Clinical signs listed in Periodic Safety Update report data submitted to the VMD

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Provided by Veterinary Medicines Directorate

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Dataset information

Country of origin
Updated
Created
2019.03.03
Available languages
English
Keywords
veterinary medicine, PSUR, therapeutic group, periodic safety update report, clinical signs, adverse event, VeDDRA, side effect
Quality scoring

Dataset description

The dataset includes all the clinical signs included in the line listings submitted with periodic safety update reports submitted to the Veterinary Medicines Directorate during a one year period. Periodic safety update reports have to be submitted to the VMD for all authorised veterinary medicines at intervals set in legislation, depending on how long the product has been on the market. These reports should include all adverse events to which the marketing authorisation holder has been made aware of during that reporting period. Individual products are not identified by product names but by therapeutic group. The dataset includes clinical signs classified according VeDDRA terminology: SOC = system organ class HLT = higher level term PT = preferred term LLT = lower level term. Further information on VeDDRA can be found at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000173.jsp&mid=WC0b01ac058002dea6#section3
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32
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2019
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