Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Xigduo   
Auth. number : EU/1/13/900
Active substance : dapagliflozin/metformin
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD15 - metformin and dapagliflozin
(See WHO ATC Index)
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 (see sections 4.4, 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 tablets.
Marketing Authorisation Holder: AstraZeneca AB
151 85 Södertälje, Sverige
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/01/2014 Centralised - Authorisation EMEA/H/C/2672 (2014)308 of 16/01/2014
25/04/2014 Centralised - Variation EMEA/H/C/2672/IB/2
Updated with Decision(2014)7364 of 03/10/2014
22/05/2014 Centralised - Variation EMEA/H/C/2672/WS/537
Updated with Decision(2014)7364 of 03/10/2014
24/07/2014 Centralised - Variation EMEA/H/C/2672/II/WS/510
Updated with Decision(2014)7364 of 03/10/2014
24/07/2014 Centralised - Variation EMEA/H/C/2672/II/WS/536
Updated with Decision(2014)7364 of 03/10/2014
7/10/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2672/T/5 (2014)7364 of 3/10/2014
17/02/2015 Centralised - Variation EMEA/H/C/2672/IAIN/9/G
Updated with Decision(2016)940 of 11/02/2016
15/02/2016 Centralised - Yearly update (2016)940 of 11/02/2016
2/05/2016 Referral EMEA/H/A-20/1419/C/2672/12 (2016)2755 of 28/04/2016
25/05/2016 Corrigendum (2016)2755 of 28/04/2016
14/12/2016 Referral EMEA/H/A-31/1432/C/2672 (2016)8652 of 12/12/2016
19/01/2017 Centralised - Variation EMEA/H/C/2672/WS/1056/26
Updated with Decision(2017)2764 of 20/04/2017
21/04/2017 Centralised - Variation EMEA/H/C/2672/WS/1055
Updated with Decision(2017)9087 of 20/12/2017
24/04/2017 Referral EMEA/H/A-20/1442/C/2672/24 (2017)2764 of 20/04/2017
20/07/2017 Centralised - Variation EMEA/H/C/2672/WS/1092
Updated with Decision(2017)9087 of 20/12/2017
12/10/2017 Centralised - Notification EMEA/H/C/2672/WS/1167
Updated with Decision(2017)9087 of 20/12/2017
22/12/2017 Centralised - 2-Monthly update EMEA/H/C/2672/WS/1271/G (2017)9087 of 20/12/2017
2/10/2018 Centralised - Renewal EMEA/H/C/2672/R/44 (2018)6462 of 28/09/2018
14/11/2018 Centralised - 2-Monthly update EMEA/H/C/2672/WS/1380/45 (2018)7607 of 12/11/2018