Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Abasaglar   
Auth. number : EU/1/14/944
Active substance : Insulin glargine
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AE - Insulins and analogues for injection, long-acting
Chemical substance: A10AE04 - Insulin glargine
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above
Marketing Authorisation Holder: Eli Lilly Regional Operations GmbH.
Kölblgasse 8-10, 1030 Wien, Österreich
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
11/09/2014 Centralised - Authorisation EMEA/H/C/2835 (2014)6474 of 09/09/2014
03/12/2014 Centralised - Variation EMEA/H/C/2835/IAin/1
Updated with Decision(2015)9212 of 09/12/2015
17/02/2015 Centralised - Notification EMEA/H/C/2835/N/2
Updated with Decision(2015)9212 of 09/12/2015
21/05/2015 Centralised - Variation EMEA/H/C/2835/II/3
Updated with Decision(2015)9212 of 09/12/2015
11/12/2015 Centralised - Yearly update (2015)9212 of 09/12/2015
28/04/2016 Centralised - Variation EMEA/H/C/2835/II/8