Exubera

insulin human

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The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.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 ES = español 2008-11-16  
Exubera : EPAR - Summary for the public CS = čeština 2008-11-16  
Exubera : EPAR - Summary for the public DA = dansk 2008-11-16  
Exubera : EPAR - Summary for the public DE = Deutsch 2008-11-16  
Exubera : EPAR - Summary for the public ET = eesti keel 2008-11-16  
Exubera : EPAR - Summary for the public EL = elliniká 2008-11-16  
Exubera : EPAR - Summary for the public EN = English 2008-11-16  
Exubera : EPAR - Summary for the public FR = français 2008-11-16  
Exubera : EPAR - Summary for the public IT = italiano 2008-11-16  
Exubera : EPAR - Summary for the public LV = latviešu valoda 2008-11-16  
Exubera : EPAR - Summary for the public LT = lietuvių kalba 2008-11-16  
Exubera : EPAR - Summary for the public HU = magyar 2008-11-16  
Exubera : EPAR - Summary for the public NL = Nederlands 2008-11-16  
Exubera : EPAR - Summary for the public PL = polski 2008-11-16  
Exubera : EPAR - Summary for the public PT = português 2008-11-16  
Exubera : EPAR - Summary for the public SK = slovenčina 2008-11-16  
Exubera : EPAR - Summary for the public SL = slovenščina 2008-11-16  
Exubera : EPAR - Summary for the public FI = suomi 2008-11-16  
Exubera : EPAR - Summary for the public SV = svenska 2008-11-16  

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

Authorisation details

Product details

Product details for Exubera
NameExubera
Agency product numberEMEA/H/C/000588
Active substance

insulin human

International non-proprietary name (INN) or common name

insulin human

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AF01

Publication details

Publication details for Exubera
Marketing-authorisation holder

Pfizer Limited

Revision6
Date of issue of marketing authorisation valid throughout the European Union24/01/2006

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

09/07/2008  Exubera -EMEA/H/C/000588 -II/0015

Name Language First published Last updated
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  
Exubera : EPAR - Product Information SV = svenska 2008-11-16  

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.


Name Language First published Last updated
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  
Exubera : EPAR - All Authorised presentations SV = svenska 2008-11-16  

Name Language First published Last updated
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  
Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2008-11-16  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Exubera : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-11-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Exubera : EPAR - Procedural steps taken before authorisation SV = svenska 2008-11-16  
Exubera : EPAR - Scientific Discussion SV = svenska 2008-11-16  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Exubera