Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 12 January 2018

Indication(s)

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.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/002672
Orphan designation No
Date First Approved 16-01-2014
Type Medicinal product subject to medical prescription
Marketing authorisation holder Bristol-Myers Squibb/AstraZeneca EEIG
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions