Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Optisulin   
Auth. number : EU/1/00/133
INN : insulin glargine
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AE - Insulins and analogues for injection, long-acting
Chemical substance: A10AE04 - Insulin glargine
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
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 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
28/06/2000 Centralised - Authorisation EMEA/H/C/309 (2000)1486 of 27/06/2000
08/05/2001 Centralised - Variation EMEA/H/C/309/II/1
02/07/2001 Centralised - Variation EMEA/H/C/309/II/2, 3
13/08/2002 Centralised - Variation EMEA/H/C/309/II/4 (2002)3127 of 09/08/2002
02/05/2003 Centralised - Variation EMEA/H/C/309/I/5
25/06/2003 Centralised - Variation EMEA/H/C/309/I/7
30/09/2003 Centralised - Variation EMEA/H/C/309/II/6
11/03/2004 Centralised - Variation EMEA/H/C/309/II/8 (2004)738 of 02/03/2004
26/04/2004 Centralised - Variation EMEA/H/C/309/II/9
15/07/2004 Centralised - Variation EMEA/H/C/309/II/10 (2004)2803 of 13/07/2004
02/09/2004 Centralised - Variation EMEA/H/C/309/II/11 (2004)3393 of 31/08/2004
30/09/2004 Centralised - Variation EMEA/H/C/309/II/12
12/01/2005 Centralised - Variation EMEA/H/C/309/II/13 (2005)65 of 10/01/2005
25/02/2005 Centralised - Variation EMEA/H/C/309/II/15
29/04/2005 Centralised - Variation EMEA/H/C/309/II/14 (2005)1389 of 27/04/2005
11/07/2005 Centralised - Renewal EMEA/H/C/309/R/16 (2005)2750 of 08/07/2005
01/09/2005 Centralised - Variation EMEA/H/C/309/N/17
Updated with Decision(2006)3663 of 07/08/2006
09/03/2006 Centralised - Variation EMEA/H/C/309/IA/19
Updated with Decision(2006)3663 of 07/08/2006
30/03/2006 Centralised - Variation EMEA/H/C/309/II/18
09/08/2006 Centralised - Variation EMEA/H/C/309/II/20 (2006)3663 of 07/08/2006
22/08/2006 Centralised - Variation EMEA/H/C/309/IB/21
12/02/2007 Centralised - Variation EMEA/H/C/309/IA/22
16/03/2007 Centralised - Variation EMEA/H/C/309/IB/23
13/04/2007 Centralised - Variation EMEA/H/C/309/IA/24
22/06/2007 Centralised - Variation EMEA/H/C/309/IA/25
02/11/2007 Centralised - Variation EMEA/H/C/309/IB/29
16/11/2007 Centralised - Variation EMEA/H/C/309/II/27 (2007)5571 of 14/11/2007
19/12/2007 Centralised - Variation EMEA/H/C/309/II/28
20/12/2007 Centralised - Variation EMEA/H/C/309/IB/30
09/01/2008 Centralised - Variation EMEA/H/C/309/IA/35
09/01/2008 Centralised - Variation EMEA/H/C/309/IB/36
30/01/2008 Centralised - Variation EMEA/H/C/309/II/26
01/02/2008 Centralised - Variation EMEA/H/C/309/IB/37
02/04/2008 Centralised - Variation EMEA/H/C/309/II/31, 32, 33 (2008)1279 of 31/03/2008
27/06/2008 Centralised - Variation EMEA/H/C/309/II/34 (2008)3289 of 25/06/2008
19/09/2008 Centralised - Variation EMEA/H/C/309/II/38 (2008)5302 of 17/09/2008
27/11/2008 Centralised - Variation EMEA/H/C/309/II/40
02/12/2008 Centralised - Variation EMEA/H/C/309/II/39 (2008)7792 of 28/11/2008
11/03/2009 Centralised - Variation EMEA/H/C/309/II/41, 43 (2009)1836 of 09/03/2009
30/07/2009 Centralised - Variation EMEA/H/C/309/II/45
04/09/2009 Centralised - Variation EMEA/H/C/309/IA/48
Updated with Decision(2009)8665 of 04/11/2009
11/09/2009 Centralised - Variation EMEA/H/C/309/IB/47
21/09/2009 Centralised - Variation EMEA/H/C/309/II/44 (2009)7142 of 17/09/2009
29/09/2009 Centralised - Variation EMEA/H/C/309/IB/49
29/09/2009 Centralised - Variation EMEA/H/C/309/IB/50
06/11/2009 Centralised - Variation EMEA/H/C/309/II/46 (2009)8665 of 04/11/2009
07/05/2010 Centralised - Renewal EMEA/H/C/309/R/51 (2010)3068 of 05/05/2010
08/07/2010 Centralised - Variation EMEA/H/C/309/II/52
20/09/2010 Centralised - Variation EMEA/H/C/309/IA/55/G
29/10/2010 Centralised - Variation EMEA/H/C/309/IB/56
Updated with Decision(2011)462 of 24/01/2011
21/12/2010 Centralised - Variation EMEA/H/C/309/IA/57
27/01/2011 Centralised - Variation EMEA/H/C/309/II/54 (2011)462 of 24/01/2011
02/03/2011 Centralised - Variation EMEA/H/C/309/IB/58
Updated with Decision(2011)5950 of 10/08/2011
07/04/2011 Centralised - Variation EMEA/H/C/309/IA/11
Updated with Decision(2011)5950 of 10/08/2011
12/08/2011 Centralised - Variation (2011)5950 of 10/08/2011
29/08/2011 Centralised - Variation EMEA/H/C/309/II/61 (2011)6153 of 24/08/2011
25/04/2012 Centralised - Variation EMEA/H/C/309/WS/208 (2012)2825 of 20/04/2012
01/06/2012 Centralised - Variation EMEA/H/C/309/II/64 (2012)3611 of 25/05/2012
19/12/2012 Centralised - Variation EMEA/H/C/309/IG/243
Updated with Decision(2013)9840 of 20/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/309/II/71
Updated with Decision(2013)9840 of 20/12/2013
17/09/2013 Centralised - Variation EMEA/H/C/309/IB/74
Updated with Decision(2013)9840 of 20/12/2013
05/12/2013 Centralised - Variation EMEA/H/C/309/IB/77
18/12/2013 Centralised - Variation EMEA/H/C/309/II/76
27/12/2013 Centralised - Variation (2013)9840 of 20/12/2013