Pharmacovigilance

Pharmaber SRL has established a Pharmacovigilance System and is strongly committed to ensuring the effective management of all pharmacovigilance activities.

We work diligently to safeguard patient safety.

Any safety issues related to our products are managed in full compliance with applicable laws, regulations, and pharmacovigilance requirements.

What is Pharmacovigilance?

Pharmacovigilance encompasses all activities aimed at the detection, assessment, understanding, and prevention of suspected adverse reactions associated with the use of medicinal products.

The primary objective of pharmacovigilance is to protect patients from risks associated with drug therapy while continuously refining and improving the safety profile of medicinal products.

Pharmacovigilance is therefore an essential activity that contributes to a better understanding of medicines, provides healthcare professionals with accurate and up-to-date safety information, and helps ensure the safe use of medicinal products throughout their lifecycle.

Adverse Drug Reactions (ADRs)

The primary tool used to evaluate and monitor the safety profile of medicinal products is the spontaneous reporting of suspected Adverse Drug Reactions (ADRs).

An adverse drug reaction is a harmful and unintended response to a medicinal product.

This definition also includes reactions associated with the incorrect or unintended use of a medicinal product, including use during pregnancy and/or breastfeeding, use in pediatric or elderly patients, off-label use, overdose, abuse, misuse, medication errors, lack of therapeutic efficacy, and the use of counterfeit medicinal products.

Any individual who experiences a suspected adverse reaction may report it directly to the competent health authorities or, alternatively, through their physician or pharmacist, or by contacting the Marketing Authorization Holder (MAH) of the medicinal product.

Reporting an Adverse Drug Reaction

If you experience any undesirable or unexpected event after taking one of our medicinal products, please consult your physician or pharmacist.

Your healthcare professional will be able to answer your questions and, where appropriate, submit a report of the suspected adverse drug reaction.

To report any suspected adverse event or unexpected side effect related to a Pharmaber SRL medicinal product, please contact us using the details below:

Pharmaber SRL

Email: pharmaber@gb-pharma.it

EU Qualified Person for Pharmacovigilance (EU QPPV)

Email: lmongiardini@gb-pharma.it

Tel.: +39 0382 530059

Mobile: +39 348 8933456