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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion for Novartis' Aflunov, for active immunization against H5N1 subtype of Influenza A virus in adults 18 years of age and older.
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Novartis said that the CHMP recommendation will serve as the basis for the European Commission making its licensing decision of the Aflunov product.
Based on the CHMP approval, a marketing authorization for Aflunov is expected to be granted by year-end in the all the EU and EEA countires.
In clinical studies, Aflunov was shown to elicit cross-reactive antibodies against many of the H5 strains that have caused human disease.
Novartis Vaccines and Diagnostics Division head Andrin Oswald said that upon approval, they expect Aflunov to be an important addition to their portfolio of pandemic preparedness solutions.