Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levemir   
Auth. number : EU/1/04/278
INN : insulin detemir
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AE - Insulins and analogues for injection, long-acting
Chemical substance: A10AE05 - Insulin detemir
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus.
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
04/06/2004 Centralised - Authorisation EMEA/H/C/528 (2004)2012 of 01/06/2004
01/12/2004 Centralised - Variation EMEA/H/C/528/II/3
14/03/2005 Centralised - Variation EMEA/H/C/528/N/4
18/03/2005 Centralised - Variation EMEA/H/C/528/IA/5
31/03/2005 Centralised - Variation EMEA/H/C/528/II/1 (2005)1070 of 29/03/2005
30/06/2005 Centralised - Variation EMEA/H/C/528/IA/7
06/07/2005 Centralised - Variation EMEA/H/C/528/II/6 (2005)2570 of 04/07/2005
18/10/2005 Centralised - Variation EMEA/H/C/528/II/8
22/11/2005 Centralised - Variation EMEA/H/C/528/II/9
20/12/2005 Centralised - Variation EMEA/H/C/528/II/10
27/03/2006 Centralised - Variation EMEA/H/C/528/II/11
31/05/2006 Centralised - Variation EMEA/H/C/528/IB/13
10/07/2006 Centralised - Variation EMEA/H/C/528/II/12 (2006)3180 of 06/07/2006
25/09/2006 Centralised - Variation EMEA/H/C/528/II/14
22/11/2006 Centralised - Variation EMEA/H/C/528/II/15
29/01/2007 Centralised - Variation EMEA/H/C/528/II/17
27/02/2007 Centralised - Variation EMEA/H/C/528/II/19
01/03/2007 Centralised - Variation EMEA/H/C/528/II/16 (2007)713 of 27/02/2007
12/06/2007 Centralised - Variation EMEA/H/C/528/II/21 (2007)2557 of 08/06/2007
25/06/2007 Centralised - Variation EMEA/H/C/528/II/20 (2007)3133 of 21/06/2007
25/09/2007 Centralised - Variation EMEA/H/C/528/II/22
18/10/2007 Centralised - Variation EMEA/H/C/528/II/23 (2007)5146 of 15/10/2007
21/11/2007 Centralised - Variation EMEA/H/C/528/II/24
15/01/2008 Centralised - Variation EMEA/H/C/528/IA/29
31/01/2008 Centralised - Variation EMEA/H/C/528/N/25
Updated with Decision(2008)1632 of 18/04/2008
28/02/2008 Centralised - Variation EMEA/H/C/528/II/26
17/03/2008 Centralised - Variation EMEA/H/C/528/N/28
Updated with Decision(2008)1632 of 18/04/2008
17/03/2008 Centralised - Variation EMEA/H/C/528/N/27
Updated with Decision(2008)1632 of 18/04/2008
22/04/2008 Centralised - Variation EMEA/H/C/528/II/30 (2008)1632 of 18/04/2008
07/05/2008 Centralised - Variation EMEA/H/C/528/IA/33
03/06/2008 Centralised - Variation EMEA/H/C/528/IB/34
Updated with Decision(2009)54 of 07/01/2009
06/06/2008 Centralised - Variation EMEA/H/C/528/II/32
15/07/2008 Centralised - Variation EMEA/H/C/528/IB/35
02/09/2008 Centralised - Variation EMEA/H/C/528/IA/36
03/10/2008 Corrigendum EMEA/H/C/528/II/30 (2008)1632 corr of 01/10/2008
09/01/2009 Centralised - Variation (2009)54 of 07/01/2009
20/04/2009 Centralised - Renewal EMEA/H/C/528/R/37 (2009)3026 of 16/04/2009
27/04/2009 Centralised - Variation EMEA/H/C/528/II/38
05/05/2009 Centralised - Variation EMEA/H/C/528/IA/40
04/06/2009 Centralised - Variation EMEA/H/C/528/II/39
26/11/2009 Centralised - Variation EMEA/H/C/528/II/41
10/12/2009 Centralised - Variation EMEA/H/C/528/IA/42
Updated with Decision(2010)2273 of 30/03/2010
10/12/2009 Centralised - Variation EMEA/H/C/528/IA/43
Updated with Decision(2010)2273 of 30/03/2010
06/04/2010 Centralised - Variation (2010)2273 of 30/03/2010
19/08/2010 Centralised - Variation EMEA/H/C/528/IA/45
Updated with Decision(2011)1219 of 21/02/2011
27/09/2010 Centralised - Variation EMEA/H/C/528/X/44 (2010)6717 of 23/09/2010
28/02/2011 Centralised - Variation (2011)1219 of 21/02/2011
28/03/2011 Centralised - Variation EMEA/H/C/528/IG/48/G
30/03/2011 Centralised - Variation EMEA/H/C/528/II/46/G
30/03/2011 Centralised - Variation EMEA/H/C/528/WS/91 (2011)2261 of 28/03/2011
26/04/2011 Centralised - Variation EMEA/H/C/528/IA/50
Updated with Decision(2011)3866 of 27/05/2011
01/06/2011 Centralised - Variation EMEA/H/C/528/II//47/G (2011)3866 of 27/05/2011
26/10/2011 Centralised - Variation EMEA/H/C/528/II/48, 51 (2011)7778 of 24/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/528/II/53/G (2011)8676 of 22/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/528/II/52 (2011)9960 of 19/12/2011
15/03/2012 Centralised - Variation EMEA/H/C/528/N/59
Updated with Decision(2014)562 of 29/01/2014
30/07/2013 Centralised - Variation EMEA/H/C/528/N/64
Updated with Decision(2014)562 of 29/01/2014
31/01/2014 Centralised - Variation EMEA/H/C/528/II/66 (2014)562 of 29/01/2014