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 medicinal product and the observed adverse event(s).
  • This website provides information on suspected adverse events that primarily reflect the reporter's observations and opinions. A scientific assessment of the adverse events is part of the continuous monitoring of the benefits and risks of a medicine; the assessment takes into account many other factors.
  • The information may include known adverse events already listed in the summary of product characteristics (SPC) and package leaflet.
  • The number of suspected adverse events in EudraVigilance Veterinary should not serve as a basis for determining the likelihood of an adverse event occurring. This is because the numbers need to be considered in context with other factors, such as how widely a product is used.
  • Each individual case in EudraVigilance Veterinary refers generally to one or more animals; and more than one adverse event may have been included in a report. Therefore, the number of adverse event will not always be the same as the number of individual cases.
  • The suspected adverse event reports in EudraVigilance Veterinary do not represent all available information concerning the benefits and risks of a veterinary medicinal product and should not be used in isolation to make decisions regarding a treatment. Other sources of information, including the product leaflet or a veterinary healthcare professional should be consulted first.

Incidence of suspected adverse event reports

  • Incidence figures are 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 medicinal product.
  • Incidence figures cannot be used to compare the relative frequency of adverse events of veterinary medicinal products.
  • Incidence figures in this database may differ from the frequency categories listed in the summary of product characteristics (SPC) and package leaflet.
 EMA
EudraVigilance