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Disclaimers

Each time you search for a report, you will be shown a disclaimer. To view individual reports, you must confirm that you have read and understood the disclaimer.

Suspected adverse event reports

• The information on this website does not imply confirmation of a potential link between the veterinary medicine and the observed adverse event(s).
• This website provides information on suspected adverse events that reflect the primary reporter's (e.g. veterinarian, animal owner, farmer, pharmacist or other animal healthcare professional) observations and opinions. A scientific assessment of the suspected adverse events is part of the continuous monitoring of the benefits and risks of a veterinary medicine; and the assessment takes into account many other factors (e.g. underlying diseases or health status of the animal, other medicines administered at the same time).
• The information may include known adverse events already listed in the product information.
• The number of suspected adverse events in EudraVigilance Veterinary cannot be used to determine the likelihood of an adverse event occurring. This is because the number of adverse events needs to be considered in the context of other factors, such as how widely a veterinary medicine is used, as well as how long it has been available on the market. For these reasons, different veterinary medicines should not be directly compared based on the number of reports of suspected adverse events.
• An individual case report in EudraVigilance Veterinary may refer to one or more animals; and more than one adverse event may have been included in a report. Therefore, the number of adverse events will not always be the same as the number of individual case reports.
• The suspected adverse event reports in EudraVigilance Veterinary do not represent all available information concerning the benefits and risks of a veterinary medicine and should not be used in isolation to make decisions regarding a treatment. Other sources of information, including the product information or a veterinary healthcare professional should be consulted first.

Incidence (reporting frequency) of suspected adverse event reports

• Incidences (reporting frequencies) are calculated based on volume of sales data submitted by marketing authorisation holders on an annual basis into the Union Product Database. The incidence by reaction group (reporting frequency) is calculated based solely on the sales data from EU/EEA countries where adverse events have been reported.
• Considering that not all adverse events that occur are reported, the reporting frequencies are only estimates of the relative frequency of adverse events in relation to the estimated product use. They do not imply a causal relationship between the suspected adverse event and the veterinary medicine.
• Reporting frequencies figures cannot be used to compare the relative frequency of adverse events between veterinary medicines or to draw conclusions about the relative safety of one veterinary medicine compared to another. Reporting frequencies in this database may differ from the frequency categories listed in the product information.