Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


SUSPENDED  

Product information

Invented name: Avandamet   
Auth. number : EU/1/03/258
Active substance : rosiglitazone / metformin
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: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD03 - Metformin and rosiglitazone
(See WHO ATC Index)
Indication: Treatment of type 2 diabetes mellitus patients
Marketing Authorisation Holder: SmithKline Beecham Ltd
980 Great West Road, Brentford, Middlesex TW8 9GS, 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
22/10/2003 Centralised - Authorisation EMEA/H/C/522 (2003)3960 of 20/10/2003
04/03/2004 Centralised - Variation EMEA/H/C/522/IA/3
Updated with Decision(2004)2801 of 13/07/2004
23/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/4
23/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/5
18/06/2004 Centralised - Notification EMEA/H/C/522/N/7
Updated with Decision(2004)2801 of 13/07/2004
06/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/9
15/07/2004 Centralised - Variation EMEA/H/C/522/II/6 (2004)2801 of 13/07/2004
06/09/2004 Centralised - Variation EMEA/H/C/522/X/1, 2 (2004)3423 of 02/09/2004
13/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/11
26/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/13
24/01/2005 Centralised - Variation EMEA/H/C/522/II/8, 10 (2005)156 of 20/01/2005
02/02/2005 Centralised - Variation EMEA/H/C/522/IB/14
Updated with Decision(2005)3533 of 13/09/2005
24/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/16
24/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/15
28/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/II/12
14/09/2005 Centralised - Variation (2005)3533 of 13/09/2005
16/11/2005 Centralised - Variation EMEA/H/C/522/IB/20
Updated with Decision(2006)287 of 30/01/2006
16/11/2005 Centralised - Variation EMEA/H/C/522/IB/19
Updated with Decision(2006)287 of 30/01/2006
18/11/2005 Centralised - Variation EMEA/H/C/522/II/17 (2005)4489 of 15/11/2005
01/02/2006 Centralised - Variation EMEA/H/C/522/II/18 (2006)287 of 30/01/2006
09/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/24
21/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/25
08/06/2006 Centralised - Variation EMEA/H/C/522/II/21 (2006)2295 of 02/06/2006
09/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/27
27/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/29
27/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/28
26/07/2006 Centralised - Variation EMEA/H/C/522/II/22 (2006)3380 of 20/07/2006
21/08/2006 Centralised - Notification EMEA/H/C/522/N/26
Updated with Decision(2006)5179 of 24/10/2006
19/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/35
26/10/2006 Centralised - Variation EMEA/H/C/522/II/30 (2006)5179 of 24/10/2006
24/11/2006 Centralised - Variation EMEA/H/C/522/II/32, 33, 34 (2006)5732 of 22/11/2006
26/01/2007 Centralised - Variation EMEA/H/C/522/II/23 (2007)262 of 24/01/2007
30/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/37
31/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/38
06/06/2007 Centralised - Variation EMEA/H/C/522/II/36 (2007)2442 of 04/06/2007
25/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/41
25/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/39
26/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/40
19/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/I/42
08/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/43, 44
12/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/45
06/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/47
05/03/2008 Centralised - Variation EMEA/H/C/522/II/46 (2008)897 of 03/03/2008
19/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/49
03/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/51, 52
30/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/53
12/08/2008 Centralised - Renewal EMEA/H/C/522/R/48 (2008)4414 of 08/08/2008
13/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/50
30/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/54
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IA/54
01/12/2008 Centralised - Variation EMEA/H/C/522/IB/55
Updated with Decision(2009)4466 of 04/06/2009
04/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/56
08/06/2009 Centralised - Variation (2009)4466 of 04/06/2009
27/08/2009 Centralised - Variation EMEA/H/C/522/II/57, 58 (2009)6663 of 25/08/2009
02/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/522/IB/61
16/12/2009 Centralised - Variation EMEA/H/C/522/IA/62
Updated with Decision(2010)402 of 20/01/2010
22/01/2010 Centralised - Variation EMEA/H/C/522/II/60 (2010)402 of 20/01/2010
30/03/2010 Centralised - Variation EMEA/H/C/522/II/59 (2010)2150 of 26/03/2010
07/12/2010 Referral EMEA/H/C/522/A-20/63 (2010)8904 of 03/12/2010
19/01/2011 Centralised - Variation EMEA/H/C/522/IG/34/G