About
The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.
| Name | Language | First published | Last updated |
|---|---|---|---|
| Exubera : EPAR - Summary for the public | 16/11/2008 |
This EPAR was last updated on 16/11/2008 .
More detail is available in the Summary of Product Characteristics
Authorisation details
Product information
Product information
09/07/2008 Exubera -EMEA/H/C/000588 -II/0015
Contents
- Annex I - Summary of product Characteristics
- Annex IIA - Manufacturing Authorisation Holder responsible for Batch Release
- Annex IIB - Conditions of the Marketing Authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package Leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmaco-therapeutic Group
Drugs used in diabetes
Therapeutic Indication
EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus not
adequately controlled with oral antidiabetic agents and requiring insulin therapy.
EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in
addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of
adding inhaled insulin outweigh the potential safety concerns (see section 4.4).
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Exubera : EPAR - Procedural steps taken and scientific information after authorisation | EN = English | 16/11/2008 |
Initial Marketing authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Exubera : EPAR - Scientific Discussion | EN = English | 16/11/2008 | |
| Exubera : EPAR - Procedural steps taken before authorisation | EN = English | 16/11/2008 |
Withdrawn
This medicine is now withdrawn from use in the European Union