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

• Published by: Veterinary Medicines Directorate
• Last updated: 03 April 2017
• Topic: Not added
• Licence: Open Government Licence

Summary

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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Data links

Link to the data	Format	File added	Data preview
Clinical signs listed in Periodic Safety Update report data submitted to the VMD	XLS	03 April 2017	Not available
Clinical signs listed in Periodic Safety Update report data submitted to the VMD	XML	03 April 2017	Not available

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