Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Victoza   
Auth. number : EU/1/09/529
INN : liraglutide
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: A10BX07 - Liraglutide
(See WHO ATC Index)
Indication: Victoza is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark

  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
02/07/2009 Centralised - Authorisation EMEA/H/C/1026 (2009)5388 of 30/06/2009
03/12/2009 Centralised - Variation EMEA/H/C/1026/IB/1
26/01/2010 Centralised - Variation EMEA/H/C/1026/N/2
Updated with Decision(2010)9635 of 20/12/2010
12/04/2010 Centralised - Variation EMEA/H/C/1026/IA/3
27/12/2010 Centralised - Variation EMEA/H/C/1026/II/4 (2010)9635 of 20/12/2010
15/03/2011 Centralised - Variation EMEA/H/C/1026/IG/48/G
15/11/2011 Centralised - Variation EMEA/H/C/1026/II/5/G (2011)8250 of 10/11/2011
25/11/2011 Centralised - Variation EMEA/H/C/1026/II/6/G (2011)5388 of 22/11/2011
24/02/2012 Centralised - Variation EMEA/H/C/1026/II/10 (2012)1278 of 21/02/2012
24/04/2012 Centralised - Variation EMEA/H/C/1026/II/11 (2012)2830 of 20/04/2012
31/05/2012 Centralised - Variation EMEA/H/C/1026/II/13 (2012)3609 of 25/05/2012
26/10/2012 Centralised - Variation EMEA/H/C/1026/II/16 (2012)7612 of 23/10/2012
13/03/2013 Centralised - Modification EMEA/H/C/1026/PSU/8 (2013)1537 of 11/03/2013
02/09/2013 Centralised - Variation EMEA/H/C/1026/N/20
Updated with Decision(2014)2646 of 11/04/2014
15/04/2014 Centralised - Renewal EMEA/H/C/1026/R/25 (2014)2646 of 11/04/2014
30/04/2014 Centralised - Variation EMEA/H/C/1026/II/23, 24 (2014)2925 of 28/04/2014