Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NovoRapid   
Auth. number : EU/1/99/119
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: A10AB - Insulins and analogues for injection, fast-acting
Chemical substance: A10AB05 - Insulin aspart
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus in adults and adolescents and children aged 2 to 17 years.
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
10/02/2000 Centralised - Variation EMEA/H/C/258/II/2, 3, 4 (2000)181 of 08/02/2000
17/04/2000 Centralised - Variation EMEA/H/C/258/II/5 (2000)181 of 13/04/2000
23/01/2001 Centralised - Variation EMEA/H/C/258/II/6 (2001)6 of 15/01/2001
02/04/2001 Centralised - Variation EMEA/H/C/258/I/9
25/04/2001 Centralised - Variation EMEA/H/C/258/II/7 (2001)839 of 23/04/2001
27/07/2001 Centralised - Variation EMEA/H/C/258/II/8 (2001)2038 of 26/07/2001
07/11/2001 Centralised - Variation EMEA/H/C/258/II/10
08/01/2002 Centralised - Variation EMEA/H/C/258/I/11
26/02/2002 Centralised - Variation EMEA/H/C/258/II/12
26/02/2002 Centralised - Variation EMEA/H/C/258/I/14
04/04/2002 Centralised - Variation EMEA/H/C/258/I/15 (2002)1372 of 02/04/2002
27/05/2002 Centralised - Variation (2002)2021 of 24/05/2002
07/06/2002 Centralised - Variation EMEA/H/C/258/I/17
10/07/2002 Centralised - Variation EMEA/H/C/258/I/18
17/07/2002 Centralised - Variation EMEA/H/C/258/II/13 (2002)2789 of 15/07/2002
06/06/2003 Centralised - Variation EMEA/H/C/258/X/19 (2003)1839 of 04/06/2003
06/06/2003 Centralised - Variation EMEA/H/C/258/X/16 (2003)1838 of 04/06/2003
06/06/2003 Centralised - Variation EMEA/H/C/258/II/21 (2003)1837 of 04/06/2003
12/06/2003 Centralised - Variation EMEA/H/C/258/II/22 (2003)1883 of 06/06/2003
23/07/2003 Centralised - Variation EMEA/H/C/258/I/24 (2003)2714 of 18/07/2003
26/08/2003 Centralised - Variation EMEA/H/C/258/I/25 (2003)3141 of 22/08/2003
29/09/2003 Centralised - Variation EMEA/H/C/258/I/26
31/03/2004 Centralised - Variation EMEA/H/C/258/II/30
14/04/2004 Centralised - Variation EMEA/H/C/258/II/28, 29 (2004)1437 of 07/04/2004
28/04/2004 Centralised - Variation EMEA/H/C/258/II/31
26/08/2004 Centralised - Variation EMEA/H/C/258/X/27 (2004)3340 of 24/08/2004
15/09/2004 Centralised - Authorisation EMEA/H/C/258 (1999)2865 of 07/09/1999
18/10/2004 Centralised - Renewal EMEA/H/C/258/R/32 (2004)4058 of 13/10/2004
19/10/2004 Centralised - Variation EMEA/H/C/258/II/33 (2004)4126 of 15/10/2004
21/12/2004 Centralised - Variation EMEA/H/C/258/IA/37
21/12/2004 Centralised - Variation EMEA/H/C/258/IA/38
Updated with Decision(2005)1084 of 30/03/2005
27/01/2005 Centralised - Variation EMEA/H/C/258/II/35
27/01/2005 Centralised - Variation EMEA/H/C/258/II/36
14/03/2005 Centralised - Variation EMEA/H/C/258/N/42
Updated with Decision(2006)1353 of 29/03/2006
01/04/2005 Centralised - Variation EMEA/H/C/258/II/34 (2005)1084 of 30/03/2005
24/05/2005 Centralised - Variation EMEA/H/C/258/IA/45
30/06/2005 Centralised - Variation EMEA/H/C/258/II/43
12/07/2005 Centralised - Variation EMEA/H/C/258/II/41 (2005)2739 of 08/07/2005
