Pharmacovigilance

“Pharmacovigilance is the discipline and set of activities aimed at identifying, evaluating and preventing adverse effects or other problems related to the use of medicines”
(OMS)

Laboratori Baldacci produces, distributes and/or markets medicines, medical devices, and food supplements and it is its responsibility to monitor their safety and effectiveness.

What is pharmacovigilance?

All medicines can cause side effects. A medicine is approved for use when its evaluation shows that its benefit for a particular disease is greater than its risk. Pharmacovigilance continually evaluates this risk/ benefit and is essential to safeguard the safety of medicines throughout their life cycle.

The aim of pharmacovigilance is to protect the patient from potential risks related to the use of a medicine and to provide complete and updated information on the safety profile of medicines.

Why is it important to report a side effect?

Although medicines are extensively tested in clinical trials before they are given marketing authorisation, it is impossible to know all their side effects until they have been used for a long time by many people. Every day we discover something new about medicines.

By reporting any side effects, you can help provide more information about medicines and ultimately make them safer.

Are you experiencing or have you experienced an unwanted effect?

You can report any “harmful and undesirable effect following the use of a medicine” (adverse reaction) that you suspect may have been caused by taking the medicine.

Suspected adverse reactions resulting from the use of the drug not in accordance with the approved indications (for example: overdose, misuse, off-label use, abuse, therapeutic errors) can also be reported. In addition to the harmful and unwanted effect, those situations in which there is a lack of therapeutic effect or an unexpected benefit should also be reported, as well as any effects during pregnancy or breastfeeding.

All patients have the right to report side effects of a medicine directly to the authorities. It is also possible to report a side effect on behalf of a patient, such as a child or relative. There is no time limit for when to report, but the sooner the reporting form is sent, the sooner it will be possible to evaluate it and carry out the necessary investigations.

How to report a side effect?

Reporting of side effects is usually carried out by healthcare professionals; it is therefore recommended to contact these figures, in particular your physician or pharmacist. However, you too can report side effects.

Physician, healthcare workers and citizens can report a medicine to AIFA via the online form.

Fill the AIFA form

For suspected adverse reactions that occur after taking food supplements, reporting can be done through the VigiErbe online phytovigilance system

Report on VigiErbe

If the product suspected of having caused the adverse reaction is one of the Laboratori Baldacci medicines, you can fill out the “Report Form” online

Fill the form

Report an adverse reaction

Fill out the form
*Mandatory fields

Reporter data
Qualification of the reporter *

Name

Surname

Phone number *

E-mail

Country of origin *

Patient data
Sex *

Age at time of reaction *

Current or previous relevant diseases and medical conditions

Information on the suspect product
Laboratori Baldacci product suspected *

Pharmaceutical form and dosage

Lot number

How did you take the medicine (orally, injected, applied under the skin, etc.)?

In what dose and how many times a day?

For wich indication was the drug taken?

Start date of administration

End date of administration

in progress

Other concomitant drugs

Description of suspected adverse reaction

Adverse reaction *

Date of onset of reaction

I have read and accept the privacy policy*

Pharmacovigilance

Report an adverse reaction

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