Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NovoMix   
Auth. number : EU/1/00/142
INN : Insulin aspart
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AD - Insulins and analogues for injection, intermediate-acting combined with fast-acting
Chemical substance: A10AD05 - Insulin aspart
(See WHO ATC Index)
Indication: NovoMix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
NovoMix 50 is indicated for treatment of diabetes mellitus in adults.
NovoMix 70 is indicated for treatment of diabetes mellitus in adults.
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
07/08/2000 Centralised - Authorisation EMEA/H/C/308 (2000)2365 of 01/08/2000
20/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/I/2
04/12/2000 Centralised - Variation (2000)3395 of 29/11/2000
23/01/2001 Centralised - Variation EMEA/H/C/308/I/3 (2001)50 of 22/01/2001
31/01/2001 Centralised - Variation EMEA/H/C/308/II/1 (2001)94 of 29/01/2001
08/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/4
28/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/5
28/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/6
28/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/I/7
13/11/2002 Centralised - Variation (2002)4445 of 08/11/2002
30/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/14
26/08/2003 Centralised - Variation EMEA/H/C/308/I/8 (2003)3146 of 22/08/2003
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/I/10
10/10/2003 Centralised - Variation EMEA/H/C/308/I/9 (2003)3726 of 08/10/2003
19/04/2004 Centralised - Variation EMEA/H/C/308/II/12, 13 (2004)1503 of 15/04/2004
27/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/16
22/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IB/17
12/07/2004 Centralised - Variation EMEA/H/C/308/II/15 (2004)2747 of 07/07/2004
26/08/2004 Centralised - Variation EMEA/H/C/308/X/11 (2004)3339 of 24/08/2004
21/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/23
21/12/2004 Centralised - Variation EMEA/H/C/308/IA/24
Updated with Decision(2005)1807 of 10/06/2005
11/03/2005 Other procedure EMEA/H/C/308/N/27
21/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/20
23/03/2005 Centralised - Variation EMEA/H/C/308/IA/29
Updated with Decision(2005)1807 of 10/06/2005
12/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/26
14/06/2005 Centralised - Variation EMEA/H/C/308/II/25 (2005)1807 of 10/06/2005
08/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/28
10/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/21
20/09/2005 Centralised - Renewal EMEA/H/C/308/R/30 (2005)3586 of 15/09/2005
10/10/2005 Centralised - Variation EMEA/H/C/308/X/19 (2005)3800 of 05/10/2005
10/10/2005 Centralised - Variation EMEA/H/C/308/X/18 (2005)3797 of 05/10/2005
31/03/2006 Centralised - Variation EMEA/H/C/308/II/31 (2006)1349 of 29/03/2006
25/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IB/32
27/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/34
27/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/33
15/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/37
26/04/2007 Centralised - Variation EMEA/H/C/308/II/35 (2007)1889 of 24/04/2007
29/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/36
29/08/2007 Centralised - Variation EMEA/H/C/308/II/38 (2007)4076 of 27/08/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/39
20/12/2007 Centralised - Variation EMEA/H/C/308/II/40 (2007)6760 of 18/12/2007
30/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/41
18/03/2008 Centralised - Notification EMEA/H/C/308/N/44
Updated with Decision(2008)1636 of 18/04/2008
18/03/2008 Centralised - Notification EMEA/H/C/308/N/45
Updated with Decision(2008)1636 of 18/04/2008
22/04/2008 Centralised - Variation EMEA/H/C/308/II/42 (2008)1636 of 18/04/2008
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/50
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/48
20/06/2008 Centralised - Variation EMEA/H/C/308/II/43 (2008)3075 of 18/06/2008
30/07/2008 Centralised - Variation EMEA/H/C/308/II/49 (2008)4109 of 28/07/2008
01/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/52
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/51
20/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/53
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/54
05/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/55
07/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/L56
15/10/2009 Centralised - Variation EMEA/H/C/308/II/57, 58 (2009)7964 of 13/10/2009
04/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IA/59
07/07/2010 Centralised - Renewal EMEA/H/C/308/R/60 (2010)4717 of 02/07/2010
01/08/2010 Centralised - Variation EMEA/H/C/308/IA/62
Updated with Decision(2011)1483 of 28/02/2011
14/09/2010 Centralised - Variation EMEA/H/C/308/IA/64
Updated with Decision(2011)1483 of 28/02/2011
29/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/II/61
06/10/2010 Centralised - Variation EMEA/H/C/308/IB/63/G
Updated with Decision(2011)1483 of 28/02/2011
04/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/308/IB/65
03/03/2011 Centralised - Variation (2011)1483 of 28/02/2011
22/03/2011 Centralised - Variation EMEA/H/C/308/WS/91 (2011)1897 of 17/03/2011
20/03/2012 Centralised - Notification EMEA/H/C/308/N/71
Updated with Decision(2014)8606 of 13/11/2014
30/07/2013 Centralised - Notification EMEA/H/C/308/N/75
Updated with Decision(2014)8606 of 13/11/2014
21/11/2013 Centralised - Variation EMEA/H/C/308/II/77
Updated with Decision(2014)8606 of 13/11/2014
24/07/2014 Centralised - Variation EMEA/H/C/308/II/80/G
Updated with Decision(2014)8606 of 13/11/2014
17/11/2014 Centralised - Yearly update (2014)8606 of 13/11/2014