019
Company name
AstraZeneca AB
Status
Positive
Application type
Post-authorisation

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