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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Repaglinide Accord   

   This product is authorised under a different brand name in the EU in the following languages:
   - Repaglinid Accord (DE)
   - Repaglinida Accord (PT)
Auth. number : EU/1/11/743
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: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
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
28/12/2011 Centralised - Authorisation EMEA/H/C/2318 (2011)10092 of 22/12/2011
27/07/2012 Centralised - Variation EMEA/H/C/2318/IB/2
Updated with Decision(2012)8011 of 31/10/2012
12/11/2012 Centralised - Variation (2012)8011 of 31/10/2012
15/09/2015 Centralised - Variation EMEA/H/C/2318/IAin/4/G
Updated with Decision(2016)6091 of 19/09/2016
21/09/2016 Centralised - Renewal EMEA/H/C/2318/R/5 (2016)6091 of 19/09/2016