Exubera

RSS

insulin human

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.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

Authorisation details

Product details
Name
Exubera
Agency product number
EMEA/H/C/000588
Active substance
insulin human
International non-proprietary name (INN) or common name
insulin human
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AF01
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
24/01/2006
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

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.

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).

Assessment history

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