Press Release: European Medicines Agency recommends interim measures for Pandemrix

Author (Corporate)
Series Title
Series Details EMA/CHMP/297822/2011 (15.4.11)
Publication Date 15/04/2011
Content Type

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), in April 2011, recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.
Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/04/news_detail_001244.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/CHMP/297822/2011 (15.4.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/04/WC500105278.pdf
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