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What is Pharmaco-Vigilance?

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.
What is an adverse reaction?

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?

The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important to allow a continuous monitoring of its benefit / risk balance. Each country has laws governing the reporting of adverse reactions or undesirable effects, therefore, if you experience adverse reactions or undesirable effects with the use of any of our products, please, contact your Physician/Pharmacist or the local Healthcare Authority to report your experience.