Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Insuman   
Auth. number : EU/1/97/030
Active substance : human insulin
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: Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus.
Marketing Authorisation Holder: Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland
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
24/02/1997 Centralised - Authorisation EMEA/H/C/201 (97)494 of 21/02/1997
13/11/1998 Centralised - Authorisation EMEA/H/C/201 (1998)3496 of 11/11/1998
24/02/1999 Centralised - Authorisation EMEA/H/C/201/II/1, 2 (1999)373 of 18/02/1999
20/01/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/5
23/02/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/10
27/03/2000 Centralised - Authorisation EMEA/H/C/201 (2000)764 of 20/03/2000
28/04/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/6
07/08/2000 Centralised - Authorisation EMEA/H/C/201/X/3 (2000)2364 of 01/08/2000
15/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/8
15/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/I/7
04/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/11
18/06/2001 Centralised - Variation EMEA/H/C/201/I/10 (2001)1317 of 14/06/2001
18/06/2001 Centralised - Variation EMEA/H/C/201/II/9 (2001)1317 of 14/06/2001
02/04/2002 Centralised - Renewal EMEA/H/C/201/R/13 (2002)1288 of 22/03/2002
30/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/14
05/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/I/17
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/I/16
28/10/2003 Centralised - Variation EMEA/H/C/201/II/15 (2003)4032 of 24/10/2003
27/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/18
06/08/2004 Centralised - Variation EMEA/H/C/201/II/19 (2004)3095 of 04/08/2004
29/09/2004 Centralised - Variation EMEA/H/C/201/II/20 (2004)3646 of 24/09/2004
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/21
16/02/2006 Centralised - Variation EMEA/H/C/201/II/22 (2006)512 of 14/02/2006
11/05/2006 Centralised - Variation EMEA/H/C/201/II/23 (2006)1956 of 05/05/2006
02/06/2006 Centralised - Variation EMEA/H/C/201/I/24
Updated with Decision(2006)5354 of 31/10/2006
27/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/26
06/11/2006 Centralised - Variation EMEA/H/C/201/II/27 (2006)5354 of 31/10/2006
02/02/2007 Centralised - Renewal EMEA/H/C/201/R/25 (2007)170 of 16/01/2007
01/07/2007 Centralised - Variation EMEA/H/C/201/IA/38
Updated with Decision(2007)6761 of 18/12/2007
31/07/2007 Centralised - Variation EMEA/H/C/201/IB/32
Updated with Decision(2007)6761 of 18/12/2007
31/07/2007 Centralised - Variation EMEA/H/C/201/IB/28
Updated with Decision(2007)6761 of 18/12/2007
31/07/2007 Centralised - Variation EMEA/H/C/201/IB/29
Updated with Decision(2007)6761 of 18/12/2007
31/07/2007 Centralised - Variation EMEA/H/C/201/IB/30
Updated with Decision(2007)6761 of 18/12/2007
31/07/2007 Centralised - Variation EMEA/H/C/201/IB/31
Updated with Decision(2007)6761 of 18/12/2007
07/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IA/54
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/52
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/46
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/45
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/44
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/43
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/41
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/42
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/40
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/39
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/47
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/33
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/34
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/35
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/36
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/37
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/48
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/49
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/50
Updated with Decision(2007)6761 of 18/12/2007
08/08/2007 Centralised - Variation EMEA/H/C/201/IA/51
Updated with Decision(2007)6761 of 18/12/2007
20/12/2007 Centralised - Variation EMEA/H/C/201/II/55 (2007)6761 of 18/12/2007
31/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/53
28/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/58
20/06/2008 Centralised - Variation EMEA/H/C/201/II/56 (2008)3069 of 18/06/2008
18/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IA/61
26/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/63
30/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/62
18/11/2008 Centralised - Variation EMEA/H/C/201/II/59 (2008)6717 of 04/11/2008
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/II/60
17/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/65
23/02/2009 Centralised - Variation EMEA/H/C/201/X/57 (2009)1244 of 19/02/2009
03/06/2009 Centralised - Variation EMEA/H/C/201/II/66 (2009)4342 of 29/05/2009
29/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/69
04/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/67
11/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/72
11/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IB/7
13/11/2009 Centralised - Variation EMEA/H/C/201/II/70 (2009)9014 of 11/11/2009
26/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IA/74
27/05/2010 Centralised - Variation EMEA/H/C/201/IA/4G
Updated with Decision(2010)6240 of 06/09/2010
18/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IA/75/G
09/09/2010 Centralised - Variation (2010)6240 of 06/09/2010
02/12/2010 Centralised - Variation EMEA/H/C/201/IB/78
Updated with Decision(2011)684 of 01/02/2011
20/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/201/IA/79
19/01/2011 Centralised - Variation EMEA/H/C/201/IB/80
Updated with Decision(2011)6373 of 05/09/2011
03/02/2011 Centralised - Variation EMEA/H/C/201/II/77 (2011)684 of 01/02/2011
07/09/2011 Centralised - Variation (2011)6373 of 05/09/2011
26/04/2012 Centralised - Variation EMEA/H/C/201/WS/208 (2012)2860 of 20/04/2012
05/07/2012 Centralised - Variation EMEA/H/C/201/WS/229 (2012)4705 of 03/07/2012
05/03/2013 Corrigendum EMEA/H/C/201/WS/229 (2012)4705 of 03/07/2012
17/09/2013 Centralised - Variation EMEA/H/C/201/IB/95
Updated with Decision(2014)7362 of 03/10/2014
23/09/2013 Centralised - Variation EMEA/H/C/201/X/91 (2013)6225 of 19/09/2013
05/12/2013 Centralised - Variation EMEA/H/C/201/IB/95
Updated with Decision(2014)7362 of 03/10/2014
15/09/2014 Corrigendum (2013)6225 of 11/09/2014
07/10/2014 Centralised - Yearly update (2014)7362 of 03/10/2014
21/07/2015 Centralised - Notification EMEA/H/C/201/N/106
Updated with Decision(2018)3889 of 14/06/2018
28/04/2016 Centralised - Notification EMEA/H/C/201/N/113
Updated with Decision(2018)3889 of 14/06/2018
29/06/2017 Centralised - Variation EMEA/H/C/201/IB/118/G
Updated with Decision(2018)3889 of 14/06/2018
21/02/2018 Centralised - Variation EMEA/H/C/201/IB/119
Updated with Decision(2018)3889 of 14/06/2018
03/04/2018 Centralised - Variation EMEA/H/C/201/IB/122
Updated with Decision(2018)3889 of 14/06/2018
19/06/2018 Centralised - Yearly update (2018)3889 of 14/06/2018