FOI release

FOI ATI1140 - Closamectin 5 mg/ml + 200 mg/ml Pour-on solution for cattle adverse reaction reports

Published 5 February 2026

1. ATI1140 Request

All adverse reaction reports for Closamectin 5 mg/ml + 200 mg/ml Pour-on solution for cattle (VM 0200/4280) received for the period 1 January 2020 to 31 October 2025.

2. Our reply

Attachment: Response to ATI1140

Data published by the VMD are not subject to independent verification and the VMD does not guarantee their accuracy. VMD databases change over time as new and follow-up information is constantly being received and reviewed. 

An Excel file with two spreadsheets and line listings containing the information you have requested has been attached. The spreadsheet titled ‘Electronic database reports’ contains data extracted from the VMD’s electronic database. The spreadsheet titled ‘PSUR reports’ contains data extracted from Periodic Safety Update Reports (PSURs) that were submitted to the VMD by the Marketing Authorisation Holder (MAH). Prior to 17th May 2024, non-serious adverse event reports did not have to be submitted electronically but could instead be submitted within PSURs. Please note that several of the Excel fields listed below are blank for adverse event cases from these reports as they contain significantly less detail than electronically submitted reports. Some reports would have been submitted both electronically and via PSURs, these reports have only been included once in the spreadsheets to avoid duplication. 

The following fields are provided in the Excel spreadsheets: 

• Date first received: 

  This is the date the report was received by the VMD or the MAH from the reporter. Please be aware that a small number of reports with an adverse event start date prior to 1 January 2020 have been included in the Excel file as they were submitted to the VMD within the requested period of 1 January 2020 to 31 October 2025. 

• Dose start: 

  This is the date of administration of the first dose. Please note that occasionally partial dates may have been reported and some dates may be estimates by the reporter. 

• Dose: 

  This field is not mandatory and would not have been completed by all reporters, however, where this field was completed, we have added this into the Excel file. 

• Treatment: 

  This field indicates whether the adverse reaction was treated. You requested ‘Action taken after reaction’, however there is no VICH (Guidelines / vichsec) or previous VMD online reporting form field for this. There is a field titled ‘Was the adverse reaction treated’ which we have added to the Excel file instead. 

• Batch no:

  This is the batch number of the product where provided by the reporter. 

• VeDDRA PT: 

  You requested ‘Description or classification of the adverse reaction’. We have provided a list of all clinical signs that occurred within the adverse event case coded to Preferred Term (PT) level as per VeDDRA (VeDDRA (Veterinary Dictionary for Drug Regulatory Activities)). All adverse events submitted to the VMD directly or from MAHs have their clinical signs coded using this standardised approach. The VeDDRA codes used may not exactly correlate verbatim with the details provided by the reporter, however the closest possible VeDDRA match would have been selected. PT terms can appear more than once within the same adverse event case as animals may have more than one clinical sign belonging to the same PT. 

• Outcome of reaction: 

  • # reacted:

    This is the number of animals affected, i.e., the number of animals that experienced an adverse event. 

  • # died:

    This is the number of animals that died. Deaths following euthanasia are not included in this number. The number of animal deaths is not the number of confirmed deaths. In many of these cases further investigations and post-mortem examinations were not performed, or the results were not reported to us, and therefore it is not known whether the product was linked to the cause of death. The number of animal deaths also includes all reports when the product was used off-label (i.e., not according to manufacturer’s recommendations), or reports where, on further evaluation, it was confirmed that there were other reasons for the death. 

  • # euthanised:

    This is the number of animals that died following euthanasia.  

  • # alive with sequelae:

    This is the number of animals alive with sequelae. 

  • # recovered:

    This is the number of animals that recovered from the adverse event. 

  • # unknown:

    This is the number of animals where the outcome was unknown. 

• Reporter category: 

  You requested a field with the category of the reporter. We do not hold this information in an easily extractable format and most reports are submitted to the VMD by the Marketing Authorisation Holder (MAH), therefore the original reporter category is not always known. The field provided has information extracted from the field ‘Method’ which holds information on the electronic process used to transmit the report to the VMD. This has been translated to indicate whether the report was transmitted to us by the MAH or transmitted in a different way, for example through paper forms or our previous VMD online reporting form (non-MAH). 

In addition to these fields, you have requested information on ‘frequency’ and ‘Assessment outcome’. Administration details such as dose frequency are not mandatory fields in the VICH adverse event report format, and therefore this information is not available for every adverse event report and the VMD does not hold this data in an easily retrievable format. Regarding the assessment outcome, the VMD does not perform causality assessments of individual reports. Assessment of adverse event reports is carried out during further downstream processes, such as signal detection. During this process, all cases are evaluated and statistical analysis is performed on this data to search for groups of reports (a statistically significant number of reports with the same or similar event) which could indicate a problem with a product. The signal detection process is crucial to detect potential problems regarding the efficacy and/or safety of any veterinary medicinal product. 

Please be aware that the line listings provided include all adverse event reports, this includes reports: 

• when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, including prescribing of unauthorised medicines following the cascade 

• where the reporters, medical professionals or MAH did not consider an association between the product administration and the adverse event to be likely 

• where, on further evaluation, there may have been other reasons for the adverse reaction occurring such as underlying illnesses or an alternative cause for the clinical signs seen 

• where more than one product was used. There may have been prior exposure to the reported product or to other products, and other products may have been administered at the same time