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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.
There are no records to display.