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Reporting adverse events

Pharmacovigilance

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 contacting us from Italy If outside Italy, please select your country If you want to contact the Alfasigma Pharmacovigilance Office

If you are contacting us from Italy

Clicca qui per italiano

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:

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 il cittadino” (Form for Citizens);
Reporting it online at the website AIFA.

Clicca qui per italiano

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 AIFA.

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