Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Insulin Human Winthrop   
Auth. number : EU/1/06/368
INN : Insulin human
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
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
02/02/2007 Centralised - Authorisation EMEA/H/C/761 (2007)185 of 17/01/2007
16/03/2007 Corrigendum EMEA/H/C/761
30/08/2007 Centralised - Variation EMEA/H/C/761/IA/2
27/12/2007 Centralised - Variation EMEA/H/C/761/II/3 (2007)6806 of 20/12/2007
25/01/2008 Centralised - Variation EMEA/H/C/761/II/1
04/03/2008 Centralised - Variation EMEA/H/C/761/IB/6
20/06/2008 Centralised - Variation EMEA/H/C/761/II/5 (2008)3076 of 18/06/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/20
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/21
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/22
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/23
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/24
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/25
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/26
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/27
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/28
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/29
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/30
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/31
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/32
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IB/9
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IB/10
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IB/11
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IB/12
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/19
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/18
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/17
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/16
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/15
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/14
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IB/8
Updated with Decision(2008)6662 of 31/10/2008
17/07/2008 Centralised - Variation EMEA/H/C/761/IA/13
Updated with Decision(2008)6662 of 31/10/2008
18/09/2008 Centralised - Variation EMEA/H/C/761/IA/34
26/09/2008 Centralised - Variation EMEA/H/C/761/IB/36
30/09/2008 Centralised - Variation EMEA/H/C/761/IB/35
04/11/2008 Centralised - Variation EMEA/H/C/761/II/7 (2008)6662 of 31/10/2008
25/11/2008 Centralised - Variation EMEA/H/C/761/II/33
27/01/2009 Centralised - Variation EMEA/H/C/761/II/37
17/02/2009 Centralised - Variation EMEA/H/C/761/IB/38
23/02/2009 Centralised - Variation EMEA/H/C/761/X/4 (2009)1239 of 19/02/2009
02/06/2009 Centralised - Variation EMEA/H/C/761/II/39 (2009)4326 of 28/05/2009
28/07/2009 Centralised - Variation EMEA/H/C/761/IB/42
05/08/2009 Centralised - Variation EMEA/H/C/761/IB/40
04/11/2009 Centralised - Variation EMEA/H/C/761/II/43 (2009)8597 of 30/10/2009
16/11/2009 Centralised - Variation EMEA/H/C/761/IB/45
15/03/2010 Corrigendum EMEA/H/C/761/II/43 (2009)8597 corr of 11/03/2010
27/05/2010 Centralised - Variation EMEA/H/C/IG/4/G
Updated with Decision(2010)5845 of 18/08/2010
03/06/2010 Centralised - Variation EMEA/H/C/761/IA/46
20/08/2010 Centralised - Variation (2010)5845 of 18/08/2010
31/08/2010 Centralised - Variation EMEA/H/C/762/IA/47/G
06/12/2010 Centralised - Variation EMEA/H/C/761/IB/50
Updated with Decision(2011)685 of 01/02/2011
21/12/2010 Centralised - Variation EMEA/H/C/761/IA/51
02/02/2011 Centralised - Variation EMEA/H/C/761/IB/52
Updated with Decision(2011)6231 of 26/08/2011
03/02/2011 Centralised - Variation EMEA/H/C/761/II/49 (2011)685 of 01/02/2011
31/08/2011 Centralised - Variation (2011)6231 of 26/08/2011
23/11/2011 Centralised - Renewal EMEA/H/C/761/R/55 (2011)8645 of 21/11/2011
25/04/2012 Centralised - Variation EMEA/H/C/761/WS/208 (2012)2819 of 20/04/2012
04/07/2012 Centralised - Variation EMEA/H/C/761/WS/229 (2012)4587 of 28/06/2012
17/09/2013 Centralised - Variation EMEA/H/C/761/IB/67
05/12/2013 Centralised - Variation EMEA/H/C/761/IB/68