Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Repaglinide Krka   
Auth. number : EU/1/09/579
INN : 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 patients with Type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.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 continues to be 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