What is Pharmacovigilance?
Pharmacovigilance is one of the main activities carried out by the Italian Medicines Agency (AIFA). It consists of the collection, management and analysis of reports of suspected adverse drug reactions, in order to ensure that the benefit/risk ratio, for all medicinal products on the market, is favourable to the patient. To carry out this activity throughout the territory, AIFA has set up the 'National Pharmacovigilance Network', which includes regions, pharmaceutical companies, healthcare facilities, pharmacies, healthcare professionals and patients.
What is an adverse reaction?
European legislation requires all healthcare professionals and citizens to report any suspected adverse reaction (serious and non-serious, known and unknown).
An adverse reaction is a harmful and unintended effect resulting from:
- to the use of a medicinal product in accordance with the indications in the marketing authorisation
- to therapeutic errors
- uses not in accordance with the indications in the marketing authorisation, including overdose, misuse, abuse of the medicinal product, as well as associated with occupational exposure.
How to report an adverse reaction?
If you experience any undesirable effect, including those not listed in the leaflets accompanying Euro-Pharma S.r.l. proprietary products, please contact your doctor or a pharmacist. Please also report such effects in the following ways:
- By filling in the suspected adverse reaction report form and sending it by e-mail to your facility's Pharmacovigilance contact point: the form can be downloaded from Italian Medicines Agency (AIFA) website at https://www.aifa.gov.it/en/moduli-segnalazione-reazioni-avverse
- Online on the AIFA website at the link https://servizionline.aifa.gov.it/schedasegnalazioni/#/
- Contacting Euro-Pharma S.r.l at: +39 3461524287 or by filling in and sending the following form:
