Exubera
Withdrawn
This medicine's authorisation has been withdrawn
insulin human
MedicineHumanWithdrawn
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- 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decision the European Public Assessment Report for Exubera is updated to reflect that the marketing authorisation is no longer valid.
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).
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 diabetesTherapeutic 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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