This list provides access to signals of potential safety, efficacy or environmental issues that are identified during post-authorisation monitoring of veterinary medicinal products authorised in the EU/EEA in line with Article 75 of Regulation (EU) 2019/6.
A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation to confirm or refute the involvement of a veterinary medicine. Regulatory action will be taken when the benefit/risk of a veterinary medicine is assumed to be affected.
The annual statement serves as a confirmation by the pharmaceutical company that the evaluation of suspected side effects for their specific veterinary medicine has been conducted according to the guidelines published by the European Medicines Agency.