Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Humalog-Humaject
Auth. number : EU/1/97/036
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, 3991 RA Houten, Nederland

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
17/06/1997 Centralised - Authorisation EMEA/H/C/138 (97)1893 of 16/06/1997
02/12/1997 Centralised - Variation EMEA/H/C/138/1/2/II/4 (97)3821 of 01/12/1997
16/04/1998 Centralised - Variation EMEA/H/C/138/II/5 (1998)947 of 15/04/1998
22/04/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/138/1/2/I/8
12/11/1998 Centralised - Variation EMEA/H/C/138/1/2/II/9 (1998)3494 of 06/11/1998
25/11/1998 Centralised - Variation EMEA/H/C/138/X/7 (1998)3527 of 19/11/1998
29/01/1999 Centralised - Variation EMEA/H/C/138/I/11 (1999)178 of 27/01/1999
30/06/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/138/1/2/II/13
04/08/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/138/I/14-15
05/10/1999 Centralised - Variation EMEA/H/C/138/II/12 (1999)3163 of 01/10/1999
03/04/2000 Centralised - Variation EMEA/H/C/138/II/16 (2000)879 of 30/03/2000
01/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/138/I/18
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/138/I/17