The Pharmacovigilance system collects and studies adverse events (=noxious) which may be associated to a drug treatment, in order to

• assess their incidence
• identify the cause-effect relationship with the use of the drug
• identify any possible risk factors for the occurrence of such adverse events
• identify possible means for the prevention of such adverse events

When a drug is marketed, only the adverse events from pre-registration clinical studies are known: such studies are generally conducted on a number of patients sufficient to detect only the most common adverse events.

A drug can be administered to a higher number of patients only after its marketing, that is when it is possible to gain more insight into the risk/benefit ratio related to the use of the drug, by means of a systematic collection of adverse events.

Therefore, spontaneous reporting of adverse events by physicians, pharmacists, other healthcare professionals and patients is essential to enable both Health Authorities in charge of pharmacovigilance activities and Pharmaceutical Companies to define and constantly update the tolerability and safety profile of drugs (benefits vs risks) under the real condition of use.

To report an adverse drug reaction and to request medical and scientific information or information on the use of our drugs, you can fill the FORM or call 02 64431.