The safety of our drugs is vital issue for Stendhal

We have developed a program where we record and track information of our products, where we can find potential new indications and possible related adverse reactions. For this purpose, our pharmacovigilance program is governed by procedures and timely reporting of suspected adverse reactions, which are channeled to the relevant health authorities.

At Stendhal, we are committed to be fully informed about possible security problems detected in our patients, ensuring the authenticity, quality, and confidentiality of the information collected to maintain an ongoing assessment of the associated risks.



What is Pharmacovigilance?

According to the World Health Organization, Pharmacovigilance is:


"The science that is responsible for collecting, monitoring, researching, assessing and evaluating information provided by health professionals and patients regarding the adverse effects of drugs, biological, and herbal products as well as medications used in traditional medicine, seeking to identify new information relating to adverse reactions and preventing harm in patients."



What is an Adverse Reaction?

Any unfavorable or non-intentional medical occurrence with a patient or an individual trial subject who is using a drug. An adverse event can be any sign (including laboratory abnormalities), symptom or disease associated with the use of the product, which may or may not be related to it.

(WHO ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, 1995)

It is worth mentioning that inefficiencies, accidental or intentional overdoses, exposure during pregnancy and lactation, paternal exposure (masculine individual who receives treatment and during this period his partner gets pregnant), adverse events due to discontinuation, in-use or prescription errors and dispensing are also included within this definition.


Pharmacovigilance Objectives


  • Safe and rational use of medicines.

  • Assessment and report of risks and benefits in the use of drugs.

  • Continuing education and dissemination of true information for patients.



Why Pharmacovigilance?

There are a large number of factors considered in order for a drug to be classified as safe.

Only a few substances pass the marketing tests.

Substance control is consistent at all experimentation stages, from animals to humans, but there is always the possibility of adverse reactions.

This is why pharmacovigilance is in effect, since the information and results obtained from clinical trials do not always consider the effects of substances on racial groups, special populations, and drug interactions, among others.

The circumstances of each country and their populations may present distinct information by applying identical clinical trials. The presence of Pharmacovigilance is vital due to the diverse medical practices between different countries.




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