Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Actraphane   
Auth. number : EU/1/02/229
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: A10AD - Insulins and analogues for injection, intermediate-acting combined with fast-acting
Chemical substance: A10AD01 - 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 continues to be 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/427 (2002)3788 of 07/10/2002
28/01/2003 Centralised - Variation EMEA/H/C/427/II/1
15/08/2003 Centralised - Variation EMEA/H/C/427/I/2 (2003)3051 of 13/08/2003
26/08/2003 Centralised - Variation EMEA/H/C/427/I/4 (2003)3144 of 22/08/2003
01/10/2003 Centralised - Variation EMEA/H/C/427/I/5
01/10/2003 Centralised - Variation EMEA/H/C/427/II/3
27/10/2003 Centralised - Variation EMEA/H/C/424/I/6
03/08/2004 Centralised - Variation EMEA/H/C/427/II/8
04/08/2004 Centralised - Variation EMEA/H/C/427/II/7 (2004)3045 of 02/08/2004
03/03/2005 Centralised - Variation EMEA/H/C/427/IA/11
Updated with Decision(2005)3788 of 05/10/2005
15/03/2005 Centralised - Variation EMEA/H/C/427/N/10
Updated with Decision(2005)3788 of 05/10/2005
24/05/2005 Centralised - Variation EMEA/H/C/427/IA/14
06/06/2005 Centralised - Variation EMEA/H/C/427/II/12
10/10/2005 Centralised - Variation (2005)3788 of 05/10/2005
25/04/2006 Centralised - Variation EMEA/H/C/427/IB/18
10/05/2006 Centralised - Variation EMEA/H/C/427/II/16
07/06/2006 Centralised - Variation EMEA/H/C/427/II/17
22/11/2006 Centralised - Variation EMEA/H/C/427/II/20
23/01/2007 Centralised - Variation EMEA/H/C/427/IA/23
27/02/2007 Centralised - Variation EMEA/H/C/427/II/22
20/03/2007 Centralised - Variation EMEA/H/C/427/IB/25
10/04/2007 Centralised - Variation EMEA/H/C/427/IA/27
03/05/2007 Centralised - Variation EMEA/H/C/427/II/24
05/07/2007 Centralised - Variation EMEA/H/C/427/IA/28
20/09/2007 Centralised - Renewal EMEA/H/C/427/R/26 (2007)4387 of 18/09/2007
24/10/2007 Centralised - Variation EMEA/H/C/427/II/29
21/11/2007 Centralised - Variation EMEA/H/C/427/II/30
18/03/2008 Centralised - Variation EMEA/H/C/427/N/31
Updated with Decision(2008)8807 of 17/12/2008
18/03/2008 Centralised - Variation EMEA/H/C/427/N/32
Updated with Decision(2008)8807 of 17/12/2008
05/06/2008 Centralised - Variation EMEA/H/C/427/II/34
07/07/2008 Centralised - Variation EMEA/H/C/427/IA/35
31/07/2008 Centralised - Variation EMEA/H/C/427/IA/36
22/12/2008 Centralised - Variation EMEA/H/C/427/II/37 (2008)8807 of 17/12/2008
29/04/2009 Centralised - Variation EMEA/H/C/427/II/38
12/05/2009 Centralised - Variation EMEA/H/C/427/IA/39
30/06/2009 Centralised - Variation EMEA/H/C/427/IA/40
06/10/2009 Centralised - Variation EMEA/H/C/427/X/9 (2009)7656 of 01/10/2009
25/11/2009 Centralised - Variation EMEA/H/C/427/N/41
Updated with Decision(2010)7720 of 03/11/2010
21/12/2009 Centralised - Variation EMEA/H/C/427/IA/42
05/03/2010 Centralised - Variation EMEA/H/C/427/II/43
26/04/2010 Centralised - Variation EMEA/H/C/427/IB/44
Updated with Decision(2010)7720 of 03/11/2010
19/08/2010 Centralised - Variation EMEA/H/C/427/IA/45
Updated with Decision(2010)7720 of 03/11/2010
08/11/2010 Centralised - Variation (2010)7720 of 03/11/2010
22/03/2011 Centralised - Variation EMEA/H/C/427/WS/91 (2011)1893 of 17/03/2011
08/04/2011 Centralised - Variation EMEA/H/C/427/IA/48/G
15/11/2011 Centralised - Variation (2011)8230 of 10/11/2011
15/11/2011 Centralised - Variation EMEA/H/C/427/IA/46
Updated with Decision(2011)8230 of 10/11/2011
29/06/2012 Centralised - Variation EMEA/H/C/427/II/52/G (2012)4493 of 27/06/2012
22/11/2012 Centralised - Variation EMEA/H/C/427/II/WS/273 (2012)8589 of 19/11/2012
11/01/2013 Centralised - Variation EMEA/H/C/427/IG/251
Updated with Decision(2013)9719 of 18/12/2013
20/12/2013 Centralised - Variation (2013)9719 of 18/12/2013
21/03/2014 Centralised - Variation EMEA/H/C/427/IA/407