Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Insulatard   
Auth. number : EU/1/02/233
INN : Insulin human (rDNA)
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AC - Insulins and analogues for injection, intermediate-acting
Chemical substance: A10AC01 - Insulin (human)
(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
09/10/2002 Centralised - Authorisation EMEA/H/C/441 (2002)3806 of 07/10/2002
29/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/1
15/08/2003 Centralised - Variation EMEA/H/C/441/I/2 (2003)3054 of 13/08/2003
27/08/2003 Centralised - Variation EMEA/H/C/441/I/4 (2003)3154 of 25/08/2003
01/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/3
01/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/I/5
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/I/6
03/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/8
04/08/2004 Centralised - Variation EMEA/H/C/441/II/7 (2004)3036 of 02/08/2004
07/03/2005 Centralised - Variation EMEA/H/C/441/IA/11
Updated with Decision(2005)3789 of 05/10/2005
14/03/2005 Centralised - Notification EMEA/H/C/441/N/10
Updated with Decision(2005)3789 of 05/10/2005
24/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/14
06/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/12
10/10/2005 Centralised - Variation (2005)3789 of 05/10/2005
25/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IB/17
10/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/16
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/20
23/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/24
27/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/23
27/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/21
03/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/25
05/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/28
23/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/27
20/09/2007 Centralised - Renewal EMEA/H/C/441/R/26 (2007)4389 of 18/09/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/29
18/03/2008 Centralised - Notification EMEA/H/C/441/N/31
Updated with Decision(2008)1633 of 18/04/2008
18/03/2008 Centralised - Notification EMEA/H/C/441/N/32
Updated with Decision(2008)1633 of 18/04/2008
22/04/2008 Centralised - Variation EMEA/H/C/441/II/30 (2008)1633 of 18/04/2008
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/34
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/36
31/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/37
19/09/2008 Centralised - Notification EMEA/H/C/441/N/35
Updated with Decision(2009)7660 of 01/10/2009
27/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/II/38
05/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/39
30/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/40
27/08/2009 Centralised - Variation EMEA/H/C/441/IA/41
Updated with Decision(2010)2951 of 29/04/2010
05/10/2009 Centralised - Variation EMEA/H/C/441/X/9 (2009)7660 of 01/10/2009
16/11/2009 Centralised - Notification EMEA/H/C/441/N/42
Updated with Decision(2010)2951 of 29/04/2010
21/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IA/43
18/02/2010 Corrigendum
03/05/2010 Centralised - Variation (2010)2951 of 29/04/2010
16/08/2010 Centralised - Variation EMEA/H/C/441/IA/44
Updated with Decision(2011)1225 of 21/02/2011
25/02/2011 Centralised - Variation (2011)1225 of 21/02/2011
16/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/441/IG/48/G
28/03/2011 Centralised - Variation EMEA/H/C/441/WS/91 (2011)2095 of 24/03/2011
19/04/2011 Centralised - Variation EMEA/H/C/441/IA/45
Updated with Decision(2011)9744 of 14/12/2011
21/12/2011 Centralised - Variation (2011)9744 of 14/12/2011
02/07/2012 Centralised - Variation EMEA/H/C/441/II/51/G (2012)4512 of 27/06/2012
22/11/2012 Centralised - Variation EMEA/H/C/441/WS/273/G (2012)8582 of 19/11/2012
11/01/2013 Centralised - Variation EMEA/H/C/441/IG/251
Updated with Decision(2014)415 of 22/01/2014
24/01/2014 Centralised - Yearly update (2014)415 of 22/01/2014
26/06/2014 Centralised - Variation EMEA/H/C/441/WS/454