Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: BYDUREON   
Auth. number : EU/1/11/696
Active substance : 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: Treatment of type 2 diabetes mellitus in combination with
  • Metformin
  • Sulphonylurea
  • Thiazolidinedione
  • Metformin and sulphonylurea
  • Metformin and thiazolidinedione
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies
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
23/06/2011 Centralised - Authorisation EMEA/H/C/2020 (2011)4479 of 17/06/2011
12/12/2012 Centralised - Variation EMEA/H/C/2020/IB/6
Updated with Decision(2013)1654 of 13/03/2013
15/03/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2020/T/7 (2013)1654 of 13/03/2013
21/03/2013 Centralised - Variation EMEA/H/C/2020/II/4/G
Updated with Decision(2013)5009 of 26/07/2013
30/05/2013 Centralised - Variation EMEA/H/C/2020/II/8/G
Updated with Decision(2014)81 of 08/01/2014
31/07/2013 PSUSA - Modification EMEA/H/C/2020/PSU/14 (2013)5009 of 26/07/2013
08/11/2013 Centralised - Variation EMEA/H/C/2020/IAin/15/G
Updated with Decision(2014)5633 of 31/07/2014
18/12/2013 Centralised - Variation EMEA/H/C/2020/II/13
Updated with Decision(2014)5633 of 31/07/2014
10/01/2014 PSUSA - Modification EMEA/H/C/2020/PSUV/14 (2014)81 of 08/01/2014
25/04/2014 Centralised - Variation EMEA/H/C/2020/II/19
Updated with Decision(2014)5633 of 31/07/2014
24/07/2014 Centralised - Variation EMEA/H/C/2020/II/17/G
Updated with Decision(2014)7193 of 01/10/2014
04/08/2014 PSUSA - Modification EMEA/H/C/2020/PSUV/18 (2014)5633 of 31/07/2014
03/10/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2020/T/26 (2014)7193 of 01/10/2014
19/12/2014 Centralised - Variation EMEA/H/C/2020/IAIN/27/G
21/01/2015 PSUSA - Modification EMEA/H/C/2020/PSUV/24 (2015)287 of 19/01/2015