Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Humalog   
Auth. number : EU/1/96/007
Active substance : Insulin lispro
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: A10AB04 - Insulin lispro
(See WHO ATC Index)
Indication: For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland
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
01/05/1996 Centralised - Authorisation EMEA/H/C/88 (96)1077 of 30/04/1996
27/08/1996 Centralised - Variation EMEA/H/C/88/I/1 (96)2431 of 26/08/1996
06/12/1996 Centralised - Variation EMEA/H/C/88/I/2 (96)3589 of 05/12/1996
01/04/1997 Centralised - Authorisation EMEA/H/C/88/X (97)892 of 26/03/1997
13/05/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/V/4
17/06/1997 Centralised - Variation EMEA/H/C/88/II/5 (97)1805 of 16/06/1997
31/07/1997 Centralised - Variation EMEA/H/C/88/I/3 (97)2693 of 29/07/1997
24/09/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/8
01/12/1997 Centralised - Variation EMEA/H/C/88/II/6 (97)3658 of 28/11/1997
11/03/1998 Centralised - Variation EMEA/H/C/88/II/7 (1998)579 of 10/03/1998
12/05/1998 Centralised - Variation EMEA/H/C/88/II/10 (1998)1296 of 11/05/1998
12/11/1998 Centralised - Variation EMEA/H/C/88/II/9 (1998)3492 of 06/11/1998
25/11/1998 Centralised - Authorisation EMEA/H/C/88/X/11 (1998)3527 of 19/11/1998
29/01/1999 Centralised - Variation EMEA/H/C/88/I/12 (1999)176 of 26/01/1999
11/06/1999 Centralised - Variation EMEA/H/C/88/I/14 (1999)1497 of 03/06/1999
09/07/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/13, 16
05/08/1999 Centralised - Variation (1999)2570 of 30/07/1999
11/11/1999 Centralised - Variation EMEA/H/C/88/II/15 (1999)3701 of 10/11/1999
17/04/2000 Centralised - Variation EMEA/H/C/88/II/20 (2000)970 of 13/04/2000
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/21
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/22
03/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/28
22/05/2001 Centralised - Variation EMEA/H/C/88/II/23 (2001)1244 of 18/05/2001
28/06/2001 Centralised - Renewal EMEA/H/C/88/R/24, 26 (2001)1363 of 27/06/2001
05/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/25
05/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/27
13/11/2001 Centralised - Variation EMEA/H/C/88/II/30, 33 (2001)3522 of 09/11/2001
07/12/2001 Centralised - Variation EMEA/H/C/88/II/34 (2001)4028 of 05/12/2001
25/03/2002 Centralised - Variation EMEA/H/C/88/X/29 (2002)1273 of 21/03/2002
20/06/2002 Centralised - Notification EMEA/H/C/88/N/36 (2002)2297 of 17/06/2002
04/10/2002 Centralised - Variation EMEA/H/C/88/I/37 (2002)3708 of 02/10/2002
15/11/2002 Centralised - Variation EMEA/H/C/88/I/38, 39 (2002)4516 of 13/11/2002
19/12/2002 Centralised - Variation EMEA/H/C/88/I/40 (2002)5410 of 16/12/2002
13/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/41
11/08/2003 Centralised - Variation EMEA/H/C/88/II/42 (2003)2989 of 07/08/2003
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/44
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/43
13/11/2003 Centralised - Variation EMEA/H/C/88/II/45 (2003)4289 of 11/11/2003
24/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/I/46
04/03/2004 Centralised - Notification EMEA/H/C/88/N/47 (2004)743 of 02/03/2004
30/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/48
18/05/2004 Centralised - Notification EMEA/H/C/88/N/50
Updated with Decision(2006)73 of 13/01/2006
07/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/49
23/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/51
07/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/52
21/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/53
14/04/2005 Centralised - Variation EMEA/H/C/88/IB/55
Updated with Decision(2006)73 of 13/01/2006
11/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/58
19/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/56
17/01/2006 Centralised - Variation (2006)73 of 13/01/2006
13/02/2006 Centralised - Renewal EMEA/H/C/88/R/57 (2006)449 of 09/02/2006
01/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/59
