European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
Community Register of medicinal products
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
| Invented name: | Exubera |
| Auth. number : | EU/1/05/327 |
| INN : | Insulin human |
| ATC: | A - Alimentary tract and metabolism A10 - Drugs used in diabetes A10A - Insulins and analogues A10AF - Insulins and analogues, for inhalation A10AF01 - Insulin (human) (See WHO ATC Index) |
| Indication: | treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy |
| Marketing Authorisation Holder: | Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EPAR and active package presentations
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 |
| 25/01/2006 | Centralised - Authorisation - Decision addressed to Member States | EMEA/H/C/588 | (2006)189 of 24/01/2006 | |||
| 26/01/2006 | Centralised - Authorisation | EMEA/H/C/588 | (2006)188 of 24/01/2006 | |||
| 23/03/2006 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/588/T/1 | (2006)977 of 20/03/2006 | |||
| 05/04/2006 | Corrigendum | EMEA/H/C/588/T/1 | (2006)977 corr of 03/04/2006 | |||
| 12/04/2006 | Centralised - Variation | EMEA/H/C/588/IA/2 | ||||
| Updated with Decision(2006)5421 of 07/11/2006 | ||||||
| 09/11/2006 | Centralised - Variation | - | (2006)5421 of 07/11/2006 | |||
| 18/12/2006 | Centralised - Variation | EMEA/H/C/588/IA/8 | ||||
| 19/12/2006 | Centralised - Variation | EMEA/H/C/588/II/5 | ||||
| 29/01/2007 | Centralised - Variation | EMEA/H/C/588/II/6 | ||||
| 16/02/2007 | Centralised - Variation | EMEA/H/C/588/N/7 | ||||
| Updated with Decision(2007)4100 of 29/08/2007 | ||||||
| 08/03/2007 | Centralised - Variation | EMEA/H/C/588/IA/9 | ||||
| Updated with Decision(2007)4100 of 29/08/2007 | ||||||
| 18/04/2007 | Centralised - Variation | EMEA/H/C/588/IA/10 | ||||
| Updated with Decision(2007)4100 of 29/08/2007 | ||||||
| 24/07/2007 | Centralised - Variation | EMEA/H/C/588/II/12 | ||||
| 31/08/2007 | Centralised - Variation | EMEA/H/C/588/II/11 | (2007)4100 of 29/08/2007 | |||
| 29/01/2008 | Centralised - Variation | EMEA/H/C/588/II/14 | (2008)389 of 25/01/2008 | |||
| 11/07/2008 | Centralised - Variation | EMEA/H/C/588/II/15 | (2008)3614 of 09/07/2008 | |||
| 30/09/2008 | Centralised - Withdrawal | - | (2008)5595 of 26/09/2008 |