Our Company / Ethics&transparency / Pharmacovigilance

Reporting
adverse events

Pharmacovigilance is a set of activities aimed at identifying, assessing, understanding and preventing adverse events, in other words, any unfavourable and undesirable effect that arises after taking a medicinal product.

Reporting an adverse event associated with the use of a medicinal product is extremely valuable because it allows keeping the doctors who prescribed it well informed, safeguarding the patients who are taking it and ensuring a favourable benefit-risk balance for the population.

How to report an adverse event
If you are a patient

If you experience an adverse event or side effect during or following pharmacological treatment, please report it immediately to a health authority or your physician or pharmacist. You can report a suspected adverse event in one of the following ways:

If you are a healthcare professional
Healthcare professionals have a duty to report any medicinal product-related adverse event to the Agenzia Italiana del Farmaco (AIFA) – the Italian Medicines Agency. If you are a healthcare professional, you can report a suspected adverse event in one of the following ways:
  • using the form made available by the Agenzia Italiana del Farmaco (AIFA) – the Italian Medicines Agency – at the link Moduli di segnalazione di reazioni avverse, under “Scheda per operatore sanitario” (Form for Healthcare Professionals);
  • reporting it online at the website VigiFarmaco.

The AIFA website constantly provides new information on pharmacovigilance-related topics

Alfasigma Pharmacovigilance Office contact info

Call

Report an adverse event