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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 procedures |
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 | ||||
28/04/2016 | Centralised - Notification | EMEA/H/C/201/N/113 | ||||
29/06/2017 | Centralised - Variation | EMEA/H/C/201/IB/118/G | ||||
21/02/2018 | Centralised - Variation | EMEA/H/C/201/IB/119 | ||||
03/04/2018 | Centralised - Variation | EMEA/H/C/201/IB/122 | ||||