Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Exubera
Auth. number : EU/1/05/327
Active substance : Insulin human
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AF - Insulins and analogues, for inhalation
Chemical substance: 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

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
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 cor 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 (no change in Commission Decision) EMEA/H/C/588/IA/8
19/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/588/II/5
29/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/588/II/6
16/02/2007 Centralised - Notification 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 (no change in Commission Decision) 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