The biological responses to exposure to a medicinal product vary from one individual to another. That is why not all undesired effects (known also as adverse reactions) associated with medicinal products can be established during their clinical development before putting them on the market.
The reporting of undesired effects by health care operators and private individuals represents an important tool for monitoring the safety of the pharmaceutical products on the market and acquiring more information on the risk/benefit ratio of treatments.
Mediolanum Farmaceutici collects and assesses these reports so as to keep the information on the safety of the Group’s medicinal products up to date, which is a precise legal obligation that helps to guarantee public health.
In accordance with Italian law, the onset of any undesired effect can be reported in any of the following ways:
- For the private individual, by reporting the event to his general practitioner or pharmacist or by filling in the suspected adverse reaction reporting form for private individuals
- For the health care operator, by filling in the suspected adverse reaction reporting form for health care operators
Both forms may be downloaded from the web site of the Italian Medicines Agency at http://www.agenziafarmaco.gov.it/it/content/modalit%C3%A0-di-segnalazione-delle-sospette-reazioni-avverse-ai-medicinali
In either case, the form should be filled in and then sent to the Pharmacovigilance manager of the local health authority, whose address may be found at http://www.agenziafarmaco.gov.it/it/responsabili
The Pharmacovigilance Department of the Mediolanum group may be contacted by calling +39 02-89132.1 or sending an e-mail to firstname.lastname@example.org
Your data will be processed in conformance with the personal data protection provisions laid down in Legislative decree no. 196/2003