Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Synjardy   
Auth. number : EU/1/15/1003
Active substance : empagliflozin / 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: A10BD20 - metformin and empagliflozin
(See WHO ATC Index)
Indication: Synjardy is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
• in patients insufficiently controlled on their maximally tolerated dose of metformin alone
• in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
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
29/05/2015 Centralised - Authorisation EMEA/H/C/3770 (2015)3656 of 27/05/2015
16/10/2015 Centralised - Variation EMEA/H/C/3770/IAIN/7
Updated with Decision(2016)2762 of 28/04/2016
16/10/2015 Centralised - Variation EMEA/H/C/3770/IAIN/8/G
Updated with Decision(2016)2762 of 28/04/2016
22/10/2015 Centralised - Variation EMEA/H/C/3770/WS/800
Updated with Decision(2016)2762 of 28/04/2016
22/10/2015 Centralised - Variation EMEA/H/C/3770/WS/801
Updated with Decision(2016)2762 of 28/04/2016
7/01/2016 Centralised - Variation EMEA/H/C/3770/IB/11/G
Updated with Decision(2016)2762 of 28/04/2016
2/05/2016 Referral EMEA/H/A-20/1419/C/3770/1 (2016)2762 of 28/04/2016
19/07/2016 PSUSA - Modification EMEA/H/C/PSUSA/10388/201510 (2016)4756 of 15/07/2016
21/07/2016 Centralised - Variation EMEA/H/C/3770/WS/939
Updated with Decision(2016)8665 of 12/12/2016
10/11/2016 Centralised - Variation EMEA/H/C/3770/WS/926
Updated with Decision(2017)1605 of 03/03/2017
14/12/2016 Referral EMEA/H/A-31/1432/C/3370/13 (2016)8665 of 12/12/2016
7/03/2017 Centralised - 2-Monthly update EMEA/H/C/3770/II/15 (2017)1605 of 3/03/2017
24/04/2017 Referral EMEA/H/A-20/1442/C/3770/22 (2017)2763 of 20/04/2017
1/06/2017 Centralised - Variation EMEA/H/C/3770/WS/1135
Updated with Decision(2018)134 of 08/01/2018
22/06/2017 Centralised - Variation EMEA/H/C/3770/WS/1171
Updated with Decision(2018)134 of 08/01/2018
21/07/2017 PSUSA - Modification EMEA/H/C/PSUSA/10388/201610 (2017)5246 of 19/07/2017
10/01/2018 PSUSA - Modification EMEA/H/C/PSUSA/10388/201704 (2018)134 of 8/01/2018
31/05/2018 Centralised - Variation EMEA/H/C/3770/WS/1316