Exubera

RSS
Withdrawn

This medicine's authorisation has been withdrawn

insulin human
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 24 January 2006 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Exubera, human insulin, 1 mg and 3 mg inhalation powder for inhalation use, which had been approved for the treatment of type II diabetes mellitus. The marketing authorisation holder (MAH) responsible for Exubera was Pfizer Limited. 

The European Commission was notified by letter dated 26 June 2008 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Exubera for commercial reasons. 

On 26 September 2008 the European Commission issued a decision to withdraw the marketing authorisation for Exubera. 

Pursuant to this decision the European Public Assessment Report for Exubera is updated to reflect that the marketing authorisation is no longer valid.

español (ES) (261.68 KB - PDF)

View

čeština (CS) (404.45 KB - PDF)

View

dansk (DA) (261.44 KB - PDF)

View

Deutsch (DE) (263.12 KB - PDF)

View

eesti keel (ET) (259.54 KB - PDF)

View

ελληνικά (EL) (430.61 KB - PDF)

View

français (FR) (255.85 KB - PDF)

View

italiano (IT) (255.02 KB - PDF)

View

latviešu valoda (LV) (406.88 KB - PDF)

View

lietuvių kalba (LT) (380.17 KB - PDF)

View

magyar (HU) (394.92 KB - PDF)

View

Nederlands (NL) (262.23 KB - PDF)

View

polski (PL) (406.78 KB - PDF)

View

português (PT) (255.5 KB - PDF)

View

slovenčina (SK) (398.6 KB - PDF)

View

slovenščina (SL) (391.05 KB - PDF)

View

Suomi (FI) (259.93 KB - PDF)

View

svenska (SV) (260.49 KB - PDF)

View

Product information

български (BG) (1.32 MB - PDF)

View

español (ES) (946.37 KB - PDF)

View

čeština (CS) (1.1 MB - PDF)

View

dansk (DA) (897.71 KB - PDF)

View

Deutsch (DE) (953.36 KB - PDF)

View

eesti keel (ET) (925.54 KB - PDF)

View

ελληνικά (EL) (1.28 MB - PDF)

View

français (FR) (952.41 KB - PDF)

View

italiano (IT) (1005.16 KB - PDF)

View

latviešu valoda (LV) (1.12 MB - PDF)

View

lietuvių kalba (LT) (1.03 MB - PDF)

View

magyar (HU) (1 MB - PDF)

View

Malti (MT) (1.06 MB - PDF)

View

Nederlands (NL) (897.16 KB - PDF)

View

polski (PL) (1.17 MB - PDF)

View

português (PT) (934.15 KB - PDF)

View

română (RO) (1.24 MB - PDF)

View

slovenčina (SK) (1.11 MB - PDF)

View

slovenščina (SL) (963.27 KB - PDF)

View

Suomi (FI) (881.61 KB - PDF)

View

svenska (SV) (905.45 KB - PDF)

View
Latest procedure affecting product information: II/0015
09/07/2008
icon globe

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

български (BG) (353.17 KB - PDF)

View

español (ES) (233.55 KB - PDF)

View

čeština (CS) (325.63 KB - PDF)

View

dansk (DA) (230.28 KB - PDF)

View

Deutsch (DE) (231.22 KB - PDF)

View

eesti keel (ET) (231.06 KB - PDF)

View

ελληνικά (EL) (329.88 KB - PDF)

View

français (FR) (231.01 KB - PDF)

View

italiano (IT) (230.85 KB - PDF)

View

latviešu valoda (LV) (327.64 KB - PDF)

View

lietuvių kalba (LT) (304.46 KB - PDF)

View

magyar (HU) (250.02 KB - PDF)

View

Malti (MT) (349.51 KB - PDF)

View

Nederlands (NL) (233.13 KB - PDF)

View

polski (PL) (329.13 KB - PDF)

View

português (PT) (231.34 KB - PDF)

View

română (RO) (318.91 KB - PDF)

View

slovenčina (SK) (326.68 KB - PDF)

View

slovenščina (SL) (321.84 KB - PDF)

View

Suomi (FI) (230.18 KB - PDF)

View

svenska (SV) (231.04 KB - PDF)

View

español (ES) (229 KB - PDF)

View

čeština (CS) (318.18 KB - PDF)

View

dansk (DA) (229.14 KB - PDF)

View

Deutsch (DE) (228.72 KB - PDF)

View

eesti keel (ET) (228.59 KB - PDF)

View

ελληνικά (EL) (316.55 KB - PDF)

View

français (FR) (227.63 KB - PDF)

View

italiano (IT) (228.12 KB - PDF)

View

latviešu valoda (LV) (319.33 KB - PDF)

View

lietuvių kalba (LT) (296.27 KB - PDF)

View

magyar (HU) (313.81 KB - PDF)

View

Nederlands (NL) (227.85 KB - PDF)

View

polski (PL) (313.64 KB - PDF)

View

português (PT) (222.89 KB - PDF)

View

slovenčina (SK) (318.77 KB - PDF)

View

slovenščina (SL) (311.47 KB - PDF)

View

Suomi (FI) (227.48 KB - PDF)

View

svenska (SV) (229.5 KB - PDF)

View

Product details

Name of medicine
Exubera
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

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).

Authorisation details

EMA product number
EMEA/H/C/000588
Marketing authorisation holder
Pfizer Limited

Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Marketing authorisation issued
24/01/2006
Withdrawal of marketing authorisation
26/09/2008
Revision
6

Assessment history

This page was last updated on

Share this page