Pharmacovigilance studies the detection, evaluation, interpretation and prevention of adverse effects or any other type of problem associated with veterinary medicinal products once they have been released onto the market. It has therefore an added value as it provides essential additional information for the evaluation of the risk-benefit balance for each veterinary medicinal product. Pharmacovigilance is a shared responsibility between the registration holder, veterinary professionals and Regulatory Agencies. Any Suspected Adverse Event (SAE) must be reported as stated in Article 73(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council:
(a) any unfavourable and unintended reaction in any animal to a veterinary medicinal product,
(b) any observation of lack of efficacy of a veterinary medicinal product following administration to an animal, whether or not this occurred in accordance with the summary of product characteristics;
(c) any environmental incident observed following the administration of a veterinary medicinal product to an animal,
(d) any adverse reaction in people exposed to a veterinary medicinal product,
(e) any finding of a pharmacologically active substance or a marker residue in a product of animal origin in excess of the maximum residue limits established in accordance with Regulation (EC) No 470/2009 after the withdrawal period has been observed,
(f) any suspected transmission of an infectious agent via a veterinary medicinal product,
g) any unfavourable and unintended reaction in an animal to a medicinal product for human use.
Syva Laboratories welcomes the notification of possible events or any other relevant Pharmacovigilance information related to our products.
We would like to remind you that notifications are essential for Public Health and that the data provided will only be used and communicated for Pharmacovigilance purposes.
The data are necessary to be able to contact the notifier and to acquire complete and quality information on the potential adverse event reported, as well as to follow up the case if necessary.
To report a suspected adverse event, please complete the form below. You can also contact our Pharmacovigilance Unit directly at email@example.com or by telephone on +34 606 55 40 28 and 987 800 800. We will contact you as soon as possible.
Complete the information below so that we can contact you again in case the information we have is incomplete.
Please note the following information concerning the treatment by Laboratorios Syva S.A.U. of any personal data provided in relation to the notification of a possible adverse event.
Your personal data will only be used and communicated for Pharmacovigilance purposes. When the data are communicated to the corresponding authorities, we will provide adequate protection of the data.