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Reference
European Medicines Agency. Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines. Internet Document : 1 Sep 2014. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/08/news_detail_002160.jsp&mid=WC0b01ac058004d5c1
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Updated EMA guidance on periodic safety update reports. Reactions Weekly 1519, 5 (2014). https://doi.org/10.1007/s40278-014-3424-7
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DOI: https://doi.org/10.1007/s40278-014-3424-7