Sanofi Pasteur pulls European MAA for Emerflu pandemic flu vaccine
Sanofi Pasteur, the vaccines unit of French drug major Sanofi-Aventis (Euronext: SAN) has formally withdrawn its application for a centralized marketing authorization for Emerflu, a pandemic influenza vaccine (split virion, inactivated, adjuvanted) A/Vietnam/1194/2004 NIBRG-14, 30mcg of hemagglutinin + aluminium hydroxide adjuvant, suspension for injection, the European Medicines Agency (EMA) revealed yesterday.
This vaccine was intended to be used for prophylaxis of influenza in an officially declared pandemic situation. A core pandemic dossier was submitted in the context of flu prevention in an officially declared pandemic situation, according to the mock-up vaccine procedure.
The application for Emerflu was submitted to the Agency on April 27, 2007. Emerflu received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 19, 2009, and at the time of withdrawal a European Commission decision was pending.
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