Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prandin   
Auth. number : EU/1/00/162
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: Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark

  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
31/01/2001 Centralised - Authorisation EMEA/H/C/362 (2001)91 of 29/01/2001
16/07/2001 Centralised - Variation EMEA/H/C/362/I/2
08/08/2001 Centralised - Variation EMEA/H/C/362/I/1 (2001)2093 of 06/08/2001
05/11/2001 Centralised - Variation EMEA/H/C/362/I/5
14/11/2001 Centralised - Variation EMEA/H/C/362/II/3 (2001)3526 of 12/11/2001
31/01/2002 Centralised - Variation EMEA/H/C/362/I/4 (2002)400 of 28/01/2002
23/04/2002 Centralised - Variation EMEA/H/C/362/I/15
23/04/2002 Centralised - Variation EMEA/H/C/362/I/9, 14
20/06/2002 Centralised - Variation EMEA/H/C/362/N/6 (2002)2295 of 17/06/2002
12/09/2002 Centralised - Variation EMEA/H/C/362/II/8 (2002)3381 of 10/09/2002
25/11/2002 Centralised - Variation EMEA/H/C/362/I/17
17/01/2003 Centralised - Variation EMEA/H/C/362/N/16 (2003)319 of 15/01/2003
13/06/2003 Centralised - Variation EMEA/H/C/362/N/19 (2003)1894 of 11/06/2003
07/08/2003 Centralised - Renewal EMEA/H/C/362/R/18 (2003)2902 of 01/08/2003
10/10/2003 Centralised - Variation EMEA/H/C/362/II/20 (2003)3720 of 08/10/2003
10/12/2003 Centralised - Variation EMEA/H/C/362/IA/24
10/12/2003 Centralised - Variation EMEA/H/C/362/IA/23
15/12/2003 Centralised - Variation EMEA/H/C/362/IA/22
07/04/2004 Centralised - Variation EMEA/H/C/362/II/25 (2004)1391 of 05/04/2004
30/06/2004 Centralised - Variation EMEA/H/C/362/IA/26
10/09/2004 Centralised - Variation EMEA/H/C/362/IA/28
Updated with Decision(2005)332 of 04/02/2005
18/01/2005 Centralised - Variation EMEA/H/C/362/IA/29
03/02/2005 Centralised - Variation EMEA/H/C/362/IA/30
08/02/2005 Centralised - Variation EMEA/H/C/362/II/27 (2005)332 of 04/02/2005
02/03/2005 Centralised - Variation EMEA/H/C/362/IB/31
02/03/2005 Centralised - Variation EMEA/H/C/362/IB/33
03/03/2005 Centralised - Variation EMEA/H/C/362/IA/35
30/03/2005 Centralised - Variation EMEA/H/C/362/IB/34
28/04/2005 Centralised - Variation EMEA/H/C/362/II/32
01/06/2005 Centralised - Variation EMEA/H/C/362/II/36
09/06/2005 Centralised - Variation EMEA/H/C/362/IA/38
30/06/2005 Centralised - Variation EMEA/H/C/362/IB/37
09/11/2005 Centralised - Variation EMEA/H/C/362/IA/39
Updated with Decision(2006)2142 of 22/05/2006
24/05/2006 Centralised - Variation (2006)2142 of 22/05/2006
12/07/2006 Centralised - Variation EMEA/H/C/362/IA/41
12/10/2006 Centralised - Variation EMEA/H/C/362/N/43
Updated with Decision(2007)3297 of 29/06/2007
05/07/2007 Centralised - Variation EMEA/H/C/362/II/44 (2007)3297 of 29/06/2007
09/08/2007 Centralised - Variation EMEA/H/C/362/IB/45
05/11/2007 Centralised - Variation EMEA/H/C/362/IA/46
26/02/2008 Centralised - Variation EMEA/H/C/362/II/48
26/02/2008 Centralised - Variation EMEA/H/C/362/II/49
25/07/2008 Centralised - Renewal EMEA/H/C/362/R/50 (2008)4025 of 23/07/2008
08/10/2008 Centralised - Variation EMEA/H/C/362/IA/52
24/10/2008 Centralised - Variation EMEA/H/C/362/IB/53
22/12/2008 Centralised - Variation EMEA/H/C/362/II/51 (2008)8815 of 17/12/2008
14/01/2009 Centralised - Variation EMEA/H/C/362/IA/54
28/03/2011 Centralised - Variation EMEA/H/C/362/N/55
Updated with Decision(2012)2855 of 20/04/2012
26/04/2012 Centralised - Variation EMEA/H/C/362/WS/223 (2012)2855 of 20/04/2012