Pharmaceuticals - Community Register


Community register of medicinal products for human use


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: A10BX - Other oral blood glucose lowering drugs
Chemical substance: A10BX12 - Empagliflozin
(See WHO ATC Index)
Indication: Empagliflozin
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
18/12/2014 Centralised - Variation EMEA/H/C/2677/II/2