The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.
Exubera : EPAR - Summary for the public (PDF/258.76 KB)
First published: 16/11/2008
Last updated: 16/11/2008
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09/07/2008 Exubera - EMEA/H/C/000588 - II/0015
- 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
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Drugs used in diabetes
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).