Pharmaco-Vigilance is a set of activities aimed at continuously evaluating all information relating to the safety of drugs, medical devices and all the products that Fidia has on the market.
In line with this general definition, the main objectives of Fidia’s Pharmaco-Vigilance are:
- To prevent any harm in humans using Fidia’s products;
- To promote the safe and effective use of products, in particular, promptly communicating information on the safety of the products to patients, health professionals and the public.
An adverse reaction is a noxious and unintended response to a medicinal product.
Adverse reactions may result from authorized or unauthorized use of the medicinal product.
Special situations such as occupational exposure, exposure in pregnancy and lactation, lack of efficacy, overdose, off label use, abuse, misuse and medication errors, falsified medicinal product, elderly and paediatric population are also of interest to Pharmacovigilance.
What to do in case of suspected adverse reaction or undesirable effects to medicines, food supplements or cosmetics? What to do in case of incident related to the use of medical devices?