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At Chiesi Farmacêutica, we have a Pharmacovigilance System in place to enable us to take responsibility for our drugs (whether marketed or in the clinical development stage) and

take appropriate measures when necessary. We must ensure that all relevant information regarding the risk-benefit profile of our drugs is continuously evaluated, so that when important safety issues arise, we can promptly notify health professionals, patients and regulatory agencies in accordance with current legislation.

 

What is Pharmacovigilance?
It is the science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other problems relating to the use of drugs.

In line with this definition and in accordance with current legislation, the main objectives of Pharmacovigilance are to:

Prevent damage caused by adverse reactions in humans;
Promote the safe and effective use of medicines, in particular timely information on drug safety for patients, healthcare professionals and the general public.
 
Pharmacovigilance is therefore an activity that contributes to patient and public health protection.


What is an Adverse Event?
It is any unfavorable medical occurrence that may occur during treatment with a drug, but does not necessarily have a causal relationship to that treatment. Adverse events are considered as the following:

  • suspected adverse reactions to drugs;
  • adverse events due to drug quality issues;
  • adverse events resulting from the unapproved use of medicines;
  • drug interactions;
  • total or partial lack of therapeutic efficacy;
  • drug-related intoxications;
  • drug abuse;
  • potential and real drug errors.
     

 

What is an Adverse Reaction?
It is any unintentional harmful or undesirable response to a drug, which occurs at the doses usually employed in humans for disease prophylaxis, diagnosis or therapy or for the modification of physiological functions.
 

How to Report an Adverse Event
Anyone can report the occurrence of an adverse event regardless of whether they are a patient, a patient’s family member/friend or a health professional. If you, or someone you know, have experienced any adverse events while using a Chiesi drug, please contact us through any of the communication channels mentioned below.


We emphasize that all information is totally confidential.

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 0800 11 45 25
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+55 11 3095-2800
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