Pharmacovigilance

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“Set of activities for detecting, recording and evaluating adverse reactions, with the aim of determining the incidence, severity and connection of causality with medicines, based on the systematic and multidisciplinary study of the effects of medicines” (WHO). (OMS).

Baldacci Portugal SA produces, distributes and/or markets medicines, medical devices, cosmetics and dietary supplements, and it is your responsibility to monitor its safety and effectiveness.

All medicines can cause undesirable effects. A medicine is approved for use when its evaluation determines that its benefit for a given disease is greater than the risk.

What is an adverse reaction?

Adverse Reaction (AR), Undesirable Effect, or Secondary Effect, are synonymous and common expressions that correspond to a harmful response and unintentional to a medicine. The undesirable occurrence may or may notmay have been caused by the medicine, but theexistence or not of a relationship.

Severe or unexpected adverse reactions (not already described in the Summary of Product Characteristics). Any suspected adverse reaction that concerns a healthcare professionalmust also be notified.

Would you like to notify us of an adverse reaction?

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Or contact us at:

Pharmacovigilance Line

+351 217 783 031

Email

farmacovigilancia@baldacci.pt

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