| Author (Corporate) | European Medicines Agency |
|---|---|
| Series Title | Press Release |
| Series Details | EMA/251554/2013 (25.04.13) |
| Publication Date | 25/04/2013 |
| Content Type | News |
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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. |
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| Source Link | http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001771.jsp&mid=WC0b01ac058004d5c1 |
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| Subject Categories | Business and Industry, Health |
| Countries / Regions | Europe |
