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news.Sanofi Pasteur has withdrawn its application for a centralised marketing authorisation (MAA) for Emerflu, a pandemic influenza vaccine (split virion, inactivated, adjuvanted) A/Vietnam/1194/2004 NIBRG-14, 30 µg of haemagglutinin + aluminium hydroxide adjuvant, suspension for injection.
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Emerflu was intended to be used for prophylaxis of influenza in an officially declared pandemic situation.
Sanofi Pasteur has submitted the marketing authorisation application to the European Medicines Agency on 27 April 2007.
Emerflu received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on 19 March 2009 and at the time of withdrawal a European Commission decision was pending.
In its official letter, Sanofi Pasteur stated that its decision to withdraw the application was based on the CHMP’s consideration that the data provided do not allow the Committee to conclude on a positive benefit/risk balance.