Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Starlix   
Auth. number : EU/1/01/174
INN : nateglinide
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: A10BX03 - Nateglinide
(See WHO ATC Index)
Indication: Combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
05/04/2001 Centralised - Authorisation EMEA/H/C/335 (2001)827 of 03/04/2001
26/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/I/1
02/04/2002 Centralised - Notification EMEA/H/C/335/N/2 (2002)1320 of 26/03/2002
29/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/I/5, 6
21/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/I/4
15/07/2002 Centralised - Variation EMEA/H/C/335/I/3 (2002)2748 of 11/07/2002
05/09/2002 Centralised - Variation EMEA/H/C/335/I/7 (2002)3322 of 30/08/2002
14/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/I/8
16/01/2004 Centralised - Variation EMEA/H/C/335/II/9 (2004)91 of 14/01/2004
01/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/IB/10
29/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/IB/11
17/06/2004 Centralised - Notification EMEA/H/C/335/N/13
Updated with Decision(2004)3047 of 02/08/2004
04/08/2004 Centralised - Variation EMEA/H/C/335/II/12 (2004)3047 of 02/08/2004
11/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/IA/14
08/09/2005 Centralised - Variation EMEA/H/C/335/II/15 (2005)3439 of 05/09/2005
26/04/2006 Centralised - Renewal EMEA/H/C/335/R/16 (2006)1756 of 24/04/2006
17/07/2006 Centralised - Variation EMEA/H/C/335/II/17 (2006)3290 of 13/07/2006
24/07/2007 Centralised - Notification EMEA/H/C/335/N/18
Updated with Decision(2011)6181 of 24/08/2011
03/12/2007 Centralised - Notification EMEA/H/C/335/N/19
Updated with Decision(2011)6181 of 24/08/2011
31/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/335/IA/20
30/08/2011 Centralised - Variation EMEA/H/C/335/II/22 (2011)6181 of 24/08/2011
26/10/2011 Centralised - Variation EMEA/H/C/335/II/21 (2011)7781 of 24/10/2011
12/11/2013 Centralised - Notification EMEA/H/C/335/N/26