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

Published by:
Veterinary Medicines Directorate
Last updated:
08 March 2019
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

More from this publisher

All datasets from Veterinary Medicines Directorate

Search

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

Additional information

View additional metadata
Harvest GUID
https://www.vmd.defra.gov.uk/DGU/TigressPSU16
Source Metadata
XML
HTML

Contact

Enquiries

Contact Veterinary Medicines Directorate regarding this dataset

Freedom of Information (FOI) requests

Contact Veterinary Medicines Directorate regarding this dataset Freedom of information requests for this dataset