Vigilance on the Safety of Dompé Products
A key factor in the development and use of a drug, the practice of pharmacovigilance includes all the ongoing activities aiming at collecting and evaluating information on the safety of drugs, including their suspected adverse reactions.

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 industry professionals involved: local, national and international authorities and pharmaceutical companies.

The ultimate goal of pharmacovigilance activities 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.

Similar principles and purposes apply to the vigilance of cosmetic products, food supplements and/or medical devices, for which there are specific regulatory requirements which allow the reporting of any adverse events and their evaluation. 

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 notify every report in compliance with the procedures and deadlines provided by applicable laws and regulations and will evaluate each safety case report.

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

To contact Dompé pharmacovigilance fill in the following form:  

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