Horizon scanning: European CHMP issues positive opinion on licensing application for Aflunov? and Prepandemic? influenza vaccine (H5N1)

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Horizon scanning: European CHMP issues positive opinion on licensing application for Aflunov® and Prepandemic® influenza vaccine (H5N1)

Source: EMA

Date published: 24/09/2010 16:20
Summary
by: Devika Sennik

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion, recommending the granting of a marketing authorisation for Aflunov and Prepandemic influenza vaccine (H5N1, surface antigen, inactivated, adjuvanted), intended for immunisation against H5N1 subtype of influenza A virus.



The Aflunov application was a resubmission of an application that was withdrawn by the applicant on 13 June 2008, because at that time the company could not meet the Committee’s request for additional clinical data, as required by the prepandemic guideline.



It is proposed that the vaccines will be used in accordance with official recommendations. Please see links below for further information.


http://www.nelm.nhs.uk/en/NeLM-Area...lunov-and-Prepandemic-influenza-vaccine-H5N1/


full document

http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500097046.pdf