Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Onglyza   
Auth. number : EU/1/09/545
INN : saxagliptin
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: A10BH - Dipeptidyl peptidase 4 (dpp-4) inhibitors
Chemical substance: A10BH03 - Saxagliptin
(See WHO ATC Index)
Indication: Onglyza is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control:
as monotherapy
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance as dual oral therapy in combination with
• metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control.
• a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control. in patients for whom use of metformin is considered inappropriate.
• a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.
as triple oral therapy in combination with
• metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Marketing Authorisation Holder: Bristol-Myers Squibb/AstraZeneca EEIG
Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, 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
05/10/2009 Centralised - Authorisation EMEA/H/C/1039 (2009)7649 of 01/10/2009
03/12/2009 Centralised - Variation EMEA/H/C/1039/IA/1
23/03/2010 Centralised - Variation EMEA/H/C/1039/IA/2
Updated with Decision(2010)4715 of 02/07/2010
23/03/2010 Centralised - Variation EMEA/H/C/1039/IA/3
Updated with Decision(2010)4715 of 02/07/2010
07/07/2010 Centralised - Variation EMEA/H/C/1039/II/7 (2010)4715 of 02/07/2010
09/09/2010 Centralised - Variation EMEA/H/C/1039/II/5, 6 (2010)6245 of 06/09/2010
29/10/2010 Centralised - Variation EMEA/H/C/1039/IA/9/G
Updated with Decision(2011)1480 of 28/02/2011
03/03/2011 Centralised - Variation EMEA/H/C/1039/II/8 (2011)1480 of 28/02/2011
03/03/2011 Centralised - Variation EMEA/H/C/1039/X/4 (2011)1481 of 28/02/2011
26/10/2011 Centralised - Variation EMEA/H/C/1039/II/12 (2011)7785 of 24/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/1039/II/11 (2011)8694 of 22/11/2011
03/01/2012 Centralised - Variation EMEA/H/C/1039/II/14 (2011)10103 of 22/12/2011
20/02/2013 Centralised - Variation EMEA/H/C/1039/WS/295/17 (2013)1013 of 18/02/2013
28/05/2013 Centralised - Modification EMEA/H/C/1039/PSU/22 (2013)3158 of 23/05/2013
30/07/2013 Centralised - Variation EMEA/H/C/1039/II/18 (2013)5004 of 26/07/2013
25/04/2014 Centralised - Modification EMEA/H/C/1039/PSU/30 (2014)2821 of 23/04/2014
26/06/2014 Centralised - Variation EMEA/H/C/1039/WS/528
22/07/2014 Centralised - Renewal EMEA/H/C/1039/R/23 (2014)5248 of 18/07/2014
24/07/2014 Centralised - Variation EMEA/H/C/1039/WS/529