Clinical signs listed in Periodic Safety Update report data submitted to the VMD
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
Resources
| Name |
Format |
Description |
Link |
|
55 |
|
https://www.vmd.defra.gov.uk/DGU/TigressPSU.xml |
|
53 |
|
https://www.vmd.defra.gov.uk/DGU/TigressPSU.xlsx |
Tags
- periodic-safety-update-report
- therapeutic-group
- adverse-event
- veterinary-medicine
- psur
- side-effect
- clinical-signs
- veddra