Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lantus   
Auth. number : EU/1/00/134
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 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
14/06/2000 Centralised - Authorisation EMEA/H/C/284 (2000)1461 of 09/06/2000
07/02/2001 Centralised - Variation EMEA/H/C/284/II/2 (2001)219 of 06/02/2001
05/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/3
08/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/4
05/02/2002 Centralised - Variation EMEA/H/C/284/II/6 (2002)396 of 28/01/2002
20/12/2002 Centralised - Variation EMEA/H/C/284/II/8 (2002)5010 of 05/12/2002
07/03/2003 Centralised - Variation EMEA/H/C/284/II/7 (2003)756 of 04/03/2003
24/04/2003 Centralised - Variation EMEA/H/C/284/I/9 (2003)1400 of 22/04/2003
02/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/I/10
25/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/I/11
30/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/12
23/10/2003 Centralised - Notification EMEA/H/C/284/N/13 (2003)3934 of 17/10/2003
26/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/14
15/07/2004 Centralised - Variation EMEA/H/C/284/II/16 (2004)2806 of 13/07/2004
02/09/2004 Centralised - Variation EMEA/H/C/284/II/15 (2004)3391 of 31/08/2004
02/09/2004 Centralised - Variation EMEA/H/C/284/II/17 (2004)3392 of 31/08/2004
22/09/2004 Centralised - Variation EMEA/H/C/284/II/19 (2004)3577 of 20/09/2004
30/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/18
20/10/2004 Centralised - Variation EMEA/H/C/284/IA/21
Updated with Decision(2005)91 of 11/01/2005
17/01/2005 Centralised - Variation EMEA/H/C/284/II/20 (2005)91 of 11/01/2005
25/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/23
29/04/2005 Centralised - Variation EMEA/H/C/284/II/22 (2005)1387 of 27/04/2005
11/07/2005 Centralised - Renewal EMEA/H/C/284/R/24 (2005)2748 of 08/07/2005
01/09/2005 Centralised - Notification EMEA/H/C/284/N/25
Updated with Decision(2006)1954 of 05/05/2006
09/03/2006 Centralised - Variation EMEA/H/C/284/IA/28
Updated with Decision(2006)1954 of 05/05/2006
30/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/27
11/05/2006 Centralised - Variation EMEA/H/C/284/II/26 (2006)1954 of 05/05/2006
09/08/2006 Centralised - Variation EMEA/H/C/284/II/30 (2006)3662 of 07/08/2006
22/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/33
06/09/2006 Centralised - Variation EMEA/H/C/284/II/29 (2006)4057 of 01/09/2006
14/11/2006 Centralised - Variation EMEA/H/C/284/II/31, 32 (2006)5347 of 31/10/2006
06/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/34
06/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/34
12/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IA/36
16/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/37
12/04/2007 Centralised - Notification EMEA/H/C/284/N/35
Updated with Decision(2008)3287 of 25/06/2008
13/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IA/38
22/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IA/39
02/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/43
27/11/2007 Centralised - Variation EMEA/H/C/284/II/41 (2007)5846 of 23/11/2007
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/42
20/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/44
09/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/I/46
09/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/48
30/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/40
01/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/47
21/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/49
27/06/2008 Centralised - Variation EMEA/H/C/284/II/45 (2008)3287 of 25/06/2008
19/09/2008 Centralised - Variation EMEA/H/C/284/II/50 (2008)5303 of 17/09/2008
27/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/52
02/12/2008 Centralised - Variation EMEA/H/C/284/II/51 (2008)7791 of 28/11/2008
17/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/54
18/03/2009 Centralised - Notification EMEA/H/C/284/N/53
Updated with Decision(2009)7138 of 17/09/2009
30/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/56
04/09/2009 Centralised - Variation EMEA/H/C/284/IA/59
Updated with Decision(2009)8661 of 04/11/2009
11/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/58
21/09/2009 Centralised - Variation EMEA/H/C/284/II/55 (2009)7138 of 17/09/2009
25/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/61
25/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IB/60
06/11/2009 Centralised - Variation EMEA/H/C/284/II/57 (2009)8661 of 04/11/2009
07/05/2010 Centralised - Renewal EMEA/H/C/284/R/62 (2010)3072 of 05/05/2010
08/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/II/63
20/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IA/66/G
29/10/2010 Centralised - Variation EMEA/H/C/284/IB/67
Updated with Decision(2011)463 of 24/01/2011
21/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/284/IA/68
27/01/2011 Centralised - Variation EMEA/H/C/284/II/65 (2011)463 of 24/01/2011
02/03/2011 Centralised - Variation EMEA/H/C/284/IB/69
Updated with Decision(2011)5949 of 10/08/2011
15/04/2011 Centralised - Variation EMEA/H/C/284/IA/71
Updated with Decision(2011)5949 of 10/08/2011
12/08/2011 Centralised - Variation (2011)5949 of 10/08/2011
30/08/2011 Centralised - Variation EMEA/H/C/284/II/72 (2011)6163 of 24/08/2011
25/04/2012 Centralised - Variation EMEA/H/C/284/WS/208 (2012)2833 of 20/04/2012
01/06/2012 Centralised - Variation EMEA/H/C/284/II/75 (2012)3612 of 25/05/2012
19/12/2012 Centralised - Variation EMEA/H/C/284/IG/243
Updated with Decision(2013)9841 of 20/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/284/II/82
Updated with Decision(2013)9841 of 20/12/2013
17/09/2013 Centralised - Variation EMEA/H/C/284/IB/85
Updated with Decision(2013)9841 of 20/12/2013
05/12/2013 Centralised - Variation EMEA/H/C/284/IB/88
18/12/2013 Centralised - Variation EMEA/H/C/284/II/87
27/12/2013 Centralised - Yearly update (2013)9841 of 20/12/2013
18/07/2014 Centralised - Variation EMEA/H/C/284/IB/91