What is Pharmacovigilance?

Pharmacovigilance is the discipline that studies the adverse events potentially associated with pharmacological treatment, in order to evaluate the incidence and identify the relative causality relationship.

In line with this general definition, the objectives underlying pharmacovigilance, in accordance with current European legislation, are:

• prevent damage caused by adverse reactions resulting from the use of a medicine according to the authorization conditions;

• promote the safe and effective use of medicinal products, in particular by providing timely information on the safety of medicines to patients, healthcare professionals and the general public.

What is an adverse reaction?

An adverse reaction is any harmful and unwanted event – sign, symptom or disease – that occurs in a subject / patient who has been given a medicine.

How to report an adverse reaction?

Promptly report the adverse reaction, occurred to you or the person for whom you intend to report, to your doctor or other healthcare professional.

It is possible to report an adverse reaction by following the instructions on the site of the Health Authority (AIFA, Italian Medicines Agency), at the following page http://www.aifa.gov.it/en/content/reporting-adverse-reaction.

If you have taken a drug produced by ITEL and want to report an adverse reaction, you can write an email to itel@itelte.it, inserting the object ” SEGNALAZIONE PV ” providing the following information:

Subject / patient who has had the adverse reaction: initials of name and surname, gender, age, city of residence;

Drug: name of the drug administered;

• Adverse reaction: description of the effect;

Reporter: name and surname of the person reporting, email or other address, profession.

and attaching the consent form according to the privacy policy downloadable from this link.

Privacy Information for Pharmacovigilance reports

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