Thursday, November 13, 2008

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

10 November 2008: 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.

The details can be read here.

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