EU Commission clears Novartis and GSK's influenza pandemic (H1N1) 2009 vaccines
Following the positive scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) on September 24 (The Pharma Letter September 25), the European Commission has now granted variations to two existing authorizations for vaccines for influenza pandemic (H1N1) 2009.
The products concerned are Swiss drug major Novartis' Focetria and Pandemrix, from UK giant GlaxoSmithKline. The vaccines will be authorized for use in all European Union member states and the EEA (Iceland, Liechtenstein and Norway).
The authorization takes effect upon their notification to the marketing authorisation holder, which the Commission ensures via express courier and is to be expected by October 1 at the latest.
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