Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Enyglid   
Auth. number : EU/1/09/580
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 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
16/10/2009 Centralised - Authorisation EMEA/H/C/1065 (2009)8011 of 14/10/2009
24/11/2009 Centralised - Notification EMEA/H/C/1065/N/1
Updated with Decision(2010)7726 of 03/11/2010
06/04/2010 Centralised - Variation EMEA/H/C/1065/IA/2/G
Updated with Decision(2010)7726 of 03/11/2010
09/11/2010 Centralised - Variation (2010)7726 of 03/11/2010
23/03/2011 Centralised - Notification EMEA/H/C/1065/N/3
Updated with Decision(2012)8177 of 08/11/2012
11/07/2012 Centralised - Variation EMEA/H/C/1065/IB/5
Updated with Decision(2012)8177 of 08/11/2012
27/07/2012 Centralised - Variation EMEA/H/C/1065/IB/6
Updated with Decision(2012)8177 of 08/11/2012
12/11/2012 Centralised - Variation (2012)8177 of 08/11/2012
18/12/2013 Centralised - Variation EMEA/H/C/1065/IAin/9/G
Updated with Decision(2014)6101 of 22/08/2014
26/08/2014 Centralised - Renewal EMEA/H/C/1065/R/10 (2014)6101 of 22/08/2014