Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Avaglim
Auth. number : EU/1/06/349
INN : Rosiglitazone / glimepiride
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: A10BD04 - Glimepiride and rosiglitazone
(See WHO ATC Index)
Indication: Treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
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
29/06/2006 Centralised - Authorisation EMEA/H/C/675 (2006)3043 of 27/06/2006
24/07/2006 Centralised - Variation EMEA/H/C/675/IA/4
08/09/2006 Centralised - Variation EMEA/H/C/675/IA/7
13/09/2006 Centralised - Variation EMEA/H/C/675/IB/3
13/10/2006 Centralised - Variation EMEA/H/C/675/N/6
Updated with Decision(2006)5859 of 24/11/2006
31/10/2006 Centralised - Variation EMEA/H/C/675/II/1, 2 (2006)5246 of 27/10/2006
28/11/2006 Centralised - Variation EMEA/H/C/675/II/5 (2006)5859 of 24/11/2006
22/01/2007 Centralised - Variation EMEA/H/C/675/II/8 (2007)193 of 18/01/2007
14/02/2007 Centralised - Variation EMEA/H/C/675/IA/9
Updated with Decision(2007)2359 of 30/05/2007
14/02/2007 Centralised - Variation EMEA/H/C/675/IA/10
Updated with Decision(2007)2359 of 30/05/2007
05/03/2007 Centralised - Variation EMEA/H/C/675/IA/11
Updated with Decision(2007)2359 of 30/05/2007
01/06/2007 Centralised - Variation EMEA/H/C/675/II/12 (2007)2359 of 30/05/2007
17/09/2007 Centralised - Variation EMEA/H/C/675/IA/14
09/10/2007 Centralised - Variation EMEA/H/C/675/IA/15
12/11/2007 Centralised - Variation EMEA/H/C/675/IA/16
27/11/2007 Centralised - Variation EMEA/H/C/675/II/13 (2007)5843 of 23/11/2007
05/03/2008 Centralised - Variation EMEA/H/C/675/II/17 (2008)898 of 03/03/2008
02/07/2008 Centralised - Variation EMEA/H/C/675/IB/18
02/07/2008 Centralised - Variation EMEA/H/C/675/IB/19
11/09/2008 Centralised - Variation EMEA/H/C/675/N/20
Updated with Decision(2009)7038 of 14/09/2009
18/09/2008 Centralised - Variation EMEA/H/C/675/IB/21
01/10/2008 Centralised - Variation EMEA/H/C/675/IA/22
15/09/2009 Centralised - Variation EMEA/H/C/675/II/23, 24 (2009)7038 of 14/09/2009
16/12/2009 Centralised - Variation EMEA/H/C/675/IA/27
Updated with Decision(2010)404 of 20/01/2010
22/01/2010 Centralised - Variation EMEA/H/C/675/II/26 (2010)404 of 20/01/2010
13/04/2010 Centralised - Variation EMEA/H/C/675/II/25 (2010)2413 of 09/04/2010
21/10/2010 Centralised - Variation EMEA/H/C/675/IA/28
07/12/2010 Referral EMEA/H/C/675/A-20/29 (2010)8905 of 03/12/2010
19/01/2011 Centralised - Variation EMEA/H/C/675/IG/34/G
Updated with Decision(2011)5533 of 26/07/2011
28/07/2011 Centralised - Renewal EMEA/H/C/675/R/33 (2011)5533 of 26/07/2011