Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Jardiance   
Auth. number : EU/1/14/930
Active substance : Empagliflozin
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: A10BK - Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Chemical substance: A10BK03 - Empagliflozin
(See WHO ATC Index)
Indication: Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance
- in addition to other medicinal products for the treatment of diabetes
For study results with respect to combinations, effects on glycaemic control and cardiovascular events,
and the populations studied, see sections 4.4, 4.5 and 5.1.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-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
27/05/2014 Centralised - Authorisation EMEA/H/C/2677 (2014)3539 of 22/05/2014
28/11/2014 Centralised - Notification EMEA/H/C/2677/N/4
Updated with Decision(2015)9548 of 14/12/2015
18/12/2014 Centralised - Variation EMEA/H/C/2677/II/2
Updated with Decision(2015)9548 of 14/12/2015
22/10/2015 Centralised - Variation EMEA/H/C/2677/WS/801
Updated with Decision(2015)9548 of 14/12/2015
16/12/2015 Centralised - Yearly update (2015)9548 of 14/12/2015
27/04/2016 Referral EMEA/H/A-20/1419/C/2677/7 (2016)2628 of 25/04/2016
19/07/2016 PSUSA - Modification EMEA/H/C/PSUSA/10388/201510 (2016)4746 of 15/07/2016
21/07/2016 Centralised - Variation EMEA/H/C/2677/WS/939
Updated with Decision(2017)379 of 19/01/2017
02/09/2016 Centralised - Variation EMEA/H/C/2677/IAIN/24/G
Updated with Decision(2017)379 of 19/01/2017
15/09/2016 Centralised - Variation EMEA/H/C/2677/II/21
Updated with Decision(2017)379 of 19/01/2017
10/11/2016 Centralised - Variation EMEA/H/C/2677/WS/926
Updated with Decision(2017)379 of 19/01/2017
23/01/2017 Centralised - 2-Monthly update EMEA/H/C/002677/II/14 (2017)379 of 19/01/2017
24/04/2017 Referral EMEA/H/A-20/1442/C/2677/23 (2017)2758 of 20/04/2017
28/04/2017 Centralised - Variation EMEA/H/C/2677/IA/31
Updated with Decision(2017)5250 of 19/07/2017
01/06/2017 Centralised - Variation EMEA/H/C/2677/WS/1135
21/07/2017 PSUSA - Modification EMEA/H/C/PSUSA/10388/201610 (2017)5250 of 19/07/2017