14/07/2005 Centralised - Variation EMEA/H/C/258/IA/46
03/08/2005 Centralised - Variation EMEA/H/C/258/II/40
14/09/2005 Centralised - Variation EMEA/H/C/258/IA/47
Updated with Decision(2006)1353 of 29/03/2006
25/10/2005 Centralised - Variation EMEA/H/C/258/IA/49
25/11/2005 Centralised - Variation EMEA/H/C/258/II/48
03/04/2006 Centralised - Variation (2006)1353 of 29/03/2006
25/04/2006 Centralised - Variation EMEA/H/C/258/IB/53
02/05/2006 Centralised - Variation EMEA/H/C/258/II/51
26/07/2006 Centralised - Variation EMEA/H/C/258/II/52 (2006)3385 of 20/07/2006
21/11/2006 Centralised - Variation EMEA/H/C/258/II/55
21/11/2006 Centralised - Variation EMEA/H/C/258/II/56
30/05/2007 Centralised - Variation EMEA/H/C/258/II/57
05/09/2007 Centralised - Variation EMEA/H/C/258/II/58 (2007)4169 of 30/08/2007
25/09/2007 Centralised - Variation EMEA/H/C/258/II/59
23/11/2007 Centralised - Variation EMEA/H/C/258/II/60
25/02/2008 Centralised - Variation EMEA/H/C/258/IA/66
Updated with Decision(2008)1705 of 23/04/2008
19/03/2008 Centralised - Variation EMEA/H/C/258/N/63
Updated with Decision(2008)1705 of 23/04/2008
19/03/2008 Centralised - Variation EMEA/H/C/258/N/62
Updated with Decision(2008)1705 of 23/04/2008
25/04/2008 Centralised - Variation EMEA/H/C/258/II/65 (2008)1705 of 23/04/2008
11/06/2008 Centralised - Variation EMEA/H/C/258/II/69
29/07/2008 Centralised - Variation EMEA/H/C/258/II/68
03/10/2008 Corrigendum (2008)5708 corr of 01/10/2008
08/01/2009 Centralised - Variation EMEA/H/C/258/IA/74
03/03/2009 Centralised - Variation EMEA/H/C/258/II/73
05/05/2009 Centralised - Renewal EMEA/H/C/258/R/72 (2009)3577 of 30/04/2009
05/05/2009 Centralised - Variation EMEA/H/C/258/IA/76
12/05/2009 Centralised - Variation EMEA/H/C/258/II/75
07/07/2009 Centralised - Variation EMEA/H/C/258/IA/78
30/07/2009 Centralised - Variation EMEA/H/C/258/II/77 (2009)6110 of 27/07/2009
08/12/2009 Centralised - Variation EMEA/H/C/258/N/79
Updated with Decision(2011)2629 of 08/04/2011
16/08/2010 Centralised - Variation EMEA/H/C/258/IA/81
Updated with Decision(2011)2629 of 08/04/2011
30/09/2010 Centralised - Variation EMEA/H/C/258/II/80
08/11/2010 Centralised - Variation EMEA/H/C/258/IB/82
08/11/2010 Centralised - Variation EMEA/H/C/258/IA/83/G
Updated with Decision(2011)2629 of 08/04/2011
14/12/2010 Centralised - Variation EMEA/H/C/258/IB/84/G
12/04/2011 Centralised - Variation EMEA/H/C/258/WS/91 (2011)2629 of 08/04/2011
14/04/2011 Centralised - Variation EMEA/H/C/258/IA/86
Updated with Decision(2011)5149 of 11/07/2011
13/07/2011 Centralised - Variation EMEA/H/C/258/II/85/G (2011)5149 of 11/07/2011
03/08/2012 Centralised - Variation EMEA/H/C/258/II/91 (2012)5613 of 31/07/2012
11/01/2013 Centralised - Variation EMEA/H/C/258/IG/251
Updated with Decision(2014)136 of 10/01/2014
30/07/2013 Centralised - Variation EMEA/H/C/258/N/96
Updated with Decision(2014)136 of 10/01/2014
21/11/2013 Centralised - Variation EMEA/H/C/258/II/92
Updated with Decision(2014)136 of 10/01/2014
14/01/2014 Centralised - Variation (2014)136 of 10/01/2014