Pharmaco-vigilance and Vigilance

Safety First: Know, Inform, Protect

Through a continuous review of the safety profile of the medicinal products, the Company may evaluate the implementation of appropriate risk minimization measures and ensures that, provided the authorised terms of use are met, marketed products have a benefit-risk ratio that is favourable for the population.
Hence, pharmacovigilance is essential to better know a drug, to properly inform the physicians who prescribe it and to protect the patients who take it, ensuring it is safely used over time, through a close cooperation among all professionals involved: local, national and international authorities and pharmaceutical companies.
The ultimate goal of pharmacovigilance is an ongoing evaluation of the tolerability profile of a drug throughout its use, from the first clinical trials up to and through the post-marketing stage.

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Drugs and Adverse Drug Reactions

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.

What to do in a case of suspected Adverse Drug Reaction

Each country has its own pharmacovigilance rules and legislation to regulate the reporting requirements. Patients and healthcare professionals must refer to national provisions for reporting or may report directly to the Marketing Authorisation Holder (MAH) of the drug that is suspected to have caused the adverse reaction.The MAH will evaluate each safety case report and will notify every report in compliance with the procedures and deadlines provided by applicable laws and regulations.

Before taking any clinical treatment initiative for a suspected adverse reaction, citizens should always consult a physician, providing all the available details about the event and their medical history.

Vigilance of medical device, cosmetic and food supplement

Adverse events may occur during (or after) the use of a medical device, a cosmetic or a food supplement.Users may report adverse events to the concerned Regulatory Authority as per national applicable requirements and provisions and may inform Dompé directly.