Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ebymect   
Auth. number : EU/1/15/1051
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: Ebymect 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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/11/2015 Centralised - Authorisation EMEA/H/C/4162 (2015)8132 of 16/11/2015
30/03/2016 Centralised - Notification EMEA/H/C/4162/N/9
Updated with Decision(2016)8657 of 12/12/2016
25/05/2016 Centralised - Variation EMEA/H/C/4162/IAIN/11
Updated with Decision(2016)8657 of 12/12/2016
14/12/2016 Referral EMEA/H/C/4162/A31/1432 (2016)8657 of 12/12/2016
19/01/2017 Centralised - Variation EMEA/H/C/4162/WS/1056
Updated with Decision(2017)3114 of 04/05/2017
21/04/2017 Centralised - Variation EMEA/H/C/4162/WS/1055
Updated with Decision(2017)9089 of 20/12/2017
08/05/2017 Referral EMEA/H/C/4162/A-20/13 (2017)3114 of 04/05/2017
20/07/2017 Centralised - Variation EMEA/H/C/4162/WS/1092
Updated with Decision(2017)9089 of 20/12/2017
12/10/2017 Centralised - Variation EMEA/H/C/4162/WS/1167
Updated with Decision(2017)9089 of 20/12/2017
22/12/2017 Centralised - 2-Monthly update EMEA/H/C/4162/WS/1271G (2017)9089 of 20/12/2017