Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Humalog-Pen
Auth. number : EU/1/97/042
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/153 (97)1806 of 16/06/1997
28/10/1997 Centralised - Variation EMEA/H/C/153/I/3 (97)3296 of 27/10/1997
4/03/1998 Centralised - Variation EMEA/H/C/153/II/5 (1998)525 of 3/03/1998
15/04/1998 Centralised - Variation EMEA/H/C/153/II/6 (1998)939 of 14/04/1998
22/04/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/153/I/8
12/11/1998 Centralised - Variation EMEA/H/C/153/II/9 (1998)3493 of 6/11/1998
22/11/1998 Centralised - Variation EMEA/H/C/153/X/7 (1998)3579 of 19/11/1998
2/02/1999 Centralised - Variation EMEA/H/C/153/N/10 (1999)179 of 27/01/1999
30/06/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/153/II/11
4/08/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/153/I/13-14
4/10/1999 Centralised - Variation EMEA/H/C/153/II/11 (1999)3122 of 30/09/1999
4/04/2000 Centralised - Variation EMEA/H/C/153/II/15 (2000)881 of 30/03/2000
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/153/I/17
12/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/153/I/18