Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Repaglinide Teva   
Auth. number : EU/1/09/530
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.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
01/07/2009 Centralised - Authorisation EMEA/H/C/1067 (2009)5326 of 29/06/2009
21/12/2009 Centralised - Variation EMEA/H/C/1067/IA/1
25/03/2011 Centralised - Variation EMEA/H/C/1067/N/2
Updated with Decision(2011)8238 of 10/11/2011
10/08/2011 Centralised - Variation EMEA/H/C/1067/IA/3/G
Updated with Decision(2011)8238 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8238 of 10/11/2011
28/06/2012 Centralised - Variation EMEA/H/C/1067/IB/5
Updated with Decision(2012)7932 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7932 of 29/10/2012
14/12/2012 Centralised - Variation EMEA/H/C/1067/IAin/6/G
Updated with Decision(2013)9750 of 18/12/2013
24/12/2013 Centralised - Variation (2013)9750 of 18/12/2013
23/06/2014 Centralised - Renewal EMEA/H/C/1067/R/8 (2014)4282 of 19/06/2014