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IP/09/1384

Brussels, 29 th September 2009

Commission paves the way for vaccinations for influenza pandemic (H1N1) 2009

Following the positive scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) on 24 September, today the European Commission granted variations to two existing authorisations for vaccines for influenza pandemic (H1N1) 2009. The products concerned are Focetria® (Novartis), and Pandemrix® (GlaxoSmithKline). The vaccines will be authorised for use in all Member States of the EU and the EEA (Iceland, Liechtenstein and Norway). That should ensure that sufficient vaccines will be available before the start of the flu season and will reduce the risks for illnesses and deaths for European Citizens.

Commissioner Verheugen states: "I am very satisfied that the Commission was able to decide in the shortest possible time. I wish to thank everybody, all the people who worked day and night to make this happen."

The authorisation takes effect upon their notification to the marketing authorisation holder, which the Commission ensures via express courier and is to be expected by 1 October at the latest. The authorisations will be available in all official languages and are sent to the Member States.

For more information:

Details of the Regulatory process for the authorisation of antiviral medicines and vaccines in the protection against Pandemic Influenza (H1N1) 2009 can be found on:

http://ec.europa.eu/health/ph_threats/com/Influenza/docs/flu_staff4_en.pdf

Detailed information on the vaccines can be found on the website of the European Medicines Agency

http://www.emea.europa.eu/influenza/home.htm

Regularly updated information on the Pandemic H1N1 2009 can be found on the websites of the European Commission, Directorate General Health and Consumers:

http://ec.europa.eu/health/ph_threats/com/Influenza/novelflu_en.htm

European centre of Disease Prevention and Control (ECDC):

http://ecdc.europa.eu/en/healthtopics/Pages/Influenza_A(H1N1)_Outbreak.aspx

World Health Organization (WHO): http://www.who.int/en/


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