Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Repaglinide Accord   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Repaglinid Accord (DE)
   - Repaglinida Accord (PT)
Auth. number : EU/1/11/743
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. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
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