Exubera

insulin human

The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 16/11/2008 .

More detail is available in the summary of product characteristics

Product details

Publication details

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.

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Pharmacotherapeutic 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).

Changes since initial authorisation of medicine

Initial marketing-authorisation documents