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Community register of medicinal products for human use


Product information

Invented name: Repaglinide Krka   
Auth. number : EU/1/09/579
Active substance : Repaglinide
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: A10BX02 - repaglinide
(See WHO ATC Index)
Indication: Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Marketing Authorisation Holder: Krka d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
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
06/11/2009 Centralised - Authorisation EMEA/H/C/1066 (2009)8668 of 04/11/2009
10/07/2012 Centralised - Variation EMEA/H/C/1066/IB/2
Updated with Decision(2012)7855 of 29/10/2012
27/07/2012 Centralised - Variation EMEA/H/C/1066/IB/3/G
Updated with Decision(2012)7855 of 29/10/2012
05/11/2012 Centralised - Variation (2012)7855 of 29/10/2012
18/12/2013 Centralised - Variation EMEA/H/C/1066/IAIN/6/G
Updated with Decision(2014)6091 of 22/08/2014
26/08/2014 Centralised - Renewal EMEA/H/C/1066/R/7 (2014)6091 of 22/08/2014
23/03/2016 Centralised - Variation EMEA/H/C/1066/IAIN/9
Updated with Decision(2017)1212 of 16/02/2017
28/06/2016 Centralised - Variation EMEA/H/C/1066/IB/11/G
Updated with Decision(2017)1212 of 16/02/2017
20/02/2017 Centralised - Yearly update (2017)1212 of 16/02/2017
27/10/2017 Centralised - Notification EMEA/H/C/1066/N/15