Press Release: European Medicines Agency gives first opinion for a vaccine for use outside the EU

The European Medicines Agency (EMA), on 22 June 2012, issued a scientific opinion recommending that the benefits of the vaccine Hexaxim outweigh its risks and that it can be used in regions outside the European Union (EU). This is the first such opinion on a vaccine.

The vaccine, developed by Sanofi Pasteur, offers protection against six World Health Organization (WHO) priority diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, polio and invasive disease caused by the bacterium Haemophilus influenzae type B, including meningitis. It is given to children between six weeks and two years of age.

• Primary Source

EMA: Press Release: EMA/421125/2012 (22.6.12): European Medicines Agency gives first opinion for a vaccine for use outside the EU http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/06/WC500129099.pdf

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