Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Actrapid   
Auth. number : EU/1/02/230
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: A10AB - Insulins and analogues for injection, fast-acting
Chemical substance: A10AB01 - 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/424 (2002)3793 of 07/10/2002
28/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/1
15/08/2003 Centralised - Variation EMEA/H/C/424/I/2 (2003)3049 of 13/08/2003
26/08/2003 Centralised - Variation EMEA/H/C/424/I/4 (2003)3142 of 22/08/2003
01/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/I/5
01/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/3
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/I/6
04/08/2004 Centralised - Variation EMEA/H/C/424/II/7 (2004)3033 of 02/08/2004
03/03/2005 Centralised - Variation EMEA/H/C/424/IA/10
Updated with Decision(2005)3791 of 05/10/2005
15/03/2005 Centralised - Notification EMEA/H/C/424/N/9
24/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/13
06/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/11
10/10/2005 Centralised - Variation (2005)3791 of 05/10/2005
25/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IB/16
10/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/15
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/18
27/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/20
27/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/21
03/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/22
05/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/24
20/09/2007 Centralised - Renewal EMEA/H/C/424/R/23 (2007)4400 of 18/09/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/25
18/03/2008 Centralised - Notification EMEA/H/C/424/N/26
Updated with Decision(2008)8814 of 17/12/2008
18/03/2008 Centralised - Notification EMEA/H/C/424/N/27
Updated with Decision(2008)8814 of 17/12/2008
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/29
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/30
31/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/31
22/12/2008 Centralised - Variation EMEA/H/C/424/II/32 (2008)8814 of 17/12/2008
29/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/33
12/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/34
30/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/36
29/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/II/35
05/10/2009 Centralised - Variation EMEA/H/C/424/X/8 (2009)7655 of 01/10/2009
04/11/2009 Centralised - Notification EMEA/H/C/424/N/37
Updated with Decision(2011)1152 of 18/02/2011
21/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/38
19/08/2010 Centralised - Variation EMEA/H/C/424/IA/39
Updated with Decision(2011)1152 of 18/02/2011
22/02/2011 Centralised - Variation (2011)1152 of 18/02/2011
17/03/2011 Centralised - Variation EMEA/H/C/424/WS/91 (2011)1790 of 14/03/2011
08/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/424/IA/48/G
15/11/2011 Centralised - Variation (2011)8231 of 10/11/2011
15/11/2011 Centralised - Variation EMEA/H/C/424/IA/40
Updated with Decision(2011)8231 of 10/11/2011
29/06/2012 Centralised - Variation EMEA/H/C/424/II/46/G (2012)4492 of 27/06/2012
22/11/2012 Centralised - Variation EMEA/H/C/424/II/WS/273/G (2012)8587 of 19/11/2012
11/01/2013 Centralised - Variation EMEA/H/C/424/IG/251
Updated with Decision(2013)9721 of 18/12/2013
30/07/2013 Centralised - Notification EMEA/H/C/424/N/51
Updated with Decision(2013)9721 of 18/12/2013
20/12/2013 Centralised - Yearly update (2013)9721 of 18/12/2013
26/06/2014 Centralised - Variation EMEA/H/C/424/WS/454