Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NovoNorm   
Auth. number : EU/1/98/076
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
18/08/1998 Centralised - Authorisation EMEA/H/C/187 (1998)2522 of 17/08/1998
24/01/2000 Centralised - Variation EMEA/H/C/187/II/17, 21 (2000)39 of 20/01/2000
22/02/2000 Centralised - Variation EMEA/H/C/187/II/22
04/05/2000 Centralised - Variation EMEA/H/C/187/I/24
04/05/2000 Centralised - Variation EMEA/H/C/187/I/25
04/05/2000 Centralised - Variation EMEA/H/C/187/I/23
28/11/2000 Centralised - Variation EMEA/H/C/187/I/30
28/11/2000 Centralised - Variation EMEA/H/C/187/I/29
28/11/2000 Centralised - Variation EMEA/H/C/187/I/28
23/01/2001 Centralised - Variation EMEA/H/C/187/I/27 (2001)49 of 22/01/2001
31/01/2001 Centralised - Variation (2001)93 of 29/01/2001
07/03/2001 Centralised - Variation EMEA/H/C/187/II/26 (2001)312 of 05/03/2001
19/09/2001 Centralised - Variation EMEA/H/C/187/II/31 (2001)2202 of 17/09/2001
05/11/2001 Centralised - Variation EMEA/H/C/187/I/33
31/01/2002 Centralised - Variation EMEA/H/C/187/I/32 (2002)399 of 28/01/2002
30/04/2002 Centralised - Variation EMEA/H/C/187/I/42
30/04/2002 Centralised - Variation EMEA/H/C/187/I/36, 37, 38, 39, 40, 41, 42
11/09/2002 Centralised - Variation EMEA/H/C/187/II/35 (2002)3367 of 09/09/2002
26/11/2002 Centralised - Variation EMEA/H/C/187/I/43
05/08/2003 Centralised - Renewal EMEA/H/C/187/R/44 (2003)2901 of 01/08/2003
10/10/2003 Centralised - Variation EMEA/H/C/187/II/45 (2003)3727 of 08/10/2003
08/12/2003 Centralised - Variation EMEA/H/C/187/IA/48
08/12/2003 Centralised - Variation EMEA/H/C/187/IA/49
11/12/2003 Centralised - Variation EMEA/H/C/187/IA/47
02/04/2004 Centralised - Variation EMEA/H/C/187/II/50 (2004)1322 of 31/03/2004
30/06/2004 Centralised - Variation EMEA/H/C/187/II/65
10/09/2004 Centralised - Variation EMEA/H/C/187/IA/53
Updated with Decision(2005)289 of 02/02/2005
18/01/2005 Centralised - Variation EMEA/H/C/187/IA/54
03/02/2005 Centralised - Variation EMEA/H/C/187/IA/55
04/02/2005 Centralised - Variation EMEA/H/C/187/II/52 (2005)289 of 02/02/2005
02/03/2005 Centralised - Variation EMEA/H/C/187/IB/58
02/03/2005 Centralised - Variation EMEA/H/C/187/IB/56
03/03/2005 Centralised - Variation EMEA/H/C/187/IA/60
30/03/2005 Centralised - Variation EMEA/H/C/187/IB/59
12/05/2005 Centralised - Variation EMEA/H/C/187/II/57
01/06/2005 Centralised - Variation EMEA/H/C/187/II/61
30/06/2005 Centralised - Variation EMEA/H/C/187/IA/63
30/06/2005 Centralised - Variation EMEA/H/C/187/IB/62
31/05/2006 Centralised - Variation (2006)2181 of 29/05/2006
12/07/2006 Centralised - Variation EMEA/H/C/187/IA/66
12/07/2006 Centralised - Variation EMEA/H/C/187/IA/67
01/11/2006 Centralised - Variation EMEA/H/C/187/IA/64
Updated with Decision(2006)2181 of 29/05/2006
05/07/2007 Centralised - Variation EMEA/H/C/187/II/68 (2007)3298 of 29/06/2007
09/08/2007 Centralised - Variation EMEA/H/C/187/IB/69
30/10/2007 Corrigendum EMEA/H/C/187/II/68 (2007)3298 corr of 29/06/2007
05/11/2007 Centralised - Variation EMEA/H/C/187/IA/70
26/02/2008 Centralised - Variation EMEA/H/C/187/II/71
26/02/2008 Centralised - Variation EMEA/H/C/187/II/12
05/06/2008 Centralised - Withdrawal
25/07/2008 Centralised - Renewal EMEA/H/C/187/R/73 (2003)4027 of 23/07/2008
08/10/2008 Centralised - Variation EMEA/H/C/187/IA/76
24/10/2008 Centralised - Variation EMEA/H/C/187/IB/75
22/12/2008 Centralised - Variation EMEA/H/C/187/II/74 (2008)8813 of 17/12/2008
14/01/2009 Centralised - Variation EMEA/H/C/187/IA/77
12/10/2010 Centralised - Variation EMEA/H/C/187/IG/21
26/03/2012 Centralised - Variation EMEA/H/C/187/WS/223 (2012)2865 of 20/04/2012
30/07/2013 Centralised - Variation EMEA/H/C/187/N/84