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Community Register of medicinal products
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
| Invented name: | Humalog-Pen |
| Auth. number : | EU/1/97/042 |
| INN : | Insulin lispro |
| ATC: | A - Alimentary tract and metabolism A10 - Drugs used in diabetes A10A - Insulins and analogues A10AB - Insulins and analogues for injection, fast-acting 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 |
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | |||
| 04/03/1998 | Centralised - Variation | EMEA/H/C/153/II/5 | (1998)525 of 03/03/1998 | |||
| 15/04/1998 | Centralised - Variation | EMEA/H/C/153/II/6 | (1998)939 of 14/04/1998 | |||
| 12/11/1998 | Centralised - Variation | EMEA/H/C/153/II/9 | (1998)3493 of 06/11/1998 | |||
| 02/02/1999 | Centralised - Variation | EMEA/H/C/153/N/10 | (1999)179 of 27/01/1999 | |||
| 30/06/1999 | Centralised - Variation | EMEA/H/C/153/II/11 | ||||
| 04/10/1999 | Centralised - Variation | EMEA/H/C/153/II/11 | (1999)3122 of 30/09/1999 | |||
| 04/04/2000 | Centralised - Variation | EMEA/H/C/153/II/15 | (2000)881 of 30/03/2000 | |||
| 12/09/2000 | Centralised - Variation | EMEA/H/C/153/I/17 | ||||
| 22/05/2001 | Other procedure | - |