28/03/2006 Corrigendum (2006)73 corr of 27/03/2006
31/03/2006 Corrigendum EMEA/H/C/88/R/57 (2006)449 corr of 29/03/2006
31/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/61
20/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/63
07/09/2006 Centralised - Variation EMEA/H/C/88/II/62 (2006)4065 of 01/09/2006
16/11/2006 Centralised - Variation EMEA/H/C/88/II/60 (2006)5543 of 14/11/2006
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/65
08/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/66
30/03/2007 Centralised - Variation EMEA/H/C/88/II/67 (2007)1519 of 28/03/2007
02/04/2007 Centralised - Variation EMEA/H/C/88/II/65 (2007)1532 of 29/03/2007
07/05/2007 Centralised - Variation EMEA/H/C/88/II/68 (2007)2043 of 03/05/2007
30/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/69
28/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/72
04/02/2008 Centralised - Variation EMEA/H/C/88/II/70 (2008)444 of 31/01/2008
19/02/2008 Centralised - Notification EMEA/H/C/88/N/71
Updated with Decision(2009)56 of 07/01/2009
05/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/73
18/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/76
06/06/2008 Centralised - Variation EMEA/H/C/88/IB/77
Updated with Decision(2009)56 of 07/01/2009
22/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/74
22/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/75
11/09/2008 Centralised - Variation EMEA/H/C/88/IA/78
Updated with Decision(2009)56 of 07/01/2009
19/09/2008 Centralised - Variation EMEA/H/C/88/IA/80
Updated with Decision(2009)56 of 07/01/2009
08/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/81
09/01/2009 Centralised - Variation (2009)56 of 07/01/2009
15/01/2009 Centralised - Variation EMEA/H/C/88/IA/82
Updated with Decision(2009)5401 of 01/07/2009
04/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/85
06/05/2009 Centralised - Notification EMEA/H/C/88/N/84
Updated with Decision(2009)5401 of 01/07/2009
28/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/88
02/06/2009 Centralised - Variation EMEA/H/C/88/IB/86
Updated with Decision(2009)5401 of 01/07/2009
03/07/2009 Centralised - Variation EMEA/H/C/88/II/83 (2009)5401 of 01/07/2009
11/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/89
14/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/87
22/10/2009 Centralised - Notification EMEA/H/C/88/N/90
Updated with Decision(2011)2080 of 24/03/2011
03/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IA/91
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/93
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/92
29/04/2010 Centralised - Notification EMEA/H/C/88/N/96
Updated with Decision(2011)2080 of 24/03/2011
28/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/94
05/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/95
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/IB/98
08/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/88/II/97/G
28/03/2011 Centralised - Variation EMEA/H/C/88/WS/105 (2011)2080 of 24/03/2011
21/04/2011 Centralised - Variation EMEA/H/C/88/WS/111 (2011)2849 of 18/04/2011
26/07/2011 Centralised - Notification EMEA/H/C/88/N/102
Updated with Decision(2012)7766 of 25/10/2012
16/04/2012 Centralised - Variation EMEA/H/C/88/IB/106
Updated with Decision(2012)7766 of 25/10/2012
10/08/2012 Centralised - Variation EMEA/H/C/88/IB/108/G
Updated with Decision(2012)7766 of 25/10/2012
30/10/2012 Centralised - Variation (2012)7766 of 25/10/2012
20/09/2013 Centralised - Notification EMEA/H/C/88/N/117
Updated with Decision(2014)7144 of 30/09/2014
14/11/2013 Centralised - Variation EMEA/H/C/88/IB/124
Updated with Decision(2014)7144 of 30/09/2014
24/04/2014 Centralised - Variation EMEA/H/C/88/IB/126
Updated with Decision(2014)7144 of 30/09/2014
08/07/2014 Centralised - Variation EMEA/H/C/88/IG/455
Updated with Decision(2014)7144 of 30/09/2014
02/10/2014 Centralised - Variation EMEA/H/C/88/X/125 (2014)7144 of 30/09/2014
20/05/2015 Centralised - Variation EMEA/H/C/88/IA/567
29/06/2015 Centralised - Variation EMEA/H/C/88/IA/135