Press Release: European Medicines Agency publishes initial list of medicines under additional monitoring

Author (Corporate)
Series Title
Series Details EMA/251554/2013 (25.04.13)
Publication Date 25/04/2013
Content Type

The European Medicines Agency (EMA), on 25 April 2013, publised the initial list of medicines that are subject to additional monitoring. This represents an important deliverable of the new European pharmacovigilance legislation. These medicines will have to display an inverted back triangle in their package leaflet and in the information for healthcare professionals called the summary of product characteristics (SmPC), together with a short sentence explaining what the triangle means.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001771.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/251554/2013 (25.04.13): European Medicines Agency publishes initial list of medicines under additional monitoring http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/04/WC500142466.pdf

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