Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Byetta   
Auth. number : EU/1/06/362
INN : exenatide
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: A10BX04 - Exenatide
(See WHO ATC Index)
Indication: Byetta is indicated for treatment of type 2 diabetes mellitus in combination with metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, metformin and a thiazolidinedione in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. BYETTA is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.
Marketing Authorisation Holder: AstraZeneca AB
SE-151 85 Södertälje, Sverige

  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
22/11/2006 Centralised - Authorisation EMEA/H/C/698 (2006)5664 of 20/11/2006
05/09/2007 Centralised - Variation EMEA/H/C/698/II/1 (2007)4160 of 30/08/2007
07/11/2007 Centralised - Variation EMEA/H/C/698/II/2 (2007)5432 of 31/10/2007
30/01/2008 Centralised - Variation EMEA/H/C/698/II/3 (2008)419 of 28/01/2008
11/09/2008 Centralised - Notification EMEA/H/C/698/N/5
Updated with Decision(2009)48 of 07/01/2009
09/01/2009 Centralised - Variation EMEA/H/C/698/II/6 (2009)48 of 07/01/2009
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IB/8
10/03/2009 Centralised - Variation EMEA/H/C/698/II/7 (2009)1708 of 06/03/2009
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/16
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/12
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/13
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/14
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/17
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/15
20/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IB/20
08/03/2010 Centralised - Variation EMEA/H/C/698/IB/22
Updated with Decision(2010)5602 of 06/08/2010
17/03/2010 Centralised - Variation EMEA/H/C/698/II/11, 18 (2010)1764 of 15/03/2010
30/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IB/23
03/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IB/24
10/08/2010 Centralised - Variation EMEA/H/C/698/II/21 (2010)5602 of 06/08/2010
01/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/II/25/G
30/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/698/IA/26/G
08/03/2011 Centralised - Variation EMEA/H/C/698/IA/27/G
Updated with Decision(2011)4842 of 29/06/2011
05/07/2011 Centralised - Variation (2011)4842 of 29/06/2011
22/09/2011 Centralised - Renewal EMEA/H/C/698/R/28 (2011)6647 of 19/09/2011
22/03/2012 Centralised - Variation EMEA/H/C/698/II/29 (2012)1926 of 19/03/2012
22/06/2012 Centralised - Variation EMEA/H/C/698/IB/30
Updated with Decision(2012)7912 of 29/10/2012
14/11/2012 Centralised - Variation (2012)7912 of 29/10/2012
08/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/698/T/32 (2013)1419 of 06/03/2013
02/10/2013 Centralised - Variation EMEA/H/C/698/IAin/38/G
Updated with Decision(2014)5503 of 28/07/2014
18/12/2013 Centralised - Variation EMEA/H/C/698/II/39
Updated with Decision(2014)5503 of 28/07/2014
25/04/2014 Centralised - Variation EMEA/H/C/698/II/43
Updated with Decision(2014)5503 of 28/07/2014
30/07/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/698/T/44 (2014)5503 of 28/07/2014
23/10/2014 Centralised - Variation EMEA/H/C/698/II/46