Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


SUSPENDED  

Product information

Invented name: Avandia   
Auth. number : EU/1/00/137
INN : Rosiglitazone
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: A10BG - Thiazolidinediones
Chemical substance: A10BG02 - Rosiglitazone
(See WHO ATC Index)
Indication: Diabetes mellitus
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
18/07/2000 Centralised - Authorisation EMEA/H/C/268 (2000)1799 of 11/07/2000
18/12/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/I/2, 3, 4
22/03/2001 Centralised - Variation EMEA/H/C/268/II/1 (2001)620 of 20/03/2001
11/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/II/5
01/11/2001 Centralised - Variation EMEA/H/C/268/II/6 (2001)2985 of 31/10/2001
10/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/I/7
23/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/I/8
07/05/2002 Centralised - Variation EMEA/H/C/268/I/9 (2002)1837 of 02/05/2002
07/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/I/11
23/09/2002 Centralised - Variation EMEA/H/C/I268/I/14 (2002)3550 of 18/09/2002
22/10/2002 Centralised - Variation EMEA/H/C/268/II/12 (2002)4081 of 18/10/2002
13/12/2002 Centralised - Notification EMEA/H/C/268/N/15 (2002)5195 of 11/12/2002
28/04/2003 Centralised - Variation EMEA/H/C/268/II/16 (2003)1429 of 23/04/2003
01/09/2003 Centralised - Variation EMEA/H/C/268/II/18 (2003)3170 of 28/08/2003
01/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/20
14/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/24
21/07/2004 Centralised - Variation EMEA/H/C/268/II/21 (2004)2882 of 19/07/2004
22/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/II/27
22/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/28
01/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/29
08/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/30
12/01/2005 Centralised - Variation EMEA/H/C/268/II/23, 25, 26 (2005)70 of 10/01/2005
14/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/36, 37
19/04/2005 Centralised - Variation EMEA/H/C/268/IA/34
Updated with Decision(2005)1811 of 10/06/2005
27/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/38
13/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/35
14/06/2005 Centralised - Variation EMEA/H/C/268/II/31 (2005)1811 of 10/06/2005
12/07/2005 Centralised - Renewal EMEA/H/C/268/R/33 (2005)2738 of 08/07/2005
29/07/2005 Centralised - Variation EMEA/H/C/268/II/32 (2005)2964 of 27/07/2005
13/10/2005 Centralised - Variation EMEA/H/C/268/IA/39
Updated with Decision(2006)1953 of 05/05/2006
25/10/2005 Centralised - Notification EMEA/H/C/268/N/40
Updated with Decision(2006)1953 of 05/05/2006
22/11/2005 Centralised - Variation EMEA/H/C/268/IB/42
Updated with Decision(2006)1953 of 05/05/2006
22/11/2005 Centralised - Variation EMEA/H/C/268/IB/41
Updated with Decision(2006)1953 of 05/05/2006
21/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/45
11/05/2006 Centralised - Variation (2006)1953 of 05/05/2006
02/06/2006 Centralised - Variation EMEA/H/C/268/II/43 (2006)2226 of 31/05/2006
14/07/2006 Centralised - Variation EMEA/H/C/268/II/44 (2006)3275 of 12/07/2006
08/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/50
08/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/49
26/10/2006 Centralised - Variation EMEA/H/C/268/II/46, 47 (2006)5166 of 24/10/2006
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/51
24/11/2006 Centralised - Variation EMEA/H/C/268/II/48 (2006)5733 of 22/11/2006
01/06/2007 Centralised - Variation EMEA/H/C/268/II/53 (2007)2357 of 30/05/2007
08/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/54
14/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/56
23/11/2007 Centralised - Variation EMEA/H/C/268/II/52 (2007)5741 of 21/11/2007
31/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/58
05/03/2008 Centralised - Variation EMEA/H/C/268/II/57 (2008)896 of 03/03/2008
22/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/59
05/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/63
05/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/60
16/05/2008 Centralised - Variation EMEA/H/C/268/IA/61
Updated with Decision(2008)8816 of 17/12/2008
20/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/62
16/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/65
01/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/64
11/09/2008 Centralised - Notification EMEA/H/C/268/N/66
Updated with Decision(2008)8816 of 17/12/2008
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IA/67
22/12/2008 Centralised - Variation (2008)8816 of 17/12/2008
06/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/268/IB/69
01/06/2009 Centralised - Variation EMEA/H/C/268/II/68 (2009)4324 of 28/05/2009
25/08/2009 Centralised - Variation EMEA/H/C/268/II/70 (2009)6630 of 21/08/2009
25/11/2009 Centralised - Variation EMEA/H/C/268/IA/73
Updated with Decision(2010)411 of 20/01/2010
22/01/2010 Centralised - Variation EMEA/H/C/268/II/72 (2010)411 of 20/01/2010
30/03/2010 Centralised - Variation EMEA/H/C/268/II/71 (2010)2151 of 26/03/2010
28/05/2010 Centralised - Renewal EMEA/H/C/268/R/74 (2010)3502 of 26/05/2010
07/12/2010 Referral EMEA/H/C/268/A-20/75 (2010)8909 of 03/12/2010