Pharmacovigilance

Pharmacovigilance refers to a program of activities aimed at safeguarding and promoting patients’ health and supporting the development of safe and effective medicines. This process involves identifying, assessing, understanding, and preventing any problems arising from using medicines, including suspected adverse reactions.

What is an Adverse Drug Reaction?

An Adverse Drug Reaction (ADR) is any response to a drug which is noxious and unintended.

Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Use outside the marketing authorisation includes off-label use, overdose, misuse, abuse and medication errors.

At Italfarmaco, all information relevant to patient safety and the risk-benefit ratio of our products is continuously evaluated. In case important safety issues arise, if applicable, we promptly notify applicable regulatory agencies concerned in accordance with current legislation to safe guard the health of patients and evaluate together how to inform the healthcare professionals.

Pharmacovigilance Italfarmaco SpA

Reporting an adverse event

Reporting an adverse event associated with the use of a medicinal product means providing valuable information for everyone’s health because it is part of that process that allows keeping the prescribing doctors well informed, safeguarding the patients who are taking it and ensuring a favorable benefit-risk balance for the population.

What to do in a case of suspected Adverse Drug Reaction

If you experience an adverse event or side effect during or following pharmacological treatment, please consult your doctor before taking any clinical action, then report it immediately to your health authority, or the pharmaceutical company, or pharmacist.

Pharmacovigilance regulations and legislation vary from country to country. Therefore, whether you are a patient, caregiver, or healthcare professional, we recommend that you consult your country’s relevant authorities.

PHARMACOVIGILANCE · LOCAL CONTACTS

Here you see the contacts to our local affiliates to get more information.

(add local affiliate legal name)
A: (add local affiliate legal address)
T: (add local affiliate phone number)
E: (add local affiliate e-mail address)

Italfarmaco Pharmacovigilance

To contact Italfarmaco pharmacovigilance directly, please complete the following form in English.