Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Liprolog   
Auth. number : EU/1/01/195
INN : 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. Liprolog 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
03/08/2001 Centralised - Authorisation EMEA/H/C/393 (2001)2074 of 01/08/2001
16/04/2002 Centralised - Variation EMEA/H/C/393/II/1
27/03/2003 Centralised - Variation EMEA/H/C/393/I/3, 5 (2003)1031 of 24/03/2003
27/05/2003 Centralised - Variation EMEA/H/C/393/I/6
03/10/2003 Centralised - Variation EMEA/H/C/393/I/7
11/11/2003 Centralised - Variation EMEA/H/C/393/II/8, 11 (2003)4170 of 07/11/2003
11/11/2003 Centralised - Variation EMEA/H/C/393/II/8 (2003)4174 of 07/11/2003
25/11/2003 Centralised - Variation EMEA/H/C/393/I/13
30/03/2004 Centralised - Variation EMEA/H/C/393/II/14
09/06/2004 Centralised - Variation EMEA/H/C/393/II/15
23/06/2004 Centralised - Variation EMEA/H/C/393/IA/16
05/11/2004 Centralised - Variation EMEA/H/C/393/II/17, 18 (2004)4328 of 29/10/2004
07/12/2004 Centralised - Variation EMEA/H/C/393/IB/20
23/02/2005 Centralised - Variation EMEA/H/C/393/II/21
03/03/2005 Centralised - Variation EMEA/H/C/393/II/27
06/06/2005 Centralised - Variation EMEA/H/C/393/II/22
22/08/2005 Centralised - Variation EMEA/H/C/393/N/24
Updated with Decision(2006)503 of 13/02/2006
18/10/2005 Centralised - Variation EMEA/H/C/393/II/23
16/11/2005 Centralised - Variation EMEA/H/C/393/IB/26
15/02/2006 Centralised - Renewal EMEA/H/C/393/R/25 (2006)503 of 13/02/2006
31/03/2006 Centralised - Variation EMEA/H/C/393/IB/29
19/07/2006 Centralised - Variation EMEA/H/C/393/IA/31
07/09/2006 Centralised - Variation EMEA/H/C/393/II/30 (2006)4073 of 01/09/2006
22/11/2006 Centralised - Variation EMEA/H/C/393/II/28 (2006)5668 of 20/11/2006
08/01/2007 Centralised - Variation EMEA/H/C/393/II/17, 18
16/03/2007 Centralised - Variation EMEA/H/C/393/II/34 (2007)1275 of 14/03/2007
29/03/2007 Centralised - Variation EMEA/H/C/393/II/32 (2007)1493 of 27/03/2007
04/05/2007 Centralised - Variation EMEA/H/C/393/II/35 (2007)2003 of 02/05/2007
13/08/2007 Centralised - Variation EMEA/H/C/393/IA/36
28/01/2008 Centralised - Variation EMEA/H/C/3993/IA/40
31/01/2008 Centralised - Variation EMEA/H/C/393/II/37 (2008)426 of 29/01/2008
19/02/2008 Centralised - Variation EMEA/H/C/393/N/38
Updated with Decision(2008)3702 of 11/07/2008
05/03/2008 Centralised - Variation EMEA/H/C/393/IB/41
18/04/2008 Centralised - Variation EMEA/H/C/393/IA/44
02/07/2008 Centralised - Variation EMEA/H/C/393/II/42
02/07/2008 Centralised - Variation EMEA/H/C/393/II/43
15/07/2008 Centralised - Variation EMEA/H/C/393/X/39 (2008)3702 of 11/07/2008
02/09/2008 Centralised - Variation EMEA/H/C/393/IA/45
Updated with Decision(2009)2474 of 27/03/2009
19/09/2008 Centralised - Variation EMEA/H/C/393/IA/47
Updated with Decision(2009)2474 of 27/03/2009
08/12/2008 Centralised - Variation EMEA/H/C/393/IA/48
01/04/2009 Centralised - Variation (2009)2474 of 27/03/2009
24/04/2009 Centralised - Variation EMEA/H/C/393/II/46 (2009)3183 of 22/04/2009
04/05/2009 Centralised - Variation EMEA/H/C/393/IA/51
06/05/2009 Centralised - Variation EMEA/H/C/393/N/50
Updated with Decision(2009)5403 of 01/07/2009
28/05/2009 Centralised - Variation EMEA/H/C/393/IB/54
02/06/2009 Centralised - Variation EMEA/H/C/393/IB/52
Updated with Decision(2009)5403 of 01/07/2009
03/07/2009 Centralised - Variation EMEA/H/C/393/II/49 (2009)5403 of 01/07/2009
11/08/2009 Centralised - Variation EMEA/H/C/393/IB/55
18/08/2009 Centralised - Variation EMEA/H/C/393/II/53
22/10/2009 Centralised - Variation EMEA/H/C/393/N/56
Updated with Decision(2011)1895 of 17/03/2011
09/12/2009 Centralised - Variation EMEA/H/C/393/IA/57
01/02/2010 Centralised - Variation EMEA/H/C/393/IB/59
23/03/2010 Centralised - Variation EMEA/H/C/393/II/58
29/04/2010 Centralised - Variation EMEA/H/C/393/N/62
Updated with Decision(2011)1895 of 17/03/2011
25/06/2010 Centralised - Variation EMEA/H/C/393/IB/60
30/06/2010 Centralised - Variation EMEA/H/C/393/II/61
27/09/2010 Centralised - Variation EMEA/H/C/393/IB/64
25/11/2010 Centralised - Variation EMEA/H/C/393/II/63/G
23/02/2011 Centralised - Variation EMEA/H/C/393/IA/66/G
22/03/2011 Centralised - Variation EMEA/H/C/393/WS/105 (2011)1895 of 17/03/2011
27/04/2011 Centralised - Variation EMEA/H/C/393/WS/111 (2011)2937 of 20/04/2011
13/04/2012 Centralised - Variation EMEA/H/C/393/IB/74
Updated with Decision(2012)7738 of 25/10/2012
15/07/2012 Centralised - Variation EMEA/H/C/393/N/69
Updated with Decision(2012)7738 of 25/10/2012
10/08/2012 Centralised - Variation EMEA/H/C/393/IB/76/G
Updated with Decision(2012)7738 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7738 of 25/10/2012
20/09/2013 Centralised - Variation EMEA/H/C/393/N/85
14/11/2013 Centralised - Variation EMEA/H/C/393/IB/91
23/04/2014 Centralised - Variation EMEA/H/C/393/IB/93
08/07/2014 Centralised - Variation EMEA/H/C/393/IG/455