Exubera

Withdrawn

This medicine's authorisation has been withdrawn

insulin human

Overview

The marketing authorisation for Exubera has been withdrawn at the request of the marketing authorisation holder.

Exubera : EPAR - Summary for the public

Product information

Exubera : EPAR - Product Information

Latest procedure affecting product information: II/0015

09/07/2008

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).

Exubera : EPAR - All Authorised presentations

Exubera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

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
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Exubera : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Exubera : EPAR - Procedural steps taken before authorisation

Exubera : EPAR - Scientific Discussion