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Public Statement On Exubera (Insulin Human) Withdrawal Of The Marketing Authorisation In The European Union

LONDON 10 November 2008On 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 mellitus1.

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the European Public Assessment Report for Exubera will be updated to reflect that the marketing authorisation is no longer valid.

Noël Wathion
Head of Unit for the Post-Authorisation Evaluation
of Medicinal Products for Human use

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68

Posted: November 2008